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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG070942 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Bureau of Economic Research, Inc. | OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
| National Institute on Aging (NIA) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Community-dwelling patients of treated study prescribers | Patients attributed to physicians who received overprescribing letters in the primary study who reside in the community. |
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| Community-dwelling patients of control study prescribers | Patients attributed to physicians who received placebo letters in the primary study who reside in the community. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overprescribing letter to attributed physician | Behavioral | Letter telling patient's attributed physician they were under review for high prescribing |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Days of Quetiapine Received | Days of quetiapine received during the outcome measurement period | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Adam Sacarny, PhD | Columbia University | Principal Investigator |
| Michael L Barnett, MD, MS | Harvard School of Public Health (HSPH) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard T.H. Chan School of Public Health | Boston | Massachusetts | 02115 | United States | ||
| National Bureau of Economic Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38662373 | Derived | Harnisch M, Barnett ML, Coussens S, Thomas KS, Olfson M, Berhane K, Sacarny A. Physician Antipsychotic Overprescribing Letters and Cognitive, Behavioral, and Physical Health Outcomes Among People With Dementia: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e247604. doi: 10.1001/jamanetworkopen.2024.7604. |
| Label | URL |
|---|---|
| ClinicalTrials.gov entry for original randomized trial | View source |
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Because this study uses restricted-access Medicare data, we will not be able to share individual participant data.
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| Placebo letter to attributed physician | Behavioral | Letter to patient's attributed physician about unrelated Medicare regulation |
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| Cambridge |
| Massachusetts |
| 02138 |
| United States |
| Columbia University | New York | New York | 10032 | United States |
| OSF.io Project Page | View source |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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