Dataset Information

The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study).

ABSTRACT: BACKGROUND:Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting. METHODS:We will conduct a hybrid type 2 effectiveness-implementation trial in partnership with a primary care clinic in a low-income, majority Latino community. Families with 2- to 5-year-old children will be eligible to participate. Families will be randomized to receive the intervention (n = 130) or services as usual (n = 70) and will be assessed annually over three years. Outcomes are informed by the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance). Effectiveness outcomes include child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting). Early stage implementation outcomes are also included (e.g., cost, acceptability, appropriateness, and feasibility). Effectiveness outcomes will be assessed via intent-to-treat (ITT) analyses. Implementation outcomes will be primarily descriptive with comparisons to prior trials of FCU4Health and the original FCU. PROJECTED OUTCOMES:This trial will provide evidence related to the potential of integrated primary care settings to deliver evidence-based preventive interventions with a dual focus on behavioral and physical health.

SUBMITTER: Berkel C

PROVIDER: S-EPMC7374139 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study).

Berkel Cady C Smith Justin D JD Bruening Meg M MM Jordan Neil N Fu Emily E Mauricio Anne M AM Grimm Kevin J KJ Winslow Emily E Ray Kristen K Bourne Annette A Dishion Thomas J TJ

Contemporary clinical trials 20200722

<h4>Background</h4>Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptat ...[more]

PMID: 32707101

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Project description:BACKGROUND:Evidence-based medicines, technologies, and protocols exist to prevent many of the annual 300,000 maternal, 2.7 million neonatal, and 9 million child deaths, but they are not being effectively implemented and utilized in rural areas. Nepal, one of South Asia's poorest countries with over 80% of its population living in rural areas, exemplifies this challenge. Community health workers are an important cadre in low-income countries where human resources for health and health care infrastructure are limited. As local women, they are uniquely positioned to understand and successfully navigate barriers to health care access. Recent case studies of large community health worker programs have highlighted the importance of training, both initial and ongoing, and accountability through structured management, salaries, and ongoing monitoring and evaluation. A gap in the evidence regarding whether such community health worker systems can change health outcomes, as well as be sustainably adopted at scale, remains. In this study, we plan to evaluate a community health worker system delivering an evidence-based integrated reproductive, maternal, newborn, and child health intervention as it is scaled up in rural Nepal. METHODS:We will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of an integrated reproductive, maternal, newborn, and child health intervention and the implementation process via a professional community health worker system. The intervention integrates five evidence-based approaches: (1) home-based antenatal care and post-natal care counseling and care coordination; (2) continuous surveillance of all reproductive age women, pregnancies, and children under age 2 years via a mobile application; (3) Community-Based Integrated Management of Newborn and Childhood Illness; (4) group antenatal and postnatal care; and 5) the Balanced Counseling Strategy to post-partum contraception. We will evaluate effectiveness using a pre-post quasi-experimental design with stepped implementation and implementation using the RE-AIM framework. DISCUSSION:This is the first hybrid effectiveness-implementation study of an integrated reproductive, maternal, newborn, and child health intervention in rural Nepal that we are aware of. As Nepal takes steps towards achieving the Sustainable Development Goals, the data from this three-year study will be useful in the detailed planning of a professionalized community health worker cadre delivering evidence-based reproductive, maternal, newborn, and child health interventions to the country's rural population. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03371186 , registered 04 December 2017, retrospectively registered.

Project description:BACKGROUND:In Nepal, the burden of noncommunicable, chronic diseases is rapidly rising, and disproportionately affecting low and middle-income countries. Integrated interventions are essential in strengthening primary care systems and addressing the burden of multiple comorbidities. A growing body of literature supports the involvement of frontline providers, namely mid-level practitioners and community health workers, in chronic care management. Important operational questions remain, however, around the digital, training, and supervisory structures to support the implementation of effective, affordable, and equitable chronic care management programs. METHODS:A 12-month, population-level, type 2 hybrid effectiveness-implementation study will be conducted in rural Nepal to evaluate an integrated noncommunicable disease care management intervention within Nepal's new municipal governance structure. The intervention will leverage the government's planned roll-out of the World Health Organization's Package of Essential Noncommunicable Disease Interventions (WHO-PEN) program in four municipalities in Nepal, with a study population of 80,000. The intervention will leverage both the WHO-PEN and its cardiovascular disease-specific technical guidelines (HEARTS), and will include three evidence-based components: noncommunicable disease care provision using mid-level practitioners and community health workers; digital clinical decision support tools to ensure delivery of evidence-based care; and training and digitally supported supervision of mid-level practitioners to provide motivational interviewing for modifiable risk factor optimization, with a focus on medication adherence, and tobacco and alcohol use. The study will evaluate effectiveness using a pre-post design with stepped implementation. The primary outcomes will be disease-specific, "at-goal" metrics of chronic care management; secondary outcomes will include alcohol and tobacco consumption levels. DISCUSSION:This is the first population-level, hybrid effectiveness-implementation study of an integrated chronic care management intervention in Nepal. As low and middle-income countries plan for the Sustainable Development Goals and universal health coverage, the results of this pragmatic study will offer insights into policy and programmatic design for noncommunicable disease care management in the future. TRIAL REGISTRATION:ClinicalTrials.gov, NCT04087369. Registered on 12 September 2019.

