A realist process evaluation of Enhanced Triple P for Baby and Mellow Bumps, within a Trial of Healthy Relationship Initiatives for the Very Early years (THRIVE): study protocol for a randomized controlled trial.
ABSTRACT: BACKGROUND:THRIVE is a three-arm randomised controlled trial (RCT) that aims to evaluate whether antenatal and early postnatal interventions, Enhanced Triple B for Baby (ETPB) plus care as usual (CAU) or Mellow Bumps (MB) plus CAU (versus CAU alone), can: 1) improve the mental health and well-being of pregnant women with complex health and social care needs; 2) improve mother-infant bonding and interaction; 3) reduce child maltreatment; and 4) improve child language acquisition. This paper focuses on THRIVE's realist process evaluation, which is carefully monitoring what is happening in the RCT. METHODS:Realistic evaluation provides the theoretical rationale for the process evaluation. We question: 1) how faithfully are MB and ETPB implemented? 2) What are the mechanisms by which they work, if they do, and who do they work for and how? 3) What contextual factors are necessary for the programmes to function, or might prevent them functioning? The mixed-methods design includes quantitative measures, which are pre- and post-training/intervention questionnaires for facilitators and mothers-to-be, and post-session evaluation forms. Qualitative data collection methods include participant observation of facilitator training and the delivery of a series of antenatal sessions in selected intervention groups (n = 3 for ETPB and n = 3 for MB), semi-structured interviews with facilitators, pregnant women, partners, and referring facilitators, and telephone interviews examining the content of the postnatal components of ETPB and MB. DISCUSSION:The findings of this process evaluation will help researchers and decision makers interpret the outcomes of THRIVE. It will provide a greater understanding of: how the interventions work (if they do); the extent and quality of their implementation; contextual factors facilitating and constraining intervention functioning; variations in response within and between subgroups of vulnerable parents; and benefits or unintended consequences of either intervention. Few studies to date have published detailed research protocols illustrating how realist process evaluation is designed and conducted as an integral part of a randomised controlled trial. TRIAL REGISTRATION:ISRCTN, ISRCTN21656568 . Registered on 8 November 2013.
Project description:<h4>Introduction</h4>Process evaluations provide insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a cluster randomised trial of a digital depression prevention intervention delivered to secondary school students (the Future Proofing Study). The purpose is to describe the methods that will be used to capture process evaluation data within this trial.<h4>Methods and analysis</h4>Using a hybrid type 1 design, a mixed-methods approach will be used with data collected in the intervention arm of the Future Proofing Study. Data collection methods will include semistructured interviews with school staff and study facilitators, automatically collected intervention usage data and participant questionnaires (completed by school staff, school counsellors, study facilitators and students). Information will be collected about: (1) how the intervention was implemented in schools, including fidelity; (2) school contextual factors and their association with intervention reach, uptake and acceptability; (3) how school staff, study facilitators and students responded to delivering or completing the intervention. How these factors relate to trial effectiveness outcomes will also be assessed. Overall synthesis of the data will provide school cluster-level and individual-level process outcomes.<h4>Ethics and dissemination</h4>Ethics approval was obtained from the University of New South Wales (NSW) Human Research Ethics Committee (HC180836; 21st January 2019) and the NSW Government State Education Research Applications Process (SERAP 2019201; 19th August 2019). Results will be submitted for publication in peer-reviewed journals and discussed at conferences. Our process evaluation will contextualise the trial findings with respect to how the intervention may have worked in some schools but not in others. This evaluation will inform the development of a model for rolling out digital interventions for the prevention of mental illness in schools.<h4>Trial registration number</h4>ANZCTRN12619000855123; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377664&isReview=true.
