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Completed

NCT Number: NCT05616689

Bundled Hyperpolypharmacy Deprescribing

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.

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Key information

Conditions

Polypharmacy

Age range

76 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Division of Research

Oakland, California, 94612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bundled hyperpolypharmacy

Other

Bundled hyperpolypharmacy playbook to be used by pharmacist, with physician approval, in shared decision making with participant,

Primary outcomes

  1. 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)

  2. 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

  1. Utilization

    Time frame: Difference between (days 181-365 after randomization) and (180 days before randomization)

    Change in number of outpatient visits, inpatient visits, and emergency department visits.

Other outcomes

  1. Adverse drug withdrawal effects

    Time frame: Difference between (days 181-365 after randomization) and (180 days before randomization)

    Change in prevalence of lower respiratory, cardiovascular, gastrointestinal, hyperuricemia, and elevated blood glucose

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Nov 15, 2022
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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