Shared Decision Making About Medication Use for People With Multiple Health Problems

Dementia Clinical Trial

Official title: Shared Decision Making About Medication Use for People With Multiple Health Problems

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Chronic Disease
• Cognitive Dysfunction
• Dementia
• Deprescribing
• Mild Cognitive Impairment
• Multiple Chronic Conditions
• Polypharmacy

• NCT number: NCT05156073
• Study type: Interventional
• Source: Johns Hopkins University
• Status: Completed
• Phase: N/A
• Start date: May 22, 2023
• Completion date: November 3, 2023