Trial Outcomes & Findings for A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy (NCT NCT02979353)

NCT ID: NCT02979353

Last Updated: 2023-07-19

Results Overview

The number of medications a participant is taking. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 372 participants
• Primary outcome timeframe: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC
• Results posted on: 2023-07-19

Participant Flow

Participant milestones

Measure	Shed-Meds: A Patient-Centered Deprescribing Intervention Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.	Control Group Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.
Overall Study STARTED	186	186
Overall Study Hospital Phase	174	181
Overall Study Post-Acute Care Phase	142	142
Overall Study 7-Day Follow-Up	137	133
Overall Study 60-Day Follow-Up	128	125
Overall Study COMPLETED	116	115
Overall Study NOT COMPLETED	70	71

Reasons for withdrawal

Measure	Shed-Meds: A Patient-Centered Deprescribing Intervention Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.	Control Group Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.
Overall Study Hospital Discharge to Non-Partner PAC or Non- PAC Location	24	29
Overall Study Withdrawal by Subject	16	12
Overall Study Death	10	11
Overall Study Transfer to Hospice Care	19	14
Overall Study Lost to Follow-up	1	5

Baseline Characteristics

The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.

Baseline characteristics by cohort

Measure	Shed-Meds: A Patient-Centered Deprescribing Intervention n=186 Participants Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.	Control Group n=186 Participants Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.	Total n=372 Participants Total of all reporting groups
Age, Continuous	76.4 years n=186 Participants	76.9 years n=186 Participants	76.8 years n=372 Participants
Sex: Female, Male Female	117 Participants n=186 Participants	112 Participants n=186 Participants	229 Participants n=372 Participants
Sex: Female, Male Male	69 Participants n=186 Participants	74 Participants n=186 Participants	143 Participants n=372 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=186 Participants	3 Participants n=186 Participants	3 Participants n=372 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	186 Participants n=186 Participants	182 Participants n=186 Participants	368 Participants n=372 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=186 Participants	1 Participants n=186 Participants	1 Participants n=372 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=186 Participants	0 Participants n=186 Participants	0 Participants n=372 Participants
Race (NIH/OMB) Asian	1 Participants n=186 Participants	1 Participants n=186 Participants	2 Participants n=372 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=186 Participants	0 Participants n=186 Participants	0 Participants n=372 Participants
Race (NIH/OMB) Black or African American	27 Participants n=186 Participants	30 Participants n=186 Participants	57 Participants n=372 Participants
Race (NIH/OMB) White	158 Participants n=186 Participants	155 Participants n=186 Participants	313 Participants n=372 Participants
Race (NIH/OMB) More than one race	0 Participants n=186 Participants	0 Participants n=186 Participants	0 Participants n=372 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=186 Participants	0 Participants n=186 Participants	0 Participants n=372 Participants
Region of Enrollment United States	186 participants n=186 Participants	186 participants n=186 Participants	372 participants n=372 Participants
Total Number of Medications at Enrollment	24.0 Medications n=186 Participants	23.0 Medications n=186 Participants	23.0 Medications n=372 Participants
Anticholinergic and Sedative Drug Burden Index	4.1 score on a scale n=186 Participants	4.5 score on a scale n=186 Participants	4.2 score on a scale n=372 Participants
Vulnerable Elders Survey 13 (VES-13)	7 score on a scale n=157 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.	7 score on a scale n=153 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.	7 score on a scale n=310 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.
Adherence to Refills and Medications Scale (ARMS)	14 score on a scale n=141 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.	15 score on a scale n=136 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.	15 score on a scale n=277 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.

PRIMARY outcome

Timeframe: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC

Population: Outcomes are reported for three different study time points (Hospital Discharge, Post-Acute Care Discharge, and 90-Day Follow Up After PAC Discharge). Both the Intervention and Control groups experienced attrition at each time point. The "number analyzed" below for each time point reflects the number of participants who completed that particular study time point.

The number of medications a participant is taking. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications.

