Effectiveness of Bundled Hyperpolypharmacy Deprescribing Compared With Usual Care Among Older Adults: A Randomized Clinical Trial

Abstract

Importance: Older patients using many prescription drugs (hyperpolypharmacy) may be at increased risk of adverse drug effects.

Objective: To test the effectiveness and safety of a quality intervention intended to reduce hyperpolypharmacy.

Design, setting, and participants: This randomized clinical trial allocated patients 76 years or older who used 10 or more prescription medications to a deprescribing intervention or to usual care (1:1 ratio) at an integrated health system with multiple preexisting deprescribing workflows. Data were collected from October 15, 2020, to July 29, 2022.

Intervention: Physician-pharmacist collaborative drug therapy management, standard-of-care practice recommendations, shared decision-making, and deprescribing protocols administered by telephone over multiple cycles for a maximum of 180 days after allocation.

Main outcomes and measures: Primary end points were change in the number of medications and in the prevalence of geriatric syndrome (falls, cognition, urinary incontinence, and pain) from 181 to 365 days after allocation compared with before randomization. Secondary outcomes were use of medical services and adverse drug withdrawal effects.

Results: Of a random sample of 2860 patients selected for potential enrollment, 2470 (86.4%) remained eligible after physician authorization, with 1237 randomized to the intervention and 1233 to usual care. A total of 1062 intervention patients (85.9%) were reached and agreed to enroll. Demographic variables were balanced. The median age of the 2470 patients was 80 (range, 76-104) years, and 1273 (51.5%) were women. In terms of race and ethnicity, 185 patients (7.5%) were African American, 234 (9.5%) were Asian or Pacific Islander, 220 (8.9%) were Hispanic, 1574 (63.7%) were White (63.7%), and 257 (10.4%) were of other (including American Indian or Alaska Native, Native Hawaiian, or >1 race or ethnicity) or unknown race or ethnicity. During follow-up, both the intervention and usual care groups had slight reductions in the number of medications dispensed (mean changes, -0.4 [95% CI, -0.6 to -0.2] and -0.4 [95% CI, -0.6 to -0.3], respectively), with no difference between the groups (P = .71). There were no significant changes in the prevalence of a geriatric condition in the usual care and intervention groups at the end of follow-up and no difference between the groups (baseline prevalence: 47.7% [95% CI, 44.9%-50.5%] vs 42.9% [95% CI, 40.1%-45.7%], respectively; difference-in-differences, 1.0 [95% CI, -3.5 to 5.6]; P = .65). No differences in use of medical services or adverse drug withdrawal effects were observed.

Conclusions and relevance: In this randomized clinical trial from an integrated care setting with various preexisting deprescribing workflows, a bundled hyperpolypharmacy deprescribing intervention was not associated with reduction in medication dispensing, prevalence of geriatric syndrome, utilization of medical services, or adverse drug withdrawal effects. Additional research is needed in less integrated settings and in more targeted populations.

Trial registration: ClinicalTrials.gov Identifier: NCT05616689.

Figure 1.. Hyperpolypharmacy Program Tool

Tool uses the US Agency for Healthcare Research and Quality (AHRQ) SHARE (seek your patient’s participation; help your patient explore and compare treatment options; assess your patient’s values and preferences; reach a decision with your patient; and evaluate your patient’s decision) approach. Patients were able to decline or withdraw consent for participation at any point. CEASE indicates confirm, estimate, assess, sort, and eliminate.

Figure 2.. Study Flow Diagram

ITT indicates intention to treat; PCP, primary care physician. ^aSome patients were excluded for multiple reasons. ^bOf the 2687 patients, a total of 216 lost eligibility after physician authorization: 202 reduced their medication count below 10, 24 had active cancer, 11 entered hospice, and 8 died, with some patients excluded for multiple reasons.