Analgesics OpioidNCT03809507
A Strategy to Reduce Opioid Drug Prescribing by Clinicians
An observational study of Analgesics Opioid, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Under the auspices of the Oral Health Section of the NC Department of Health and Human Services clinician-investigators from the UNC Oral and Maxillofacial Surgery Department are conducting a survey to assess current analgesic prescribing practices in NC with a goal of eventually reaching consensus among clinicians… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesics Opioid
- What is being tested?
- Qualtrics survey questions
- How many people
- 895 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2019to 31 Aug 2021
- Phase
- Observational
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General dentists, Endodontists, Periodontists, Oral and Maxillofacial Surgeons. Emergency Room Physicians
Who may be able to join
- NC licensed dentists or physicians with active DEA registration.
Who cannot join
- NC licensed dentists or physicians with no active DEA registration.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina School of Dentistry
Chapel Hill, North Carolina, 27599-7450
About this study
Official title: A Strategy to Reduce Opioid Drug Prescribing by Clinicians: Survey of Clinicians Analgesic Drug Prescribing
Under the auspices of the Oral Health Section of the NC Department of Health and Human Services clinician-investigators from the UNC Oral and Maxillofacial Surgery Department are conducting a survey to assess current analgesic prescribing practices in NC with a goal of eventually reaching consensus among clinicians for a wide range of procedures and conditions where pain control is important for successful patient outcomes. We hope that about 850 dentists and 600 physicians will agree to take part in this research study. Participation in this Qualtrics survey e-mailed in mid-February 2019 will take about 15 minutes or less.
Read the detailed description
METHODS
Participants:
Dentists, emergency room physicians and primary care physicians who are in active practice will be surveyed using the lists of active practitioners with Drug Enforcement Administration(DEA) licenses provided by the NC Department of Public Health.
Inclusion criteria for dentists: Active dentist with DEA license including: endodontists, general practice dentists, oral and maxillofacial surgeons, and periodontists.
Given the small numbers per specialty, all endodontists (n=128), periodontists(n=114), and oral and maxillofacial surgeons (n=178) will be surveyed. A stratified random sample (n = 400) of general dentists (n=3905) will be selected from the list using region of the state as the stratification factor.
Inclusion criteria for emergency room clinical staff: MD/DO/PA with a primary area of practice as emergency medicine or urgent care and area(s) of practice as emergency medicine, urgent care, family medicine, or adolescent \& young adult medicine All DO (n = 191) will be surveyed. A stratified random sample (n= 400) of MD's (N = 1407) and PA's will be selected from the list using region of the state as the stratification factor.
Qualtrics Survey:
The survey will be divided into two general areas: 1) personal and practice demographics (sex, age, time in practice (years), practice size) and 2) clinical scenarios typical of patients seen by the respective practitioners who might be expected to experience acute pain. For each of the scenarios, practitioners will be asked the type(s) of medication that would be prescribed, the strength in mg, and the number of doses for each medication.
The survey will be pre-tested by a sample of potential survey subjects who will be asked to provide open-ended comments regarding ease of completion, confusing items, and word changes. The survey methods of Salant and Dillman will be used as a guide.(8)
A Qualtics linkage file will be created accessible only to the project investigators. The linkage file will only be used to identify non-respondents for follow-up. Surveys will be coded to maintain respondents' confidentiality. Linkage file will be in a pass word protected file separate from survey responses.
Distribution:
A mixed mode of distribution of the surveys will be used. Qualtrics software (Qualtrics, Provo, UT) will be used to create electronic versions of the survey to be sent to providers via email with an accompanying letter describing the purpose of the project and how confidentiality will be maintained. Teleform (Cardiff Software, Vista, CA) will be used as a paper alternative for providers who do not wish to respond to the electronic version. For these individuals a cover letter will be included describing the study along with a postage paid return envelope. Up to three attempts will be made at two-week intervals, depending on response versus non-response, to optimize subject participation.(8) The mode for the third round will be determined by the response rate from each of the first two rounds.
Statistical Analysis:
All survey responses will be de-identified to maintain provider confidentiality. The electronic and Teleform responses will be merged and analyzed using SAS (version 9.4, Cary, NC). Respondents will be excluded from data analysis if they do not complete the data for the prescribing practices.The primary outcome variable will be the clinicians prescribing opioid drugs for each survey scenario or not. Secondary analyses will explore possible explanatory variables for the primary outcome. Bivariate analysis will be done by status (degree and practice mode) to explore the effect of the explanatory variables (age; gender; time in practice; practice location; and practice size) on the preferred medication option for each clinical scenario. Comparisons among degree/specialty holders is not possible given that the scenarios presented are unique to the different groups. The use of Chi-square or Fisher's Exact test for the bivariate analysis will be determined based on the cell frequencies. Level of significance was set at 0.05.
- Conditions
- Analgesics Opioid
- Being tested
- Qualtrics survey questions
- Keywords
- opioids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualtrics survey questionsOther
Qualtrics Survey:
For each of the scenarios, practitioners will be asked whether opioids are prescribed or not, and the type(s) of other analgesic medications that would be prescribed, the strength in mg, and the number of doses for each medication
| Study group | Role | What they receive |
|---|---|---|
| NC Clinicians | Qualtrics Survey of NC Clinicians with DEA registration Receives: Other: Qualtrics survey questions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Clinicians Prescribing Opioid Drugs for each Survey Scenario
Qualtrics Survey of NC Clinicians with DEA registration. Yes/No responses for opioid drug prescribing for 2 to 3 scenarios differing by target group of clinicians will be asked of 6 different clinician types, emergency room physicians, general dentists and dental specialists..
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start5 Apr 2019
- Primary completion31 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesics OpioidStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 895 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Raymond P White, Jr, DDS. PhD, Study director, Oral and Maxillofacial Surgery, UNC School of DentistryGlenn Reside, DMD, Principal investigator, Oral and Maxillofacial Surgery, UNC School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809507
- Sponsor's protocol ID
- 18-2495
- Status last verified
- Sep 2020
- First submitted
- 15 Jan 2019
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data that supports results will be shared provided the investigator who proposes use of the data has Institutional Review Board(IRB), Independent Ethics Committee, or Research Ethics Board, as applicable, and executes a data use/sharing agreement with UNC
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Strategy to Reduce Opioid Drug Prescribing by Clinicians: Survey of Clinicians Analgesic Drug Prescribing
- ClinicalTrials.gov ID
- NCT03809507
- Acronym / sponsor ID
- 18-2495
- Conditions
- Analgesics Opioid
- Keywords
- opioids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 895 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Department of Health and Human Services
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 18 Jan 2019 (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.
Under the auspices of the Oral Health Section of the NC Department of Health and Human Services clinician-investigators from the UNC Oral and Maxillofacial Surgery Department are conducting a survey to assess current analgesic prescribing practices in NC with a goal of eventually reaching consensus among clinicians for a wide range of procedures and conditions where pain control is important for successful patient outcomes. We hope that about 850 dentists and 600 physicians will agree to take part in this research study. Participation in this Qualtrics survey e-mailed in mid-February 2019 will take about 15 minutes or less.
Detailed description
METHODS
Participants:
Dentists, emergency room physicians and primary care physicians who are in active practice will be surveyed using the lists of active practitioners with Drug Enforcement Administration(DEA) licenses provided by the NC Department of Public Health.
Inclusion criteria for dentists: Active dentist with DEA license including: endodontists, general practice dentists, oral and maxillofacial surgeons, and periodontists.
Given the small numbers per specialty, all endodontists (n=128), periodontists(n=114), and oral and maxillofacial surgeons (n=178) will be surveyed. A stratified random sample (n = 400) of general dentists (n=3905) will be selected from the list using region of the state as the stratification factor.
Inclusion criteria for emergency room clinical staff: MD/DO/PA with a primary area of practice as emergency medicine or urgent care and area(s) of practice as emergency medicine, urgent care, family medicine, or adolescent \& young adult medicine All DO (n = 191) will be surveyed. A stratified random sample (n= 400) of MD's (N = 1407) and PA's will be selected from the list using region of the state as the stratification factor.
Qualtrics Survey:
The survey will be divided into two general areas: 1) personal and practice demographics (sex, age, time in practice (years), practice size) and 2) clinical scenarios typical of patients seen by the respective practitioners who might be expected to experience acute pain. For each of the scenarios, practitioners will be asked the type(s) of medication that would be prescribed, the strength in mg, and the number of doses for each medication.
The survey will be pre-tested by a sample of potential survey subjects who will be asked to provide open-ended comments regarding ease of completion, confusing items, and word changes. The survey methods of Salant and Dillman will be used as a guide.(8)
A Qualtics linkage file will be created accessible only to the project investigators. The linkage file will only be used to identify non-respondents for follow-up. Surveys will be coded to maintain respondents' confidentiality. Linkage file will be in a pass word protected file separate from survey responses.
Distribution:
A mixed mode of distribution of the surveys will be used. Qualtrics software (Qualtrics, Provo, UT) will be used to create electronic versions of the survey to be sent to providers via email with an accompanying letter describing the purpose of the project and how confidentiality will be maintained. Teleform (Cardiff Software, Vista, CA) will be used as a paper alternative for providers who do not wish to respond to the electronic version. For these individuals a cover letter will be included describing the study along with a postage paid return envelope. Up to three attempts will be made at two-week intervals, depending on response versus non-response, to optimize subject participation.(8) The mode for the third round will be determined by the response rate from each of the first two rounds.
Statistical Analysis:
All survey responses will be de-identified to maintain provider confidentiality. The electronic and Teleform responses will be merged and analyzed using SAS (version 9.4, Cary, NC). Respondents will be excluded from data analysis if they do not complete the data for the prescribing practices.The primary outcome variable will be the clinicians prescribing opioid drugs for each survey scenario or not. Secondary analyses will explore possible explanatory variables for the primary outcome. Bivariate analysis will be done by status (degree and practice mode) to explore the effect of the explanatory variables (age; gender; time in practice; practice location; and practice size) on the preferred medication option for each clinical scenario. Comparisons among degree/specialty holders is not possible given that the scenarios presented are unique to the different groups. The use of Chi-square or Fisher's Exact test for the bivariate analysis will be determined based on the cell frequencies. Level of significance was set at 0.05.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NC Clinicians | – | Other: Qualtrics survey questionsQualtrics Survey of NC Clinicians with DEA registration |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General dentists, Endodontists, Periodontists, Oral and Maxillofacial Surgeons. Emergency Room Physicians
Key inclusion criteria (1 listed)
- NC licensed dentists or physicians with active DEA registration.
Key exclusion criteria (1 listed)
- NC licensed dentists or physicians with no active DEA registration.
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 |
|---|---|---|
| Qualtrics survey questionsQualtrics Survey: For each of the scenarios, practitioners will be asked whether opioids are prescribed or not, and the type(s) of other analgesic medications that would be prescribed, the strength in mg, and the number of doses for each medication | Other | NC Clinicians |
Primary outcome
Number of Clinicians Prescribing Opioid Drugs for each Survey Scenario
Time frame: one year
Qualtrics Survey of NC Clinicians with DEA registration. Yes/No responses for opioid drug prescribing for 2 to 3 scenarios differing by target group of clinicians will be asked of 6 different clinician types, emergency room physicians, general dentists and dental specialists..
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 30 Sep 2021.
- Individual participant dataSharing planned: Yes. Deidentified data that supports results will be shared provided the investigator who proposes use of the data has Institutional Review Board(IRB), Independent Ethics Committee, or Research Ethics Board, as applicable, and executes a data use/sharing agreement with UNC
Related trials for Analgesics Opioid
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingPhase 3
Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tegileridine for Post-Operative Analgesia in Patients Undergoing Bariatric Surgery
Pain Management, Overweight , Obesity
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
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.
Raymond P White, Jr, DDS. PhD study director
Oral and Maxillofacial Surgery, UNC School of Dentistry
Glenn Reside, DMD principal investigator
Oral and Maxillofacial Surgery, UNC School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesics Opioid, run by University of North Carolina, Chapel Hill 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 30 Sep 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?
Number of Clinicians Prescribing Opioid Drugs for each Survey Scenario (time frame: one year). 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 30 Sep 2021.