Bundled Hyperpolypharmacy Deprescribing

NCT05616689 | Completed DMC

• 1 other identifier: RDO KPNC 20 - 008
• Study Type: interventional
• Target: 2,471
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy

Keywords

deprescribing; polypharmacy; drug safety; randomized controlled trial; pharmacist; shared decision making; optimal prescribing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Utilization

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

Other Outcomes (1)

• Adverse drug withdrawal effects

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

Study Arms (2)

Bundled hyperpolypharmacy intervention

EXPERIMENTAL

Eligible participants with physician authorization who are randomly assigned to intervention

Other: Bundled hyperpolypharmacy

Control

NO INTERVENTION

Eligible participants with physician authorization who are randomly assigned to usual care

Interventions

Bundled hyperpolypharmacy OTHER

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

Bundled hyperpolypharmacy intervention

Eligibility Criteria

• Age: 76 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Division of Research

Oakland, California, 94612, United States

Location

Related Publications (1)

• Herrinton LJ, Lo K, Alavi M, Alexeeff SE, Butler KM, Chang C, Chang CC, Chu VL, Krishnaswami A, Deguzman LH, Prausnitz S, Mason MD, Draves M. Effectiveness of Bundled Hyperpolypharmacy Deprescribing Compared With Usual Care Among Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2322505. doi: 10.1001/jamanetworkopen.2023.22505.

  PMID: 37428504 DERIVED

Study Officials

• Lisa Herrinton, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 15, 2022
• Study Start: October 19, 2020
• Primary Completion: July 29, 2022
• Study Completion: May 24, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)