Clinical trial NCT04682730: An Implementation Strategy for the Adoption of an Evidence-Based Guideline for Pit-and-Fissure Sealants
Official title: An Implementation Strategy for the Adoption of an Evidence-Based Guideline for Pit-and-Fissure Sealants: Using a Framework From Organizational Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pit-and-Fissure Sealants
Keywords: evidence-based clinical practice guideline
dental sealants
Deliberative Democracy
Deliberative Loop
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: Kaiser Permanente
First posted: 2020-12-24
Enrollment: 896
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge. In addition to the vanguard clinic, there will be five steps, each with three clinics.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this implementation science study is to determine whether Deliberative Loops are effective in increasing providers' adherence to the non-cavitated caries component of the American Dental Association's pit-and-fissure sealant evidence-based clinical practice guideline. The investigators use a stepped wedge design to randomly assign dental clinics to the Deliberative Loop intervention. In a Deliberative Loop, stakeholders receive background information, participate in a facilitated discussion, and share their views with leadership. The Deliberative Loop intervention is designed to help stakeholders form informed opinions; in this study, stakeholders will be forming informed opinions about the implementation interventions they think will increase their clinic's adherence to the guideline. The investigators hypothesize that compared with the pre-intervention period, following the intervention, providers will place or treatment plan sealants for significantly more occlusal non-cavitated carious lesions.

Detailed description: The purpose of this implementation science study is to determine whether Deliberative Loops are effective in increasing providers' adherence to the non-cavitated caries component of the American Dental Association's pit-and-fissure sealant evidence-based clinical practice guideline. The investigators use a stepped wedge design to randomly assign dental clinics to the Deliberative Loop intervention. In a Deliberative Loop, stakeholders receive background information, participate in a facilitated discussion, and share their views with leadership. The Deliberative Loop intervention is designed to help stakeholders form informed opinions; in this study, stakeholders will be forming informed opinions about the implementation interventions they think will increase their clinic's adherence to the guideline. The investigators hypothesize that compared with the pre-intervention period, following the intervention, providers will place or treatment plan sealants for significantly more occlusal non-cavitated carious lesions (NCCL).

All persons employed by Kaiser Permanente Northwest or Permanente Dental Associates and who work in a Kaiser Permanente Northwest dental clinic at any level \[e.g., part time, full time\] will be eligible to participate in the study. This includes both service providers and front-of-the-house staff, approximately 1,200 employees.

This is a Stage III study.

Participating sites include the 16 general dental clinics of Kaiser Permanente Northwest. All clinics are located within the United States.

The estimated time from when the study opens to enrollment until completion of data collection is 16 months. It will take approximately one to two months for each individual participant to complete all study-related tasks, depending on how soon after the introductory session the Deliberative session can be scheduled.

Eligibility criteria: Inclusion Criteria:

* Employed by Kaiser Permanente Northwest Dental or Permanente Dental Associates
* Work in a Kaiser Permanente Northwest dental clinic

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in Providers' Rates of Placing or Treatment Planning Sealants for Occlusal NCCLs
timeFrame: from one month before the first step to two months after the final step, 1 year.
Secondary outcomes:
measure: Total Program Costs
timeFrame: from planning the survey to gather background information to two months after the final step; an average of 1 year
measure: Cost Per Clinic
timeFrame: from planning the survey to gather background information to two months after the final step; an average of 1 year
measure: Cost Per Member Per Month (PMPM)
timeFrame: from planning the survey to gather background information to two months after the final step; an average of 1 year
measure: Annualized Costs for Guideline Implementation Interventions
timeFrame: from planning the survey to gather background information to two months after the final step; an average of 1 year
measure: NCCL Treatment Costs- Total Program Costs Per Sealant
timeFrame: from planning the survey to gather background information to two months after the final step; an average of 1 year
measure: NCCL Treatment Costs- Total Program Costs Per Sealant Per Clinic
timeFrame: from planning the survey to gather background information to two months after the final step; an average of 1 year
measure: NCCL Treatment Costs- Per Sealant Per Member Per Month (PMPM)
timeFrame: from planning the survey to gather background information to two months after the final step; an average of 1 year
measure: Sealant Treatment Plan Resolution
timeFrame: when a clinic was exposed to the intervention (when they received their survey results) to December 31, 2021. (Vanguard- 9.34 months; Cluster 1- 7.84 months; Cluster 2- 6.39 months; Cluster 3- 5.30 months; Cluster 4- 3.33 months; Cluster 5- 2.75 months)
measure: Cost Effectiveness
timeFrame: from one month before the first step to two months after the final step, 1 year
Other outcomes:
measure: Acceptability, Management - Deliberative Loop Process
timeFrame: A single assessment following completion of all data analyses, approximately 1.5 years after the data collection end date.
measure: Acceptability, Stakeholders - Deliberative Loop Process
timeFrame: One survey was available for participants to complete immediately following the deliberative loop session and the survey stayed available for 1 week following the deliberative loop session.
measure: Acceptability, Stakeholders - Context Setting Document
timeFrame: One survey was available for participants to complete immediately following the deliberative loop session and the survey stayed available for 1 week following the deliberative loop session.
measure: Helpfulness of Group Discussion
timeFrame: One survey was available for participants to complete immediately following the deliberative loop session and the survey stayed available for 1 week following the deliberative loop session.
measure: Promotive Voice
timeFrame: One survey was available for participants to complete immediately following the deliberative loop session and the survey stayed available for 1 week following the deliberative loop session.
measure: Prohibitive Voice
timeFrame: One survey was available for participants to complete immediately following the deliberative loop session and the survey stayed available for 1 week following the deliberative loop session.
measure: Future Leadership Responsiveness
timeFrame: One survey was available for participants to complete immediately following the deliberative loop session and the survey stayed available for 1 week following the deliberative loop session.
measure: Past Leadership Responsiveness
timeFrame: One survey was available for participants to complete immediately following the deliberative loop session and the survey stayed available for 1 week following the deliberative loop session.
measure: Overall Voice
timeFrame: One survey was available for participants to complete immediately following the deliberative loop session and the survey stayed available for 1 week following the deliberative loop session.
measure: Perceptions of Discussion
timeFrame: One survey was available for participants to complete immediately following the deliberative loop session and the survey stayed available for 1 week following the deliberative loop session.
measure: List of Implementation Strategies Endorsed by Stakeholders
timeFrame: One survey was available for participants to complete immediately following the deliberative loop session and the survey stayed available for 1 week following the deliberative loop session.
measure: List of Barriers Perceived by Stakeholders
timeFrame: One survey was available for participants to complete immediately following the DL session and the survey stayed available for 1 week following the session.
measure: List of Implementation Strategies Adopted by the Clinics, Quantitative
timeFrame: 3 months after receiving the clinic summary report
measure: List of Implementation Strategies Adopted by the Clinics, Qualitative
timeFrame: 3 months after receiving the clinic summary report
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
affiliation: University of Pittsburgh
name: Deborah E Polk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polk DE, Guerrero EG, Gruss I, Shah NH, Yosuf NM, Dawson T, Kaplan CD, Pihlstrom DJ, Fellows JL. Study protocol: A stepped-wedge, cluster-randomized trial of the effectiveness of a deliberative loop in identifying implementation strategies for the adoption of a dental sealant guideline in dental clinics. Implement Sci Commun. 2021 Aug 28;2(1):96. doi: 10.1186/s43058-021-00199-6.