PolypharmacyShed-MedsNCT02979353

A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy

A study testing Shed-Meds: A Patient-Centered Deprescribing Intervention in people with Polypharmacy and Care Transitions, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Polypharmacy, Care Transitions, Geriatric Syndromes
What is being tested?: Shed-Meds: A Patient-Centered Deprescribing Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 372 participants
Where: 1 siteUnited States
Study dates: 6 Mar 2017to 1 May 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hospitalized at Vanderbilt University Medical Center
Medicare-eligible
Discharged from VUMC to a post acute care facility
Has polypharmacy as defined by > 5 medications
Able to self-consent or has a proxy (surrogate)
Speaks English (due to interview-based assessments)
Primary home residence within one of 9 surrounding counties (due to home visit during follow-up phase)

Who cannot join

Resides in long-term care
Is currently on hospice or otherwise has a limited life expectancy (< 6 months).
Enrolled in a clinical drug trial
Has Stage IV Cancer Diagnosis
Incarcerated or homeless
Unable to self-consent and does not have a surrogate

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37212

Other trials in United States

About this study

Official title: A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy Transferred From the Hospital to Skilled Nursing Facilities

This randomized, controlled trial will evaluate the effects of an intervention to reduce exposure to medications among hospitalized older adults discharged to skilled nursing facilities (SNFs). 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. The investigators will evaluate the effects of the intervention on the total number of medications prescribed to patients at hospital and SNF discharge and at home 90-days after SNF discharge along with the prevalence of eight geriatric syndromes, medication adherence, and health status.

Read the detailed description

This randomized, controlled trial will evaluate the effects of an intervention to reduce exposure to medications among hospitalized older adults discharged to skilled nursing facilities (SNFs). This study will be conducted in one university-affiliated hospital and 14 area SNFs to enroll approximately 1,300 total participants across five project years. Patients discharged to SNF represent the largest segment of Medicare beneficiaries discharged to post-acute care services and are a particularly high risk group for loss of independence and other poor clinical outcomes. This investigative team recently completed a Centers for Medicare and Medicaid Services (CMS) Innovation Award, which provides strong preliminary data related to the prevalence of polypharmacy and the relationship between polypharmacy and geriatric syndromes (e.g., medications associated with falls) in this patient population. Based on these data, the investigators developed a structured deprescribing intervention protocol ("Shed-Meds") coupled with standardized screening assessments for eight geriatric syndromes to be implemented in the hospital and continued during the SNF stay. 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. This trial will evaluate the effects of this intervention on medication exposure, medication adherence, geriatric syndromes, and health status across the care transitions from hospital to SNF to home to include a 90-day follow-up period after SNF discharge. The overarching hypothesis is that reducing medications for older patients across the continuum of care will favorably impact geriatric syndromes.

Conditions: Polypharmacy, Care Transitions, Geriatric Syndromes
Being tested: Shed-Meds: A Patient-Centered Deprescribing Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Shed-Meds: A Patient-Centered Deprescribing InterventionBehavioural
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.

Study groups in NCT02979353
Study group	Role	What they receive
Shed-Meds: A Patient-Centered Deprescribing Intervention	Experimental	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. Receives: Behavioral: Shed-Meds: A Patient-Centered Deprescribing Intervention
Control Group	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Number of Medications
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.
Measured: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC

Secondary outcomes (1)

Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug
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).
Measured: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from PAC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 20171 May 2021

First posted1 Dec 2016 (estimated)
Study start6 Mar 2017
Primary completion1 May 2021
Study completion1 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for PolypharmacyStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 372 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02979353
Sponsor's protocol ID: R01AG053264-01
Other IDs: R01AG053264
Acronym: Shed-Meds
Status last verified: Jun 2023
First submitted: 22 Nov 2016
Last updated: 19 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified data may be shared, per written request and completion of formal data sharing agreement approved by the institution

