Optimal Medication Management in Alzheimer's Disease and Dementia

NCT03984396 | Completed DMC

• 1 other identifier: R33AG057289
• Study Type: interventional
• Target: 7,398
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Treatment change

  12 months post initial brochure mailing

• Selected adverse drug event (ADE) rates

  12 months post brochure mailing

• Hospitalization Rate, Skilled Nursing Facility Admissions Rate, Emergency Department Visit Rate

  12 months post brochure mailing

• Activities of daily living as reported in the Medicare Health Risk Assessment (MHRA)

  3 days to 365 days after a participant's study index date

Study Arms (2)

Intervention - Patient and Clinician

EXPERIMENTAL

Intervention educational materials provided to patient and family and clinician

Other: Educational Materials - Patient & Clinician

Delayed Intervention

NO INTERVENTION

Usual care

Interventions

Educational Materials - Patient & Clinician OTHER

deprescribing information for patient \& clinician

Intervention - Patient and Clinician

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• \* PCP for adult patients in the KPCO Denver-Boulder service area.
• \* PCP for adult patients at the Longmont Medical Office since Longmont was the pilot study site.

Sponsors & Collaborators

• Kaiser Permanente: lead
• Johns Hopkins University: collaborator
• Duke University: collaborator
• Monash University: collaborator

Study Sites (1)

Kaiser Permanente

Aurora, Colorado, 80014, United States

Location

Related Publications (8)

• Reeve E, Bayliss EA, Shetterly S, Maiyani M, Gleason KS, Norton JD, Sheehan OC, Green AR, Maciejewski ML, Drace M, Sawyer J, Boyd CM. Willingness of older people living with dementia and mild cognitive impairment and their caregivers to have medications deprescribed. Age Ageing. 2023 Jan 8;52(1):afac335. doi: 10.1093/ageing/afac335.

  PMID: 36702513 BACKGROUND

• Bayliss EA, Shetterly SM, Drace ML, Norton JD, Maiyani M, Gleason KS, Sawyer JK, Weffald LA, Green AR, Reeve E, Maciejewski ML, Sheehan OC, Wolff JL, Kraus C, Boyd CM. Deprescribing Education vs Usual Care for Patients With Cognitive Impairment and Primary Care Clinicians: The OPTIMIZE Pragmatic Cluster Randomized Trial. JAMA Intern Med. 2022 May 1;182(5):534-542. doi: 10.1001/jamainternmed.2022.0502.

  PMID: 35343999 BACKGROUND

• Green AR, Boyd CM, Gleason KS, Wright L, Kraus CR, Bedoy R, Sanchez B, Norton J, Sheehan OC, Wolff JL, Reeve E, Maciejewski ML, Weffald LA, Bayliss EA. Designing a Primary Care-Based Deprescribing Intervention for Patients with Dementia and Multiple Chronic Conditions: a Qualitative Study. J Gen Intern Med. 2020 Dec;35(12):3556-3563. doi: 10.1007/s11606-020-06063-y. Epub 2020 Jul 29.

  PMID: 32728959 BACKGROUND

• Bayliss EA, Shetterly SM, Drace ML, Norton J, Green AR, Reeve E, Weffald LA, Wright L, Maciejewski ML, Sheehan OC, Wolff JL, Gleason KS, Kraus C, Maiyani M, Du Vall M, Boyd CM. The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial. Trials. 2020 Jun 18;21(1):542. doi: 10.1186/s13063-020-04482-0.

  PMID: 32552857 BACKGROUND

• Sheehan OC, Gleason KS, Bayliss EA, Green AR, Drace ML, Norton J, Reeve E, Shetterly SM, Weffald LA, Sawyer JK, Maciejewski ML, Kraus C, Maiyani M, Wolff J, Boyd CM. Intervention design in cognitively impaired populations-Lessons learned from the OPTIMIZE deprescribing pragmatic trial. J Am Geriatr Soc. 2023 Mar;71(3):774-784. doi: 10.1111/jgs.18148. Epub 2022 Dec 12.

  PMID: 36508725 BACKGROUND

• Orla Sheehan and others, Intervention Design With Cognitively Impaired Populations: The Optimize Deprescribing Intervention, Innovation in Aging, Volume 5, Issue Supplement_1, 2021, Page 401, https://doi.org/10.1093/geroni/igab046.1558

  BACKGROUND

• Green AR, Weffald LA, Powers JD, Drace ML, Norton JD, Boyd CM, Bayliss EA. Assessing medication appropriateness as a deprescribing outcome. J Am Geriatr Soc. 2023 Dec;71(12):3918-3920. doi: 10.1111/jgs.18562. Epub 2023 Aug 26. No abstract available.

  PMID: 37632424 BACKGROUND

• Boyd CM, Shetterly SM, Powers JD, Weffald LA, Green AR, Sheehan OC, Reeve E, Drace ML, Norton JD, Maiyani M, Gleason KS, Sawyer JK, Maciejewski ML, Wolff JL, Kraus C, Bayliss EA. Evaluating the Safety of an Educational Deprescribing Intervention: Lessons from the Optimize Trial. Drugs Aging. 2024 Jan;41(1):45-54. doi: 10.1007/s40266-023-01080-y. Epub 2023 Nov 20.

  PMID: 37982982 BACKGROUND

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic cluster randomized educational intervention with a delayed control.

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 13, 2019
• Study Start: March 6, 2019
• Primary Completion: April 1, 2021
• Study Completion: January 31, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)