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

Intervention / Treatment

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

  • United States
    • 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.
Behavioral: Overprescribing letter to attributed physician
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.
Behavioral: Placebo letter to attributed physician
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.
Behavioral: Overprescribing letter to attributed physician
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.
Behavioral: Placebo letter to attributed physician
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

Columbia University

Collaborators

National Institute on Aging (NIA)
Harvard School of Public Health (HSPH)
National Bureau of Economic Research, Inc.

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.

Helpful Links

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

Keywords

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.

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