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

Sponsor

Columbia University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05172687

Collaborator

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

266,510

Enrollment

Locations

35.5

Anticipated Duration (Months)

88836.7

Patients Per Site

2503.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Dementia Prescribing, Off-Label	Behavioral: Overprescribing letter to attributed physician Behavioral: Placebo letter to attributed physician

Study Design

Study Type:

Observational

Anticipated Enrollment :

266510 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 15, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Number of Days of Quetiapine Received [90 days]
Days of quetiapine received during the outcome measurement period

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard T.H. Chan School of Public Health	Boston	Massachusetts	United States	02115
2	National Bureau of Economic Research	Cambridge	Massachusetts	United States	02138
3	Columbia University	New York	New York	United States	10032