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

Columbia University

Status: Completed

Conditions: Alzheimer Disease; Prescribing, Off-Label; Dementia

Treatments: Behavioral: Overprescribing letter to attributed physician; Behavioral: Placebo letter to attributed physician

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05172687

AAAT2250

R21AG070942 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 336,460 patients

Sex: All

Volunteers: No 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

Trial design

336,460 participants in 4 patient groups

Nursing home patients of treated study prescribers

Description:

Patients attributed to physicians who received overprescribing letters in the primary study who reside in a nursing home.

Treatment:

Behavioral: Overprescribing letter to attributed physician

Nursing home patients of control study prescribers

Description:

Patients attributed to physicians who received placebo letters in the primary study who reside in a nursing home.

Treatment:

Behavioral: Placebo letter to attributed physician

Community-dwelling patients of treated study prescribers

Description:

Patients attributed to physicians who received overprescribing letters in the primary study who reside in the community.

Treatment:

Behavioral: Overprescribing letter to attributed physician

Community-dwelling patients of control study prescribers

Description:

Patients attributed to physicians who received placebo letters in the primary study who reside in the community.

Treatment:

Behavioral: Placebo letter to attributed physician