NCT04425668

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

June 3, 2020

Last Update Submit

May 29, 2021

Conditions

Keywords

Dentist

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, up to 3 months

Secondary Outcomes (1)

  • Change in the number of opioid prescriptions

    baseline, up to 3 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR
Other: Continuing educational

Academic detailing intervention

EXPERIMENTAL
Behavioral: Academic detailing (AD)

Interventions

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.

Academic detailing intervention

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.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dentists in the state of Michigan with an active drug enforcement agency (DEA) license.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chad Brummett

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chad Brummett, M.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Single blinded- dentists to be blinded; Analyses will be done by blinded analyst
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology Research, Senior Associate Chair for Research

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 11, 2020

Study Start

April 29, 2020

Primary Completion

May 29, 2021

Study Completion

May 29, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations