Trial Outcomes & Findings for Drug Reduction in Older Patients: The DROP Trial (NCT NCT03722017)
NCT ID: NCT03722017
Last Updated: 2024-08-27
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
260 participants
Primary outcome timeframe
Hospital Discharge, SNF Discharge, and 90-days after SNF Discharge
Results posted on
2024-08-27
Participant Flow
Study participants were recruited at the Nashville VA Medical Center (part of the Tennessee Valley VA Health Services) from October 2019 through November 2022. A total of 260 veterans were enrolled.
Participant milestones
| Measure |
Control--usual Care
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.
|
Intervention--deprescribing Protocol
Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Nurse Practitioner, Physician, or Pharmacist) followed by a patient interview to assess their willingness to deprescribe medications based on the study team's recommendations. The study team will coordinate with the participant's hospital treatment team to ensure the medication dose reductions or discontinuations to which the participant agreed were reflected in the hospital discharge orders. The goal of the intervention is to safely deprescribe medications based on both clinical criteria and Veteran preference.
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
130
|
|
Overall Study
Hospital Discharge
|
123
|
122
|
|
Overall Study
SNF Discharge
|
70
|
84
|
|
Overall Study
7-Day Follow-Up
|
99
|
104
|
|
Overall Study
COMPLETED
|
89
|
94
|
|
Overall Study
NOT COMPLETED
|
41
|
36
|
Reasons for withdrawal
Withdrawal data not reported
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 |
Control--usual Care
n=130 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.
|
Intervention--deprescribing Protocol
n=130 Participants
Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Nurse Practitioner, Physician, or Pharmacist) followed by a patient interview to assess their willingness to deprescribe medications based on the study team's recommendations. The study team will coordinate with the participant's hospital treatment team to ensure the medication dose reductions or discontinuations to which the participant agreed were reflected in the hospital discharge orders. The goal of the intervention is to safely deprescribe medications based on both clinical criteria and Veteran preference.
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=129 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.
|
73 years
n=130 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.
|
72 years
n=259 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.
|
|
Sex: Female, Male
Female
|
15 Participants
n=129 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.
|
8 Participants
n=130 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.
|
23 Participants
n=259 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.
|
|
Sex: Female, Male
Male
|
114 Participants
n=129 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.
|
122 Participants
n=130 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.
|
236 Participants
n=259 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=130 Participants
|
1 Participants
n=130 Participants
|
4 Participants
n=260 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=130 Participants
|
124 Participants
n=130 Participants
|
247 Participants
n=260 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=130 Participants
|
5 Participants
n=130 Participants
|
9 Participants
n=260 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=130 Participants
|
3 Participants
n=130 Participants
|
4 Participants
n=260 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=130 Participants
|
1 Participants
n=130 Participants
|
1 Participants
n=260 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=130 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=260 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=130 Participants
|
29 Participants
n=130 Participants
|
51 Participants
n=260 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=130 Participants
|
94 Participants
n=130 Participants
|
199 Participants
n=260 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=130 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=260 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=130 Participants
|
3 Participants
n=130 Participants
|
5 Participants
n=260 Participants
|
|
Region of Enrollment
United States
|
130 Participants
n=130 Participants
|
130 Participants
n=130 Participants
|
260 Participants
n=260 Participants
|
|
Vulnerable Elders Survey 13 (VES-13)
|
6 Score on a Scale
n=111 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.
|
6 Score on a Scale
n=115 Participants • The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.
|
6 Score on a Scale
n=226 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 Medication Scale (ARMS)
|
15 Score on a Scale
n=93 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=94 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=187 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, SNF Discharge, and 90-days after SNF DischargePopulation: Outcomes are reported for three different study time points (Hospital Discharge, Skilled Nursing Facility \[SNF\] Discharge, and 90-Day Follow Up After SNF 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 |
Control--usual Care
n=123 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.
|
Intervention--deprescribing Protocol
n=122 Participants
Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Nurse Practitioner, Physician, or Pharmacist) followed by a patient interview to assess their willingness to deprescribe medications based on the study team's recommendations. The study team will coordinate with the participant's hospital treatment team to ensure the medication dose reductions or discontinuations to which the participant agreed were reflected in the hospital discharge orders. The goal of the intervention is to safely deprescribe medications based on both clinical criteria and Veteran preference.
|
|---|---|---|
|
Total Number of Medications
Hospital Discharge - approximately 5 days after enrollment
|
15 Medications
Interval 12.0 to 19.0
|
13 Medications
Interval 11.0 to 17.0
|
|
Total Number of Medications
90 Day Follow Up- approximately 110 days after enrollment
|
15 Medications
Interval 11.0 to 17.0
|
12.5 Medications
Interval 10.0 to 16.0
|
|
Total Number of Medications
SNF Discharge - approximately 30 days after enrollment
|
15.5 Medications
Interval 12.0 to 18.0
|
14 Medications
Interval 10.0 to 17.0
|
SECONDARY outcome
Timeframe: Hospital Discharge, SNF Discharge, and 90 Days after SNF DischargePopulation: Outcomes are reported for three different study time points (Hospital Discharge, Skilled Nursing Facility \[SNF\] Discharge, and 90-Day Follow Up After SNF 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 |
Control--usual Care
n=123 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.
|
Intervention--deprescribing Protocol
n=122 Participants
Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Nurse Practitioner, Physician, or Pharmacist) followed by a patient interview to assess their willingness to deprescribe medications based on the study team's recommendations. The study team will coordinate with the participant's hospital treatment team to ensure the medication dose reductions or discontinuations to which the participant agreed were reflected in the hospital discharge orders. The goal of the intervention is to safely deprescribe medications based on both clinical criteria and Veteran preference.
