Study Design
The DISGO study used a cluster-randomized, stepped-wedge design. Based on both clinic volume and provider staffing full-time equivalents in 2019, we categorized clinics into tertiles according to size as large, medium, or small. One of the study analysts used the rand function in SAS on a Uniform(0, 1) distribution to order clinics within each tertile, numbering them 1 - 5. Clinics were assigned to five clusters defined by this ordering, with every cluster containing a single clinic from each tertile. One of the study project managers then enrolled clinics by the cluster number. We deployed the deliberative engagement process by cluster, allowing six weeks between each cluster. Prior to launching the deliberative engagement process in the clusters, we deployed it in one vanguard clinic. Each clinic had its own nonintervention and intervention periods. For the study as a whole, the nonintervention period began January 1, 2021, and the intervention period ended December 31, 2021. For each clinic, their intervention period began when the providers and staff in that clinic received a summary report of their recommendations following their deliberative forum. The deliberative engagement process was deployed in the vanguard clinic in March 2021 and in the final clinic of the last cluster in October 2021.
Study Site and Sample
The Kaiser Permanente Dental (KPD) program is part of the Kaiser Permanente Northwest (KPNW) integrated health care system and provides comprehensive, prepaid dental care services to over 250,000 dental plan members in Oregon and southwest Washington. Across all KPD plans, there are no age or frequency limitations for placing dental sealants. In addition, KPD is part of Health Share of Oregon (www.healthshareoregon.org), a large coordinated care organization that services the state’s Medicaid population in the tri-county Portland metropolitan area.
Staff are employed in two different organizations. Dental hygienists, expanded function dental assistants, and administrative staff are employed by KPNW and are mostly unionized. Dentists and denturists are employed by Permanente Dental Associates (PDA), which is employee-owned and which has a contract with KPNW to provide dental services. Kaiser Permanente engages with its workforces through a labor-management partnership. In the dental clinics, this partnership is manifested in a self-directed decision-making structure called a Unit-Based Team (UBT), which is co-led by a manager, a staff member, and a dentist. The team includes all the members of the work group, which enables it to build on the diverse perspectives and expertise of the team members. The purpose of the UBT is to address issues affecting performance or the work environment, and thus these meetings may serve as a facilitator to implementation.
We included all clinics that were not dedicated urgent care clinics. The deliberative engagement process targeted general and pediatric dentists, dental hygienists, expanded function dental assistants, and administrative staff in the clinics. Specialists who would not be likely to place sealants, such as periodontists, endodontists, and prosthodontists, were excluded.
Deliberative Engagement Process
To address the first component of a deliberative engagement process, access to expert information providing background information about an issue, during a UBT meeting, clinic providers and staff watched a 15-minute pre-recorded video introduction to the study and to the deliberative engagement process. Subsequently, via email, they received a 27-page workbook providing background material, the two barriers, and possible implementation interventions to consider (see the clinical protocol (18) and Additional File 1 for a description of the workbook).
To address the second component of the deliberative engagement process, participating in a facilitated small group discussion, and third component, considering options, about a month after receiving the background information, clinic providers and staff participated in an online, chat- (text-) based, facilitated small group discussion (i.e., deliberative forum) using the Common Ground for Action platform (Kettering Foundation and the National Issues Forums Institute, Dayton, Ohio). The target group size was 6-8, and to ensure role diversity within each group, clinic providers and staff were assigned to specific groups based on their role. Each discussion lasted 1 ½ hours, in place of a standing UBT meeting.
To address the fourth component of the deliberative engagement process, sharing informed opinions with leadership, immediately following each small group discussion, we provided clinic providers and staff a link to a Qualtrics survey (Qualtrics, Provo, Utah) where they could both record their recommendations to leadership and complete a survey about the process and their perception of voice. Although in the deliberative forum, eight possible implementation interventions were presented, on the post-session survey, we included only the five with the strongest evidence base as determined in our formative research (19). We summarized survey responses by clinic and provided 4-page reports to clinic leadership, clinic providers and staff, and practice leadership including the PDA Dental Director for Evidence-Based Practice.
Evidence-Based Practice in the Guideline
The PDA guideline recommends that dentists and dental hygienists apply either of two sealant materials, resin or glass ionomer. If a resin sealant is applied, first the tooth surface is cleaned. Then the tooth is isolated, dried, and rinsed. After rinsing, the tooth is re-isolated and dried again. Then, the etching is checked, and the sealant is applied, cured with a light, and checked. If a glass ionomer sealant is applied, first the tooth is isolated and cleaned. Then, the sealant is applied and checked.
Primary Outcome
The primary outcome, a measure of Reach, the extent to which a program attracts its intended audience (20), was calculated for each clinic and for each dentist as the difference in the rates of sealant application for occlusal, enamel carious lesions between the intervention and nonintervention periods. This represents patient-level receipt of guideline-concordant care. Providers’ rates of sealant application for occlusal enamel lesions were extracted from the electronic health record.
