EconomicsNCT03202745
The Effect of Informative Letters on the Prescription and Receipt of Opioids
A study testing Patient Consequences Letter and Prescriber Consequences Letter in people with Economics and Fraud, run by Abdul Latif Jameel Poverty Action Lab.
Trial summary
Inappropriate prescribing exposes patients to health risks and results in wasteful public expenditures. This study will evaluate an approach to fighting abusive prescription: sending letters to suspected potentially inappropriate prescribers warning them that they are outliers compared to their peers and have been… 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?
- Patient Consequences Letter and Prescriber Consequences Letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2019
- 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
- Outlier with respect to prescribing of Schedule II opioids relative to peers, measured in prescription drug events (PDE), in 2014Q3-2015Q2 and 2015Q3-2016Q2
- Outlier with respect to prescribing of Schedule II opioids relative to peers, measured in 30-day equivalents, in 2014Q3-2015Q2 and 2015Q3-2016Q2
Who cannot join
- Deceased
- Fewer than 75 Schedule II Opioid PDE in 2015Q3-2016Q2
- Specialty listed as "Student in an Organized Health Care Education/Training Program"
About this study
Inappropriate prescribing exposes patients to health risks and results in wasteful public expenditures. This study will evaluate an approach to fighting abusive prescription: sending letters to suspected potentially 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 opioids in the Schedule II controlled substances class. Two types of letters will be tested: one focusing on the health consequences of inappropriate prescribing for patients, and the other focusing on the consequences for prescribers including e.g. potential administrative actions. Using claims data, the investigators will assess the effect of the letters on prescribing of opioids, receipt of opioids by patients, substitution behavior by prescribers and patients, and health outcomes of patients.
- Conditions
- Economics, Fraud, Delivery of Health Care, Health Expenditures, Prescribing, Centers for Medicare and Medicaid Services (U.S.)
- Being tested
- Patient Consequences Letter, Prescriber Consequences Letter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Consequences LetterOther
This letter focuses on the consequences of inappropriate prescribing for patients. It also includes a peer comparison.
Prescriber Consequences LetterOther
This letter focuses on the consequences of inappropriate prescribing for prescribers. It also includes a peer comparison.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control arm will not receive any communications as a result of this study. |
| Patient Consequences | Experimental | The patient consequences arm prescribers receive an initial patient consequences letter followed by 2 followup letters at approximately 3 month intervals. The letters focus on the consequences of inappropriate prescribing for patients. Receives: Other: Patient Consequences Letter |
| Prescriber Consequences | Experimental | The prescriber consequences arm prescribers receive an initial prescriber consequences letter followed by 2 followup letters at approximately 3 month intervals. The letters focus on the consequences of inappropriate prescribing for prescribers. Receives: Other: Prescriber Consequences Letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Milligrams Equivalent (MME)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: Intervention never conducted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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
- NCT03202745
- Sponsor's protocol ID
- JPAL-LETTERS-OPIOIDS
- Status last verified
- Aug 2021
- First submitted
- 27 Jun 2017
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 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 Opioids
- ClinicalTrials.gov ID
- NCT03202745
- Acronym / sponsor ID
- JPAL-LETTERS-OPIOIDS
- Conditions
- Economics, Fraud, Delivery of Health Care, Health Expenditures, Prescribing, Centers for Medicare and Medicaid Services (U.S.)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Intervention never conducted
- Enrolment
- 0 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
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 29 Jun 2017 (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.
Inappropriate prescribing exposes patients to health risks and results in wasteful public expenditures. This study will evaluate an approach to fighting abusive prescription: sending letters to suspected potentially 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 opioids in the Schedule II controlled substances class. Two types of letters will be tested: one focusing on the health consequences of inappropriate prescribing for patients, and the other focusing on the consequences for prescribers including e.g. potential administrative actions. Using claims data, the investigators will assess the effect of the letters on prescribing of opioids, receipt of opioids 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control arm will not receive any communications as a result of this study. |
| Patient Consequences | Experimental | Other: Patient Consequences LetterThe patient consequences arm prescribers receive an initial patient consequences letter followed by 2 followup letters at approximately 3 month intervals. The letters focus on the consequences of inappropriate prescribing for patients. |
| Prescriber Consequences | Experimental | Other: Prescriber Consequences LetterThe prescriber consequences arm prescribers receive an initial prescriber consequences letter followed by 2 followup letters at approximately 3 month intervals. The letters focus on the consequences of inappropriate prescribing for prescribers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Outlier with respect to prescribing of Schedule II opioids relative to peers, measured in prescription drug events (PDE), in 2014Q3-2015Q2 and 2015Q3-2016Q2
- Outlier with respect to prescribing of Schedule II opioids relative to peers, measured in 30-day equivalents, in 2014Q3-2015Q2 and 2015Q3-2016Q2
Key exclusion criteria (3 listed)
- Deceased
- Fewer than 75 Schedule II Opioid PDE in 2015Q3-2016Q2
- Specialty listed as "Student in an Organized Health Care Education/Training Program"
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 |
|---|---|---|
| Patient Consequences LetterThis letter focuses on the consequences of inappropriate prescribing for patients. It also includes a peer comparison. | Other | Patient Consequences |
| Prescriber Consequences LetterThis letter focuses on the consequences of inappropriate prescribing for prescribers. It also includes a peer comparison. | Other | Prescriber Consequences |
Primary outcome
Morphine Milligrams Equivalent (MME)
Time frame: 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Economics
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Not yet recruiting
Medico-Economic Evaluation of MRI Versus CT as Diagnostic Imaging Strategies in Patients With Suspected Ischemic Stroke: the MAGRITTE Study.
Stroke
Active, not recruiting
Acute Non-severe Osteomyelitis in Children - Outpatient Management Strategy With Oral Antibiotic Therapy Compared to a Standard Strategy With Conventional Hospitalization and Intravenous Antibiotic Therapy: a Randomized Open-label Non-inferiority Study With Bayesian and Medical-economic Analyses.
Osteomyelitis
Not yet recruitingPhase 3
MUTTON-HF Pilot Expansion
Heart Failure
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 Patient Consequences Letter and Prescriber Consequences 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 3 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: withdrawn, as of the sponsor's last update on 12 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Morphine Milligrams Equivalent (MME) (time frame: 9 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 12 Aug 2021.