The Effect of De-Prescribing Antipsychotics on Health and Quality of Life for People With Dementia
2 other identifiers
observational
336,460
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2015
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFirst Submitted
Initial submission to the registry
December 13, 2021
CompletedFirst Posted
Study publicly available on registry
December 29, 2021
CompletedFebruary 13, 2024
February 1, 2024
3.8 years
December 13, 2021
February 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Days of Quetiapine Received
Days of quetiapine received during the outcome measurement period
90 days
Study Arms (4)
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.
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.
Community-dwelling patients of treated study prescribers
Patients attributed to physicians who received overprescribing letters in the primary study who reside in the community.
Community-dwelling patients of control study prescribers
Patients attributed to physicians who received placebo letters in the primary study who reside in the community.
Interventions
Letter telling patient's attributed physician they were under review for high prescribing
Letter to patient's attributed physician about unrelated Medicare regulation
Eligibility Criteria
Repeated cross sections of patients attributed to study prescribers. Analyses are conducted separately for patients residing in nursing homes and patients living in the community. The investigators look at a series of sequential 90 day periods with the first period beginning at the start of the intervention. The investigators measure outcomes based on health care assessments, encounters, and claims that occur during the period. The investigators attribute patients to study prescribers based on their evaluation and management encounters during the 90 days preceding the period for nursing home patients and during the 180 days preceding the period for community-dwelling patients. The patient is attributed to the physician who rendered the most of these services.
You may qualify if:
- 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)
You may not qualify if:
- Died during 90 day period used to attribute patient to physician
- For nursing home patients: Short-stay nursing facility patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Bureau of Economic Research, Inc.collaborator
- Harvard School of Public Health (HSPH)collaborator
- National Institute on Aging (NIA)collaborator
Study Sites (3)
Harvard T.H. Chan School of Public Health
Boston, Massachusetts, 02115, United States
National Bureau of Economic Research
Cambridge, Massachusetts, 02138, United States
Columbia University
New York, New York, 10032, United States
Related Publications (1)
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.
PMID: 38662373DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Sacarny, PhD
Columbia University
- STUDY DIRECTOR
Michael L Barnett, MD, MS
Harvard School of Public Health (HSPH)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Health Policy and Management
Study Record Dates
First Submitted
December 13, 2021
First Posted
December 29, 2021
Study Start
April 1, 2015
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
February 13, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share
Because this study uses restricted-access Medicare data, we will not be able to share individual participant data.