A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy (Shed-Meds)
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|ClinicalTrials.gov Identifier: NCT02979353|
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : July 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Polypharmacy Care Transitions Geriatric Syndromes||Behavioral: Shed-Meds: A Patient-Centered Deprescribing Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy Transferred From the Hospital to Skilled Nursing Facilities|
|Actual Study Start Date :||March 6, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
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.
- Change in Total number of Medications [ Time Frame: 7, 60 and 90 days after discharge from the skilled nursing facility ]We will assess the change in the total number of prescribed medications
- Change in Functional Health Status [ Time Frame: 7 and 90 days after discharge from the skilled nursing facility ]We will use the Vulnerable Elders Survey (VES-13) as a functional measure of health status that assesses a patient's cognitive, physical and self-care activities and which also includes an item for self-rated health status
- Change in Drug Burden Index: Anticholinergic and sedative drug burden of prescribed medications [ Time Frame: 90 days after discharge from the skilled nursing facility ]The drug burden is the sum of each individual anticholinergic/sedative medication's prescribed daily dose divided by the sum of the minimum effective dose (as estimated by the FDA minimum recommended dose) and the patient's daily dose
- Change in Medication Adherence [ Time Frame: 60 and 90 days after discharge from the skilled nursing facility ]We will use the Adherence to Refills and Medication Scale (ARMS) to assess patients' medication adherence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979353
|Contact: Sandra F Simmons, PhD||615-343-6729||Sandra.Simmons@vumc.org|
|Contact: Eduard Vasilevskis, MD||615-936-1935||Ed.Vasilevskis@vumc.org|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37212|
|Contact: Sandra F Simmons, PhD 615-343-6729 Sandra.Simmons@vumc.org|
|Contact: Eduard Vasilevskis, MD 615-936-1935 Ed.Vasilevskis@vumc.org|
|Principal Investigator: Sandra F Simmons, PhD|
|Principal Investigator: Eduard Vasilveskis, MD|
|Principal Investigator:||Sandra F Simmons, PhD||Vanderbilt University Medical Center|