Dataset Information

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.

ABSTRACT:

Background

The American Dental Association (ADA) recommends dental providers apply dental sealants to the occlusal surfaces of permanent molars for the prevention or treatment of non-cavitated dental caries. Despite the evidence-based support for this guideline, adherence among general dentists is low, ranging from less than 5 to 38.5%. Thus, an evidence-to-practice gap exists, and it is unclear which implementation strategies would best support providers in adopting and implementing the evidence-based practice. One potential approach to selecting and tailoring implementation strategies is a deliberative loop process, a stakeholder-engaged approach to decision-making. This trial aims to test the acceptability, feasibility, and effectiveness of using a deliberative loop intervention with stakeholders (i.e., providers and staff) to enable managers to select implementation strategies that facilitate the adoption of an evidence-based dental practice.

Methods

Sixteen dental clinics within Kaiser Permanente Northwest Dental will be cluster randomized to determine the timing of receiving the intervention in this stepped-wedge trial. In the three-part deliberative loop intervention, clinic stakeholders engage in the following activities: (1) receive background information, (2) participate in facilitated small-group discussions designed to promote learning from each other's lived experiences and develop informed opinions about effective clinic-level implementation strategies, and (3) share their informed opinions with clinic leaders, who may then choose to select and deploy implementation strategies based on the stakeholders' informed opinions. The primary outcome of Reach will be defined as patient-level receipt of guideline-concordant care. Secondary outcomes will include the cost-effectiveness, acceptability, and feasibility of the deliberative loop process. Implementation strategies deployed will be catalogued over time.

Discussion

These results will establish the extent to which the deliberative loop process can help leaders select and tailor implementation strategies with the goal of improving guideline-concordant dental care.

Trial registration

This project is registered at ClinicalTrials.gov with ID NCT04682730. The trial was first registered on 12/18/2020. https://clinicaltrials.gov/ct2/show/NCT04682730.

SUBMITTER: Polk DE

PROVIDER: S-EPMC8401236 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesSelecting effective implementation strategies to support guideline-concordant dental care is a complex process. For this research project, an online deliberative forum brought together staff from dental clinics to discuss the strengths and weaknesses of implementation strategies and barriers to implementation of a component of a dental (pit-and-fissure) guideline. The goal was to determine whether deliberative engagement enabled participants' sharing of promotive and prohibitive voice about implementation strategies to promote guideline-concordant care.DesignQualitative analysis of online chat transcripts of facilitated deliberations from 31 small group sessions.SettingKaiser Permanente Dental (KP Dental) in the USA.ParticipantsAll staff from 16 dental offices.ResultsThe directed content analysis revealed that participants shared prohibitive and promotive voice when offering critique of the barriers and the implementation strategies suggested by the researchers. The analysis also revealed that the focus of the deliberations often was not on the aspect of the pit-and-fissure guideline intended by the research team for deliberation.ConclusionsThe deliberative forum discussions were a productive venue to ask staff in dental clinics to share their perspectives on strategies to promote guideline-concordant care as well as barriers. Participants demonstrated prohibitive voice and engaged critically with the materials the research team had put together. An important limitation of the deliberation was that the discussion often centred around an aspect of the pit-and-fissure guideline that already was implemented well. To ensure a deliberation oriented towards resolving challenging aspects of the pit-and-fissure guideline, greater familiarity with the guideline would have been important, as well as more intimate knowledge of the current discrepancies in guideline-concordant care.Trial registration numberThis project is registered at ClinicalTrials.gov with ID NCT04682730. The trial was first registered on 18 December 2020. https://clinicaltrials.gov/ct2/show/NCT04682730.

Project description:BackgroundSelecting effective implementation strategies to support guideline-concordant dental care is a complex process. We are drawing on data collected during the DISGO study to reflect on barriers we encountered in implementing a deliberative engagement process for discussing implementation strategies relevant to the evidence-based guideline targeted in this intervention. The goal is to identify factors that may influence the success of deliberative engagement as a technique to involve healthcare staff in identifying priorities for implementation strategies.MethodsWe drew on online chat transcripts from the deliberative engagement forums collected during the DISGO study. The chat transcripts were automatically generated for each discussion and captured the written exchanges between participants and moderators in all participating dental clinics. Chat transcripts were analyzed following a content analysis approach.ResultsOur findings revealed barriers to the successful implementation of deliberative engagement in the context of the DISGO study. Participants were not familiar with the materials that had been prepared for the forum and lacked familiarity with the topic of deliberation. Participants also did not share divergent viewpoints and reinforced existing ideas rather than introducing new ideas.ConclusionsIn order to ensure that obstacles that were encountered in this study are not repeated, it is important to carefully consider how staff can effectively be prepared for the deliberations. Participants must be familiar with the content of the guideline, and most questions about the content and evidence should be answered before the deliberative engagement sessions. If perspectives among staff on a guideline are homogenous, briefing materials should introduce perspectives that complement existing views among staff. It is also necessary to create an environment in which staff are comfortable introducing opinions that may not be held by the majority of colleagues.Trial registrationThis project is registered at ClinicalTrials.gov with ID NCT04682730. The trial was first registered on 12/18/2020. https://clinicaltrials.gov/ct2/show/NCT04682730 .

