Alzheimer DiseaseNCT05172687
The Effect of De-Prescribing Antipsychotics on Health and Quality of Life for People With Dementia
An observational study of Alzheimer Disease and Dementia, run by Columbia University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease, Dementia, Prescribing, Off-Label
- What is being tested?
- Overprescribing letter to attributed physician
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336,460 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2015to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Died during 90 day period used to attribute patient to physician
- For nursing home patients: Short-stay nursing facility patient
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Harvard T.H. Chan School of Public Health
Boston, Massachusetts, 02115
National Bureau of Economic Research
Cambridge, Massachusetts, 02138
Columbia University
New York, New York, 10032
About this study
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.
- Conditions
- Alzheimer Disease, Dementia, Prescribing, Off-Label
- Being tested
- Overprescribing letter to attributed physician, Placebo letter to attributed physician
- Keywords
- antipsychotics, alzheimers, dementia, prescribing, deprescribing, nursing homes, long-term care
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overprescribing letter to attributed physicianBehavioural
Letter telling patient's attributed physician they were under review for high prescribing
Placebo letter to attributed physicianBehavioural
Letter to patient's attributed physician about unrelated Medicare regulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Overprescribing letter to attributed physician | |
| 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. Receives: Behavioral: Placebo letter to attributed physician | |
| Community-dwelling patients of treated study prescribers | Patients attributed to physicians who received overprescribing letters in the primary study who reside in the community. Receives: Behavioral: Overprescribing letter to attributed physician | |
| Community-dwelling patients of control study prescribers | Patients attributed to physicians who received placebo letters in the primary study who reside in the community. Receives: Behavioral: Placebo letter to attributed physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days of Quetiapine Received
Days of quetiapine received during the outcome measurement period
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study startApr 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 336,460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Bureau of Economic Research, Inc., Harvard School of Public Health (HSPH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Adam Sacarny, PhD, Columbia University
- Investigators
- Adam Sacarny, PhD, Principal investigator, Columbia UniversityMichael L Barnett, MD, MS, Study director, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172687
- Sponsor's protocol ID
- AAAT2250
- Other IDs
- R21AG070942
- Status last verified
- Feb 2024
- First submitted
- 13 Dec 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because this study uses restricted-access Medicare data, we will not be able to share individual participant data.
Publications
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.
PubMed 38662373
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of De-Prescribing Antipsychotics on Health and Quality of Life for People With Dementia
- ClinicalTrials.gov ID
- NCT05172687
- Acronym / sponsor ID
- AAAT2250
- Conditions
- Alzheimer Disease, Dementia, Prescribing, Off-Label
- Keywords
- antipsychotics, alzheimers, dementia, prescribing, deprescribing, nursing homes, long-term care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 336,460 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Bureau of Economic Research, Inc., Harvard School of Public Health (HSPH), National Institute on Aging (NIA)
- Study start
- Apr 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nursing home patients of treated study prescribers | – | Behavioral: Overprescribing letter to attributed physicianPatients attributed to physicians who received overprescribing letters in the primary study who reside in a nursing home. |
| Nursing home patients of control study prescribers | – | Behavioral: Placebo letter to attributed physicianPatients attributed to physicians who received placebo letters in the primary study who reside in a nursing home. |
| Community-dwelling patients of treated study prescribers | – | Behavioral: Overprescribing letter to attributed physicianPatients attributed to physicians who received overprescribing letters in the primary study who reside in the community. |
| Community-dwelling patients of control study prescribers | – | Behavioral: Placebo letter to attributed physicianPatients attributed to physicians who received placebo letters in the primary study who reside in the community. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- Died during 90 day period used to attribute patient to physician
- For nursing home patients: Short-stay nursing facility patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overprescribing letter to attributed physicianLetter telling patient's attributed physician they were under review for high prescribing | Behavioural | Community-dwelling patients of treated study prescribers, Nursing home patients of treated study prescribers |
| Placebo letter to attributed physicianLetter to patient's attributed physician about unrelated Medicare regulation | Behavioural | Community-dwelling patients of control study prescribers, Nursing home patients of control study prescribers |
Primary outcome
Number of Days of Quetiapine Received
Time frame: 90 days
Days of quetiapine received during the outcome measurement period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 38662373Harnisch 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.
- ClinicalTrials.gov entry for original randomized trialLink provided by the sponsor.
- OSF.io Project PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Because this study uses restricted-access Medicare data, we will not be able to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Sacarny, PhD principal investigator
Columbia University
Michael L Barnett, MD, MS study director
Harvard School of Public Health (HSPH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia, run by Columbia University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days of Quetiapine Received (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.