A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy

Polypharmacy Clinical Trial

— Shed-Meds  

Official title:

A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy Transferred From the Hospital to Skilled Nursing Facilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979353
• Other study ID #: R01AG053264-01
• Secondary ID: R01AG053264
• Status: Completed
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: May 1, 2021

Study information

• Verified date: June 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Care Transitions
• Geriatric Syndromes
• Polypharmacy

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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