Project description:BACKGROUND:Process evaluation can illuminate barriers and facilitators to intervention implementation as well as the drivers of intervention outcomes. However, few obesity intervention studies have documented process evaluation methods and results. Community-based participatory research (CBPR) requires that process evaluation methods be developed to (a) prioritize community members' power to adapt the program to local needs over strict adherence to intervention protocols, (b) share process evaluation data with implementers to maximize benefit to participants, and (c) ensure partner organizations are not overburdened. Co-designed with low-income parents using CBPR, Communities for Healthy Living (CHL) is a family-centered intervention implemented within Head Start to prevent childhood obesity and promote family well-being. We are currently undertaking a randomized controlled trial to test the effectiveness of CHL in 23 Head Start centers in the greater Boston area. In this protocol paper, we outline an embedded process evaluation designed to monitor intervention adherence and adaptation, support ongoing quality improvement, and examine contextual factors that may moderate intervention implementation and/or effectiveness. METHODS:This mixed methods process evaluation was developed using the Pérez et al. framework for evaluating adaptive interventions and is reported following guidelines outlined by Grant et al. Trained research assistants will conduct structured observations of intervention sessions. Intervention facilitators and recipients, along with Head Start staff, will complete surveys and semi-structured interviews. De-identified data for all eligible children and families will be extracted from Head Start administrative records. Qualitative data will be analyzed thematically. Quantitative and qualitative data will be integrated using triangulation methods to assess intervention adherence, monitor adaptations, and identify moderators of intervention implementation and effectiveness. DISCUSSION:A diverse set of quantitative and qualitative data sources are employed to fully characterize CHL implementation. Simultaneously, CHL's process evaluation will provide a case study on strategies to address the challenges of process evaluation for CBPR interventions. Results from this process evaluation will help to explain variation in intervention implementation and outcomes across Head Start programs, support CHL sustainability and future scale-up, and provide guidance for future complex interventions developed using CBPR. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03334669 . Registered on October 10, 2017.
Project description:BACKGROUND:Digital innovations have shown promise for improving maternal health service delivery. However, low- and middle-income countries are still at the adoption-utilization stage. Evidence on mobile health has been described as a black box, with gaps in theoretical explanations that account for the ecosystem of health care and their effect on adoption mechanisms. Bliss4Midwives, a modular integrated diagnostic kit to support antenatal care service delivery, was piloted for 1 year in Northern Ghana. Although both users and beneficiaries valued Bliss4Midwives, results from the pilot showed wide variations in usage behavior and duration of use across project sites. OBJECTIVE:To strengthen the design and implementation of an improved prototype, the study objectives were two-fold: to identify causal factors underlying the variation in Bliss4Midwives usage behavior and understand how to overcome or leverage these in subsequent implementation cycles. METHODS:Using a multiple case study design, a realist evaluation of Bliss4Midwives was conducted. A total of 3 candidate program theories were developed and empirically tested in 6 health facilities grouped into low and moderate usage clusters. Quantitative and qualitative data were collected and analyzed using realist thinking to build configurations that link intervention, context, actors, and mechanisms to program outcomes, by employing inductive and deductive reasoning. Nonparametric t test was used to compare the perceived usefulness and perceived ease of use of Bliss4Midwives between usage clusters. RESULTS:We found no statistically significant differences between the 2 usage clusters. Low to moderate adoption of Bliss4Midwives was better explained by fear, enthusiasm, and high expectations for service delivery, especially in the absence of alternatives. Recognition from pregnant women, peers, supervisors, and the program itself was a crucial mechanism for device utilization. Other supportive mechanisms included ownership, empowerment, motivation, and adaptive responses to the device, such as realignment and negotiation. Champion users displayed high adoption-utilization behavior in contexts of participative or authoritative supervision, yet used the device inconsistently. Intervention-related (technical challenges, device rotation, lack of performance feedback, and refresher training), context-related (staff turnover, competing priorities, and workload), and individual factors (low technological self-efficacy, baseline knowledge, and internal motivation) suppressed utilization mechanisms. CONCLUSIONS:This study shed light on optimal conditions necessary for Bliss4Midwives to thrive in a complex social and organizational setting. Beyond usability and viability studies, advocates of innovative technologies for maternal care need to consider how implementation strategies and contextual factors, such as existing collaborations and supervision styles, trigger mechanisms that influence program outcomes. In addition to informing scale-up of the Bliss4Midwives prototype, our results highlight the need for interventions that are guided by research methods that account for complexity.