Project description:BackgroundSuccessful and sustainable models for HIV pre-exposure prophylaxis (PrEP) delivery in public health systems in Africa are needed. We aimed to evaluate the implementation of PrEP delivery integrated in public HIV care clinics in Kenya.MethodsAs part of Kenya's national PrEP roll-out, we conducted a stepped-wedge cluster-randomised pragmatic trial to catalyse scale-up of PrEP delivery integrated in 25 public HIV care clinics. We selected high-volume clinics in these regions (ie, those with a high number of people living with HIV enrolled in HIV care and treatment). Clinics (each representing a cluster) were stratified by region and randomly assigned to the order in which clinic staff would receive PrEP training and ongoing technical support using numbered opaque balls picked from a bag. There was no masking. PrEP provision was done by clinic staff without additional financial support. Data were abstracted from records of individuals initiating PrEP. The primary outcome was the number of people initiating PrEP per clinic per month comparing intervention to control periods. Other outcomes included PrEP continuation, adherence, and incident HIV infections. This trial is registered with ClinicalTrials.gov, NCT03052010.FindingsAfter the baseline period, which started in January, 2017, every month two to six HIV care clinics crossed over from control to intervention, until August, 2017, when all clinics were implementing the intervention. Of 4898 individuals initiating PrEP (27 during the control period and 4871 during the intervention period), 2640 (54%) were women, the median age was 31 years (IQR 25-39), and 4092 (84%) reported having a partner living with HIV. The mean monthly number of PrEP initiations per clinic was 0·1 (SD 0·5) before the intervention and 7·5 (2·7) after intervention introduction (rate ratio 23·7, 95% CI 14·2-39·5, p<0·0001). PrEP continuation was 57% at 1 month, 44% at 3 months, and 34% at 6 months, and 12% of those who missed a refill returned later for PrEP re-initiation. Tenofovir diphosphate was detected in 68 (96%) of 71 blood samples collected from a randomly selected subset of participants. Six HIV infections were observed over 2531 person-years of observation (incidence 0·24 cases per 100 person-years), three of which occurred at the first visit after PrEP initiation.InterpretationWe observed high uptake, reasonable continuation with high adherence, frequent PrEP restarts, and low HIV incidence. Integration of PrEP services within public HIV care clinics in Africa is feasible.FundingNational Institute of Mental Health and Bill & Melinda Gates Foundation.

Project description:BackgroundDentists and oral surgeons are leading prescribers of opioids to adolescents and young adults (AYA), who are at high risk for developing problematic opioid use after an initial exposure. Most opioids are prescribed after tooth extraction, but non-opioid analgesics provide similar analgesia and are recommended by multiple professional organizations.MethodsThis multi-site stepped wedge cluster-randomized trial will assess whether a multicomponent behavioral intervention can influence opioid prescribing behavior among dentists and oral surgeons compared to usual practice. Across up to 12 clinical practices (clusters), up to 33 dentists/oral surgeons (provider participants) who perform tooth extractions for individuals 12-25 years old will be enrolled. After enrollment, all provider participants will receive the intervention at a time based on the sequence to which their cluster is randomized. The intervention consists of prescriber education via academic detailing plus provision of standardized patient post-extraction instructions and blister packs of acetaminophen and ibuprofen. Provider participants will dispense the blister packs and distribute the patient instructions at their discretion to AYA undergoing tooth extraction, with or without additional analgesics. The primary outcome is a binary, patient-level indicator of electronic post-extraction opioid prescription. Data for the primary outcome will be collected from the provider participant's electronic health records quarterly throughout the study. Provider participants will complete a survey before and approximately 3 months after transitioning into the intervention condition to assess implementation outcomes. AYA patients undergoing tooth extraction will be offered a survey to assess pain control and satisfaction with pain management in the week after their extraction. Primary analyses will use generalized estimating equations to compare the binary patient-level indicator of being prescribed a post-extraction opioid in the intervention condition compared to usual practice. Secondary analyses will assess provider participants' perceptions of feasibility and appropriateness of the intervention, and patient-reported pain control and satisfaction with pain management. Analyses will adjust for patient-level factors (e.g., sex, number of teeth extracted, etc.).DiscussionThis real-world study will address an important need, providing information on the effectiveness of a multicomponent intervention at modifying dental prescribing behavior and reducing opioid prescriptions to AYA.ClinicaltrialsGOV: NCT06275191.

