NCT03984396: Optimize

Optimal Medication Management in Alzheimer's Disease and Dementia

Completed NA Last updated 1 February 2024

What this trial tests

NA trial testing Educational Materials - Patient & Clinician in Dementia in 7,398 participants. Completed in 31 January 2024.

Timeline

6 March 2019

Primary endpoint
1 April 2021

31 January 2024

Quick facts

Lead sponsor	Kaiser Permanente
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	7,398
Start date	6 March 2019
Primary completion	1 April 2021
Estimated completion	31 January 2024
Sites	1 location across United States

Drugs / interventions tested

• Educational Materials - Patient & Clinician

Conditions studied

• Dementia — all drugs for Dementia →

Sponsor

Kaiser Permanente — full company profile →

Who can join

65 and older, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 will be a pragmatic, cluster randomized trial of medication optimization through increased awareness of deprescribing for the ADRD-MCC population. It will be delivered in primary care at the clinic level with a wait-list control design. 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 will have 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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Barriers and facilitators to deprescribing in primary care: a systematic review.
   Doherty AJ, Boland P, Reed J, Clegg AJ, et al · · 2020 · cited 141× · PMID 32723784 · DOI 10.3399/bjgpopen20x101096
2. Deprescribing Education vs Usual Care for Patients With Cognitive Impairment and Primary Care Clinicians: The OPTIMIZE Pragmatic Cluster Randomized Trial.
   Bayliss EA, Shetterly SM, Drace ML, Norton JD, et al · · 2022 · cited 72× · PMID 35343999 · DOI 10.1001/jamainternmed.2022.0502
3. The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial.
   Bayliss EA, Shetterly SM, Drace ML, Norton J, et al · · 2020 · cited 28× · PMID 32552857 · DOI 10.1186/s13063-020-04482-0
4. Expanding Evidence for Clinical Care of Older Adults: Beyond Clinical Trial Traditions and Finding New Approaches.
   Steinman MA, Boyd CM, Schmader KE. · · 2021 · cited 13× · PMID 34292309 · DOI 10.1001/jama.2021.12134
5. Evaluating the Safety of an Educational Deprescribing Intervention: Lessons from the Optimize Trial.
   Boyd CM, Shetterly SM, Powers JD, Weffald LA, et al · · 2024 · cited 7× · PMID 37982982 · DOI 10.1007/s40266-023-01080-y