Dataset Information

CATCH-UP vaccines: protocol for a randomized controlled trial using the multiphase optimization strategy (MOST) framework to evaluate education interventions to increase COVID-19 vaccine uptake in Oklahoma.

ABSTRACT:

Background

Oklahoma's cumulative COVID-19 incidence is higher in rural than urban counties and higher than the overall US incidence. Furthermore, fewer Oklahomans have received at least one COVID-19 vaccine compared to the US average. Our goal is to conduct a randomized controlled trial using the multiphase optimization strategy (MOST) to test multiple educational interventions to improve uptake of COVID-19 vaccination among underserved populations in Oklahoma.

Methods

Our study uses the preparation and optimization phases of the MOST framework. We conduct focus groups among community partners and community members previously involved in hosting COVID-19 testing events to inform intervention design (preparation). In a randomized clinical trial, we test three interventions to improve vaccination uptake: (1) process improvement (text messages); (2) barrier elicitation and reduction (electronic survey with tailored questions/prompts); and (2) teachable moment messaging (motivational interviewing) in a three-factor fully crossed factorial design (optimization).

Discussion

Because of Oklahoma's higher COVID-19 impact and lower vaccine uptake, identifying community-driven interventions is critical to address vaccine hesitancy. The MOST framework provides an innovative and timely opportunity to efficiently evaluate multiple educational interventions in a single study.

Trial registration

ClinicalTrials.gov: NCT05236270, First Posted: February 11, 2022, Last Update Posted: August 31, 2022.

SUBMITTER: Janitz AE

PROVIDER: S-EPMC10265558 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

CATCH-UP vaccines: protocol for a randomized controlled trial using the multiphase optimization strategy (MOST) framework to evaluate education interventions to increase COVID-19 vaccine uptake in Oklahoma.

Janitz Amanda E AE Neil Jordan M JM Bray Laura A LA Jervis Lori L LL Ross Laura L Campbell Janis E JE Doescher Mark P MP Spicer Paul G PG Williams Mary L ML Lopez April K AK Uribe-Frias Conce A CA Chen Sixia S James Judith A JA VanWagoner Timothy M TM

BMC public health 20230614 1

<h4>Background</h4>Oklahoma's cumulative COVID-19 incidence is higher in rural than urban counties and higher than the overall US incidence. Furthermore, fewer Oklahomans have received at least one COVID-19 vaccine compared to the US average. Our goal is to conduct a randomized controlled trial using the multiphase optimization strategy (MOST) to test multiple educational interventions to improve uptake of COVID-19 vaccination among underserved populations in Oklahoma.<h4>Methods</h4>Our study u ...[more]

PMID: 37316843

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Project description:BackgroundReports of children's engagement in active transportation outline low participation rates in many countries despite many associated mental, physical, and social health benefits. One of the main contributors to this phenomenon is a cited lack of education and knowledge among children regarding active travel (AT), specifically road safety. To address this issue, the aim of this study was to evaluate the feasibility and effectiveness of an online road safety education intervention to promote AT among children and their parents.MethodsApplying the Multiphase Optimization Strategy (MOST) for intervention development, implementation, and evaluation, we designed and assessed a four-module online road safety education intervention with a sample of 57 parent-child dyads using a 23 factorial design featuring both qualitative and quantitative analyses.ResultsMain intervention feasibility findings include positive and critical feedback on the program's content and design, and moderate participant engagement as reflected by program retention and completion rates. With respect to the preliminary intervention effectiveness on children, a significant improvement in road safety knowledge scores was observed for groups that feature the "wheeling safety and skills" module. Slight improvements in AT knowledge scores across all the intervention groups were observed, but were not of significance. Preliminary intervention effectiveness on select parental AT practices and perceptions saw significant improvements in some groups. Groups that featured the 'wheeling safety and skills' module exhibited significantly higher guided choice scores upon completion of the program than those who did not receive this component.ConclusionThe MOST framework allowed us to design and evaluate the feasibility and preliminary effectiveness of an online road safety education intervention. The developed intervention has demonstrated that it has the potential to improve children's road safety knowledge and some areas of parental AT practices and perceptions, to which improvements may be attributed to the inclusion of the "wheeling safety and skills" module, suggesting that the targeted focus on cycling skills is a prioritized area. AT programming and practice implications are discussed. Future research is encouraged to refine modules to better reflect the priorities of children and parents and to test these refined components among larger samples.Word count9,391 (excludes abstract, tables, figures, abbreviations, and references).