|
|---|---|---|
|
Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug Burden
Hospital Discharge - approximately 5 days after enrollment
|
2.6 score on a scale
Interval 1.6 to 3.7
|
2.6 score on a scale
Interval 1.5 to 3.7
|
|
Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug Burden
SNF Discharge - approximately 30 days after enrollment
|
2.7 score on a scale
Interval 1.5 to 3.9
|
2.6 score on a scale
Interval 1.7 to 3.9
|
|
Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug Burden
90 Day Follow Up- approximately 110 days after enrollment
|
2.3 score on a scale
Interval 1.2 to 3.4
|
2.2 score on a scale
Interval 1.4 to 3.5
|
Adverse Events
Control--usual Care
Serious events: 57 serious events
Other events: 13 other events
Deaths: 9 deaths
Intervention--deprescribing Protocol
Serious events: 60 serious events
Other events: 14 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Control--usual Care
n=130 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.
|
Intervention--deprescribing Protocol
n=130 participants at risk
Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Nurse Practitioner, Physician, or Pharmacist) followed by a patient interview to assess their willingness to deprescribe medications based on the study team's recommendations. The study team will coordinate with the participant's hospital treatment team to ensure the medication dose reductions or discontinuations to which the participant agreed were reflected in the hospital discharge orders. The goal of the intervention is to safely deprescribe medications based on both clinical criteria and Veteran preference.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuro Neoplasms
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Nervous system disorders
Central nervous system vascular disorders
|
3.1%
4/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
3.1%
4/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Nervous system disorders
Neurotoxicity
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Nervous system disorders
Seizures
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
2.3%
3/130 • Number of events 3 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Psychiatric disorders
Mental disorders
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
3/130 • Number of events 3 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Musculoskeletal and connective tissue disorders
Lower extremity pain
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Blood and lymphatic system disorders
Anemia
|
0.77%
1/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
2.3%
3/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Cardiac disorders
Cardiac Arrhythmias
|
3.8%
5/130 • Number of events 5 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
3.1%
4/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
2.3%
3/130 • Number of events 3 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Cardiac disorders
Heart Failure
|
5.4%
7/130 • Number of events 10 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
6.2%
8/130 • Number of events 10 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
1.5%
2/130 • Number of events 3 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Gastrointestinal disorders
Gastrointestinal motility and defecation condition
|
2.3%
3/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Gastrointestinal disorders
Gastrointestinal signs and symptoms
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
General disorders
General systems disorders
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Hepatobiliary disorders
Alcoholic cirrhosis
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Hepatobiliary disorders
Hepatic encephalopathy
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 5 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Infections and infestations
Bacterial infectious disorders
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Infections and infestations
Infections - pathogen unspecified
|
3.1%
4/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
6.2%
8/130 • Number of events 10 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Infections and infestations
Pneumonia
|
4.6%
6/130 • Number of events 7 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
3.8%
5/130 • Number of events 5 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Infections and infestations
Sepsis - pathogen unspecified
|
4.6%
6/130 • Number of events 7 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
3.1%
4/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
2.3%
3/130 • Number of events 3 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Infections and infestations
Viral infectious disoders
|
2.3%
3/130 • Number of events 3 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
3.1%
4/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Injury, poisoning and procedural complications
Bone and joint fractures
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Injury, poisoning and procedural complications
Burn
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
7/130 • Number of events 7 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
2.3%
3/130 • Number of events 3 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Injury, poisoning and procedural complications
Procedural related injuries and complications
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Metabolism and nutrition disorders
Electrolyte and fluid balance conditions
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
2.3%
3/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Metabolism and nutrition disorders
Glucose metabolism disorder
|
1.5%
2/130 • Number of events 3 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Psychiatric disorders
Suicidal orientation
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Renal and urinary disorders
Renal disorders
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
3.1%
4/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Renal and urinary disorders
Urinary tract signs and symptoms
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorders (excludes neoplasms)
|
1.5%
2/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Respiratory, thoracic and mediastinal disorders
Embolism and thrombosis
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory disorder
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Skin and subcutaneous tissue disorders
Wound
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Social circumstances
Failure to thrive
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
2.3%
3/130 • Number of events 3 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Social circumstances
Hypothermia
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Vascular disorders
Embolism and thrombosis
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Vascular disorders
Peripheral edema
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Vascular disorders
Syncope
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.00%
0/130 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Vascular disorders
Vascular hypertensive disorders
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Vascular disorders
Vascular hypotensive disorders
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
Other adverse events
| Measure |
Control--usual Care
n=130 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.
|
Intervention--deprescribing Protocol
n=130 participants at risk
Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Nurse Practitioner, Physician, or Pharmacist) followed by a patient interview to assess their willingness to deprescribe medications based on the study team's recommendations. The study team will coordinate with the participant's hospital treatment team to ensure the medication dose reductions or discontinuations to which the participant agreed were reflected in the hospital discharge orders. The goal of the intervention is to safely deprescribe medications based on both clinical criteria and Veteran preference.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
4.6%
6/130 • Number of events 9 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
4.6%
6/130 • Number of events 6 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Gastrointestinal disorders
Gastrointestinal motility and defecation condition
|
3.1%
4/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
3.1%
4/130 • Number of events 5 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Infections and infestations
Infections - pathogen unspecified
|
3.1%
4/130 • Number of events 4 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
1.5%
2/130 • Number of events 2 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
|
Musculoskeletal and connective tissue disorders
Lower extremity pain
|
0.77%
1/130 • Number of events 1 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
3.8%
5/130 • Number of events 5 • Enrollment to 90-days post SNF Discharge (duration each participants' time in the study)
Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death.
|
Additional Information
Amanda Mixon, MD MSPH MS
Tennessee Valley Healthcare System Nashville Campus
Phone: (615) 936-3710
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place