Outcome measures

Measure	Shed-Meds: A Patient-Centered Deprescribing Intervention n=174 Participants Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.	Control Group n=181 Participants Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.
Total Number of Medications Hospital Discharge (approximately 3 days after study enrollment)	15 Medications Interval 12.0 to 18.0	16 Medications Interval 12.0 to 19.0
Total Number of Medications Post-Acute Care Discharge (approximately 31 days after study enrollment)	13 Medications Interval 10.0 to 16.0	15 Medications Interval 12.0 to 19.0
Total Number of Medications 90 Day Follow-Up After PAC Discharge (approximately 122 days after study enrollment)	12 Medications Interval 9.0 to 16.0	14 Medications Interval 11.0 to 18.0

SECONDARY outcome

Timeframe: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from PAC

Population: Outcomes are reported for three different study time points (Hospital Discharge, Post-Acute Care Discharge, and 90-Day Follow Up After PAC Discharge). Both the Intervention and Control groups experienced attrition at each time point. The "number analyzed" below for each time point reflects the number of participants who completed that particular study time point.

A Drug Burden Index (DBI) score is calculated for each anticholinergic and sedative medication by dividing the individual medication's prescribed daily dose by the sum of the minimum effective dose (per FDA minimum recommended dose) and the patient's daily dose. The score range for each individual medication is 0 to 1, and the Anticholinergic & Sedative DBI reported is the sum of the individual medication scores. The Anticholinergic & Sedative DBI has a minimum score of 0 and no maximum. Higher scores indicate a higher drug burden (i.e., lower score is a better outcome).

Outcome measures

Measure	Shed-Meds: A Patient-Centered Deprescribing Intervention n=174 Participants Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.	Control Group n=181 Participants Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.
Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug Hospital Discharge (approximately 3 days after study enrollment)	2.4 score on a scale Interval 1.5 to 3.4	2.9 score on a scale Interval 1.9 to 4.1
Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug Post-Acute Care Discharge (approximately 31 days after study enrollment)	2.2 score on a scale Interval 1.3 to 3.1	2.7 score on a scale Interval 1.5 to 4.3
Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug 90-Day Follow-Up After PAC Discharge (approximately 122 days after study enrollment)	2.0 score on a scale Interval 1.0 to 2.8	2.3 score on a scale Interval 1.3 to 3.7