Project description:BACKGROUND:Process evaluation is increasingly recognized as an important component of effective implementation research and yet, there has been surprisingly little work to understand what constitutes best practice. Researchers use different methodologies describing causal pathways and understanding barriers and facilitators to implementation of interventions in diverse contexts and settings. We report on challenges and lessons learned from undertaking process evaluation of seven hypertension intervention trials funded through the Global Alliance of Chronic Diseases (GACD). METHODS:Preliminary data collected from the GACD hypertension teams in 2015 were used to inform a template for data collection. Case study themes included: (1) description of the intervention, (2) objectives of the process evaluation, (3) methods including theoretical basis, (4) main findings of the study and the process evaluation, (5) implications for the project, policy and research practice and (6) lessons for future process evaluations. The information was summarized and reported descriptively and narratively and key lessons were identified. RESULTS:The case studies were from low- and middle-income countries and Indigenous communities in Canada. They were implementation research projects with intervention arm. Six theoretical approaches were used but most comprised of mixed-methods approaches. Each of the process evaluations generated findings on whether interventions were implemented with fidelity, the extent of capacity building, contextual factors and the extent to which relationships between researchers and community impacted on intervention implementation. The most important learning was that although process evaluation is time consuming, it enhances understanding of factors affecting implementation of complex interventions. The research highlighted the need to initiate process evaluations early on in the project, to help guide design of the intervention; and the importance of effective communication between researchers responsible for trial implementation, process evaluation and outcome evaluation. CONCLUSION:This research demonstrates the important role of process evaluation in understanding implementation process of complex interventions. This can help to highlight a broad range of system requirements such as new policies and capacity building to support implementation. Process evaluation is crucial in understanding contextual factors that may impact intervention implementation which is important in considering whether or not the intervention can be translated to other contexts.
Project description:INTRODUCTION:Significant evidence in the literature supports case management (CM) as an effective intervention to improve care for patients with complex healthcare needs. However, there is still little evidence about the facilitators and barriers to CM implementation in primary care setting. The three specific objectives of this study are to: (1) identify the facilitators and barriers of CM implementation in primary care clinics across Canada; (2) explain and understand the relationships between the actors, contextual factors, mechanisms and outcomes of the CM intervention; (3) identify the next steps towards CM spread in primary care across Canada. METHODS AND ANALYSIS:We will conduct a multiple-case embedded mixed methods study. CM will be implemented in 10 primary care clinics in five Canadian provinces. Three different units of analysis will be embedded to obtain an in-depth understanding of each case: the healthcare system (macro level), the CM intervention in the clinics (meso level) and the individual/patient (micro level). For each objective, the following strategy will be performed: (1) an implementation analysis, (2) a realist evaluation and (3) consensus building among stakeholders using the Technique for Research of Information by Animation of a Group of Experts method. ETHICS AND DISSEMINATION:This study, which received ethics approval, will provide innovative knowledge about facilitators and barriers to implementation of CM in different primary care jurisdictions and will explain how and why different mechanisms operate in different contexts to generate different outcomes among frequent users. Consensual and prioritised statements about next steps for spread of CM in primary care from the perspectives of all stakeholders will be provided. Our results will offer context-sensitive explanations that can better inform local practices and policies and contribute to improve the health of patients with complex healthcare needs who frequently use healthcare services. Ultimately, this will increase the performance of healthcare systems and specifically mitigate ineffective use and costs.
