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Optimal Medication Management in Alzheimer's Disease and Dementia

Optimal Medication Management in Alzheimer's Disease and Dementia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03984396
Acronym
Optimize
Enrollment
7398
Registered
2019-06-13
Start date
2019-03-06
Completion date
2024-01-31
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

dementia, cognitive impairment, multimorbidity/comorbidity, polypharmacy, deprescriptions, patient education, deprescribe

Brief 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.

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.

Interventions

OTHEREducational Materials - Patient & Clinician

deprescribing information for patient & clinician

Sponsors

Johns Hopkins University
CollaboratorOTHER
Duke University
CollaboratorOTHER
Monash University
CollaboratorOTHER
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

A pragmatic cluster randomized educational intervention with a delayed control.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of chronic medications6 months post brochure mailingNumber of chronic medications defined as those with at least a 28 days supply
Number of potentially inappropriate medications6 months post brochure mailingNumber of chronic medications that are listed as potentially inappropriate for older adults based on the Beers list.

Secondary

MeasureTime frameDescription
Treatment change12 months post initial brochure mailingChange in dose from baseline to outcome measurement for selected medications: benzodiazepines, opioids, antipsychotics
Selected adverse drug event (ADE) rates12 months post brochure mailingThree types of ADEs: falls; hemorrhagic events; and episodes of hypoglycemia in individuals with diabetes.
Hospitalization Rate, Skilled Nursing Facility Admissions Rate, Emergency Department Visit Rate12 months post brochure mailingPresence/ 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.)
Activities of daily living as reported in the Medicare Health Risk Assessment (MHRA)3 days to 365 days after a participant's study index dateActivities 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026