Polypharmacy Clinical Trial
— Shed-MedsOfficial title:
A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy Transferred From the Hospital to Skilled Nursing Facilities
Verified date | June 2023 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 372 |
Est. completion date | May 1, 2021 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | National Institute on Aging (NIA) |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 S — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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