Project description:BACKGROUND:Childhood Human Immunodeficiency Virus (HIV) infection occurs almost exclusively via mother to child transmission (MTCT) during pregnancy, birth, or through breastfeeding. Recent studies have shown that male involvement (MI) in antenatal care (ANC) and HIV testing, including couples voluntary counselling and testing (CVCT), increases the likelihood that women will adhere to prevention advice and comply with HIV treatment if required during their pregnancy; hence reducing the rates of MTCT of HIV. This realist review investigates how, why, when, and for whom MI in ANC works best to provide contextual advice on how MI in ANC can be best used for prevention of mother to child transmission (PMTCT) of HIV. METHODS:A realist review of existing evidence was conducted. Realist review seeks to explain how and why an intervention works, or does not work, in a given context. This was completed through the five stages of realist synthesis; Eliciting the program theory, search strategy, study selection criteria, data extraction, and data analysis and synthesis. Findings are presented as context-mechanism-outcome (CMO) configurations outlining the mechanisms that work in given contexts to give an outcome. RESULTS:Three CMO configurations were developed. These describe that 1) Couples in monogamous relationships have higher levels of trust, commitment and security leading to increased uptake of PMTCT programs together; 2) ANC spaces that make 'male friendly' adaptions promote normalisation of MI in PMTCT and are more welcoming, leading to increased willingness of male partners to participate in ANC; and 3) couples and communities with higher health literacy encourage increased informed decision making, ownership, and responsibility and thus increased participation in PMTCT of HIV. CONCLUSIONS:The CMOs developed in this review give contextual advice on how one might improve ANC services to increase MI and help reduce MTCT of HIV. We propose that MI in ANC works best where couples are monogamous and trusting, where ANC spaces actively promote being a 'male friendly space' and where there are high levels of community education programs around MTCT.
Project description:BACKGROUND:Management of diabetes through improved glycemic control and risk factor modification can help prevent long-term complications. Much diabetes management is self-management, in which healthcare providers play a supporting role. Well-designed e-Health solutions targeting behavior change can improve a range of measures, including glycemic control, perceived health, and a reduction in hospitalizations. METHODS:The primary objective of this study is to evaluate if a mobile application designed to improve self-management among patients with type 2 diabetes (T2DM) improves glycemic control compared to usual care. The secondary objectives are to determine the effects on patient experience and health system costs; evaluate how and why the intervention worked as observed; and gain insight into considerations for system-wide scale-up. This pragmatic, randomized, wait-list-control trial will recruit adult participants from three Diabetes Education Programs in Ontario, Canada. The primary outcome is glycemic control (measured by HbA1c). Secondary outcomes include patient-reported outcomes and patient-reported experience measures, health system utilization, and intervention usability. The primary outcome will be analyzed using an ANCOVA, with continuous secondary outcomes analyzed using Poisson regression. Direct observations will be conducted of the implementation and application-specific training sessions provided to each site. Semi-structured interviews will be conducted with participants, healthcare providers, organizational leaders, and system stakeholders as part of the embedded process evaluation. Thematic analysis will be applied to the qualitative data in order to describe the relationships between (a) key contextual factors, (b) the mechanisms by which they effect the implementation of the intervention, and (c) the impact on the outcomes of the intervention, according to the principles of Realist Evaluation. DISCUSSION:The use of mobile health and virtual tools is on the rise in health care, but the evidence of their effectiveness is mixed and their evaluation is often lacking key contextual data. Results from this study will provide much needed information about the clinical and cost-effectiveness of a mobile application to improve diabetes self-management. The process evaluation will provide valuable insight into the contextual factors that influence the application effectiveness, which will inform the potential for adoption and scale. TRIAL REGISTRATION:Clinicaltrials.gov NCT02813343 . Registered on 24 June 2016 (retrospectively registered). Trial Sponsor: Ontario Telemedicine Network.
Project description:Chronic Kidney Disease (CKD) is a pressing global health concern that is placing increased strain on health care resources. CKD patients regularly receive peritoneal dialysis as a common CKD treatment. An emerging technological solution is telehomecare as way to support patients receiving PD in their homes. This study protocol outlines a mixed methods evaluation exploring a telehomecare developed to enhance CKD patients' outcomes and experiences. The study aims to assess the usability, acceptability and scalability of this virtual care application.A realist evaluation using an embedded case study design will be used to understand the usability, acceptability and scalability of a telehomecare application for patients with CKD undergoing PD. The realist evaluation that is further described in this paper is part of a larger evaluation of the eQ Connect™ intervention that includes a randomized, parallel-arm control trial aimed at determining if utilizing eQ Connect improves selected clinical outcomes for PD patients (CONNECT Trial).Potential implications of this study include elucidating which components of the intervention are most effective and under what conditions with a focus on the contextual influences. Collectively, our multi-method design will yield knowledge around how best to implement, sustain and spread the telehomecare application that will be useful to guide the development, implementation and evaluation of future virtual care applications aimed at improving the quality of care outcomes and experiences of patients.NCT02670512 . Registered: January 18, 2016.
