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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05172687
• Other study ID #: AAAT2250
• Secondary ID: R21AG070942
• Status: Completed
• Start date: April 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336460
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Prescribing, Off-Label

Intervention

Behavioral:
• Overprescribing letter to attributed physician
Letter telling patient's attributed physician they were under review for high prescribing
• Placebo letter to attributed physician
Letter to patient's attributed physician about unrelated Medicare regulation

Locations

Country	Name	City	State
United States	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

Sponsors (4)

Lead Sponsor	Collaborator
Columbia University	Harvard School of Public Health (HSPH), National Bureau of Economic Research, Inc., National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days of Quetiapine Received	Days of quetiapine received during the outcome measurement period	90 days

External Links

•   ClinicalTrials.gov entry for original randomized trial
•   OSF.io Project Page