Adverse Events

Shed-Meds: A Patient-Centered Deprescribing Intervention

Serious events: 59 serious events

Other events: 12 other events

Deaths: 10 deaths

Control Group

Serious events: 76 serious events

Other events: 7 other events

Deaths: 11 deaths

Serious adverse events

Measure	Shed-Meds: A Patient-Centered Deprescribing Intervention n=186 participants at risk Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.	Control Group n=186 participants at risk Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.
Cardiac disorders Heart Failure	3.2% 6/186 • Number of events 9 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	5.9% 11/186 • Number of events 11 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Infections and infestations Pneumonia	4.3% 8/186 • Number of events 8 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	3.2% 6/186 • Number of events 7 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Cardiac disorders Cardiac Arrhythmias	4.3% 8/186 • Number of events 8 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	1.6% 3/186 • Number of events 3 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Injury, poisoning and procedural complications Fall	4.3% 8/186 • Number of events 8 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	1.6% 3/186 • Number of events 3 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Respiratory, thoracic and mediastinal disorders Respiratory Disorders	1.6% 3/186 • Number of events 3 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	4.3% 8/186 • Number of events 9 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Infections and infestations Urinary Tract Infections	2.7% 5/186 • Number of events 7 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	3.2% 6/186 • Number of events 11 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Infections and infestations Infections - Pathogen Unspecified	2.2% 4/186 • Number of events 4 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	3.2% 6/186 • Number of events 6 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Infections and infestations Bacterial Infections Disorders	1.6% 3/186 • Number of events 5 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	3.2% 6/186 • Number of events 8 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Renal and urinary disorders Renal Disorders	1.6% 3/186 • Number of events 3 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	2.2% 4/186 • Number of events 4 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Vascular disorders Vascular Hypotensive Disorders	1.1% 2/186 • Number of events 2 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	2.7% 5/186 • Number of events 5 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Nervous system disorders Encephalopathy	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	2.7% 5/186 • Number of events 5 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Infections and infestations Sepsis - Pathogen unspecified	1.6% 3/186 • Number of events 4 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	1.6% 3/186 • Number of events 3 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Injury, poisoning and procedural complications Bone & Joint Fractures	2.2% 4/186 • Number of events 4 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Nervous system disorders Central Nervous System Vascular Disorders	2.2% 4/186 • Number of events 7 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 2 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
General disorders General System Disorders (NEC)	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	2.2% 4/186 • Number of events 4 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Cardiac disorders Coronary Artery Disorder	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	1.6% 3/186 • Number of events 3 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Gastrointestinal disorders Gastrointestinal Motility and Defecation	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	1.6% 3/186 • Number of events 3 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Nervous system disorders Seizures	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	1.6% 3/186 • Number of events 3 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Respiratory, thoracic and mediastinal disorders Bronchial Disorders (excludes neoplasms)	0.54% 1/186 • Number of events 2 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	1.1% 2/186 • Number of events 2 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Metabolism and nutrition disorders Electrolyte and Fluid Balance Conditions	1.1% 2/186 • Number of events 2 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	1.6% 3/186 • Number of events 3 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Psychiatric disorders Mental Disorders	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	1.1% 2/186 • Number of events 2 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Injury, poisoning and procedural complications Cerebral Injuries	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Psychiatric disorders Depressive Disorders	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	1.1% 2/186 • Number of events 2 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Gastrointestinal disorders Exocrine Pancreas Conditions	1.1% 2/186 • Number of events 2 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Gastrointestinal disorders Gastrointestinal Signs & Symptoms	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Gastrointestinal disorders Gastrointestinal Stenosis & Obstructions	1.1% 2/186 • Number of events 2 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Metabolism and nutrition disorders Glucose Metabolism Disorder	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Vascular disorders Vascular Hypertensive Disorders	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	1.1% 2/186 • Number of events 3 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Blood and lymphatic system disorders Anaemias (NEC)	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Psychiatric disorders Anxiety Disorders & Symptoms	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Metabolism and nutrition disorders Calcium Metabolic Disorders	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Psychiatric disorders Delusion Symptoms	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
General disorders Device Issues	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Vascular disorders Embolism & Thrombosis	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Infections and infestations Fungal Infection Disorders	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Hepatobiliary disorders Gallbladder Disorders	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Investigations Haematology Investigations	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Musculoskeletal and connective tissue disorders Joint Disorders	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Respiratory, thoracic and mediastinal disorders Lower Respiratory Disorder	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Reproductive system and breast disorders Male Reproductive Tract Infections & Inflammations	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Nervous system disorders Peripheral Neuropathies	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Metabolism and nutrition disorders Phosphorous Metabolism Disorders	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Neoplasms	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Respiratory, thoracic and mediastinal disorders Pleural Disorders	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Injury, poisoning and procedural complications Poisoning & Toxicity	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Injury, poisoning and procedural complications Procedural Related Injuries & Complications	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertensions	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Blood and lymphatic system disorders Spleen Disorders	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Renal and urinary disorders Urinary Tract Signs & Symptoms	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Vascular disorders Vascular Haemorrhagic Disorders	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Infections and infestations Viral Infectious Disorders	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Blood and lymphatic system disorders White Blood Cell Disorders	0.54% 1/186 • Number of events 1 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	0.00% 0/186 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.

Other adverse events

Measure	Shed-Meds: A Patient-Centered Deprescribing Intervention n=186 participants at risk Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.	Control Group n=186 participants at risk Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.
Injury, poisoning and procedural complications Fall	4.3% 8/186 • Number of events 8 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	2.2% 4/186 • Number of events 4 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
Psychiatric disorders Mental Status Changes	2.2% 4/186 • Number of events 4 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.	2.2% 4/186 • Number of events 4 • All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days. The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.

Additional Information

Sandra F Simmons, PhD, Principle Investigator

Vanderbilt University Medical Center

Phone: 615-343-6729

Email: sandra.simmons@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place