Optimal Medication Management in Alzheimer's Disease and Dementia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-06

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A pragmatic cluster randomized educational intervention with a delayed control.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention - Patient and Clinician

Intervention educational materials provided to patient and family and clinician

Group Type EXPERIMENTAL

Educational Materials - Patient & Clinician

Intervention Type OTHER

deprescribing information for patient \& clinician

Delayed Intervention

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational Materials - Patient & Clinician

deprescribing information for patient \& clinician

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age\>=65
* Bonded to a primary care physician (PCP) in the Kaiser Permanente Colorado (KPCO) - Denver-Boulder service area
* Diagnosis of Alzheimer's Dementia or Related Dementia or Mild Cognitive Impairment (MCI) from ICD-9 or ICD-10 visit codes or from the problem list in the Electronic Health Record (EHR)
* One or more additional chronic conditions from a list of 86 chronic medical conditions
* Be taking 5 or more chronic medications (defined as a 28+ days' supply of medication on the eligibility date; excluding non-indicated medications such as vaccines and anesthetics based on 2-digit GPI codes
* Of this eligible population, those who have at least one visit with a PCP during the intervention period will receive the patient portion of the intervention.

\* PCP for adult patients in the KPCO Denver-Boulder service area.

Clinician Exclusion Criterion:

\* PCP for adult patients at the Longmont Medical Office since Longmont was the pilot study site.

Exclusion Criteria

* Individuals residing in long term care facilities or enrolled in hospice care at baseline
* Individuals residing at home but receiving all their primary care through the KPCO Complex Care Home Rounding service which replaces primary care delivery

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No