NCT02979353

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 6, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 19, 2023

Completed
Last Updated

July 19, 2023

Status Verified

June 1, 2023

Enrollment Period

4.2 years

First QC Date

November 22, 2016

Results QC Date

April 11, 2023

Last Update Submit

June 26, 2023

Conditions

PolypharmacyCare TransitionsGeriatric Syndromes

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

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

Study Arms (2)

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.

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.

Interventions

Shed-Meds: A Patient-Centered Deprescribing InterventionBEHAVIORAL

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.

Shed-Meds: A Patient-Centered Deprescribing Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (5)

  • 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.

    PMID: 36745422BACKGROUND

  • 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.

    PMID: 35881109BACKGROUND

  • 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.

    PMID: 35164584BACKGROUND

  • 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.

    PMID: 34967444BACKGROUND

  • 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.

    PMID: 30871561RESULT

Results Point of Contact

Title
Sandra F Simmons, PhD, Principle Investigator
Organization
Vanderbilt University Medical Center
sandra.simmons@vumc.org
615-343-6729

Study Officials

  • Sandra F Simmons, PhD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2016

First Posted

December 1, 2016

Study Start

March 6, 2017

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

July 19, 2023

Results First Posted

July 19, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Deidentified data may be shared, per written request and completion of formal data sharing agreement approved by the institution

Locations

US(1)