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| ID | Type | Description | Link |
|---|---|---|---|
| U01DE027452 | U.S. NIH Grant/Contract | View source | |
| 17-077-E | Other Identifier | NIDCR |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
| Kaiser Permanente | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deliberative Loop | Experimental | 28-page Context-Setting Document; 2-page addendum to Context-Setting Document; 90 minute Deliberative session; 8-page post-session survey |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah E Polk, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Center for Health Research | Portland | Oregon | 97227 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42277765 | Derived | Dawson T, Kaplan CD, Polk DE. Public health and private healthcare: a directed content analysis of citizenship behavior in transcripts from online deliberative engagement among oral healthcare providers considering implementation of an evidence-based clinical practice guideline. BMC Oral Health. 2026 Jun 11. doi: 10.1186/s12903-026-08390-8. Online ahead of print. | |
| 40415002 | Derived | 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. |
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The IPD sharing plan includes sharing with other researchers all collected, deidentified IPD.
Data from this study may be requested from other researchers up to five years after the completion of the primary endpoint.
The investigators will make available the study protocol, data dictionary, and de-identified dataset for analysis for researchers who contact the clinical site PI, Jeff Fellows, to facilitate and to provide context for any planned analysis.
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This is a stepped wedge cluster randomized trial where dental clinics were randomized to the Deliberative Loop intervention. Clinics were randomized to one of five intervention periods. We randomized three clinics at a time. The goal was to have a six-week window in which to run the three clinics that are in a given step and then a week gap before the next step's six-week window starts.
All providers and staff at 16 intervention clinics at Kaiser Permanente (KP). Overall study - January 1, 2021 - December 31, 2021
| ID | Title | Description |
|---|---|---|
| FG000 | Deliberative Loop (DL) Vanguard | January 1, 2021- March 22, 2021 (3 months) non intervention period March 23, 2021- December 31, 2021 (9 months) intervention period |
| FG001 | DL Cluster 1 | January 1, 2021 - April 29, 2021 or May 12, 2021 (4 - 4.5 months) non-intervention April 30, 2021 or May 13, 2021 (7.5 - 8 months) intervention |
| FG002 | DL Cluster 2 | January 1, 2021 - June 17 or June 21 or June 24, 2021 ( 5.5 - 6 months) non-intervention June 18 or June 22 or June 25, 2021 - December 31, 2021 (6 - 6.5 months) intervention |
| FG003 | DL Cluster 3 | January 1, 2021 - July 1 or July 28 or August 8, 2021 ( 6 - 7.5 months) non-intervention July 2 or July 29 or August 9, 2021 - December 31, 2021 (4.5 - 6 months) intervention |
| FG004 | DL Cluster 4 | January 1, 2021 - September 14 or October 7, 2021 ( 8.5 - 9 months) non-intervention September 15 or October 8, 2021 - December 31, 2021 (3 - 3.5 months) intervention |
| FG005 | DL Cluster 5 | January 1, 2021 - September 23 or October 7 or October 28, 2021 ( 9 - 10 months) non intervention September 24 or October 8 or October 29, 2021 - December 31, 2021 ( 2 - 3 months) intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The study participants were dental providers/staff & units analyzed were teeth of providers' patients. The 16 intervention clinic census at study start was 896 providers/staff. At study end, we received demographics of providers/staff at the 16 clinics & received data for 680 (data received in aggregate & we are not able to break it out by cluster.) Some staff are floaters & not assigned to 1 clinic. They rotate clinics & may have been counted several times, resulting in the census discrepancy.
| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants - Deliberative Loop | 28-page Context-Setting Document; 2-page addendum to Context-Setting Document; 90 minute Deliberative session; 8-page post-session survey 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | The study participants are dental providers/staff. However, our primary outcome measured the change in the dental providers' rates of placing or treatment planning sealants for occlusal NCCLs from before to after clinic stakeholders are exposed to the Deliberative Loop intervention. Therefore, the units analyzed were teeth of the providers' patients. The number of participant providers that apply to the 9600 teeth is not available. | Posted | Count of Units | Teeth | from one month before the first step to two months after the final step, 1 year. | Teeth | Teeth |
|
1 year in which AE and SAE data could have been collected.
As participants were dental providers/staff and the ones exposed to the intervention, collection of AE was not applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deliberative Loop | 28-page Context-Setting Document; 2-page addendum to Context-Setting Document; 90 minute Deliberative session; 8-page post-session survey 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deborah Polk, PhD | University of Pittsburgh | 14126488656 | dpolk@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2020 | Dec 15, 2022 | Prot_SAP_000.pdf |
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Stepped wedge. In addition to the vanguard clinic, there will be five steps, each with three clinics.
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| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 37735706 | Derived | 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. |
| 37407045 | Derived | 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. |
| 37205489 | Derived | 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. |
| 34454637 | Derived | 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. |
| Teeth |
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| Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Provider rate of placing or treatment planning sealants for occlusal NCCLs | Count of Units | Teeth | Teeth |
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| 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. | KPNW Dental system | Posted | Number | dollars | from planning the survey to gather background information to two months after the final step; an average of 1 year | Dental System | Dental System |
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| Secondary | Cost Per Clinic | Program costs: Cost per clinic | 16 dental clinics | Posted | Mean | 95% Confidence Interval | dollars per clinic | from planning the survey to gather background information to two months after the final step; an average of 1 year | dental clinics | dental clinics |
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| 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. | 265,200 members age 6 yrs or more on January 1, 2021 x 12 months. | Posted | Number | dollars per member per month | from planning the survey to gather background information to two months after the final step; an average of 1 year | Members/patients | Members/patients |
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| Secondary | Annualized Costs for Guideline Implementation Interventions | Program costs: Annualized costs for guideline implementation interventions | KPNW Dental System. All costs reported are automatically annualized. Originally we thought the intervention would cross calendar years. Since the intervention took place entirely in 2021, it is automatically annualized. | Posted | Number | dollars | from planning the survey to gather background information to two months after the final step; an average of 1 year | dental system | dental system |
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| 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. | Within KPNW Dental system, teeth receiving a sealant. | Posted | Number | dollars per sealant | from planning the survey to gather background information to two months after the final step; an average of 1 year | teeth | teeth |
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| Secondary | NCCL Treatment Costs- Total Program Costs Per Sealant Per Clinic | Program costs: NCCL treatment costs- Total program costs per sealant per clinic | KPNW Dental System / 16 intervention clinics | Posted | Mean | 95% Confidence Interval | dollars per sealant per clinic | from planning the survey to gather background information to two months after the final step; an average of 1 year | dental clinics | dental clinics |
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| 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. | 265,200 members age 6 yrs or more on Jan1, 2021 | Posted | Number | dollars per sealant PMPM | from planning the survey to gather background information to two months after the final step; an average of 1 year | Members/patients | Members/patients |
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| 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. | Teeth with a treatment plan | Posted | Count of Units | Teeth | 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) | Teeth | Teeth |
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| 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. | Cost-effectiveness analyses are not conducted for interventions that are found to be ineffective compared to controls. Therefore, measure could not be assessed due to the results of the primary outcome measure. | Posted | from one month before the first step to two months after the final step, 1 year |
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| Other Pre-specified | 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. | PDA Dental Director for Evidence Based Practice - this is one person | Posted | Number | score on a scale | A single assessment following completion of all data analyses, approximately 1.5 years after the data collection end date. |
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| Other Pre-specified | 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. | Participants in deliberative loop process and UBT process. Same participants. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Other Pre-specified | 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. | Post deliberative loop session survey respondents. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Other Pre-specified | 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. | Participants in both deliberative loop and UBT sessions. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Other Pre-specified | 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. | Participants in both deliberative loop and UBT sessions. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Other Pre-specified | 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. | Participants in both deliberative loop and UBT sessions. Same participants. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Other Pre-specified | 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. | Participants in deliberative loop session who filled out the post-session survey | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Other Pre-specified | 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. | Participants in the deliberative loop session who filled out the post-session survey. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Other Pre-specified | 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. | Participants in both deliberative loop and UBT sessions. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Other Pre-specified | 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. | Participants in both deliberative loop and UBT sessions | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Other Pre-specified | List of Implementation Strategies Endorsed by Stakeholders | Stakeholders' informed opinion about what implementation strategies their clinic should adopt for each barrier | Not Posted | 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. | Participants |
| Other Pre-specified | List of Barriers Perceived by Stakeholders | Stakeholders' informed opinion about barriers they perceive in their clinic | Not Posted | One survey was available for participants to complete immediately following the DL session and the survey stayed available for 1 week following the session. | Participants |
| Other Pre-specified | 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 | Not Posted | 3 months after receiving the clinic summary report | Participants |
| Other Pre-specified | List of Implementation Strategies Adopted by the Clinics, Qualitative | qualitative interviews of clinic staff, using the quantitative forms as the basis for the interview | Not Posted | 3 months after receiving the clinic summary report | Participants |
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