Optimal Medication Management in Alzheimer's Disease and Dementia — Optimize  

Dementia Clinical Trial

Official title: Optimal Medication Management in Alzheimer's Disease and Dementia

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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.

There are two components to the intervention: Patient/ care partner education and clinician education. Patient/care partner educational materials about medication optimization will be mailed to eligible members who have upcoming appointments with primary care physicians (PCPs) within 2 weeks of scheduled visits. The initial intervention period will run for 12 months and the delayed intervention period will run for 12 months. Primary care clinicians at the intervention clinics who care for adults (Internal Medicine [IM] and Family Medicine [FM]) will receive education on medication optimization and options for deprescribing through an initial presentation at a monthly team meeting at the beginning of the intervention period, as well as periodic Tip Sheet updates on managing deprescribing in specific situations. Primary care clinicians will receive notification via staff message when materials have been sent to patients with an upcoming appointment.

The intervention has two aims:

Aim 1: In a cluster randomized pragmatic trial, test the effectiveness of a primary care based, clinic level deprescribing intervention on two primary outcomes: number of chronic medications and number of potentially inappropriate medications (PIMs) among older adults with ADRD-MCC.

Aim 2: Evaluate the effect of the intervention on secondary outcomes of adverse drug events (falls, bleeding episodes, hypoglycemic episodes), reductions in dosage for selected PIMs (benzodiazepines, opioids, anti-psychotics), hospital, emergency department and skilled nursing facility utilization, and activities of daily living. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

• NCT number: NCT03984396
• Study type: Interventional
• Source: Kaiser Permanente
• Status: Completed
• Phase: N/A
• Start date: March 6, 2019
• Completion date: January 31, 2024