N/A
N=372
A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy
Polypharmacy · Care Transitions · Geriatric Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT02979353 ↗Enrolled (actual)
372
Serious AEs
36.3%
Results posted
Jul 2023
Primary outcome: Primary: Total Number of Medications — 15; 16; 13; 15 Medications — p=0.017
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Shed-Meds: A Patient-Centered Deprescribing Intervention (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Medications |
15; 16; 13; 15; 12; 14 | 0.017 sig |
| SECONDARY Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug |
2.4; 2.9; 2.2; 2.7; 2.0; 2.3 | 0.02 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02979353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.