The Effect of De-Prescribing Antipsychotics on Health and Quality of Life for People With Dementia

NCT ID: NCT05172687

Last Updated: 2024-02-13

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

Total Enrollment

336460 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-12-31

Brief Summary

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This study aims to analyze how warning letters sent to physicians prescribing high levels of the antipsychotic quetiapine affected the health and quality of life of their patients with dementia. Using a randomized controlled trial conducted by the Centers for Medicare and Medicaid Services (CMS) in 2015, this secondary study looks at the effects of potential de-prescribing of antipsychotics by study physicians induced by the letters. The central question is whether the intervention led to better health and quality of life outcomes by encouraging more guideline-concordant care and whether changes in physicians' prescription behavior caused unintended harms.

Detailed Description

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Conditions

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Alzheimer Disease Dementia Prescribing, Off-Label

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Nursing home patients of treated study prescribers

Patients attributed to physicians who received overprescribing letters in the primary study who reside in a nursing home.

Overprescribing letter to attributed physician

Intervention Type BEHAVIORAL

Letter telling patient's attributed physician they were under review for high prescribing

Nursing home patients of control study prescribers

Patients attributed to physicians who received placebo letters in the primary study who reside in a nursing home.

Placebo letter to attributed physician

Intervention Type BEHAVIORAL

Letter to patient's attributed physician about unrelated Medicare regulation

Community-dwelling patients of treated study prescribers

Patients attributed to physicians who received overprescribing letters in the primary study who reside in the community.

Overprescribing letter to attributed physician

Intervention Type BEHAVIORAL

Letter telling patient's attributed physician they were under review for high prescribing

Community-dwelling patients of control study prescribers

Patients attributed to physicians who received placebo letters in the primary study who reside in the community.

Placebo letter to attributed physician

Intervention Type BEHAVIORAL

Letter to patient's attributed physician about unrelated Medicare regulation

Interventions

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Overprescribing letter to attributed physician

Letter telling patient's attributed physician they were under review for high prescribing

Intervention Type BEHAVIORAL

Placebo letter to attributed physician

Letter to patient's attributed physician about unrelated Medicare regulation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Fully enrolled in Fee-For-Service Medicare Parts A, B, and D
* For nursing home patients: Residing in a nursing home and has a usable nursing home assessment to measure outcomes
* For community-dwelling patients: Not residing in a nursing home
* Has Alzheimer's or dementia related disease diagnosis
* Attributed to study physician (see study population description)

Exclusion Criteria

* Died during 90 day period used to attribute patient to physician
* For nursing home patients: Short-stay nursing facility patient
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Bureau of Economic Research, Inc.

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Adam Sacarny, PhD

Assistant Professor of Health Policy and Management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Sacarny, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Michael L Barnett, MD, MS

Role: STUDY_DIRECTOR

Harvard School of Public Health (HSPH)

Locations

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Harvard T.H. Chan School of Public Health

Boston, Massachusetts, United States

Site Status

National Bureau of Economic Research

Cambridge, Massachusetts, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Countries

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United States

References

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Harnisch M, Barnett ML, Coussens S, Thomas KS, Olfson M, Berhane K, Sacarny A. Physician Antipsychotic Overprescribing Letters and Cognitive, Behavioral, and Physical Health Outcomes Among People With Dementia: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e247604. doi: 10.1001/jamanetworkopen.2024.7604.

Reference Type DERIVED
PMID: 38662373 (View on PubMed)

Related Links

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https://clinicaltrials.gov/ct2/show/NCT02467933

ClinicalTrials.gov entry for original randomized trial

https://osf.io/eh47k/

OSF.io Project Page

Other Identifiers

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R21AG070942

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAT2250

Identifier Type: -

Identifier Source: org_study_id

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