EconomicsNCT02467933
The Effect of Informative Letters on the Prescription and Receipt of Seroquel
A study testing Initial Informative letter and Followup Informative Letter in people with Economics and Fraud, run by Abdul Latif Jameel Poverty Action Lab.
Trial summary
Abusive prescribing exposes patients to unnecessary health risks and results in wasteful public expenditures. This study will evaluate an innovative approach to fighting abusive prescription: sending letters to suspected inappropriate prescribers warning them that they are outliers compared to their peers and have… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Economics, Fraud, Delivery of Health Care
- What is being tested?
- Initial Informative letter and Followup Informative Letter
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,055 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- General care practitioner
- Outlier with respect to the count of Seroquel prescription drug treatments relative to peer group of prescribers in 2013 and 2014
- Outlier with respect to the count of Seroquel 30-day equivalent prescription drug treatments relative to peer group of prescribers in 2013 and 2014
Who cannot join
- Deceased
About this study
Abusive prescribing exposes patients to unnecessary health risks and results in wasteful public expenditures. This study will evaluate an innovative approach to fighting abusive prescription: sending letters to suspected inappropriate prescribers warning them that they are outliers compared to their peers and have been flagged for review. The study will target high prescribers of Seroquel (Quetiapine), an atypical antipsychotic. Using claims data, the investigators will assess the effect of the letters on prescribing of Seroquel, receipt of Seroquel by patients, substitution behavior by prescribers and patients, and health outcomes of patients.
- Conditions
- Economics, Fraud, Delivery of Health Care, Health Expenditures, Centers for Medicare and Medicaid Services (U.S.)
- Being tested
- Placebo letter, Initial Informative letter, Followup Informative Letter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo letterOther
The placebo letter describes a new rule in Medicare that requires prescribers to enroll in Medicare
Initial Informative letterOther
The intervention is a letter that describes the Seroquel prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers.
Followup Informative LetterOther
The followup informative letter is identical to the initial informative letter except it provides an update on more recent prescribing rather than a description of earlier prescribing.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo arm receives a placebo letter unrelated to Seroquel Receives: Other: Placebo letter |
| Informative Letter | Experimental | The interventional arm prescribers receive an initial informative letter (called a comparative billing report or peer activity report) followed by 2 followup informative letters at approximately 3 month intervals. Receives: Other: Initial Informative letter; Other: Followup Informative Letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day equivalent prescribing of Seroquel treatments
The prescribing of Seroquel over the 9 months following the initial sending of the letters. Prescribing is defined as the total "days supply" of Seroquel attributed to the prescriber, expressed in "30-day equivalents" i.e. divided by 30.
Measured: 9 months
Secondary outcomes (3)
30-day equivalent prescribing of Seroquel treatments
Measured: 3 months
30-day equivalent prescribing of Seroquel treatments
Measured: 6 months
30-day equivalent prescribing of Seroquel treatments
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionApr 2017
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 EconomicsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,055 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdul Latif Jameel Poverty Action Lab
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services, General Services Administration (GSA)
- Responsible party
- Sponsor
- Investigators
- Adam Sacarny, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467933
- Sponsor's protocol ID
- JPAL-LETTERS-SEROQUEL
- Status last verified
- Aug 2021
- First submitted
- 8 Jun 2015
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sacarny A, Barnett ML, Le J, Tetkoski F, Yokum D, Agrawal S. Effect of Peer Comparison Letters for High-Volume Primary Care Prescribers of Quetiapine in Older and Disabled Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Oct 1;75(10):1003-1011. doi: 10.1001/jamapsychiatry.2018.1867.
PubMed 30073273
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Informative Letters on the Prescription and Receipt of Seroquel
- ClinicalTrials.gov ID
- NCT02467933
- Acronym / sponsor ID
- JPAL-LETTERS-SEROQUEL
- Conditions
- Economics, Fraud, Delivery of Health Care, Health Expenditures, Centers for Medicare and Medicaid Services (U.S.)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,055 participants (actual)
- Lead sponsor
- Abdul Latif Jameel Poverty Action LabUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services, General Services Administration (GSA)
- Study start
- Apr 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 10 Jun 2015 (estimated)
- 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.
Abusive prescribing exposes patients to unnecessary health risks and results in wasteful public expenditures. This study will evaluate an innovative approach to fighting abusive prescription: sending letters to suspected inappropriate prescribers warning them that they are outliers compared to their peers and have been flagged for review. The study will target high prescribers of Seroquel (Quetiapine), an atypical antipsychotic. Using claims data, the investigators will assess the effect of the letters on prescribing of Seroquel, receipt of Seroquel by patients, substitution behavior by prescribers and patients, and health outcomes of patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo letterThe placebo arm receives a placebo letter unrelated to Seroquel |
| Informative Letter | Experimental | Other: Initial Informative letter, Other: Followup Informative LetterThe interventional arm prescribers receive an initial informative letter (called a comparative billing report or peer activity report) followed by 2 followup informative letters at approximately 3 month intervals. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- General care practitioner
- Outlier with respect to the count of Seroquel prescription drug treatments relative to peer group of prescribers in 2013 and 2014
- Outlier with respect to the count of Seroquel 30-day equivalent prescription drug treatments relative to peer group of prescribers in 2013 and 2014
Key exclusion criteria (1 listed)
- Deceased
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 |
|---|---|---|
| Placebo letterThe placebo letter describes a new rule in Medicare that requires prescribers to enroll in Medicare | Other | Placebo |
| Initial Informative letterThe intervention is a letter that describes the Seroquel prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers. | Other | Informative Letter |
| Followup Informative LetterThe followup informative letter is identical to the initial informative letter except it provides an update on more recent prescribing rather than a description of earlier prescribing. | Other | Informative Letter |
Primary outcome
30-day equivalent prescribing of Seroquel treatments
Time frame: 9 months
The prescribing of Seroquel over the 9 months following the initial sending of the letters. Prescribing is defined as the total "days supply" of Seroquel attributed to the prescriber, expressed in "30-day equivalents" i.e. divided by 30.
3 secondary outcomes
30-day equivalent prescribing of Seroquel treatments
Time frame: 3 months
30-day equivalent prescribing of Seroquel treatments
Time frame: 6 months
30-day equivalent prescribing of Seroquel treatments
Time frame: 1 year
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 9 Aug 2021.
- Derived from this study: PubMed 30073273Sacarny A, Barnett ML, Le J, Tetkoski F, Yokum D, Agrawal S. Effect of Peer Comparison Letters for High-Volume Primary Care Prescribers of Quetiapine in Older and Disabled Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Oct 1;75(10):1003-1011. doi: 10.1001/jamapsychiatry.2018.1867.
- American Economic Association Randomized Controlled Trials Registry EntryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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
Questions about this trial
What is this clinical trial studying?
A study testing Initial Informative letter and Followup Informative Letter in people with Economics and Fraud, run by Abdul Latif Jameel Poverty Action Lab.
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 3 inclusion and 1 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 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
30-day equivalent prescribing of Seroquel treatments (time frame: 9 months). 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 NCT02467933, 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 9 Aug 2021.