Brief Project Summary
Project Title: Optimal Medication Management in Alzheimer’s Disease and Dementia (OPTIMIZE)
PIs: Elizabeth Bayliss and Cynthia Boyd
Institution: Kaiser Permanente Colorado and Johns Hopkins University
Study Type: Clinic-level cluster randomized pragmatic trial with a delayed control group
Who, What, Where: 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.
Green AR. Boyd CM. Gleason KS. Wright L. Kraus CR. Bedoy R. Sanchez B. Norton J. Sheehan OC. Wolff JL. Reeve E. Maciejewski ML. Weffald LA. & Bayliss EA. (2020). Designing a Primary Care-Based Deprescribing Intervention for Patients with Dementia and Multiple Chronic Conditions: a Qualitative Study. Journal of general internal medicine, 35(12), 3556–3563. https://doi.org/10.1007/s11606-020-06063-y
Bayliss EA. Shetterly SM. Drace ML. Norton JD. Maiyani M. Gleason KS. Sawyer JK. Weffald LA. Green AR. Reeve E. Maciejewski ML. Sheehan OC. Wolff JL. Kraus C. & Boyd CM. Deprescribing Education vs Usual Care for Patients With Cognitive Impairment and Primary Care Clinicians: The OPTIMIZE pragmatic cluster randomized trial JAMA Intern Med. Published online March 28. 2022. doi.10.1001/Jamaintemmed.2022.0502
Example Human Subjects Material 1
1 The Principal Investigators (PIs) of this study requests that other researchers do not use portions of these documents directly (“cut and paste”) in their own study materials without specific permission. Please contact the PIs Elizabeth Bayliss ([email protected]) and Cynthia Boyd ([email protected]) to request permission, explaining what you would like to use and how you would like to use it.
OPTIMIZE Intervention Materials 2
2 © Use freely, with credit to the authors. Not for commercial use. Materials developed as part of the OPTIMIZE research project funded by the National Institute on Aging (grant# R33AG057289) are licensed under Attribution NonCommercial 4.0 international. To view a copy of this license, visit https://creativecommons.org/licenses/by-nc/4.0/.
The study objective is to conduct a pragmatic deprescribing intervention for people with Alzheimer’s Disease or Related Dementia with Multiple Chronic Conditions (ADRD-MCC) so that these patients are on ‘just right’ medication regimens.
The intervention is a pragmatic, cluster randomized trial of medication optimization through increased awareness of deprescribing for the ADRD-MCC population. As a pragmatic intervention it is designed to be relatively simple, have broad inclusion/exclusion criteria, and be implemented across the Kaiser Permanente Colorado (KPCO) system. The intervention has two components: a patient/care partner component focused on education and activation about potential deprescribing including sending out a brochure, and a clinician component focused on increasing clinician awareness through monthly Tip Sheets about options and processes for deprescribing in the ADRD-MCC population linked to upcoming visits. The intervention will take place at 18 primary care offices in the Denver-Boulder service delivery area with 9 as initial intervention sites and 9 as delayed intervention sites. Any deprescribing is conducted by clinicians; research team members do not do any deprescribing. Primary outcomes are total number of chronic medications and total number of potentially inappropriate medications (PIMs).
Approaches to Human Subjects’ protection for the OPTIMIZE study include the following:
- Due to the pragmatic and educational nature of the intervention, the IRB granted a waiver of informed consent for eligible patients and clinicians in the intervention clinics.
- Intervention materials provided to patients and clinicians included information about the study.
- The funder (NIA) engaged a Data Safety Monitoring Board which met with the study team periodically during the intervention to review selected safety monitoring metrics. The KPCO biostatistician was not blinded to intervention or control clinics and provided safety metric information during closed DSMB sessions.