Bundled Hyperpolypharmacy Deprescribing

Polypharmacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05616689
• Other study ID #: RDO KPNC 20 - 008
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: May 24, 2023

Study information

• Verified date: December 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2471
• Est. completion date: May 24, 2023
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 76 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Polypharmacy

Intervention

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

Locations

Country	Name	City	State
United States	Kaiser Permanente Division of Research	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse drug withdrawal effects	Change in prevalence of lower respiratory, cardiovascular, gastrointestinal, hyperuricemia, and elevated blood glucose	Difference between (days 181-365 after randomization) and (180 days before randomization)
Primary	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)
Primary	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	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)