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Bundled Hyperpolypharmacy Deprescribing

NCT ID: NCT05616689

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2471 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2023-05-24

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.

Detailed Description

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Conditions

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Polypharmacy

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Bundled hyperpolypharmacy intervention

Eligible participants with physician authorization who are randomly assigned to intervention

Group Type EXPERIMENTAL

Bundled hyperpolypharmacy

Intervention Type OTHER

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bundled hyperpolypharmacy

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

Intervention Type OTHER

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.
Minimum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Herrinton, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente Division of Research

Oakland, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37428504 (View on PubMed)

Other Identifiers

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RDO KPNC 20 - 008

Identifier Type: -

Identifier Source: org_study_id