EconomicsNCT02345434
The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances
A study testing Informative letter in people with Economics and Fraud, run by Abdul Latif Jameel Poverty Action Lab.
Trial summary
Fraud and waste is estimated to cost the American health care system nearly $200 billion each year, and the public Medicare and Medicaid programs about $60 billion each year. This study will evaluate a new method for fighting fraud: mailing informative letters to outlier providers to notify them of their aberrant… 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?
- Informative letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,525 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Outlier with respect to the count of schedule II prescription drug events relative to peer group of prescribers in two of the three years 2011, 2012, and 2013
- Outlier with respect to the 30-day equivalent prescriptions of schedule II substances relative to peer group of prescribers in two of the three years 2011, 2012, and 2013
Who cannot join
- Deceased
About this study
Fraud and waste is estimated to cost the American health care system nearly $200 billion each year, and the public Medicare and Medicaid programs about $60 billion each year. This study will evaluate a new method for fighting fraud: mailing informative letters to outlier providers to notify them of their aberrant behavior. These letters are targeted at high prescribers of schedule II controlled substances in Medicare Part D. The investigators will look at the effects of these letters on the behavior of providers and their patients. These effects are of substantial policy interest as they suggest how to best design anti-fraud policies. They are also of academic interest, shedding light on the behavior of physicians and their patients.
- Conditions
- Economics, Fraud, Delivery of Health Care, Health Expenditures, Centers for Medicare and Medicaid Services (U.S.)
- Being tested
- Informative letter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informative letterOther
Also called Comparative billing report, Peer activity report
The intervention is a letter that describes the Schedule II 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.
| Study group | Role | What they receive |
|---|---|---|
| No informative letter | No intervention | This is the control arm and it involves no contact with the prescriber |
| Informative letter | Experimental | This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report) Receives: Other: Informative letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day Equivalent Prescribing of Schedule II Controlled Substances
The prescribing of schedule II controlled substances over the 3 months following the initial sending of the letters. Prescribing is defined as the total "days supply" of schedule II controlled substances attributed to the prescriber, expressed in "30-day equivalents" i.e. divided by 30.
Measured: 3 months
Secondary outcomes (4)
30-day Equivalent Prescribing of Schedule II Controlled Substances
Measured: 1 month
30-day Equivalent Prescribing of Schedule II Controlled Substances
Measured: 6 months
30-day Equivalent Prescribing of Schedule II Controlled Substances
Measured: 9 months
30-day Equivalent Prescribing of Schedule II Controlled Substances
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 posted26 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 1,525 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
- Amy Finkelstein, PhD, Principal investigator, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345434
- Sponsor's protocol ID
- JPAL-LETTERS-SII
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2014
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 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 Schedule II Controlled Substances
- ClinicalTrials.gov ID
- NCT02345434
- Acronym / sponsor ID
- JPAL-LETTERS-SII
- Conditions
- Economics, Fraud, Delivery of Health Care, Health Expenditures, Centers for Medicare and Medicaid Services (U.S.)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,525 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
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Posted 8 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fraud and waste is estimated to cost the American health care system nearly $200 billion each year, and the public Medicare and Medicaid programs about $60 billion each year. This study will evaluate a new method for fighting fraud: mailing informative letters to outlier providers to notify them of their aberrant behavior. These letters are targeted at high prescribers of schedule II controlled substances in Medicare Part D. The investigators will look at the effects of these letters on the behavior of providers and their patients. These effects are of substantial policy interest as they suggest how to best design anti-fraud policies. They are also of academic interest, shedding light on the behavior of physicians and their 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 |
|---|---|---|
| No informative letter | No intervention | –This is the control arm and it involves no contact with the prescriber |
| Informative letter | Experimental | Other: Informative letterThis is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Outlier with respect to the count of schedule II prescription drug events relative to peer group of prescribers in two of the three years 2011, 2012, and 2013
- Outlier with respect to the 30-day equivalent prescriptions of schedule II substances relative to peer group of prescribers in two of the three years 2011, 2012, and 2013
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 |
|---|---|---|
| Informative letterAlso: Comparative billing report, Peer activity reportThe intervention is a letter that describes the Schedule II 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 |
Primary outcome
30-day Equivalent Prescribing of Schedule II Controlled Substances
Time frame: 3 months
The prescribing of schedule II controlled substances over the 3 months following the initial sending of the letters. Prescribing is defined as the total "days supply" of schedule II controlled substances attributed to the prescriber, expressed in "30-day equivalents" i.e. divided by 30.
4 secondary outcomes
30-day Equivalent Prescribing of Schedule II Controlled Substances
Time frame: 1 month
30-day Equivalent Prescribing of Schedule II Controlled Substances
Time frame: 6 months
30-day Equivalent Prescribing of Schedule II Controlled Substances
Time frame: 9 months
30-day Equivalent Prescribing of Schedule II Controlled Substances
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- American Economic Association Randomized Controlled Trials Registry EntryLink provided by the sponsor.
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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.
Amy Finkelstein, PhD principal investigator
Massachusetts Institute of Technology
Questions about this trial
What is this clinical trial studying?
A study testing 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 2 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 8 Nov 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. 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?
Yes. Results are posted in the registry (first posted 8 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Schedule II Controlled Substances (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2021.