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Bundled Hyperpolypharmacy Deprescribing

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05616689
Enrollment
2471
Registered
2022-11-15
Start date
2020-10-19
Completion date
2023-05-24
Last updated
2023-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polypharmacy

Keywords

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

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.

Interventions

OTHERBundled hyperpolypharmacy

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

Sponsors

Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
76 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in number of medicationsDifference 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
Change in prevalence of geriatric syndromeDifference 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)

Secondary

MeasureTime frameDescription
UtilizationDifference between (days 181-365 after randomization) and (180 days before randomization)Change in number of outpatient visits, inpatient visits, and emergency department visits.

Other

MeasureTime frameDescription
Adverse drug withdrawal effectsDifference between (days 181-365 after randomization) and (180 days before randomization)Change in prevalence of lower respiratory, cardiovascular, gastrointestinal, hyperuricemia, and elevated blood glucose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026