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Completed

NCT Number: NCT04682730

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

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.

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Key information

Conditions

Pit-and-Fissure Sealants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Deliberative Loop

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.

Primary outcomes

  1. Change in Providers' Rates of Placing or Treatment Planning Sealants for Occlusal NCCLs

    Time frame: from one month before the first step to two months after the final step, 1 year.

    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

Secondary outcomes

  1. Total Program Costs

    Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year

    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.

  2. Cost Per Clinic

    Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year

    Program costs: Cost per clinic

  3. Cost Per Member Per Month (PMPM)

    Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year

    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.

  4. Annualized Costs for Guideline Implementation Interventions

    Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year

    Program costs: Annualized costs for guideline implementation interventions

  5. NCCL Treatment Costs- Total Program Costs Per Sealant

    Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year

    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.

  6. NCCL Treatment Costs- Total Program Costs Per Sealant Per Clinic

    Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year

    Program costs: NCCL treatment costs- Total program costs per sealant per clinic

  7. NCCL Treatment Costs- Per Sealant Per Member Per Month (PMPM)

    Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year

    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.

  8. Sealant Treatment Plan Resolution

    Time frame: 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)

    The count of occlusal NCCLs with a treatment plan for sealants that is sealed by the end of the post-intervention evaluation period.

  9. Cost Effectiveness

    Time frame: from one month before the first step to two months after the final step, 1 year

    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.

Other outcomes

  1. Acceptability, Management - Deliberative Loop Process

    Time frame: A single assessment following completion of all data analyses, approximately 1.5 years after the data collection end date.

    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.

  2. Acceptability, Stakeholders - Deliberative Loop Process

    Time frame: 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.

    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.

  3. Acceptability, Stakeholders - Context Setting Document

    Time frame: 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.

    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.

  4. Helpfulness of Group Discussion

    Time frame: 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.

    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.

  5. Promotive Voice

    Time frame: 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.

    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.

  6. Prohibitive Voice

    Time frame: 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.

    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.

  7. Future Leadership Responsiveness

    Time frame: 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.

    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.

  8. Past Leadership Responsiveness

    Time frame: 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.

    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.

  9. Overall Voice

    Time frame: 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.

    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.

  10. Perceptions of Discussion

    Time frame: 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.

    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.

  11. List of Implementation Strategies Endorsed by Stakeholders

    Time frame: 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.

    Stakeholders' informed opinion about what implementation strategies their clinic should adopt for each barrier

  12. List of Barriers Perceived by Stakeholders

    Time frame: One survey was available for participants to complete immediately following the DL session and the survey stayed available for 1 week following the session.

    Stakeholders' informed opinion about barriers they perceive in their clinic

  13. List of Implementation Strategies Adopted by the Clinics, Quantitative

    Time frame: 3 months after receiving the clinic summary report

    List of implementation strategies. Clinic staff can select strategies on the list that their clinic has adopted to document progress of the implementation process

  14. List of Implementation Strategies Adopted by the Clinics, Qualitative

    Time frame: 3 months after receiving the clinic summary report

    qualitative interviews of clinic staff, using the quantitative forms as the basis for the interview

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Kaiser Permanente
  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

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

Acronym: DISGO

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 24, 2020
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.