The Effect of De-Prescribing Antipsychotics on Health and Quality of Life for People With Dementia
February 12, 2024 updated by: Adam Sacarny, PhD, Columbia University
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
336460
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Harvard T.H. Chan School of Public Health
-
Cambridge, Massachusetts, United States, 02138
- National Bureau of Economic Research
-
-
New York
-
New York, New York, United States, 10032
- Columbia University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
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.
|
Letter to patient's attributed physician about unrelated Medicare regulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Days of Quetiapine Received
Time Frame: 90 days
|
Days of quetiapine received during the outcome measurement period
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Adam Sacarny, PhD, Columbia University
- Study Director: Michael L Barnett, MD, MS, Harvard School of Public Health (HSPH)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
December 13, 2021
First Submitted That Met QC Criteria
December 13, 2021
First Posted (Actual)
December 29, 2021
Study Record Updates
Last Update Posted (Actual)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 12, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAT2250
- R21AG070942 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Because this study uses restricted-access Medicare data, we will not be able to share individual participant data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.