Clinical trial NCT05172687: The Effect of De-Prescribing Antipsychotics on Health and Quality of Life for People With Dementia
Official title: The Effect of De-Prescribing Antipsychotics on Health and Quality of Life for People With Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Dementia
Prescribing, Off-Label
Keywords: antipsychotics
alzheimers
dementia
prescribing
deprescribing
nursing homes
long-term care
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Bureau of Economic Research, Inc.
name: Harvard School of Public Health (HSPH)
name: National Institute on Aging (NIA)
First posted: 2021-12-29
Enrollment: 336460
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Days of Quetiapine Received
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard T.H. Chan School of Public Health
state: Massachusetts
city: Cambridge
country: United States
facility: National Bureau of Economic Research
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Adam Sacarny, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Michael L Barnett, MD, MS
role: STUDY_DIRECTOR
References: