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Clinical Trials/NCT05616689
NCT05616689
Completed
Not Applicable

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

Kaiser Permanente1 site in 1 country2,471 target enrollmentOctober 19, 2020
ConditionsPolypharmacy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polypharmacy
Sponsor
Kaiser Permanente
Enrollment
2471
Locations
1
Primary Endpoint
Change in prevalence of geriatric syndrome
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 19, 2020
End Date
May 24, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in prevalence of geriatric syndrome

Time Frame: 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

Time Frame: 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 Outcomes

  • Utilization(Difference between (days 181-365 after randomization) and (180 days before randomization))

Study Sites (1)

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