Optimal Medication Management in Alzheimer's Disease and Dementia

Study Overview
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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.

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.

Official Title
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Optimal Medication Management in Alzheimer's Disease and Dementia

Conditions
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Dementia

Intervention / Treatment
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* Other: Educational Materials - Patient & Clinician


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A pragmatic cluster randomized educational intervention with a delayed control.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of chronic medications | Number of chronic medications defined as those with at least a 28 days supply | 6 months post brochure mailing | 
| Number of chronic medications | Number of chronic medications defined as those with at least a 28 days supply | 12 months post brochure mailing | 
| Number of potentially inappropriate medications | 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 | 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 | 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 | 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 | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dementia, cognitive impairment, multimorbidity/comorbidity, polypharmacy, deprescriptions, patient education, deprescribe