Optimal Medication Management in Alzheimer's Disease and Dementia (Optimize)

January 31, 2024 updated by: Kaiser Permanente

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

7398

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Kaiser Permanente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Patient 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.

Patient 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

Clinician Inclusion Criteria:

* 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention - Patient and Clinician
Intervention educational materials provided to patient and family and clinician
Other: Educational Materials - Patient & Clinician
deprescribing information for patient & clinician
No Intervention: Delayed Intervention
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of chronic medications
Time Frame: 6 months post brochure mailing
Number of chronic medications defined as those with at least a 28 days supply
6 months post brochure mailing
Number of chronic medications
Time Frame: 12 months post brochure mailing
Number of chronic medications defined as those with at least a 28 days supply
12 months post brochure mailing
Number of potentially inappropriate medications
Time Frame: 6 months post brochure mailing
Number of chronic medications that are listed as potentially inappropriate for older adults based on the Beers list.
6 months post brochure mailing
Number of potentially inappropriate medications
Time Frame: 12 months post brochure mailing
Number of chronic medications that are listed as potentially inappropriate for older adults based on the Beers list.
12 months post brochure mailing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment change
Time Frame: 12 months post initial brochure mailing
Change in dose from baseline to outcome measurement for selected medications: benzodiazepines, opioids, antipsychotics
12 months post initial brochure mailing
Selected adverse drug event (ADE) rates
Time Frame: 12 months post brochure mailing
Three types of ADEs: falls; hemorrhagic events; and episodes of hypoglycemia in individuals with diabetes.
12 months post brochure mailing
Hospitalization Rate, Skilled Nursing Facility Admissions Rate, Emergency Department Visit Rate
Time Frame: 12 months post brochure mailing
Presence/ absence of a one of these admissions over the year prior to baseline and post intervention. (We will distinguish between temporary and permanent admissions to skilled nursing facilities.)
12 months post brochure mailing
Activities of daily living as reported in the Medicare Health Risk Assessment (MHRA)
Time Frame: 3 days to 365 days after a participant's study index date
Activities of Daily Living are reported by patients/ proxy responders as part of the annual MHRA. These data will be available on the subset of participants who have completed the MHRA. Data from the most recent MHRA will be used.
3 days to 365 days after a participant's study index date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

Johns Hopkins University
Duke University
Monash University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2019

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

May 24, 2019

First Submitted That Met QC Criteria

June 10, 2019

First Posted (Actual)

June 13, 2019

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R33AG057289 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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