Opioid UseNCT03377855
Addressing Origins of the Opioid Epidemic by Improving Prescribing for Opioid-Naive Patients
A study testing Default Prescribing Change in people with Opioid Use and Opioid-Related Disorders, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
Risk of long-term opioid dependence increases with initial opioid dose/duration, but despite recent Centers for Disease Control and Prevention (CDC)-endorsed minimum doses for initial opioid prescription, primary care providers are likely to overprescribe. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Opioid-Related Disorders, Opioid Abuse
- What is being tested?
- Default Prescribing Change
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 948 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2018to 31 Dec 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prescriber - practices internal medicine at WCMC OR family practice at IFH and has prescribed opioids since 11/1/2015
Who cannot join
- Prescriber - has not written any opioid prescriptions during the study period
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Institute for Family Health
New York, New York, 10035
Weill Medical College of Cornell University
New York, New York, 10065
About this study
Risk of long-term opioid dependence increases with initial opioid dose/duration, but despite recent Centers for Disease Control and Prevention (CDC)-endorsed minimum doses for initial opioid prescription, primary care providers are likely to overprescribe. In this quality improvement project, primary care departments at Weill Cornell and the Institute for Family Health (federally qualified health center in New York City) will implement an unobtrusive "nudge" in their electronic prescribing software to promote the CDC-endorsed low doses for all opioids. In the evaluation, we will employ a quasi-experimental design with rigorous interrupted time series analysis methods to assess the effect of the "nudge" on prescribing rates. The analysis will be performed at the provider level, with deidentified physician data and a limited data set (fully deidentified except for date of prescription) of patient-level data.
Read the detailed description
The two participating institutions, WCMC (Weill Cornell Medical College) and IFH (Institute for Family Health), intend to redesign the e-prescribing interface to create a minor "nudge" to encourage prescribers to prescribe the minimum dose set by the 2016 CDC guideline for opioid-naive patients in 2018. The change to the e-prescribing system is that after a prescriber chooses the drug they wish to prescribe, the minimum recommended dosage from the CDC guidelines will be displayed. The prescriber can choose to change the dosage by overwriting in the field box. The changes to the prescriber system will be implemented at two Weill Cornell clinical organizations: Weill Cornell Internal Medicine Associates (WCIMA) and Weill Cornell Medical Associates (CMA), and at all locations at our collaborating institution IFH (Institute for Family Health). Weill Cornell and IFH will provide data for the analysis, which will be conducted by the co-investigators on this protocol. The project will assess data pre- and post- implementation to study prescribing patterns.
- Conditions
- Opioid Use, Opioid-Related Disorders, Opioid Abuse, Prescription Drug Abuse and Dependency
- Being tested
- Default Prescribing Change
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Default Prescribing ChangeOther
In the e-prescribing system, the default opioid dosage/duration is changed to the minimum recommended dosage from the CDC guidelines for short acting opioids.
| Study group | Role | What they receive |
|---|---|---|
| Default Prescribing Change | Experimental | In the e-prescribing system, the default opioid dosage/duration is changed to the minimum recommended dosage from the CDC guidelines for short acting opioids. Receives: Other: Default Prescribing Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the proportion of opioid prescriptions for opioid-naïve patients that comply with CDC recommendations before and after the intervention
Change in the proportion of opioid prescriptions for opioid-naïve patients that comply with CDC recommendations before and after the intervention
Measured: Two years prior to and six months after implementation
Secondary outcomes (1)
Change in the average days of supply of opioids for opioid naive patients
Change in the average days of supply of opioids for opioid naive patients
Measured: Two years prior to and six months after implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Feb 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 Opioid UseStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a interrupted time series study model with one study group.
- Masking
- None (open label)
- Enrolment
- 948 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Health Foundation, The Institute for Family Health
- Responsible party
- Sponsor
- Investigators
- Jessica S Ancker, PhD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377855
- Sponsor's protocol ID
- 1710018646
- Other IDs
- 17-05047
- Status last verified
- Feb 2020
- First submitted
- 13 Dec 2017
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This data is protected by HIPAA and IRB/human subjects protections. In addition, the data is scheduled to be destroyed after publication of results.
Publications
Malhotra S, Cheriff AD, Gossey JT, Cole CL, Kaushal R, Ancker JS. Effects of an e-Prescribing interface redesign on rates of generic drug prescribing: exploiting default options. J Am Med Inform Assoc. 2016 Sep;23(5):891-8. doi: 10.1093/jamia/ocv192. Epub 2016 Feb 17.
PubMed 26911828
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Origins of the Opioid Epidemic by Improving Prescribing for Opioid-Naive Patients
- ClinicalTrials.gov ID
- NCT03377855
- Acronym / sponsor ID
- 1710018646
- Conditions
- Opioid Use, Opioid-Related Disorders, Opioid Abuse, Prescription Drug Abuse and Dependency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 948 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- New York State Health Foundation, The Institute for Family Health
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Dec 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.
Risk of long-term opioid dependence increases with initial opioid dose/duration, but despite recent Centers for Disease Control and Prevention (CDC)-endorsed minimum doses for initial opioid prescription, primary care providers are likely to overprescribe. In this quality improvement project, primary care departments at Weill Cornell and the Institute for Family Health (federally qualified health center in New York City) will implement an unobtrusive "nudge" in their electronic prescribing software to promote the CDC-endorsed low doses for all opioids. In the evaluation, we will employ a quasi-experimental design with rigorous interrupted time series analysis methods to assess the effect of the "nudge" on prescribing rates. The analysis will be performed at the provider level, with deidentified physician data and a limited data set (fully deidentified except for date of prescription) of patient-level data.
Detailed description
The two participating institutions, WCMC (Weill Cornell Medical College) and IFH (Institute for Family Health), intend to redesign the e-prescribing interface to create a minor "nudge" to encourage prescribers to prescribe the minimum dose set by the 2016 CDC guideline for opioid-naive patients in 2018. The change to the e-prescribing system is that after a prescriber chooses the drug they wish to prescribe, the minimum recommended dosage from the CDC guidelines will be displayed. The prescriber can choose to change the dosage by overwriting in the field box. The changes to the prescriber system will be implemented at two Weill Cornell clinical organizations: Weill Cornell Internal Medicine Associates (WCIMA) and Weill Cornell Medical Associates (CMA), and at all locations at our collaborating institution IFH (Institute for Family Health). Weill Cornell and IFH will provide data for the analysis, which will be conducted by the co-investigators on this protocol. The project will assess data pre- and post- implementation to study prescribing patterns.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a interrupted time series study model with one study group.
| Arm | Type | Receives |
|---|---|---|
| Default Prescribing Change | Experimental | Other: Default Prescribing ChangeIn the e-prescribing system, the default opioid dosage/duration is changed to the minimum recommended dosage from the CDC guidelines for short acting opioids. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prescriber - practices internal medicine at WCMC OR family practice at IFH and has prescribed opioids since 11/1/2015
Key exclusion criteria (1 listed)
- Prescriber - has not written any opioid prescriptions during the study period
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 |
|---|---|---|
| Default Prescribing ChangeIn the e-prescribing system, the default opioid dosage/duration is changed to the minimum recommended dosage from the CDC guidelines for short acting opioids. | Other | Default Prescribing Change |
Primary outcome
Change in the proportion of opioid prescriptions for opioid-naïve patients that comply with CDC recommendations before and after the intervention
Time frame: Two years prior to and six months after implementation
Change in the proportion of opioid prescriptions for opioid-naïve patients that comply with CDC recommendations before and after the intervention
1 secondary outcome
Change in the average days of supply of opioids for opioid naive patients
Time frame: Two years prior to and six months after implementation
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 24 Feb 2020.
- Background: PubMed 26911828Malhotra S, Cheriff AD, Gossey JT, Cole CL, Kaushal R, Ancker JS. Effects of an e-Prescribing interface redesign on rates of generic drug prescribing: exploiting default options. J Am Med Inform Assoc. 2016 Sep;23(5):891-8. doi: 10.1093/jamia/ocv192. Epub 2016 Feb 17.
- Individual participant dataSharing planned: No. This data is protected by HIPAA and IRB/human subjects protections. In addition, the data is scheduled to be destroyed after publication of results.
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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.
Jessica S Ancker, PhD, MPH principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Default Prescribing Change in people with Opioid Use and Opioid-Related Disorders, run by Weill Medical College of Cornell University at 2 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 1 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Change in the proportion of opioid prescriptions for opioid-naïve patients that comply with CDC recommendations before and after the intervention (time frame: Two years prior to and six months after implementation). 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 NCT03377855, 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 24 Feb 2020.