Bundled Hyperpolypharmacy Deprescribing

Study Overview
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Brief Summary
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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.

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

Conditions
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Polypharmacy

Intervention / Treatment
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* Other: Bundled hyperpolypharmacy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bundled hyperpolypharmacy intervention<br>Eligible participants with physician authorization who are randomly assigned to intervention | Other: Bundled hyperpolypharmacy<br>* Bundled hyperpolypharmacy playbook to be used by pharmacist, with physician approval, in shared decision making with participant,<br>|
| No Intervention: Control<br>Eligible participants with physician authorization who are randomly assigned to usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization | Change in number of outpatient visits, inpatient visits, and emergency department visits. | Difference between (days 181-365 after randomization) and (180 days before randomization) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deprescribing, polypharmacy, drug safety, randomized controlled trial, pharmacist, shared decision making, optimal prescribing