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

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ClinicalTrials.gov Identifier: NCT03984396
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborators:
Johns Hopkins University
Duke University
University of South Australia
Information provided by (Responsible Party):
Kaiser Permanente

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.


Condition or disease Intervention/treatment Phase
Dementia Other: Educational Materials - Patient & Clinician Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3671 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A pragmatic cluster randomized educational intervention with a delayed control.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Optimal Medication Management in Alzheimer's Disease and Dementia
Actual Study Start Date : March 6, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2022


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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Treatment change [ Time Frame: 12 months post initial brochure mailing ]
    Change in dose from baseline to outcome measurement for selected medications: benzodiazepines, opioids, antipsychotics

  2. 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.

  3. 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.)

  4. 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984396


Contacts
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Contact: Elizabeth Bayliss, MD (303) 636 2472 Elizabeth.Bayliss@kp.org
Contact: Cynthia M Boyd, MD (410) 550-8676 cyboyd@jhmi.edu

Locations
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United States, Colorado
Kaiser Permanente Recruiting
Aurora, Colorado, United States, 80014
Contact: Elizabeth Bayliss, MD    303-636-2472    Elizabeth.Bayliss@kp.org   
Contact: Melanie L Drace, MPH    (303) 743-5935    melanie.l.drace@kp.org   
Sponsors and Collaborators
Kaiser Permanente
Johns Hopkins University
Duke University
University of South Australia

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03984396     History of Changes
Other Study ID Numbers: R33AG057289 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaiser Permanente:
dementia
cognitive impairment
multimorbidity/comorbidity
polypharmacy
deprescriptions
patient education

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders