Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03809507 |
| Other study ID # |
18-2495 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 5, 2019 |
| Est. completion date |
August 31, 2021 |
Study information
| Verified date |
September 2020 |
| Source |
University of North Carolina, Chapel Hill |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
