Deprescribing Education vs Usual Care for Patients With Cognitive Impairment and Primary Care Clinicians : The OPTIMIZE Pragmatic Cluster Randomized Trial

Key Points

Question

Can increasing awareness about deprescribing prior to primary care visits reduce the use of potentially inappropriate long-term medications for individuals with cognitive impairment?

Findings

In this pragmatic cluster randomized clinical trial of deprescribing education for 3012 older adults with cognitive impairment taking 5 or more medications and their primary care clinicians, patients from intervention clinics and control clinics were taking a similar mean number of medications (6.4 vs 6.5) at 6 months, and similar proportions of patients were taking 1 or more potentially inappropriate medications after 6 months.

Meaning

Educating patients and clinicians about deprescribing in primary care did not have an effect on the number of long-term medications or percentage of potentially inappropriate medications for older adults taking 5 or more long-term medications; findings suggest such interventions should target older adults taking relatively more medications.

Abstract

Background

Individuals with dementia or mild cognitive impairment frequently have multiple chronic conditions (defined as ≥2 chronic medical conditions) and take multiple medications, increasing their risk for adverse outcomes. Deprescribing (reducing or stopping medications for which potential harms outweigh potential benefits) may decrease their risk of adverse outcomes.

Objective

To examine the effectiveness of increasing patient and clinician awareness about the potential to deprescribe unnecessary or risky medications among patients with dementia or mild cognitive impairment.

Design, Setting, and Participants

This pragmatic, patient-centered, 12-month cluster randomized clinical trial was conducted from April 1, 2019, to March 31, 2020, at 18 primary care clinics in a not-for-profit integrated health care delivery system. The study included 3012 adults aged 65 years or older with dementia or mild cognitive impairment who had 1 or more additional chronic medical conditions and were taking 5 or more long-term medications.

Interventions

An educational brochure and a questionnaire on attitudes toward deprescribing were mailed to patients prior to a primary care visit, clinicians were notified about the mailing, and deprescribing tip sheets were distributed to clinicians at monthly clinic meetings.

Main Outcomes and Measures

The number of prescribed long-term medications and the percentage of individuals prescribed 1 or more potentially inappropriate medications (PIMs). Analysis was performed on an intention-to-treat basis.

Results

This study comprised 1433 individuals (806 women [56.2%]; mean [SD] age, 80.1 [7.2] years) in 9 intervention clinics and 1579 individuals (874 women [55.4%]; mean [SD] age, 79.9 [7.5] years) in 9 control clinics who met the eligibility criteria. At baseline, both groups were prescribed a similar mean (SD) number of long-term medications (7.0 [2.1] in the intervention group and 7.0 [2.2] in the control group), and a similar proportion of individuals in both groups were taking 1 or more PIMs (437 of 1433 individuals [30.5%] in the intervention group and 467 of 1579 individuals [29.6%] in the control group). At 6 months, the adjusted mean number of long-term medications was similar in the intervention and control groups (6.4 [95% CI, 6.3-6.5] vs 6.5 [95% CI, 6.4-6.6]; P = .14). The estimated percentages of patients in the intervention and control groups taking 1 or more PIMs were similar (17.8% [95% CI, 15.4%-20.5%] vs 20.9% [95% CI, 18.4%-23.6%]; P = .08). In preplanned subgroup analyses, adjusted differences between the intervention and control groups were –0.16 (95% CI, –0.34 to 0.01) for individuals prescribed 7 or more long-term medications at baseline (n = 1434) and –0.03 (95% CI, –0.20 to 0.13) for those prescribed 5 to 6 medications (n = 1578) ( P = .28 for interaction; P = .19 for subgroup interaction for PIMs).

Conclusions and Relevance

This large-scale educational deprescribing intervention for older adults with cognitive impairment taking 5 or more long-term medications and their primary care clinicians demonstrated small effect sizes and did not significantly reduce the number of long-term medications and PIMs. Such interventions should target older adults taking relatively more medications.

Trial Registration

ClinicalTrials.gov Identifier: NCT03984396

Abstract

This cluster randomized clinical trial examines the effectiveness of educating patients and clinicians about the potential to deprescribe unnecessary or risky medications among patients with dementia or mild cognitive impairment.