Proximal Outcomes
These outcomes included survey respondents’ agreement with the two barriers we had identified and the implementation interventions we provided (see Additional File 2). These questions were scored on a 5-point Likert-type scale ranging from “Strongly Disagree” (coded 1) to “Strongly Agree” (coded 5) and were followed by free text response boxes for comments and suggestions. Clinic providers and staff answered these questions immediately following the deliberative forum, via the post-session survey.
Mediators
We conducted exploratory analyses of three putative mediators: change in opinion, perception of voice, and adoption of clinic report recommendations. To measure change in each forum participant’s opinions, for each of the eight possible implementation interventions, we compared each forum participant’s ratings (i.e., ActionWeShould, ActionConflicted, ActionWeShouldNot, ActionUnranked) at the beginning of the deliberative forum with their ratings at the end of the deliberative forum.
We employed four measures of clinic providers’ and staffs’ perceptions of voice, which we define as having the opportunity to share one’s views. First and second, we administered the Promotive and Prohibitive Voice scales [21]. Clinic providers and staff completed the scales immediately following the deliberative forum, via the post-session survey. Clinic providers and staff completed the scales twice, first as the scales characterized their deliberative forum and second as the scales characterized past UBT meetings. Each scale has five items and is scored on a 5-point Likert-type scale ranging from “Strongly Disagree” (coded 1) to “Strongly Agree” (coded 5).
Third, the post-session survey included a question addressing the clinic providers’ and staffs’ perception of leadership responsiveness to feedback in the past year and anticipated responsiveness to the feedback from the forum. These questions were scored on a 5-point Likert-type scale ranging from “Strongly Disagree” (coded 1) to “Strongly Agree” (coded 5) and were followed by a free response box for comments and suggestions.
Fourth, we analyzed the transcripts from the deliberative forums using six codes to assess forum participant voice (results published separately; Grub, under review). An example of one of the codes is as follows: “Suggest new behaviors which are beneficial to my clinic.”
To understand the process of adoption of clinic report recommendations, we interviewed a key leader at each clinic, such as the clinic manager, three months after delivering the clinic report. To guide the interview we developed a set of 15 open-ended questions that included: “Tell me about your experience with the Deliberative [Engagement Process];” “Do you think the forum led to improved strategies and increased implementation of guidelines?;” and “Were there any conversations that took place after the forum, and can you tell me what was said?” For a description of the data analysis, please see the Additional File 3. One separate interview was conducted with the Dental Director for Evidence-Based Practice. This interview included six questions asking his thoughts about the summary reports provided to the clinics and any actions taken or planned as a result of those reports.
Power
Power was calculated using the “stepped wedge” package in Stata 16 [15], based on the approach developed by Hussey and Hughes [16]. Our null hypothesis was that providers’ rates of placing or treatment planning sealants for occlusal NCCLs would not differ between the nonintervention and intervention periods. Our alternative hypothesis was that providers’ rates of placing or treatment planning sealants for occlusal NCCLs would increase following the intervention. We assumed a Type I error of 0.05, a 3% rate of placing or treatment planning sealants in the non-intervention period, and a 10% rate in the intervention period, which is an increase seen in similar interventions [17]. Randomizing 15 clinics along with 1 vanguard clinic using a stepped-wedge approach with these assumptions, we had at least 80% power to detect a difference and close to 100% power under some scenarios.
Statistical Analysis
The primary end point was calculated as the change in the providers’ rates of placing or treatment planning sealants for occlusal NCCLs from before to after clinic providers and staff were exposed to the deliberative engagement intervention. The PDA guideline includes children, adolescents, and adults. To enable comparison with studies following the ADA guideline, in addition to analyzing lesions occurring in children, adolescents, and adults, we also conducted analyses for lesions occurring in just children and adolescents. Per the ADA, we defined “children and adolescents” as persons ranging in age from 6 through 17. The rates, and their difference, were treated as continuous variables. We used a generalized linear mixed model to model the intervention effect on sealant placement while nesting teeth within provider, and provider within clinic. We also accounted for secular time trends as a categorical fixed effect.
To examine differences between clinics and between survey respondents within clinics on agreement with the barriers and implementation interventions, we conducted ANOVA for each question to compare the mean scores by clinic (F-test) and the variance within clinic (Bartlett’s test). To quantify change in opinion from the beginning to the end of the deliberative forum, we calculated a Cohen’s kappa for each forum participant. Ratings were treated as changed if the rating made before the forum differed from the rating made at the end of the forum. We used descriptive statistics to summarize the distribution of the Cohen’s kappas and the voice self-reports. All analyses were conducted using Stata 17 (College Station, TX) and RStudio.
SARS-CoV-19 Modifications
Prior to the start of the intervention, due to SARS-CoV-19 pandemic restrictions on in-person meetings, we changed the setting of the deliberative forums from an in-person meeting to the Common Ground for Action online platform. Because the clinics were closed for several months at the beginning of the pandemic, we started the intervention 6 months later than we had originally intended, and as a result, we reduced the follow-up time from 12 months to 6 months. To accommodate the reduction in follow-up time, we changed the design of the study from a randomized, controlled clinical trial to a cluster-randomized, stepped wedge trial. Additionally, we expanded the primary outcome from sealants placed to sealants placed or treatment planned.