ALIGN: Aligning Medications With What Matters Most (Demonstration)
NCT ID: NCT06335953
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
360 participants
INTERVENTIONAL
2024-05-07
2025-10-18
Brief Summary
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The intervention consists of the following strategies: 1) a de-prescribing educational brochure designed to activate the patient and care partner; 2) a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored de-prescribing recommendations designed to be useful and actionable for the PCP.
The investigators will compare the intervention group with the waitlist control group to see if there is a difference in the primary outcome, the proportion of patients who deprescribe at least one medication by 3 months.
Detailed Description
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The use of these and other medications requires nuanced decision-making to balance potential benefits and harms for PLWD. In keeping with principles of person-centered care, people should be on the medicines that will help achieve the persons goals, but not medicines that are likely to be harmful or unhelpful.
Deprescribing statins, antihypertensives, and psychotropic medications in older adults has been shown to be safe, and may lead to improved quality of life, reductions in falls, and improvements in cognitive and psychomotor function. Lessons from successful interventions include the need to target primary care clinicians and patients, and to target more than one class of medications. Most deprescribing interventions have occurred in hospitals, long-term care facilities, or home healthcare, not in primary care - typically the first point of contact with the health care system for PLWD. Few deprescribing studies have addressed care partners of PLWD, despite the enormous strain faced due to medication-related tasks and the person's specific informational and decisional needs and conflicts. These are gaps that the proposed research would address.
The investigator's previous research has shown that care partners want primary care providers (PCPs) to discuss medication-related goals of care as dementia progresses, and to acknowledge the tradeoffs implicit in using medications for symptom management in PLWD. But PCPs cite time pressure and lack of guidance of when and how to stop medications for PLWD as barriers to having these conversations. Pharmacists are ideally suited to help address these problems by providing evidence-based, individualized deprescribing recommendations without increasing demands on PCP time.
The clinical trial consists of the following strategies: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and PLWD; 2) telehealth visit in which a pharmacist discusses benefits and harms of the medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations that are actionable for the PCP. Pharmacists will receive a laminated tip sheet and participate in a 20-minute webinar. Decisions about discontinuation or continuation of medications will ultimately be made by the PCP and patient/care partner.
The trial is designed as a cluster-randomized trial with a delayed (waitlist) control where the unit of randomization will be the clinic. The investigators will enroll 280 patients with 140 per group (intervention group and waitlist control group). PLWD may enroll independently or together with a care partner. Care partners are not required to participate but may do so independently or with the PLWD if desired. Each participant will be in the study approximately 3 months (intervention period and additional follow-up).
This protocol employs a pragmatic design. The intervention is delivered by clinical pharmacists who are integrated in primary care clinics or practice through a centralized telemedicine model.
Conditions
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Keywords
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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 a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses 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 designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention
The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
Delayed intervention (wait list control)
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses 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 designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention
The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
Interventions
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Pharmacist-led deprescribing intervention
The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of dementia from International Classification of Diseases (ICD-10) visit codes or from the EHR problem list
* Five or more medications
* Only active patients, defined as having \>1 visit to the primary care clinic within the past year will be included
Care partners:
* Family or other companions \>21 years old who regularly help the patient manage medications.
Exclusion Criteria
* Participants must hear well enough to communicate by telephone in English.
65 Years
ALL
Yes
Sponsors
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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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Johns Hopkins Community Physicians
Baltimore, Maryland, United States
Countries
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References
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Brown JD, Hutchison LC, Li C, Painter JT, Martin BC. Predictive Validity of the Beers and Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) Criteria to Detect Adverse Drug Events, Hospitalizations, and Emergency Department Visits in the United States. J Am Geriatr Soc. 2016 Jan;64(1):22-30. doi: 10.1111/jgs.13884.
Gray SL, Anderson ML, Dublin S, Hanlon JT, Hubbard R, Walker R, Yu O, Crane PK, Larson EB. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Intern Med. 2015 Mar;175(3):401-7. doi: 10.1001/jamainternmed.2014.7663.
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Page AT, Clifford RM, Potter K, Schwartz D, Etherton-Beer CD. The feasibility and effect of deprescribing in older adults on mortality and health: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016 Sep;82(3):583-623. doi: 10.1111/bcp.12975. Epub 2016 Jun 13.
Jansen J, Naganathan V, Carter SM, McLachlan AJ, Nickel B, Irwig L, Bonner C, Doust J, Colvin J, Heaney A, Turner R, McCaffery K. Too much medicine in older people? Deprescribing through shared decision making. BMJ. 2016 Jun 3;353:i2893. doi: 10.1136/bmj.i2893. No abstract available.
Scott IA, Hilmer SN, Reeve E, Potter K, Le Couteur D, Rigby D, Gnjidic D, Del Mar CB, Roughead EE, Page A, Jansen J, Martin JH. Reducing inappropriate polypharmacy: the process of deprescribing. JAMA Intern Med. 2015 May;175(5):827-34. doi: 10.1001/jamainternmed.2015.0324.
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Elliott RA, O'Callaghan C, Paul E, George J. Impact of an intervention to reduce medication regimen complexity for older hospital inpatients. Int J Clin Pharm. 2013 Apr;35(2):217-24. doi: 10.1007/s11096-012-9730-3. Epub 2012 Dec 5.
Sluggett JK, Hopkins RE, Chen EY, Ilomaki J, Corlis M, Van Emden J, Hogan M, Caporale T, Ooi CE, Hilmer SN, Bell JS. Impact of Medication Regimen Simplification on Medication Administration Times and Health Outcomes in Residential Aged Care: 12 Month Follow Up of the SIMPLER Randomized Controlled Trial. J Clin Med. 2020 Apr 8;9(4):1053. doi: 10.3390/jcm9041053.
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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.
Green AR, Lee P, Reeve E, Wolff JL, Chen CCG, Kruzan R, Boyd CM. Clinicians' Perspectives on Barriers and Enablers of Optimal Prescribing in Patients with Dementia and Coexisting Conditions. J Am Board Fam Med. 2019 May-Jun;32(3):383-391. doi: 10.3122/jabfm.2019.03.180335.
Reeve E, Bell JS, Hilmer SN. Barriers to Optimising Prescribing and Deprescribing in Older Adults with Dementia: A Narrative Review. Curr Clin Pharmacol. 2015;10(3):168-77. doi: 10.2174/157488471003150820150330.
Other Identifiers
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IRB00418404
Identifier Type: -
Identifier Source: org_study_id