Publications

Vasilevskis EE, Shah AS, Hollingsworth EK, Shotwell MS, Kripalani S, Mixon AS, Simmons SF. Deprescribing Medications Among Older Adults From End of Hospitalization Through Postacute Care: A Shed-MEDS Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):223-231. doi: 10.1001/jamainternmed.2022.6545.
PubMed 36745422
Kim JL, Lewallen KM, Hollingsworth EK, Shah AS, Simmons SF, Vasilevskis EE. Patient-Reported Barriers and Enablers to Deprescribing Recommendations During a Clinical Trial (Shed-MEDS). Gerontologist. 2023 Mar 21;63(3):523-533. doi: 10.1093/geront/gnac100.
PubMed 35881109
Hollingsworth EK, Shah AS, Shotwell MS, Simmons SF, Vasilevskis EE. Older Patient and Surrogate Attitudes Toward Deprescribing During the Transition From Acute to Post-Acute Care. J Appl Gerontol. 2022 Mar;41(3):788-797. doi: 10.1177/07334648211015756.
PubMed 35164584
Shah AS, Hollingsworth EK, Shotwell MS, Mixon AS, Simmons SF, Vasilevskis EE. Sources of medication omissions among hospitalized older adults with polypharmacy. J Am Geriatr Soc. 2022 Apr;70(4):1180-1189. doi: 10.1111/jgs.17629. Epub 2021 Dec 30.
PubMed 34967444
Vasilevskis EE, Shah AS, Hollingsworth EK, Shotwell MS, Mixon AS, Bell SP, Kripalani S, Schnelle JF, Simmons SF; Shed-MEDS Team. A patient-centered deprescribing intervention for hospitalized older patients with polypharmacy: rationale and design of the Shed-MEDS randomized controlled trial. BMC Health Serv Res. 2019 Mar 14;19(1):165. doi: 10.1186/s12913-019-3995-3.
PubMed 30871561
Lee JW, Hollingsworth EK, Shah AS, Szanton SL, Perrin N, Mixon AS, Vasilevskis EE, Boyd CM, Han HR, Green AR, Taylor JL, Simmons SF. Emergency department visits and hospital readmissions after a deprescribing intervention among hospitalized older adults. J Am Geriatr Soc. 2024 Jul;72(7):2038-2047. doi: 10.1111/jgs.18945. Epub 2024 May 9.
PubMed 38725307

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy Transferred From the Hospital to Skilled Nursing Facilities
ClinicalTrials.gov ID: NCT02979353
Acronym / sponsor ID: Shed-Meds / R01AG053264-01
Conditions: Polypharmacy, Care Transitions, Geriatric Syndromes
Study type: Interventional
Recruitment status: Completed
Enrolment: 372 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 6 Mar 2017 (actual)
Primary completion: 1 May 2021 (actual)
Study completion: 1 May 2021 (actual)
First posted: 1 Dec 2016 (estimated)
Results: Posted 19 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This randomized, controlled trial will evaluate the effects of an intervention to reduce exposure to medications among hospitalized older adults discharged to skilled nursing facilities (SNFs). 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. The investigators will evaluate the effects of the intervention on the total number of medications prescribed to patients at hospital and SNF discharge and at home 90-days after SNF discharge along with the prevalence of eight geriatric syndromes, medication adherence, and health status.

Detailed description

This randomized, controlled trial will evaluate the effects of an intervention to reduce exposure to medications among hospitalized older adults discharged to skilled nursing facilities (SNFs). This study will be conducted in one university-affiliated hospital and 14 area SNFs to enroll approximately 1,300 total participants across five project years. Patients discharged to SNF represent the largest segment of Medicare beneficiaries discharged to post-acute care services and are a particularly high risk group for loss of independence and other poor clinical outcomes. This investigative team recently completed a Centers for Medicare and Medicaid Services (CMS) Innovation Award, which provides strong preliminary data related to the prevalence of polypharmacy and the relationship between polypharmacy and geriatric syndromes (e.g., medications associated with falls) in this patient population. Based on these data, the investigators developed a structured deprescribing intervention protocol ("Shed-Meds") coupled with standardized screening assessments for eight geriatric syndromes to be implemented in the hospital and continued during the SNF stay. 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. This trial will evaluate the effects of this intervention on medication exposure, medication adherence, geriatric syndromes, and health status across the care transitions from hospital to SNF to home to include a 90-day follow-up period after SNF discharge. The overarching hypothesis is that reducing medications for older patients across the continuum of care will favorably impact geriatric syndromes.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Shed-Meds: A Patient-Centered Deprescribing Intervention	Experimental	Behavioral: Shed-Meds: A Patient-Centered Deprescribing InterventionParticipants 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.
Control Group	No intervention	–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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Hospitalized at Vanderbilt University Medical Center
Medicare-eligible
Discharged from VUMC to a post acute care facility
Has polypharmacy as defined by > 5 medications
Able to self-consent or has a proxy (surrogate)

Key exclusion criteria (6 listed)

Resides in long-term care
Is currently on hospice or otherwise has a limited life expectancy (< 6 months).
Enrolled in a clinical drug trial
Has Stage IV Cancer Diagnosis
Incarcerated or homeless

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Shed-Meds: A Patient-Centered Deprescribing InterventionThe 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.	Behavioural	Shed-Meds: A Patient-Centered Deprescribing Intervention

Primary outcome

Total Number of Medications
Time frame: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC
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.

