Bundled Hyperpolypharmacy Deprescribing

Bundled Hyperpolypharmacy Deprescribing: Implementation and Evaluation of a System-wide Quality Improvement Intervention

Older patients using many prescription drugs (hyperpolypharmacy) may be at increased risk of adverse drug effects. This randomized controlled trial tested the effectiveness and safety of a quality intervention intended to reduce hyperpolypharmacy. The study was set at Kaiser Permanente Northern California, an integrated health system with multiple pre-existing deprescribing workflows. Eligible patients were aged ≥76 years using ≥10 prescription medications. The intervention included 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. A priori primary effectiveness endpoints included change in the number of medications and in the prevalence of geriatric syndrome from 181-365 days after allocation. Second endpoints included utilization and adverse drug withdrawal effects. Information was obtained from the electronic health record.

Study Overview

• Status: Completed
• Conditions: Polypharmacy
• Intervention / Treatment: Other: Bundled hyperpolypharmacy

• Study Type: Interventional
• Enrollment (Actual): 2471
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Division of Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 76 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Kaiser Permanente patients
• Age ≥76 years

• ≥10 drugs (excluding topicals) where

  • drug filled ≥2 times in the past year and
  • drug last filled < 180 days ago

Exclusion Criteria:

• less than 12 months preceding enrollment at Kaiser Permanente
• no primary care practitioner assigned
• on dialysis
• history of heart, liver, lung, breast, or bone marrow transplant
• in hospice
• under active treatment for cancer during the past 12 months
• has received an intervention through the Pharmacy Targeted Deprescribing Program in the preceding year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bundled hyperpolypharmacy intervention; Eligible participants with physician authorization who are randomly assigned to intervention	Other: Bundled hyperpolypharmacy; Bundled hyperpolypharmacy playbook to be used by pharmacist, with physician approval, in shared decision making with participant,
No Intervention: Control; Eligible participants with physician authorization who are randomly assigned to usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in prevalence of geriatric syndrome	Change in prevalence for any of the following: Falls (hip fracture, lower leg fracture, osteoporosis with fracture, pathologic fracture, osteonecrosis; gait; repeated falls; syncope; tripping; reduced mobility), Cognition (Somnolence; awareness; dizziness; malaise; Urinary incontinence (Unspecified urinary incontinence; retention of urine, unspecified; functional urinary incontinence; stress incontinence ; other specified urinary incontinence) and Pain (Drug induced headache; joint pain; muscle weakness, rhabdomyolysis, spas; myalgia)	Difference between (days 181-365 after randomization) and (180 days before randomization)
Change in number of medications	Change in number of dispensed medications recorded in the comprehensive, integrated pharmacy information system	Difference between (days 181-365 after randomization) and (180 days before randomization)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization	Change in number of outpatient visits, inpatient visits, and emergency department visits.	Difference between (days 181-365 after randomization) and (180 days before randomization)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse drug withdrawal effects	Change in prevalence of lower respiratory, cardiovascular, gastrointestinal, hyperuricemia, and elevated blood glucose	Difference between (days 181-365 after randomization) and (180 days before randomization)

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Lisa Herrinton, PhD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): July 29, 2022
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; shared decision making; deprescribing; pharmacist; polypharmacy; drug safety; optimal prescribing
• Other Study ID Numbers: RDO KPNC 20 - 008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No