A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy (Shed-Meds)

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.

Study Overview

• Status: Completed
• Conditions: Polypharmacy; Geriatric Syndromes; Care Transitions
• Intervention / Treatment: Behavioral: Shed-Meds: A Patient-Centered Deprescribing Intervention

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 Type: Interventional
• Enrollment (Actual): 372
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shed-Meds: A Patient-Centered Deprescribing Intervention; Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay.	Behavioral: Shed-Meds: A Patient-Centered Deprescribing Intervention; The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.
No Intervention: Control Group; Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from PAC

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Sandra F Simmons, PhD, Vanderbilt University Medical Center

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimated): December 1, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: R01AG053264-01 (U.S. NIH Grant/Contract); R01AG053264 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data may be shared, per written request and completion of formal data sharing agreement approved by the institution

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No