1 secondary outcome

Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug
Time frame: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from PAC

Results and safety

Results posted to the registry on 19 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Shed-Meds: A Patient-Centered Deprescribing Intervention	186	116
Control Group	186	115

Primary outcome: Total Number of Medications

Time frame: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC. Median (Inter-Quartile Range). Unit: Medications

Measure	Shed-Meds: A Patient-Centered Deprescribing Intervention n = 174	Control Group n = 181
Hospital Discharge (approximately 3 days after study enrollment)	15 (12 to 18)	16 (12 to 19)
Post-Acute Care Discharge (approximately 31 days after study enrollment)	13 (10 to 16)	15 (12 to 19)
90 Day Follow-Up After PAC Discharge (approximately 122 days after study enrollment)	12 (9 to 16)	14 (11 to 18)

Shed-Meds: A Patient-Centered Deprescribing Intervention vs Control Group: Risk Ratio (RR): 0.96, p = 0.017, Mixed Models Analysis
Shed-Meds: A Patient-Centered Deprescribing Intervention vs Control Group: Risk Ratio (RR): 0.86, p <0.0001, Mixed Models Analysis
Shed-Meds: A Patient-Centered Deprescribing Intervention vs Control Group: Risk Ratio (RR): 0.85, p <0.0001, Mixed Models Analysis

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Shed-Meds: A Patient-Centered Deprescribing Intervention	59 of 186 (31.7%)	12 of 186 (6.5%)	10 of 186
Control Group	76 of 186 (40.9%)	7 of 186 (3.8%)	11 of 186

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36745422Vasilevskis EE, Shah AS, Hollingsworth EK, Shotwell MS, Kripalani S, Mixon AS, Simmons SF. Deprescribing Medications Among Older Adults From End of Hospitalization Through Postacute Care: A Shed-MEDS Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):223-231. doi: 10.1001/jamainternmed.2022.6545.
Background: PubMed 35881109Kim JL, Lewallen KM, Hollingsworth EK, Shah AS, Simmons SF, Vasilevskis EE. Patient-Reported Barriers and Enablers to Deprescribing Recommendations During a Clinical Trial (Shed-MEDS). Gerontologist. 2023 Mar 21;63(3):523-533. doi: 10.1093/geront/gnac100.
Background: PubMed 35164584Hollingsworth EK, Shah AS, Shotwell MS, Simmons SF, Vasilevskis EE. Older Patient and Surrogate Attitudes Toward Deprescribing During the Transition From Acute to Post-Acute Care. J Appl Gerontol. 2022 Mar;41(3):788-797. doi: 10.1177/07334648211015756.
Background: PubMed 34967444Shah AS, Hollingsworth EK, Shotwell MS, Mixon AS, Simmons SF, Vasilevskis EE. Sources of medication omissions among hospitalized older adults with polypharmacy. J Am Geriatr Soc. 2022 Apr;70(4):1180-1189. doi: 10.1111/jgs.17629. Epub 2021 Dec 30.
Results publication: PubMed 30871561Vasilevskis EE, Shah AS, Hollingsworth EK, Shotwell MS, Mixon AS, Bell SP, Kripalani S, Schnelle JF, Simmons SF; Shed-MEDS Team. A patient-centered deprescribing intervention for hospitalized older patients with polypharmacy: rationale and design of the Shed-MEDS randomized controlled trial. BMC Health Serv Res. 2019 Mar 14;19(1):165. doi: 10.1186/s12913-019-3995-3.
Derived from this study: PubMed 38725307Lee JW, Hollingsworth EK, Shah AS, Szanton SL, Perrin N, Mixon AS, Vasilevskis EE, Boyd CM, Han HR, Green AR, Taylor JL, Simmons SF. Emergency department visits and hospital readmissions after a deprescribing intervention among hospitalized older adults. J Am Geriatr Soc. 2024 Jul;72(7):2038-2047. doi: 10.1111/jgs.18945. Epub 2024 May 9.
Individual participant dataSharing planned: Yes. Deidentified data may be shared, per written request and completion of formal data sharing agreement approved by the institution

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sandra F Simmons, PhD principal investigator

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Shed-Meds: A Patient-Centered Deprescribing Intervention in people with Polypharmacy and Care Transitions, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Medications (time frame: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02979353, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.