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Completed

NCT Number: NCT05172687

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Prescribing, Off-Label Tauopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Overprescribing letter to attributed physician

Behavioral

Letter telling patient's attributed physician they were under review for high prescribing

Placebo letter to attributed physician

Behavioral

Letter to patient's attributed physician about unrelated Medicare regulation

Primary outcomes

  1. Number of Days of Quetiapine Received

    Time frame: 90 days

    Days of quetiapine received during the outcome measurement period

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2021
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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