Opioid PrescribingNCT04425668
Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry
A study testing Academic detailing (AD) and Continuing educational in people with Opioid Prescribing and Pain Management, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this project is to improve quality of care for dental patients in the state of Michigan. This will be achieved through educating dentists about best practices for opioid prescribing and includes three continuing education (CE) credits and one (or two) academic detailing (AD) visits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Prescribing, Pain Management
- What is being tested?
- Academic detailing (AD) and Continuing educational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2020to 29 May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dentists in the state of Michigan with an active drug enforcement agency (DEA) license.
Who cannot join
- All oral Surgeons in Michigan. Michigan dentists who have a significant (>5%) population living outside of Michigan (self-reported), as the prescription drug monitoring program (PDMP) data we will obtain from Michigan Automated Prescription Service (MAPS) will only cover those prescriptions filled in the state of Michigan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry: a Randomized Quality Improvement Effort
The purpose of this project is to improve quality of care for dental patients in the state of Michigan. This will be achieved through educating dentists about best practices for opioid prescribing and includes three continuing education (CE) credits and one (or two) academic detailing (AD) visits. The cohort of 90 dentists who are enrolled to the CE will be randomized into two groups upon enrollment. One of these groups, half of the cohort, will receive the academic detailing. A report will be written highlighting key findings from this project and best practices for treating patients after dental care.The quality of care for dental patients will be improved by sharing this information with both participating and non-participating dental providers statewide through reports, manuscripts, and presentations. These data will inform best practice with the potential for future academic detailing and educational interventions for dentists and oral surgeons.
- Conditions
- Opioid Prescribing, Pain Management
- Being tested
- Academic detailing (AD), Continuing educational
- Keywords
- Dentist
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Academic detailing (AD)Behavioural
In addition to continuing educational (CE) videos this group will receive up to two personalized, one-on-one, education sessions from an academic detailer. The sessions will last between 15-30 minutes. Each AD visit will consist of: an introduction, a brief needs assessment, key educational messages, a discussion of challenges the provider faces, and giving the provider leave-behind educational materials. The AD visit key educational messages are specific recommendations for opioid-prescribing practice change. When appropriate the detailer will suggest a phone call with Dr. Romesh Nalliah to discuss specific dentistry questions. There may also be a second AD visit if agreed upon by the dentist.
Continuing educationalOther
Dentists enrolled in the CE program will serve as the control group. They will have access to the 3 hours of CE content online similar to the AD group; however, they will not receive academic detailing or the opportunity to connect via phone with Dr. Nalliah.
In this group, if the dentists have content-specific questions after participating in the CE program, they may contact MichiganOPENdental@umich.edu for responses appropriately directed to Dr. Nalliah.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Other: Continuing educational |
| Academic detailing intervention | Experimental | Not described Receives: Behavioral: Academic detailing (AD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the amount of opioid prescribed measured in the total oral morphine equivalents
Opioid data from the Michigan Automated Prescription Service (MAPS), state prescription drug monitoring program (PDMP) will be used. These periods yield 63 working weekdays in each period.
Measured: baseline, up to 3 months
Secondary outcomes (1)
Change in the number of opioid prescriptions
Number of opioid prescription details through PDMP data pulled from MAPS.
Measured: baseline, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start29 Apr 2020
- Primary completion29 May 2021
- Study completion29 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid PrescribingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Responsible party
- Principal investigator, Chad Brummett, University of Michigan
- Investigators
- Chad Brummett, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425668
- Sponsor's protocol ID
- HUM00175142
- Status last verified
- May 2021
- First submitted
- 3 Jun 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry: a Randomized Quality Improvement Effort
- ClinicalTrials.gov ID
- NCT04425668
- Acronym / sponsor ID
- HUM00175142
- Conditions
- Opioid Prescribing, Pain Management
- Keywords
- Dentist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 29 May 2021 (actual)
- Study completion
- 29 May 2021 (actual)
- First posted
- 11 Jun 2020 (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.
The purpose of this project is to improve quality of care for dental patients in the state of Michigan. This will be achieved through educating dentists about best practices for opioid prescribing and includes three continuing education (CE) credits and one (or two) academic detailing (AD) visits. The cohort of 90 dentists who are enrolled to the CE will be randomized into two groups upon enrollment. One of these groups, half of the cohort, will receive the academic detailing. A report will be written highlighting key findings from this project and best practices for treating patients after dental care.The quality of care for dental patients will be improved by sharing this information with both participating and non-participating dental providers statewide through reports, manuscripts, and presentations. These data will inform best practice with the potential for future academic detailing and educational interventions for dentists and oral surgeons.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Continuing educational |
| Academic detailing intervention | Experimental | Behavioral: Academic detailing (AD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dentists in the state of Michigan with an active drug enforcement agency (DEA) license.
Key exclusion criteria (1 listed)
- All oral Surgeons in Michigan. Michigan dentists who have a significant (>5%) population living outside of Michigan (self-reported), as the prescription drug monitoring program (PDMP) data we will obtain from Michigan Automated Prescription Service (MAPS) will only cover those prescriptions filled in the state of Michigan.
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 |
|---|---|---|
| Academic detailing (AD)In addition to continuing educational (CE) videos this group will receive up to two personalized, one-on-one, education sessions from an academic detailer. The sessions will last between 15-30 minutes. Each AD visit will consist of: an introduction, a brief needs assessment, key educational messages, a discussion of challenges the provider faces, and giving the provider leave-behind educational materials. The AD visit key educational messages are specific recommendations for opioid-prescribing practice change. When appropriate the detailer will suggest a phone call with Dr. Romesh Nalliah to discuss specific dentistry questions. There may also be a second AD visit if agreed upon by the dentist. | Behavioural | Academic detailing intervention |
| Continuing educationalDentists enrolled in the CE program will serve as the control group. They will have access to the 3 hours of CE content online similar to the AD group; however, they will not receive academic detailing or the opportunity to connect via phone with Dr. Nalliah. In this group, if the dentists have content-specific questions after participating in the CE program, they may contact MichiganOPENdental@umich.edu for responses appropriately directed to Dr. Nalliah. | Other | Control Group |
Primary outcome
Change in the amount of opioid prescribed measured in the total oral morphine equivalents
Time frame: baseline, up to 3 months
Opioid data from the Michigan Automated Prescription Service (MAPS), state prescription drug monitoring program (PDMP) will be used. These periods yield 63 working weekdays in each period.
1 secondary outcome
Change in the number of opioid prescriptions
Time frame: baseline, up to 3 months
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 2 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Chad Brummett, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Academic detailing (AD) and Continuing educational in people with Opioid Prescribing and Pain Management, run by University of Michigan at 1 site 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 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 amount of opioid prescribed measured in the total oral morphine equivalents (time frame: baseline, up to 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 2 Jun 2021.