Project description:BackgroundDelivery of behavioral interventions is complex, as the majority of interventions consist of multiple components used either simultaneously, sequentially, or both. The importance of clearly delineating delivery strategies within these complex interventions-and furthermore understanding the impact of each strategy on effectiveness-has recently emerged as an important facet of intervention research. Yet, few methodologies exist to prospectively test the effectiveness of delivery strategies and how they impact implementation. In the current paper, we describe a study protocol for a large randomized controlled trial in which we will use the Multiphase Optimization Strategy (MOST), a novel framework developed to optimize interventions, i.e., to test the effectiveness of intervention delivery strategies using a factorial design. We apply this framework to delivery of Family Navigation (FN), an evidence-based care management strategy designed to reduce disparities and improve access to behavioral health services, and test four components related to its implementation.Methods/designThe MOST framework contains three distinct phases: Preparation, Optimization, and Evaluation. The Preparation phase for this study occurred previously. The current study consists of the Optimization and Evaluation phases. Children aged 3-to-12 years old who are detected as "at-risk" for behavioral health disorders (n = 304) at a large, urban federally qualified community health center will be referred to a Family Partner-a bicultural, bilingual member of the community with training in behavioral health and systems navigation-who will perform FN. Families will then be randomized to one of 16 possible combinations of FN delivery strategies (2 × 2 × 2× 2 factorial design). The primary outcome measure will be achieving a family-centered goal related to behavioral health services within 90 days of randomization. Implementation data on the fidelity, acceptability, feasibility, and cost of each strategy will also be collected. Results from the primary and secondary outcomes will be reviewed by our team of stakeholders to optimize FN delivery for implementation and dissemination based on effectiveness, efficiency, and cost.DiscussionIn this protocol paper, we describe how the MOST framework can be used to improve intervention delivery. These methods will be useful for future studies testing intervention delivery strategies and their impact on implementation.Trial registrationClinicalTrials.gov, NCT03569449. Registered on 26 June 2018.

Project description:BackgroundAmong those at highest risk for COVID-19 exposure is the large population of frontline essential workers in occupations such food service, retail, personal care, and in-home health services, among whom Black and Latino/Hispanic persons are over-represented. For those not vaccinated and at risk for exposure to COVID-19, including frontline essential workers, regular (approximately weekly) COVID-19 testing is recommended. However, Black and Latino/Hispanic frontline essential workers in these occupations experience serious impediments to COVID-19 testing at individual/attitudinal- (e.g., lack of knowledge of guidelines), social- (e.g., social norms), and structural-levels of influence (e.g., poor access), and rates of testing for COVID-19 are insufficient.Methods/designThe proposed community-engaged study uses the multiphase optimization strategy (MOST) framework and an efficient factorial design to test four candidate behavioral intervention components informed by an integrated conceptual model that combines critical race theory, harm reduction, and self-determination theory. They are A) motivational interview counseling, B) text messaging grounded in behavioral economics, C) peer education, and D) access to testing (via navigation to an appointment vs. a self-test kit). All participants receive health education on COVID-19. The specific aims are to: identify which components contribute meaningfully to improvement in the primary outcome, COVID-19 testing confirmed with documentary evidence, with the most effective combination of components comprising an "optimized" intervention that strategically balances effectiveness against affordability, scalability, and efficiency (Aim 1); identify mediators and moderators of the effects of components (Aim 2); and use a mixed-methods approach to explore relationships among COVID-19 testing and vaccination (Aim 3). Participants will be N = 448 Black and Latino/Hispanic frontline essential workers not tested for COVID-19 in the past six months and not fully vaccinated for COVID-19, randomly assigned to one of 16 intervention conditions, and assessed at 6- and 12-weeks post-baseline. Last, N = 50 participants will engage in qualitative in-depth interviews.DiscussionThis optimization trial is designed to yield an effective, affordable, and efficient behavioral intervention that can be rapidly scaled in community settings. Further, it will advance the literature on intervention approaches for social inequities such as those evident in the COVID-19 pandemic.Trial registrationClinicalTrials.gov: NCT05139927 ; Registered on 11/29/2021. Protocol version 1.0. May 2, 2022, Version 1.0.