Project description:Adolescent girls and young women account for a disproportionate fraction of new HIV infections in Africa and are a priority population for HIV prevention, including provision of pre-exposure prophylaxis (PrEP). Anchoring PrEP delivery to care settings like family planning (FP) services that women already access routinely may offer an efficient platform to reach HIV at-risk women. However, context-specific implementation science evaluation is needed. The Family Planning Plus Project is a prospective, pragmatic implementation evaluation, designed as a stepped wedge, cluster randomized trial, at 12 clinics in Kenya. In collaboration with the Kenya Ministry of Health and Kisumu County Department of Health, we will introduce integration of HIV risk screening and PrEP delivery in public health FP clinics. The core multifaceted implementation strategies to integrate PrEP in FP clinics will include: (1) PrEP delivery by existing FP clinic staff, (2) health provider training, (3) PrEP technical assistance to coach and mentor providers, (4) joint supervision with Kisumu County health officials, and (5) stakeholder engagement. All core components of PrEP delivery-including screening for HIV risk, HIV testing, dispensing, adherence and risk reduction counseling, assessment of side effects, and provision of refills, or safety assessment-will be conducted by existing FP clinic staff as part of a standard care service package. The goal is to catalyze sustainable scale-up within existing infrastructures beyond the project. We will rigorously evaluate implementation outcomes and impact, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, and we will use Organizational Readiness for Implementing Change (ORIC) and the Consolidated Framework for Implementation Science Research (CFIR) to assess readiness to implement and contextual enablers and barriers of implementation, including how clinics innovate efficient delivery systems. Anchoring PrEP delivery to existing FP systems and staffing has tremendous potential to address barriers that women face in accessing HIV prevention and PrEP care, including lack of time, cost, and stigma of visiting a facility solely for HIV prevention. The FP Plus Project will initiate preparation for full-scale and sustainable model of integration of comprehensive HIV prevention services, including PrEP implementation, in public health FP clinics in low-income settings. Trial registration Registered with ClinicalTrials.gov on December 14, 2020: NCT04666792.

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Project description:IntroductionRegulatory changes made during the COVID-19 public health emergency (PHE) that relaxed criteria for take-home dosing (THD) of methadone offer an opportunity to improve quality of care with a lifesaving treatment. There is a pressing need for research to study the long-term effects of the new PHE THD rules and to test data-driven interventions to promote more effective adoption by opioid treatment programs (OTPs). We propose a two-phase project to develop and test a multidimensional intervention for OTPs that leverages information from large State administrative data.Methods and analysisWe propose a two-phased project to develop then test a multidimensional OTP intervention to address clinical decision making, regulatory confusion, legal liability concerns, capacity for clinical practice change, and financial barriers to THD. The intervention will include OTP THD specific dashboards drawn from multiple State databases. The approach will be informed by the Health Equity Implementation Framework (HEIF). In phase 1, we will employ an explanatory sequential mixed methods design to combine analysis of large state administrative databases-Medicaid, treatment registry, THD reporting-with qualitative interviews to develop and refine the intervention. In phase 2, we will conduct a stepped-wedge trial over three years with 36 OTPs randomized to 6 cohorts of a six-month clinic-level intervention. The trial will test intervention effects on OTP-level implementation outcomes and patient outcomes (1) THD use; 2) retention in care; and 3) adverse healthcare events). We will specifically examine intervention effects for Black and Latinx clients. A concurrent triangulation mixed methods design will be used: quantitative and qualitative data collection will occur concurrently and results will be integrated after analysis of each. We will employ generalized linear mixed models (GLMMs) in the analysis of stepped-wedge trials. The primary outcome will be weekly or greater THD. The semi-structured interviews will be transcribed and analyzed with Dedoose to identify key facilitators, barriers, and experiences according to HEIF constructs using directed content analysis.DiscussionThis multi-phase, embedded mixed methods project addresses a critical need to support long-term practice changes in methadone treatment for opioid use disorder following systemic changes emerging from the PHE-particularly for Black and Latinx individuals with opioid use disorder. By combining findings from analyses of large administrative data with lessons gleaned from qualitative interviews of OTPs that were flexible with THD and those that were not, we will build and test the intervention to coach clinics to increase flexibility with THD. The findings will inform policy at the local and national level.

Project description:BackgroundStepped wedge randomised trial designs involve sequential roll-out of an intervention to participants (individuals or clusters) over a number of time periods. By the end of the study, all participants will have received the intervention, although the order in which participants receive the intervention is determined at random. The design is particularly relevant where it is predicted that the intervention will do more good than harm (making a parallel design, in which certain participants do not receive the intervention unethical) and/or where, for logistical, practical or financial reasons, it is impossible to deliver the intervention simultaneously to all participants. Stepped wedge designs offer a number of opportunities for data analysis, particularly for modelling the effect of time on the effectiveness of an intervention. This paper presents a review of 12 studies (or protocols) that use (or plan to use) a stepped wedge design. One aim of the review is to highlight the potential for the stepped wedge design, given its infrequent use to date.MethodsComprehensive literature review of studies or protocols using a stepped wedge design. Data were extracted from the studies in three categories for subsequent consideration: study information (epidemiology, intervention, number of participants), reasons for using a stepped wedge design and methods of data analysis.ResultsThe 12 studies included in this review describe evaluations of a wide range of interventions, across different diseases in different settings. However the stepped wedge design appears to have found a niche for evaluating interventions in developing countries, specifically those concerned with HIV. There were few consistent motivations for employing a stepped wedge design or methods of data analysis across studies. The methodological descriptions of stepped wedge studies, including methods of randomisation, sample size calculations and methods of analysis, are not always complete.ConclusionWhile the stepped wedge design offers a number of opportunities for use in future evaluations, a more consistent approach to reporting and data analysis is required.