Deprescribing studies may encounter some unique challenges related to human subjects protections, informed consent, and safety monitoring. To help researchers navigate these challenges, we have gathered materials to share from several ongoing deprescribing studies, including portions of IRB applications, Data Safety & Monitoring Plans, and informed consent forms.
While there is no single right way to approach these issues, these examples show how some thoughtful investigators have navigated these issues successfully in their own research.
These studies have diverse designs and settings. Please review the brief summaries below to determine which are most relevant to you, and please note the restrictions on use: please contact the individual investigators before re-using any portions of these materials.
We would like to continue expanding this collection. If you have materials to share, please email us at [email protected].
Patient-centered deprescribing intervention (Shed MEDS) for adults 50 and older that spans the continuum of hospital and post-acute care to reduce the total number of medications patients are prescribed in each care setting and at home after SNF discharge.
Document List:
- Shed MEDS Abstract and Study Overview
- Shed MEDS DSMB Closed Session Report Template_January 2020
- Shed MEDS Human Subjects Section
- Shed MEDS Patient Family Brochure
- Shed MEDS Stamped Patient Informed Consent
Shed MEDS DSMB Closed Session Report Template_January 2020Shed MEDS Human Subjects SectionShed MEDS Patient Family BrochureShed MEDS Stamped Patient Informed Consent
This randomized trial seeks to reduce exposure to medications among hospitalized older veterans being discharged to skilled nursing facilities (SNFs) through engaging patients and providers to reduce the number and/or dose of medications prior to hospital discharge.
Document List:
- VA DROP Abstract
- VA DROP DSMB Report Template
- VA DROP Human Subjects Section
- VA DROP Patient Family Brochure
- VA DROP Stamped Patient Informed Consent
- VA DROP Stamped Surrogate Informed Consent
Multisite trial to provide medication-specific educational brochures directly to veterans who may be deprescribing candidates for three cohorts taking potentially inappropriate medications (proton-pump inhibitors, diabetes medications, and gabapentin), in advance of scheduled primary care visits.
Document List:
- Study Population and Intervention
- IRB Sections
Pragmatic, primary care-based, cluster randomized trial in which older adults with Alzheimer’s Disease or Related Dementias with Multiple Chronic Conditions on 5 or more medications and their family caregivers at Kaiser Permanente Colorado (KPCO) are sent informational materials on deprescribing, and primary care providers in intervention clinics are sent monthly Tip Sheets about deprescribing.
Document List:
- DSMB Plan
- Human Subjects Section
- OPTIMIZE Consent Process Summary
- OPTIMIZE Project Summary
- Signed Consent Form_Patient or Patient w Care Partner
- Verbal Consent Form_Care Partner Only
