Bundled Hyperpolypharmacy Deprescribing

Not Applicable

Completed

• Conditions: Polypharmacy
• Interventions: Other: Bundled hyperpolypharmacy

• Registration Number: NCT05616689
• Lead Sponsor: Kaiser Permanente

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-19
• Primary Completion: 2022-07-29
• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-15
• Study Completion: 2023-05-24
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2471

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bundled hyperpolypharmacy intervention	Bundled hyperpolypharmacy	Eligible participants with physician authorization who are randomly assigned to intervention

Primary Outcome Measures

Name	Time	Method
Change in prevalence of geriatric syndrome	Difference between (days 181-365 after randomization) and (180 days before randomization)	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)
Change in number of medications	Difference between (days 181-365 after randomization) and (180 days before randomization)	Change in number of dispensed medications recorded in the comprehensive, integrated pharmacy information system

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaiser Permanente Division of Research; 🇺🇸 Oakland, California, United States