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

Pit-and-Fissure Sealants Clinical Trial

— DISGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682730
• Other study ID #: STUDY20020201
• Secondary ID: U01DE02745217-07
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 26, 2022

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 896
• Est. completion date: January 26, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Employed by Kaiser Permanente Northwest Dental or Permanente Dental Associates

• Work in a Kaiser Permanente Northwest dental clinic

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Pit-and-Fissure Sealants

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Kaiser Permanente, National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability, Management - Deliberative Loop Process	management's perceptions of the acceptability of the Deliberative Loop process measured on a 5-point Likert scale, 0=not at all acceptable to 4=completely acceptable; These ratings were dependent upon having all other analyses completed.	A single assessment following completion of all data analyses, approximately 1.5 years after the data collection end date.
Other	Acceptability, Stakeholders - Deliberative Loop Process	Stakeholders' perceptions of the acceptability of the Deliberative Loop process, 1 question, 5-point Likert scale, 0=Strongly Disagree, 4=Strongly Agree; A higher score means more acceptability.; Note: UBT stands for unit-based team. It is a group of frontline employees, including managers, dental staff (assistants, hygienists), and dentists who work together. UBTs hold regular meetings as part of their standard work flow and collaborate with one another to improve member and patient care.	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.
Other	Acceptability, Stakeholders - Context Setting Document	Stakeholders' perceptions of the acceptability of the Context-Setting Document, 3 questions measured on a 5-point Likert scale, 0=Strongly disagree to 12=Strongly agree. Note - Each item is 0 to 4, and the total score ranges from 0 - 12.; A higher score means more acceptability.	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.
Other	Helpfulness of Group Discussion	Stakeholders' perceptions of helpfulness of group discussion measured on a 3 question, 5-point Likert scale, 0=Strongly disagree to 12=Strongly agree. Note - Each item is 0 to 4, and the total score ranges from 0 - 12.; A higher score means more helpfulness.; Note: UBT stands for unit-based team. It is a group of frontline employees, including managers, dental staff (assistants, hygienists), and dentists who work together. UBTs hold regular meetings as part of their standard work flow and collaborate with one another to improve member and patient care.	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.
Other	Promotive Voice	Stakeholders' perceptions of ability to express new ideas or suggestions for improving the clinic, 5 questions, 5-point Likert scale. Note - Each item is 0 to 4, and the total score ranges from 0-20, 0=Strongly disagree to 20=Strongly agree.; A higher score means more promotive voice.; Note: UBT stands for unit-based team. It is a group of frontline employees, including managers, dental staff (assistants, hygienists), and dentists who work together. UBTs hold regular meetings as part of their standard work flow and collaborate with one another to improve member and patient care.	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.
Other	Prohibitive Voice	Stakeholders' perceptions of ability to express concern about work practices that may be harmful to the clinic, 5 questions, 5-point Likert scale. Note - Each item is 0 to 4, and the total score ranges from 0-20, 0=Strongly disagree to 20=Strongly agree.; A higher score means more prohibitive voice.; Note: UBT stands for unit-based team. It is a group of frontline employees, including managers, dental staff (assistants, hygienists), and dentists who work together. UBTs hold regular meetings as part of their standard work flow and collaborate with one another to improve member and patient care.	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.
Other	Future Leadership Responsiveness	Stakeholders' perceptions that suggestions will be taken into consideration by leadership, 1 item, 5-point Likert scale, 0=Strongly disagree to 4=Strongly agree; A higher score means more leadership responsiveness.	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.
Other	Past Leadership Responsiveness	Stakeholders' perceptions that suggestions have been taken into consideration by leadership in the past, 2 questions, 5-point Likert scale. Note - Each item is 0 to 4, and the total score ranges from 0-8, 0=Strongly disagree to 8=Strongly agree.; A higher score means more stakeholder perception of leadership responsiveness.	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.
Other	Overall Voice	Stakeholders' perceptions of voice, 1 question, 5-point Likert scale, 0=Strongly disagree to 4=Strongly agree; A higher score means more overall voice.; Note: UBT stands for unit-based team. It is a group of frontline employees, including managers, dental staff (assistants, hygienists), and dentists who work together. UBTs hold regular meetings as part of their standard work flow and collaborate with one another to improve member and patient care.	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.
Other	Perceptions of Discussion	Stakeholders' perceptions about the discussion, 2 questions, 5-point Likert scale. Note - Each item is 0 to 4, and the total score ranges from 0 - 8, 0=Strongly disagree to 8=Strongly agree.; A higher score means more consideration of important issues and points of view.; Note: UBT stands for unit-based team. It is a group of frontline employees, including managers, dental staff (assistants, hygienists), and dentists who work together. UBTs hold regular meetings as part of their standard work flow and collaborate with one another to improve member and patient care.	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.
Other	List of Implementation Strategies Endorsed by Stakeholders	Stakeholders' informed opinion about what implementation strategies their clinic should adopt for each barrier	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.
Other	List of Barriers Perceived by Stakeholders	Stakeholders' informed opinion about barriers they perceive in their clinic	One survey was available for participants to complete immediately following the DL session and the survey stayed available for 1 week following the session.
Other	List of Implementation Strategies Adopted by the Clinics, Quantitative	List of implementation strategies. Clinic staff can select strategies on the list that their clinic has adopted to document progress of the implementation process	3 months after receiving the clinic summary report
Other	List of Implementation Strategies Adopted by the Clinics, Qualitative	qualitative interviews of clinic staff, using the quantitative forms as the basis for the interview	3 months after receiving the clinic summary report
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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