Trial Outcomes & Findings for An Implementation Strategy for the Adoption of an Evidence-Based Guideline for Pit-and-Fissure Sealants (NCT NCT04682730)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

896 participants

Primary outcome timeframe

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

Results posted on

2023-07-12

Participant Flow

All providers and staff at 16 intervention clinics at Kaiser Permanente (KP). Overall study - January 1, 2021 - December 31, 2021

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.

Unit of analysis: Dental Clinic

Participant milestones

Participant milestones
Measure	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	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	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	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	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	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
Overall Study STARTED	47 1	166 3	190 3	164 3	131 3	198 3
Overall Study Intro Session	48 1	80 3	83 3	68 3	60 3	58 3
Overall Study Deliberative Forum	25 1	89 3	76 3	64 3	54 3	55 3
Overall Study Surveys Received	8 1	70 3	55 3	42 3	48 3	30 3
Overall Study COMPLETED	8 1	70 3	55 3	42 3	48 3	30 3
Overall Study NOT COMPLETED	39 0	96 0	135 0	122 0	83 0	168 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Participants - Deliberative Loop n=5983 Teeth 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	671 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Sex: Female, Male Female	549 Participants n=5 Participants
Sex: Female, Male Male	131 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	635 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	13 Participants n=5 Participants
Race (NIH/OMB) Asian	97 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants
Race (NIH/OMB) White	520 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Region of Enrollment United States	680 participants n=5 Participants
Provider rate of placing or treatment planning sealants for occlusal NCCLs	137 Teeth n=176 Teeth

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Outcome measures
Measure	Deliberative Loop n=9600 Teeth 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.
Change in Providers' Rates of Placing or Treatment Planning Sealants for Occlusal NCCLs Pre-intervention	137 Teeth
Change in Providers' Rates of Placing or Treatment Planning Sealants for Occlusal NCCLs Post-intervention	95 Teeth

SECONDARY outcome

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

Population: KPNW Dental system

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.

Outcome measures

Outcome measures
Measure	Deliberative Loop n=1 Dental System 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.
Total Program Costs	125,521 dollars

SECONDARY outcome

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

Population: 16 dental clinics

Program costs: Cost per clinic

Outcome measures

Outcome measures
Measure	Deliberative Loop n=16 dental clinics 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.
Cost Per Clinic	7845 dollars per clinic Interval 6378.0 to 9312.0

SECONDARY outcome

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

Population: 265,200 members age 6 yrs or more on January 1, 2021 x 12 months.

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.

Outcome measures

Outcome measures
Measure	Deliberative Loop n=3182400 Members/patients 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.
Cost Per Member Per Month (PMPM)	0.039 dollars per member per month

SECONDARY outcome

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

Population: 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.

Program costs: Annualized costs for guideline implementation interventions

Outcome measures

Outcome measures
Measure	Deliberative Loop n=1 dental system 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.
Annualized Costs for Guideline Implementation Interventions	125,521 dollars

SECONDARY outcome

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

Population: Within KPNW Dental system, teeth receiving a 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.

Outcome measures

Outcome measures
Measure	Deliberative Loop n=95 teeth 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.
NCCL Treatment Costs- Total Program Costs Per Sealant	1321 dollars per sealant

SECONDARY outcome

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

Population: KPNW Dental System / 16 intervention clinics

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

Outcome measures

Outcome measures
Measure	Deliberative Loop n=16 dental clinics 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.
NCCL Treatment Costs- Total Program Costs Per Sealant Per Clinic	1321 dollars per sealant per clinic Interval 845.0 to 3208.0

SECONDARY outcome

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

Population: 265,200 members age 6 yrs or more on Jan1, 2021

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.

Outcome measures

Outcome measures
Measure	Deliberative Loop n=265200 Members/patients 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.
NCCL Treatment Costs- Per Sealant Per Member Per Month (PMPM)	0.0004 dollars per sealant PMPM

SECONDARY outcome

Timeframe: 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)

Population: Teeth with a treatment plan

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

Outcome measures

Outcome measures
Measure	Deliberative Loop n=89 Teeth 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.
Sealant Treatment Plan Resolution	89 Teeth

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

Population: PDA Dental Director for Evidence Based Practice - this is one person

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.