Clinical trial NCT05156073: Shared Decision Making About Medication Use for People With Multiple Health Problems
Official title: Shared Decision Making About Medication Use for People With Multiple Health Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Dementia
Multiple Chronic Conditions
Deprescribing
Mild Cognitive Impairment
Keywords: Deprescribing
Dementia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Reading Hospital Family Health Care Center
name: National Institute on Aging (NIA)
First posted: 2021-12-14
Enrollment: 22
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Shared Decision Making about Medication Use for People with Multiple Health Problems study will assess the feasibility and acceptability of a deprescribing educational intervention in primary care for patients with mild cognitive impairment or dementia and/or multiple chronic conditions (MCC), the patients' care partners, clinicians, and medical assistants.

The intervention consists of the following strategies: 1) a patient/caregiver component focused on education and activation about deprescribing, and 2) a clinician component focused on increasing clinician awareness about options and processes for deprescribing in the MCI/dementia and/or MCC population. Clinicians will each be asked to participate in a single, 15-minute educational session on deprescribing, and medical residents will receive a 45-minute lecture. Patients, caregivers, clinicians, and medical assistants will participate in a single one-on-one debriefing interview.

Detailed description: People living with dementia are prescribed more medications and have more complex medication regimens than people without dementia. These problems are exacerbated in people with dementia and multiple chronic conditions (MCC). Having multiple diseases simultaneously (e.g., diabetes and hypertension, and dementia) leads to the use of multiple drugs (polypharmacy) and potentially inappropriate medications, in which the risks of medications outweigh the benefits, or medications do not align with the patient's treatment goals. For individuals with dementia and MCC, taking more medications is associated with a greater risk of adverse drug events, drug interactions, and treatment burden. Medication regimen complexity is a major source of burden for family caregivers of people living with dementia and has been associated with numerous adverse outcomes. Studies suggest that as many as 56% of people with dementia take at least one potentially inappropriate medication, including medications that can negatively affect cognitive function. Optimizing medication use through deprescribing (the process of reducing or stopping the use of potentially inappropriate medications or medications unlikely to be beneficial) can improve outcomes for patients with dementia and MCC. Therefore, the investigator proposes a patient-centered deprescribing educational intervention for older adults with mild cognitive impairment or dementia and/or MCC, generalizable to a range of primary care settings. This study builds on OPTIMIZE, a multisite randomized trial within Kaiser Permanente Colorado that has been recently completed. OPTIMIZE is the investigator team's primary care-based deprescribing intervention for patients with mild cognitive impairment and dementia, and MCC. OPTIMIZE consists of a patient and family component focused on education and activation about deprescribing and a clinician component to increase awareness about processes and language for deprescribing.

The investigators propose a pilot study of medication optimization through increased awareness of deprescribing for older adults with cognitive impairment and/or MCC. The intervention will have two components: a patient/ care partner component focused on education and activation about deprescribing, and a clinician component focused on increasing clinician awareness about options and processes for deprescribing in the cognitive impairment-MCC population. The proposed intervention has the following aims:

1. To establish the feasibility and acceptability of the intervention among patients, caregivers, clinicians, and medical assistants in one healthcare system by assessing:

   a. Acceptability and process measures from a qualitative analysis of debriefing interviews with patients, care partners, clinicians, and medical assistants.
2. To determine the preliminary efficacy of the intervention by assessing:

   1. Clinical documentation of deprescribing, defined as medication discontinuation or dose reduction.
   2. Clinical documentation of a discussion about medication appropriateness, safety, or effectiveness (yes/possible vs. no/absent).

Eligibility criteria: Inclusion Criteria:

This study has two cohorts: A Mild Cognitive Impairment (MCI)/Dementia cohort and a non-dementia cohort.

MCI/Dementia cohort:

* Age 65 or greater
* Diagnosis of MCI or dementia from International Classification of Diseases ICD-9 and 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
* Have a routine, scheduled visit with a primary care physician during the pilot study period (not an urgent, acute or pre-op visit)
* Patient must be able to hear well enough to participate in interviews on the telephone.

Non-dementia cohort:

* Age 75 or older
* No MCI or dementia diagnosis
* At least two chronic conditions documented
* 5 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
* Have a routine, scheduled visit with a primary care physician during the pilot study period (not an urgent, acute, or pre-op visit).
* Patient must be able to hear well enough to participate in interviews on the telephone.

Care partners:

* Age 21 years or greater
* Must be able to hear well enough to participate in interviews on the telephone.

Primary care physicians and medical assistants:

• All primary care physicians and medical assistants at the pilot site will be included. Physicians who only provide urgent care will be excluded.

Exclusion Criteria:

* As the pilot will be based in primary care, individuals residing in long-term care facilities or enrolled in hospice care at baseline will be excluded.
* Patients taking 4 or fewer different medications for all their health needs will be excluded.

Primary outcomes:
measure: Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR
timeFrame: 1 year
Secondary outcomes:
measure: Acceptability of the Intervention to be Assessed Qualitatively From Debriefing Interviews
timeFrame: 1 year
measure: Feasibility of the Intervention to be Assessed Qualitatively From Debriefing Interviews
timeFrame: 1 year
Other outcomes:
Locations:
city: Reading
country: United States
facility: Reading Hospital Family Health Care Center
state: Pennsylvania
Study officials:
affiliation: Johs Hopkins University
name: Ariel Green, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
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