Project description:BackgroundHealth and social service providers receive limited education on recognizing and responding to family violence. With adequate education, providers could be prepared to identify individuals subjected to family violence and help reduce the risk of associated impairment. Informed by the Active Implementation Frameworks, our research will determine the scope of strategies needed for the uptake and sustainability of educational interventions focused on family violence for providers. It will also determine the acceptability, feasibility, and proof-of-concept for a new educational intervention, called VEGA (Violence, Evidence, Guidance, Action), for developing and improving primary care provider knowledge and skills in family violence.MethodsThis paper details the protocol for the Researching the Impact of Service provider Education (RISE) Project. The RISE Project follows a sequential multiphase mixed method research design; qualitative and quantitative data are being collected and integrated over three conceptually and methodologically linked research phases. Activities primarily occur in Ontario, Alberta, and Quebec. Phase 1 uses a sequential exploratory mixed method research design to characterize the scope and salience of learning and implementation needs and preferences for family violence education. Phase 2 will use an embedded mixed method research design to determine whether VEGA technology supports providers to achieve their family violence learning goals with effectiveness, efficiency, and satisfaction. Phase 3 will use a concurrent mixed method research design to determine acceptability, feasibility, and proof-of-concept for evaluating whether VEGA improves primary care providers' knowledge and skills in family violence. This final phase will provide information on implementation strategies for family violence education in the "real world." It will also generate data on provider recruitment, retention, and data completeness, as well as exploratory estimates of the effect for provider outcome measures proposed for a randomized controlled trial.DiscussionThe RISE Project comprehensively integrates an implementation approach to improve family violence education for the health and social service professions. It will provide important information about factors that could influence the uptake and effectiveness of a health profession's educational intervention into the real world, as well as provide foundational evidence concerning the tenability of using a randomized controlled trial to evaluate the impact of VEGA in primary care settings.

Project description:BackgroundAsthma causes substantial morbidity and mortality in the United States, particularly among African American emerging adults (AAEAs; aged 18-30 years), but very few asthma programs have targeted this population. Interventions that provide education and address underlying motivation for managing asthma may be the most effective. However, intensive face-to-face interventions are often difficult to implement in this population.ObjectiveThe purpose of this study is to develop an effective mobile asthma management intervention to improve control among AAEAs.MethodsWe will assess the ability of multiple technologic components to assist and improve traditional asthma education. The first component is the Motivational Enhancement System for asthma management. It is a mobile 4-session intervention using supported self-regulation and motivational interviewing. Personalized content is based on each participant's activity level, daily experiences, and goals. The second component is supportive accountability. It is administered by asthma nurses using targeted mobile support (Skype/voice calls) to provide education, promote self-efficacy, and overcome barriers through a motivational interviewing-based framework. The third component is SMS text messaging. It provides reminders for asthma education, medication adherence, and physical activity. The fourth component is physical activity tracking. It uses wearable technology to help meet user-defined physical activity goals. Using a multiphase optimization strategy (MOST) framework, we will test intervention components and combinations of components to identify the most effective mobile intervention. The MOST framework is an innovative, and cost- and time-effective framework that uses engineering principles to produce effective behavioral interventions. We will conduct a component selection experiment using a factorial research design to build an intervention that has been optimized for maximum efficacy, using a clinically significant improvement in asthma. Participants (N=180) will be randomized to 1 of 6 intervention arms. Participants will be recruited from multiple sites of the American Lung Association-Airway Clinical Research Centers network and ambulatory care clinics at the Detroit Medical Center. Data collections will occur at baseline, and 3, 6, and 12 months.ResultsAt study completion, we will have an empirically supported optimized mobile asthma management intervention to improve asthma control for AAEAs. We hypothesize that postintervention (3, 6, and 12 months), participants with uncontrolled asthma will show a clinically significant improvement in asthma control. We also hypothesize that improvements in asthma management behaviors (including physical activity), quality of life, symptoms, adherence, and exacerbation (secondary outcomes) will be observed.ConclusionsAAEAs are disproportionately impacted by asthma, but have been underrepresented in research. Mobile asthma management interventions may help improve asthma control and allow people to live healthier lives. During this project, we will use an innovative strategy to develop an optimized mobile asthma management intervention using the most effective combination of nurse-delivered asthma education, a smartphone app, and text messaging.International registered report identifier (irrid)PRR1-10.2196/37946.

Dataset Information

CATCH-UP vaccines: protocol for a randomized controlled trial using the multiphase optimization strategy (MOST) framework to evaluate education interventions to increase COVID-19 vaccine uptake in Oklahoma.

Background

Methods

Discussion

Trial registration

Publications

CATCH-UP vaccines: protocol for a randomized controlled trial using the multiphase optimization strategy (MOST) framework to evaluate education interventions to increase COVID-19 vaccine uptake in Oklahoma.

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