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

Vanderbilt University Medical Center

Status: Completed

Conditions: Geriatric Syndromes; Polypharmacy; Care Transitions

Treatments: Behavioral: Shed-Meds: A Patient-Centered Deprescribing Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02979353

R01AG053264 (U.S. NIH Grant/Contract)

R01AG053264-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 372 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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372 participants in 2 patient groups

Shed-Meds: A Patient-Centered Deprescribing Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Shed-Meds: A Patient-Centered Deprescribing Intervention

Control Group

No Intervention group

Description:

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.