Study Results
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View full resultsBasic Information
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COMPLETED
NA
138 participants
INTERVENTIONAL
2021-06-03
2022-05-02
Brief Summary
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Detailed Description
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This proposed pragmatic intervention has the following aims:
Specific Aim 1: To assess the feasibility and acceptability of ALIGN in two different health care systems, to guide the subsequent evaluation of the effectiveness of the intervention in an embedded pragmatic trial (ePCT).
Specific Aim 2: To determine the feasibility of the primary and secondary outcome measures for the subsequent ePCT.
1. To determine the feasibility of measuring the primary outcome, the patient-level Medication Regimen Complexity Index (pMRCI), within the existing electronic health record (EHR) systems, and to compare it with a more pragmatic measure, chronic medication count, as the primary outcome measure for the ePCT.
2. To determine the feasibility of measuring the secondary outcome, the Family Caregiver Medication Administration Hassles Scale (FCMAHS), a caregiver-reported outcome measure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will receive a telehealth visit with a clinical pharmacist to discuss the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. pharmacist- primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations to the PCP.
Pharmacist-led deprescribing intervention
1\) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
Delayed Intervention (wait list control)
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences.
3. pharmacist- primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations to the PCP.
Pharmacist-led deprescribing intervention
1\) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
Interventions
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Pharmacist-led deprescribing intervention
1\) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of dementia from International Classification of Diseases (ICD) -9 or ICD-10 codes
* At least one other chronic condition
* Five or more chronic medications (to include all prescription and over-the-counter medications, both scheduled and as needed)
* Have a primary care physician at the pilot clinic who has enrolled in the study; this will be defined as having had at least 1 previous visit with that physician
Care partners:
\- Family or other companions age 21 years or greater who regularly help the patient with managing medications
Exclusion Criteria
* Individuals who cannot converse comfortably in English will be excluded because the FCMAHS has not been validated in other languages.
65 Years
ALL
Yes
Sponsors
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Kaiser Permanente
OTHER
National Institute on Aging (NIA)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Ariel Green, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Kaiser Permanente
Aurora, Colorado, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Countries
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References
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Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005 Aug 10;294(6):716-24. doi: 10.1001/jama.294.6.716.
Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016 Apr;12(4):459-509. doi: 10.1016/j.jalz.2016.03.001.
Lin PJ, Fillit HM, Cohen JT, Neumann PJ. Potentially avoidable hospitalizations among Medicare beneficiaries with Alzheimer's disease and related disorders. Alzheimers Dement. 2013 Jan;9(1):30-8. doi: 10.1016/j.jalz.2012.11.002.
Kelley AS, McGarry K, Gorges R, Skinner JS. The burden of health care costs for patients with dementia in the last 5 years of life. Ann Intern Med. 2015 Nov 17;163(10):729-36. doi: 10.7326/M15-0381. Epub 2015 Oct 27.
Willson MN, Greer CL, Weeks DL. Medication regimen complexity and hospital readmission for an adverse drug event. Ann Pharmacother. 2014 Jan;48(1):26-32. doi: 10.1177/1060028013510898. Epub 2013 Nov 5.
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.
Group Health Research Institute. The Chronic Care Model. Available at http://www.improvingchroniccare.org/index.php?p=CCM_Gallery&s=149. Accessed August 21, 2020
George J, Phun YT, Bailey MJ, Kong DC, Stewart K. Development and validation of the medication regimen complexity index. Ann Pharmacother. 2004 Sep;38(9):1369-76. doi: 10.1345/aph.1D479. Epub 2004 Jul 20.
Travis SS, Bernard MA, McAuley WJ, Thornton M, Kole T. Development of the family caregiver medication administration hassles scale. Gerontologist. 2003 Jun;43(3):360-8. doi: 10.1093/geront/43.3.360.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB00286353
Identifier Type: -
Identifier Source: org_study_id
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