CompletedNot Applicable

Bundled Hyperpolypharmacy Deprescribing

United States2,471 participantsStarted 2020-10-19

Plain-language 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.

Who can participate

Age range

76 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in prevalence of geriatric syndrome

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

Change in number of medications

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

Trial details

NCT IDNCT05616689

SponsorKaiser Permanente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-29

View on ClinicalTrials.gov More Polypharmacy trials