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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Implementation Strategy for the Adoption of an Evidence-Based Guideline for Pit-and-Fissure Sealants: Using a Framework From Organizational Development

Conditions
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Pit-and-Fissure Sealants

Intervention / Treatment
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* Behavioral: Deliberative Loop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Employed by Kaiser Permanente Northwest Dental or Permanente Dental Associates Work in a Kaiser Permanente Northwest dental clinic Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped wedge. In addition to the vanguard clinic, there will be five steps, each with three clinics.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deliberative Loop<br>28-page Context-Setting Document; 2-page addendum to Context-Setting Document; 90 minute Deliberative session; 8-page post-session survey | Behavioral: Deliberative Loop<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Providers' Rates of Placing or Treatment Planning Sealants for Occlusal NCCLs | The change in the providers' rates of placing or treatment planning sealants for occlusal NCCLs from before to after clinic stakeholders are exposed to the Deliberative Loop intervention | from one month before the first step to two months after the final step, 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NCCL Treatment Costs- Total Program Costs Per Sealant | Total intervention costs per sealant. Program cost analysis conducted for the Deliberative Loop (DL) intervention using an opportunity cost approach. Program costs were estimated for the DL intervention (Workbook development - including the guideline, EHR data analyses, initial practitioner survey, and evidence review - and printing; Online DL session facilitator training and delivery, and program tailoring; dental office staff time; costs for implemented strategies, if applicable; and allowed charges for dental sealant placements). All costs are reported in 2021 dollars. The study analysis period was Jan 1-Dec 31, 2021, and in 16 clinics during 2021. There were 95 sealants placed during the intervention period at 16 clinics. | from planning the survey to gather background information to two months after the final step; an average of 1 year | 
| NCCL Treatment Costs- Total Program Costs Per Sealant Per Clinic | Program costs: NCCL treatment costs- Total program costs per sealant per clinic | from planning the survey to gather background information to two months after the final step; an average of 1 year | 
| NCCL Treatment Costs- Per Sealant Per Member Per Month (PMPM) | Total intervention costs per sealant per member per month. Program cost analysis conducted for the Deliberative Loop (DL) intervention using an opportunity cost approach. Program costs were estimated for the DL intervention (Workbook development - including the guideline, EHR data analyses, initial practitioner survey, and evidence review - and printing; Online DL session facilitator training and delivery, and program tailoring; dental office staff time; costs for implemented strategies, if applicable; and allowed charges for dental sealant placements). All costs are reported in 2021 dollars. The study analysis period was Jan 1-Dec 31, 2021, and in 16 clinics during 2021. There were 95 sealants placed during the intervention period at 16 clinics. There were 265,200 members age 6 years or more on January 1, 2021, or a total of 3,182,400 member months. | from planning the survey to gather background information to two months after the final step; an average of 1 year | 
| Sealant Treatment Plan Resolution | The count of occlusal NCCLs with a treatment plan for sealants that is sealed by the end of the post-intervention evaluation period. | 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) | 
| Cost Effectiveness | Estimated incremental cost-effectiveness ratios (ICERs) for clinics after exposure to the intervention. ICERs calculated for annualized total costs, costs per clinic, and costs PMPM. | from one month before the first step to two months after the final step, 1 year | 
| Total Program Costs | Program costs: Total intervention costs. Program cost analysis conducted for the Deliberative Loop (DL) intervention using an opportunity cost approach. Program costs were estimated for the DL intervention (Workbook development - including the guideline, EHR data analyses, initial practitioner survey, and evidence review - and printing; Online DL session facilitator training and delivery, and program tailoring; dental office staff time; costs for implemented strategies, if applicable; and allowed charges for dental sealant placements). All costs are reported in 2021 dollars. The study analysis period was Jan 1-Dec 31, 2021, and in 16 clinics during 2021. | from planning the survey to gather background information to two months after the final step; an average of 1 year | 
| Cost Per Clinic | Program costs: Cost per clinic | from planning the survey to gather background information to two months after the final step; an average of 1 year | 
| Cost Per Member Per Month (PMPM) | Total intervention costs per member per month. Program cost analysis conducted for the Deliberative Loop (DL) intervention using an opportunity cost approach. Program costs were estimated for the DL intervention (Workbook development - including the guideline, EHR data analyses, initial practitioner survey, and evidence review - and printing; Online DL session facilitator training and delivery, and program tailoring; dental office staff time; costs for implemented strategies, if applicable; and allowed charges for dental sealant placements). All costs are reported in 2021 dollars. The study analysis period was Jan 1-Dec 31, 2021, and in 16 clinics during 2021. There were 265,200 members age 6 years or more on January 1, 2021, or a total of 3,182,400 member months. | from planning the survey to gather background information to two months after the final step; an average of 1 year | 
| Annualized Costs for Guideline Implementation Interventions | Program costs: Annualized costs for guideline implementation interventions | from planning the survey to gather background information to two months after the final step; an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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evidence-based clinical practice guideline, dental sealants, Deliberative Democracy, Deliberative Loop