Trial Outcomes & Findings for Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living (NCT NCT05956665)

Last Updated: 2025-10-15

Results Overview

The number of medications (including all prescribed and over-the-counter medications and both scheduled and as-needed medications) that have been deprescribed since enrollment. Deprescribed is defined as either stopping or reducing the dose/frequency of a medication.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

30 days

Results posted on

2025-10-15

Participant Flow

Study participants were recruited from memory care units at two assisted living facilities in Nashville, TN.

Participant milestones

Participant milestones
Measure	ShedMEDS Intervention ShedMEDS is a patient-centered intervention to safely deprescribe medicines, as defined by dose reductions and stopping, based on a combination of clinical criteria and patient/surrogate preference. All participants received a clinical review of their medications by a research nurse practitioner, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the research clinician's clinical recommendations. The deprescribing recommendations were discussed with the assisted living facility's medical providers, who initiated the agreed upon deprescribing. Shed-MEDS deprescribing intervention: See single arm description
Overall Study STARTED	18
Overall Study Intervention	16
Overall Study 30-Day Follow Up	16
Overall Study 60-Day Follow Up	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	ShedMEDS Intervention ShedMEDS is a patient-centered intervention to safely deprescribe medicines, as defined by dose reductions and stopping, based on a combination of clinical criteria and patient/surrogate preference. All participants received a clinical review of their medications by a research nurse practitioner, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the research clinician's clinical recommendations. The deprescribing recommendations were discussed with the assisted living facility's medical providers, who initiated the agreed upon deprescribing. Shed-MEDS deprescribing intervention: See single arm description
Overall Study Death	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ShedMEDS Intervention n=17 Participants ShedMEDS is a patient-centered intervention to safely deprescribe medicines, as defined by dose reductions and stopping, based on a combination of clinical criteria and patient/surrogate preference. All participants received a clinical review of their medications by a research nurse practitioner, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the research clinician's clinical recommendations. The deprescribing recommendations were discussed with the assisted living facility's medical providers, who initiated the agreed upon deprescribing. Shed-MEDS deprescribing intervention: See single arm description
Age, Continuous	82 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants
Brief Interview for Mental Status (BIMS)	2.5 units on a scale n=5 Participants
Charlson Comorbidity Index (CCI)	5.0 units on a scale n=5 Participants
Total Number of Medications	13 Medications n=5 Participants
Anticholinergic & Sedative Drug Burden Index	2.3 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: All participants who completed the intervention protocol (medication review, surrogate interview, and provider conversation).

Outcome measures

Outcome measures
Measure	ShedMEDS Intervention n=16 Participants ShedMEDS is a patient-centered intervention to safely deprescribe medicines, as defined by dose reductions and stopping, based on a combination of clinical criteria and patient/surrogate preference. All participants received a clinical review of their medications by a research nurse practitioner, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the research clinician's clinical recommendations. The deprescribing recommendations were discussed with the assisted living facility's medical providers, who initiated the agreed upon deprescribing. Shed-MEDS deprescribing intervention: See single arm description
Total Number of Medications That Have Been Deprescribed Since Enrollment	4 Medications Interval 2.25 to 6.0

PRIMARY outcome

Timeframe: 60 days

Population: All participants who completed and the entire intervention protocol (medication review, surrogate interview, and provider conversation).

Outcome measures

Outcome measures
Measure	ShedMEDS Intervention n=16 Participants ShedMEDS is a patient-centered intervention to safely deprescribe medicines, as defined by dose reductions and stopping, based on a combination of clinical criteria and patient/surrogate preference. All participants received a clinical review of their medications by a research nurse practitioner, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the research clinician's clinical recommendations. The deprescribing recommendations were discussed with the assisted living facility's medical providers, who initiated the agreed upon deprescribing. Shed-MEDS deprescribing intervention: See single arm description
Total Number of Medications That Have Been Deprescribed Since Enrollment	4 Medications Interval 2.25 to 6.75

PRIMARY outcome

Timeframe: 90 days

Population: All participants who completed the entire intervention protocol (medication review, surrogate interview, and provider conversation).

Outcome measures

Outcome measures
Measure	ShedMEDS Intervention n=16 Participants ShedMEDS is a patient-centered intervention to safely deprescribe medicines, as defined by dose reductions and stopping, based on a combination of clinical criteria and patient/surrogate preference. All participants received a clinical review of their medications by a research nurse practitioner, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the research clinician's clinical recommendations. The deprescribing recommendations were discussed with the assisted living facility's medical providers, who initiated the agreed upon deprescribing. Shed-MEDS deprescribing intervention: See single arm description
Total Number of Medications That Have Been Deprescribed Since Enrollment	4 Medications Interval 2.25 to 7.0

PRIMARY outcome

Timeframe: Enrollment

Population: All participants who completed the entire intervention protocol

The Dementia Quality of Life Instrument-Proxy Version (DEMQOL-Proxy) is used to evaluate health-related quality of life in participants with severe dementia as rated by their caregivers. The DEMQOL-Proxy has 31 items which are reported on a four-point Likert scale (a lot/ quite a bit/ a little/ not at all) with a total score range from 31 to 124. Higher scores indicate a better health-related quality of life (i.e., higher scores are better).

Outcome measures

Outcome measures
Measure	ShedMEDS Intervention n=16 Participants ShedMEDS is a patient-centered intervention to safely deprescribe medicines, as defined by dose reductions and stopping, based on a combination of clinical criteria and patient/surrogate preference. All participants received a clinical review of their medications by a research nurse practitioner, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the research clinician's clinical recommendations. The deprescribing recommendations were discussed with the assisted living facility's medical providers, who initiated the agreed upon deprescribing. Shed-MEDS deprescribing intervention: See single arm description
Resident Quality of Life	94 score on a scale Interval 85.5 to 106.5

PRIMARY outcome

Timeframe: 90 days

Population: All participants who completed the intervention protocol

Outcome measures

Outcome measures
Measure	ShedMEDS Intervention n=16 Participants ShedMEDS is a patient-centered intervention to safely deprescribe medicines, as defined by dose reductions and stopping, based on a combination of clinical criteria and patient/surrogate preference. All participants received a clinical review of their medications by a research nurse practitioner, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the research clinician's clinical recommendations. The deprescribing recommendations were discussed with the assisted living facility's medical providers, who initiated the agreed upon deprescribing. Shed-MEDS deprescribing intervention: See single arm description
Resident Quality of Life	104.5 score on a scale Interval 95.3 to 109.5

Adverse Events

ShedMEDS Intervention

Serious events: 3 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	ShedMEDS Intervention n=18 participants at risk ShedMEDS is a patient-centered intervention to safely deprescribe medicines, as defined by dose reductions and stopping, based on a combination of clinical criteria and patient/surrogate preference. All participants received a clinical review of their medications by a research nurse practitioner, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the research clinician's clinical recommendations. The deprescribing recommendations were discussed with the assisted living facility's medical providers, who initiated the agreed upon deprescribing. Shed-MEDS deprescribing intervention: See single arm description
Cardiac disorders Heart Failure	5.6% 1/18 • Number of events 1 • All adverse events including serious adverse events and all-cause mortality were continuously monitored from participant enrollment through final follow-up 90-days after intervention completion. The study used NIH/NIA definition for adverse and serious adverse events. Serious adverse events included hospitalization and death. Non-serious adverse events were defined as emergency room visits, which did not lead to a subsequent hospitalization. Data for all unplanned healthcare utilization and death are reported here regardless of cause or study-relatedness.
Renal and urinary disorders Chronic Kidney Disease	5.6% 1/18 • Number of events 1 • All adverse events including serious adverse events and all-cause mortality were continuously monitored from participant enrollment through final follow-up 90-days after intervention completion. The study used NIH/NIA definition for adverse and serious adverse events. Serious adverse events included hospitalization and death. Non-serious adverse events were defined as emergency room visits, which did not lead to a subsequent hospitalization. Data for all unplanned healthcare utilization and death are reported here regardless of cause or study-relatedness.
Injury, poisoning and procedural complications Fall	5.6% 1/18 • Number of events 1 • All adverse events including serious adverse events and all-cause mortality were continuously monitored from participant enrollment through final follow-up 90-days after intervention completion. The study used NIH/NIA definition for adverse and serious adverse events. Serious adverse events included hospitalization and death. Non-serious adverse events were defined as emergency room visits, which did not lead to a subsequent hospitalization. Data for all unplanned healthcare utilization and death are reported here regardless of cause or study-relatedness.

Other adverse events

Other adverse events
Measure	ShedMEDS Intervention n=18 participants at risk ShedMEDS is a patient-centered intervention to safely deprescribe medicines, as defined by dose reductions and stopping, based on a combination of clinical criteria and patient/surrogate preference. All participants received a clinical review of their medications by a research nurse practitioner, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the research clinician's clinical recommendations. The deprescribing recommendations were discussed with the assisted living facility's medical providers, who initiated the agreed upon deprescribing. Shed-MEDS deprescribing intervention: See single arm description
Injury, poisoning and procedural complications Fall	27.8% 5/18 • Number of events 5 • All adverse events including serious adverse events and all-cause mortality were continuously monitored from participant enrollment through final follow-up 90-days after intervention completion. The study used NIH/NIA definition for adverse and serious adverse events. Serious adverse events included hospitalization and death. Non-serious adverse events were defined as emergency room visits, which did not lead to a subsequent hospitalization. Data for all unplanned healthcare utilization and death are reported here regardless of cause or study-relatedness.
Psychiatric disorders Mental Status Change	5.6% 1/18 • Number of events 1 • All adverse events including serious adverse events and all-cause mortality were continuously monitored from participant enrollment through final follow-up 90-days after intervention completion. The study used NIH/NIA definition for adverse and serious adverse events. Serious adverse events included hospitalization and death. Non-serious adverse events were defined as emergency room visits, which did not lead to a subsequent hospitalization. Data for all unplanned healthcare utilization and death are reported here regardless of cause or study-relatedness.
Skin and subcutaneous tissue disorders Rash	5.6% 1/18 • Number of events 1 • All adverse events including serious adverse events and all-cause mortality were continuously monitored from participant enrollment through final follow-up 90-days after intervention completion. The study used NIH/NIA definition for adverse and serious adverse events. Serious adverse events included hospitalization and death. Non-serious adverse events were defined as emergency room visits, which did not lead to a subsequent hospitalization. Data for all unplanned healthcare utilization and death are reported here regardless of cause or study-relatedness.

Additional Information

Jennifer Kim, DNP, GNP-BC

Vanderbilt University School of Nursing

Phone: 615-936-0739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place