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

Completed

• Conditions: Prescribing, Off-Label; Dementia; Alzheimer Disease
• Interventions: Behavioral: Overprescribing letter to attributed physician; Behavioral: Placebo letter to attributed physician

• Registration Number: NCT05172687
• Lead Sponsor: Columbia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2021-12-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336460

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nursing home patients of treated study prescribers	Overprescribing letter to attributed physician	Patients attributed to physicians who received overprescribing letters in the primary study who reside in a nursing home.
Community-dwelling patients of treated study prescribers	Overprescribing letter to attributed physician	Patients attributed to physicians who received overprescribing letters in the primary study who reside in the community.
Community-dwelling patients of control study prescribers	Placebo letter to attributed physician	Patients attributed to physicians who received placebo letters in the primary study who reside in the community.
Nursing home patients of control study prescribers	Placebo letter to attributed physician	Patients attributed to physicians who received placebo letters in the primary study who reside in a nursing home.

Primary Outcome Measures

Name	Time	Method
Number of Days of Quetiapine Received	90 days	Days of quetiapine received during the outcome measurement period

Trial Locations

Locations (3)

Harvard T.H. Chan School of Public Health; 🇺🇸 Boston, Massachusetts, United States

National Bureau of Economic Research; 🇺🇸 Cambridge, Massachusetts, United States

Columbia University; 🇺🇸 New York, New York, United States