Project description:BACKGROUND:Each year in the USA, 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries. METHODS/DESIGN:The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivational-interviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons' policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally. DISCUSSION:The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons' regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results. TRIAL REGISTRATION:ClinicalTrials.gov NCT02655354 . Registered 27 July 2015.

Project description:IntroductionPatients with long-term conditions consistently report a lack of information around services and support available to them. This unmet need for information is significant among people with dementia and family carers. A quality improvement intervention is being carried out to tackle this issue as part of a co-creation initiative in the North East of England (UK). The intervention consists of the dissemination (via the local Community Mental Health Services for Older People) of a leaflet about services available to people with dementia and their family carers in the study site. This protocol is reported in accordance with the Standards for Reporting Implementation Studies.Methods and analysisThis effectiveness-implementation hybrid type 2 study aims at understanding (1) the unfolding and outcomes of the implementation strategy, (2) the outcomes of the intervention (for people with dementia and family carers, staff implementing the intervention and local service providers) and (3) the contribution of co-creation to the design and implementation of the intervention and its outcomes. The prospective theory of change of the intervention articulated by local stakeholders is used as a reference framework against which to assess the implementation and outcomes of the intervention. Evaluation data will be collected through in-depth interviews with people with dementia and family carers receiving the intervention, staff implementing the intervention and managers from local service providers. Referral data from local service providers will be collected to triangulate the interview data. A focus group with key stakeholders will support the sense-making of findings. The realist configuration of mechanism-context-outcome, operationalised using an information behaviour model, will inform data analysis and interpretation.Ethics and disseminationEthical and research governance approvals have been obtained from the West Midlands-South Birmingham Research Ethics Committee. The results of the study will be submitted for publication in peer-reviewed journals and disseminated through conferences.

Project description:BackgroundReassuring patient education and exercise therapy are widely recommended interventions for back pain in clinical guidelines. However, many patients are offered non-guideline endorsed options, and strategies for effective implementation of guideline-based care have not yet been developed. This protocol outlines the evaluation of a strategy for nationwide implementation of standardised patient education and exercise therapy for people with persistent or recurrent back pain in a hybrid implementation-effectiveness design. The strategy and the evaluation were planned using the framework of the Behaviour Change Wheel.MethodsThe main activity of the implementation strategy is a two-days course for physiotherapists and chiropractors in delivering patient education and exercise therapy that is aimed at supporting patient self-management. This comes with ready-to-use patient education materials and exercise programs. The clinical intervention is a group-based program consisting of two sessions of patient education and 8 weeks of supervised exercises. The program uses a cognitive-behavioural approach and the aim of the exercise component is to restore the patient's ability and confidence to move freely. The implementation process is evaluated in a dynamic process monitoring the penetration, adoption and fidelity of the clinical intervention. The clinical intervention and potential effect mechanisms will be evaluated at the patient-level using measures of knowledge, skills, beliefs, performance, self-efficacy and success in self-management. The education of clinicians will be evaluated via clinician-level outcomes, including the Pain Attitudes and Beliefs Scale, the Practitioner Confidence Scale, and the Determinants of Implementation Behaviour Questionnaire. Effects at a national level will be investigated via data from national registries of health care utilisation and sick-leave.DiscussionThis implementation-effectiveness study is designed to evaluate the process of implementing an evidence-based intervention for back pain. It will inform the development of strategies for implementing evidence-based care for musculoskeletal pain conditions, it will enhance the understanding of mechanisms for developing patient self-management skills, and it will demonstrate the outcomes that are achievable in everyday clinical practice.Trial registrationClinicalTrials.gov NCT03570463 . Registered 27 June 2018.

Project description:BackgroundChildhood obesity is still a major health problem in many countries, including Sweden. Childhood obesity and obesity-related behaviours in childhood, such as low physical activity and unhealthy eating habits, tend to track into adulthood, which highlights the need for early prevention. Our aims are to evaluate whether a parent-oriented mobile health app (the MINISTOP 2.0 app) integrated into primary child health care can improve diet and physical activity behaviours and reduce the prevalence of overweight and obesity in preschool-aged children as well as to evaluate the implementation among child health care nurses and parents.MethodsThis trial uses a hybrid type 1 effectiveness-implementation design. Families (n = 500) who attend a routine visit to one of 15-20 primary child health care centres throughout Sweden, when their child is 2.5 years, are offered participation in a randomised controlled trial (effectiveness evaluation). After acceptance, families will be randomised (1:1) to control or intervention groups. The intervention group receives a 6-month parent-oriented smartphone intervention aimed at improving the dietary and activity behaviours of their child (the MINISTOP 2.0 app) and the control group receives routine child health care. Dietary habits, physical activity and screen time (primary outcomes), body weight and height in children, and parental self-efficacy (secondary outcomes) are measured at baseline and at 6 months post randomisation. Implementation outcomes (i.e. perceived acceptability, appropriateness, and feasibility) of the intervention will be assessed among primary child health care nurses and parents in the trial through questionnaires and qualitative interviews.DiscussionThis trial will evaluate whether the MINISTOP 2.0 app can be used in primary child health care to improve diet and physical activity behaviours, and prevent overweight and obesity, in preschool-aged children. If effectiveness is proven, and the MINISTOP 2.0 app is considered acceptable, appropriate and feasible, it can be implemented nationally as part of the preventive strategies to combat childhood obesity provided by routine child health care.Trial registrationThe trial was registered at the Clinicaltrials.gov register platform (ID NCT04147039 ) on 31 October 2019.

Dataset Information

The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study).

Publications

The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study).

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