PolypharmacyNCT05616689
Bundled Hyperpolypharmacy Deprescribing
A study testing Bundled hyperpolypharmacy in people with Polypharmacy, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 76 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polypharmacy
- What is being tested?
- Bundled hyperpolypharmacy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,471 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 24 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 76 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Division of Research
Oakland, California, 94612
About this study
Official title: Bundled Hyperpolypharmacy Deprescribing: Implementation and Evaluation of a System-wide Quality Improvement Intervention
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.
- Conditions
- Polypharmacy
- Being tested
- Bundled hyperpolypharmacy
- Keywords
- deprescribing, polypharmacy, drug safety, randomized controlled trial, pharmacist, shared decision making, optimal prescribing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bundled hyperpolypharmacyOther
Bundled hyperpolypharmacy playbook to be used by pharmacist, with physician approval, in shared decision making with participant,
| Study group | Role | What they receive |
|---|---|---|
| Bundled hyperpolypharmacy intervention | Experimental | Eligible participants with physician authorization who are randomly assigned to intervention Receives: Other: Bundled hyperpolypharmacy |
| Control | No intervention | Eligible participants with physician authorization who are randomly assigned to usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Difference between (days 181-365 after randomization) and (180 days before randomization)
Secondary outcomes (1)
Utilization
Change in number of outpatient visits, inpatient visits, and emergency department visits.
Measured: Difference between (days 181-365 after randomization) and (180 days before randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start19 Oct 2020
- Primary completion29 Jul 2022
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Herrinton, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616689
- Sponsor's protocol ID
- RDO KPNC 20 - 008
- Status last verified
- Dec 2023
- First submitted
- 19 Oct 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37428504
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bundled Hyperpolypharmacy Deprescribing: Implementation and Evaluation of a System-wide Quality Improvement Intervention
- ClinicalTrials.gov ID
- NCT05616689
- Acronym / sponsor ID
- RDO KPNC 20 - 008
- Conditions
- Polypharmacy
- Keywords
- deprescribing, polypharmacy, drug safety, randomized controlled trial, pharmacist, shared decision making, optimal prescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,471 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bundled hyperpolypharmacy intervention | Experimental | Other: Bundled hyperpolypharmacyEligible participants with physician authorization who are randomly assigned to intervention |
| Control | No intervention | –Eligible participants with physician authorization who are randomly assigned to usual care |
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Kaiser Permanente patients
- Age ≥76 years
- ≥10 drugs (excluding topicals) where
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bundled hyperpolypharmacyBundled hyperpolypharmacy playbook to be used by pharmacist, with physician approval, in shared decision making with participant, | Other | Bundled hyperpolypharmacy intervention |
Primary outcome
Change in prevalence of geriatric syndrome
Time frame: Difference 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)
Change in number of medications
Time frame: Difference 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
1 secondary outcome
Utilization
Time frame: Difference between (days 181-365 after randomization) and (180 days before randomization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 37428504Herrinton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Herrinton, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bundled hyperpolypharmacy in people with Polypharmacy, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in prevalence of geriatric syndrome (time frame: Difference between (days 181-365 after randomization) and (180 days before randomization)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05616689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.