Project description:INTRODUCTION:Somali-born women comprise a large group of immigrant women of childbearing age in Sweden, with increased risks for perinatal morbidity and mortality and poor experiences of care, despite the goal of providing equitable healthcare for the entire population. Rethinking how care is provided may help to improve outcomes. OVERALL AIM:To develop and test the acceptability, feasibility and immediate impacts of group antenatal care for Somali-born immigrant women, in an effort to improve experiences of antenatal care, knowledge about childbearing and the Swedish healthcare system, emotional well-being and ultimately, pregnancy outcomes. This protocol describes the rationale, planning and development of the study. METHODS AND ANALYSIS:An intervention development and feasibility study. Phase I includes needs assessment and development of contextual understanding using focus group discussions. In phase II, the intervention and evaluation tools, based on core values for quality care and person-centred care, are developed. Phase III includes the historically controlled evaluation in which relevant outcome measures are compared for women receiving individual care (2016-2018) and women receiving group antenatal care (2018-2019): care satisfaction (Migrant Friendly Maternity Care Questionnaire), emotional well-being (Edinburgh Postnatal Depression Scale), social support, childbirth fear, knowledge of Swedish maternity care, delivery outcomes. Phase IV includes the process evaluation, investigate process, feasibility and mechanisms of impact using field notes, observations, interviews and questionnaires. All phases are conducted in collaboration with a stakeholder reference group. ETHICS AND DISSEMINATION:The study is approved by the Regional Ethical Review Board, Stockholm, Sweden. Participants receive information about the study and their right to decline/withdraw without consequences. Consent is given prior to enrolment. Findings will be disseminated at antenatal care units, national/international conferences, through publications in peer-reviewed journals, seminars involving stakeholders, practitioners, community and via the project website. Participating women will receive a summary of results in their language.
Project description:BACKGROUND:Reduction of cardiovascular disease (CVD) is a worldwide health priority and innovative uses of technology-based interventions may assist patients with improving prevention behaviours. Targeting these interventions to recipients most likely to benefit requires understanding how contexts of use influence responsiveness to the intervention, and how this interaction favours or discourages health behaviour. Using a realist evaluation approach, the aim of this study was to examine the contextual factors influencing behaviour change within a multi-feature eHealth intervention with personalised data integration from the primary care electronic health record (EHR). METHODS:Realist evaluation of qualitative data from the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) randomised trial (N?=?934). Thirty-six participants from the intervention group (N?=?486) who had completed 12?months of study follow-up were interviewed. Coding of transcripts was structured around configurations of contexts, mechanisms, and outcomes of intervention use. Contextual narratives were derived from thematic analysis of the interviews. RESULTS:Mechanisms favouring positive health behaviour occurred when participants responded to four interactive features of the intervention. Facilitating mechanisms included greater cognitive engagement whereby participants perceived value and benefit, and felt motivated, confident and incentivised. Participants moved from being unconcerned (or unaware) to more task-oriented engagement with personal CVD risk profile and prevention. Increased personalisation occurred when modifiable CVD risk factors became relatable to lifestyle behaviour; and experiences of feeling greater agency/self-efficacy emerged. Use and non-use of the intervention were influenced by four overarching narratives within the individual's micro-level and meso-level environments: illness experiences; receptiveness to risk and prevention information; history of the doctor-patient relationship; and relationship with technology. CONCLUSIONS:Intervention-context interactions are central to understanding how change mechanisms activate within complex interventions to exert their impact on recipients. Intervention use and non-use were context-dependent, underscoring the need for further research to target eHealth innovations to those most likely to benefit.