An Implementation Strategy for the Adoption of an Evidence-Based Guideline for Pit-and-Fissure Sealants

NCT ID: NCT04682730

Last Updated: 2023-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 896 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-01-26

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.

Conditions

Pit-and-Fissure Sealants

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Deliberative Loop

28-page Context-Setting Document; 2-page addendum to Context-Setting Document; 90 minute Deliberative session; 8-page post-session survey

Group Type: EXPERIMENTAL

Deliberative Loop

Intervention Type: BEHAVIORAL

The investigators will give background information to the stakeholders before they engage in the Deliberative session.

Stakeholders from a given clinic will come together for a Deliberative session (i.e., facilitated conversation), enabling them to hear the full range of perspectives held by their fellow colleagues and to share their own perspective regarding how best to implement the guideline in small-group discussions.

Following the Deliberative session, each stakeholder will have the opportunity to record their opinions regarding possible implementation interventions. The investigators will share these opinions with the clinic's decision-makers to help guide their decision-making about which implementation interventions to deploy. If a stakeholder happens to be absent the day of their clinic's Deliberative session, they will still have the opportunity to complete the survey.

Interventions

Deliberative Loop

The investigators will give background information to the stakeholders before they engage in the Deliberative session.

Stakeholders from a given clinic will come together for a Deliberative session (i.e., facilitated conversation), enabling them to hear the full range of perspectives held by their fellow colleagues and to share their own perspective regarding how best to implement the guideline in small-group discussions.

Following the Deliberative session, each stakeholder will have the opportunity to record their opinions regarding possible implementation interventions. The investigators will share these opinions with the clinic's decision-makers to help guide their decision-making about which implementation interventions to deploy. If a stakeholder happens to be absent the day of their clinic's Deliberative session, they will still have the opportunity to complete the survey.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Deborah Polk

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah E Polk, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Kaiser Permanente Center for Health Research

Portland, Oregon, United States

Countries

United States

References

Polk DE, Shah NH, Dawson T, Gruss I, Pihlstrom DJ, Kaplan CD, Guerrero EG, Fellows JL. Results from a cluster-randomized, stepped-wedge trial testing a deliberative engagement intervention to increase guideline adherence among U.S. oral health providers. Sci Rep. 2025 May 25;15(1):18180. doi: 10.1038/s41598-025-03236-9.

Reference Type: DERIVED

PMID: 40415002 (View on PubMed)

Gruss I, Dawson T, Kaplan CD, Pihlstrom DJ, Fellows JL, Polk DE. Utilizing deliberative engagement for identifying implementation strategy priorities: lessons learned from an online deliberative forum with dental professionals. Implement Sci Commun. 2023 Sep 21;4(1):119. doi: 10.1186/s43058-023-00496-2.

Reference Type: DERIVED

PMID: 37735706 (View on PubMed)

Gruss I, Dawson T, Kaplan CD, Pihlstrom DJ, Reich S, Fellows JL, Polk DE. Sharing voice during deliberative engagement to improve guideline adherence in dental clinics: findings from a qualitative evaluation of an online deliberative forum discussion. BMJ Open. 2023 Jul 5;13(7):e072727. doi: 10.1136/bmjopen-2023-072727.

Reference Type: DERIVED

PMID: 37407045 (View on PubMed)

Polk D, Shah NH, Dawson T, Gruss I, Pihlstrom DJ, Kaplan CD, Guerrero EG, Fellows JL. Testing a Deliberative Democracy Engagement Intervention to Increase Guideline-Concordance Among Oral Health Providers: Results from the DISGO Cluster-Randomized, Stepped-Wedge Trial. Res Sq [Preprint]. 2023 May 4:rs.3.rs-2757518. doi: 10.21203/rs.3.rs-2757518/v1.

Reference Type: DERIVED

PMID: 37205489 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34454637 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U01DE027452

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-077-E

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY20020201

Identifier Type: -

Identifier Source: org_study_id