Planning implementation and scale-up of physical activity interventions for people with walking difficulties: study protocol for the process evaluation of the ComeBACK trial

Background There is currently little evidence of planning for real-world implementation of physical activity interventions. We are undertaking the ComeBACK (Coaching and Exercise for Better Walking) study, a 3-arm hybrid Type 1 randomised controlled trial evaluating a health coaching intervention and a text messaging intervention. We used an implementation planning framework, the PRACTical planning for Implementation and Scale-up (PRACTIS), to guide the process evaluation for the trial. The aim of this paper is to describe the protocol for the process evaluation of the ComeBACK trial using the framework of the PRACTIS guide. Methods A mixed methods process evaluation protocol was developed informed by the Medical Research Council (MRC) guidance on process evaluations for complex interventions and the PRACTIS guide. Quantitative data, including participant questionnaires, health coach and administrative logbooks, and website and text message usage data, is being collected over the trial period. Semi-structured interviews and focus groups with trial participants, health coaches and health service stakeholders will explore expectations, factors influencing the delivery of the ComeBACK interventions and potential scalability within existing health services. These data will be mapped against the steps of the PRACTIS guide, with reporting at the level of the individual, provider, organisational and community/systems. Quantitative and qualitative data will elicit potential contextual barriers and facilitators to implementation and scale-up. Quantitative data will be reported descriptively, and qualitative data analysed thematically. Discussion This process evaluation integrates an evaluation of prospective implementation and scale-up. It is envisaged this will inform barriers and enablers to future delivery, implementation and scale-up of physical activity interventions. To our knowledge, this is the first paper to describe the application of PRACTIS to guide the process evaluation of physical activity interventions. Trial registration Australian and New Zealand Clinical Trials Registry (ANZCTR) Registration date: 10/12/2018.

Mechanisms and Contextual Factors Affecting the Implementation of Animal Health Surveillance in Tanzania: A Process Evaluation

A strong animal health surveillance system is an essential determinant of the health of animal and human population. To ensure its functionality and performance, it needs to be evaluated regularly. Therefore, a process evaluation was conducted in this study to assess animal health surveillance processes, mechanisms and the contextual factors which facilitate or hinder uptake, implementation and sustainability of the system in Tanzania. A mixed-method study design was used to evaluate the national animal health surveillance system guided by a framework for process evaluation of complex interventions developed by Moore and others. The system was assessed against standard guidelines and procedures using the following attributes: fidelity, adherence, exposure, satisfaction, participation rate, recruitment and context. Quantitative and qualitative data were collected using a cross-sectional survey, key informant interviews, document review, site visits and non-participant observation. Data from questionnaires were downloaded, cleaned and analyzed in Microsoft™ Excel. Qualitative data were analyzed following deductive thematic and content analysis methods. Fidelity attribute showed that case identification is mainly based on clinical signs due to limited laboratory services for confirmation. Data collection was not well-coordinated and there were multiple disparate reporting channels. Adherence in terms of the proportion of reports submitted per month was only 61% of the target. District-level animal health officials spent an average of 60% of their weekly time on surveillance-related activities, but only 12% of them were satisfied with the surveillance system. Their dissatisfaction was caused by large area coverage with little to no facilitation, poor communication, and lack of a supporting system. The cost of surveillance data was found to be 1.4 times higher than the annual surveillance budget. The timeliness of the system ranged between 0 and 153 days from the observation date (median = 2 days, mean = 6 days). The study pointed out some deviations in animal health surveillance processes from the standard guidelines and their implication on the system's performance. The system could be improved by developing a user-friendly unified reporting system, the active involvement of subnational level animal health officials, optimization of data sources and an increase in the horizon of the financing mechanism.

Fit for purpose. Co-production of complex behavioural interventions. A practical guide and exemplar of co-producing a telehealth-delivered exercise intervention for people with stroke

Background Careful development of interventions using principles of co-production is now recognized as an important step for clinical trial development, but practical guidance on how to do this in practice is lacking. This paper aims (1) provide practical guidance for researchers to co-produce interventions ready for clinical trial by describing the 4-stage process we followed, the challenges experienced and practical tips for researchers wanting to co-produce an intervention for a clinical trial; (2) describe, as an exemplar, the development of our intervention package. Method We used an Integrated Knowledge Translation (IKT) approach to co-produce a telehealth-delivered exercise program for people with stroke. The 4-stage process comprised of (1) a start-up planning phase with the co-production team. (2) Content development with knowledge user informants. (3) Design of an intervention protocol. (4) Protocol refinement. Results and reflections The four stages of intervention development involved an 11-member co-production team and 32 knowledge user informants. Challenges faced included balancing conflicting demands of different knowledge user informant groups, achieving shared power and collaborative decision making, and optimising knowledge user input. Components incorporated into the telehealth-delivered exercise program through working with knowledge user informants included: increased training for intervention therapists; increased options to tailor the intervention to participant’s needs and preferences; and re-naming of the program. Key practical tips include ways to minimise the power differential between researchers and consumers, and ensure adequate preparation of the co-production team. Conclusion Careful planning and a structured process can facilitate co-production of complex interventions ready for clinical trial. Graphical Abstract

Co-designing complex interventions with people living with dementia and their supporters

Background and objectives We engaged people living with dementia, family carers and health and social care professionals in co-designing two dementia care interventions: for family carers and people living with dementia (New Interventions for Independence in Dementia Study (NIDUS)-family and home-care workers (NIDUS-professional training programme). Research design and methods Over October 2019–March 2020, we invited public and patient (PPI) and professional members of our NIDUS co-design groups to complete the PPI Engagement Evaluation Tool (designed to assess engagement activities), and non-professional PPI members to participate in qualitative telephone interviews. We thematically analysed and integrated mixed-methods findings. Results Most (15/20; 75%) of the PPI members approached participated. We identified four themes: (1) Creating the right atmosphere: participants found group meetings positive and enabling, though one health professional was unsure how to position themselves within them; (2) Participants influencing the outcome: while most members felt that they had some influence, for one carer consultation seemed too late to influence; (3) Having the right information: several carers wanted greater clarity and more regular updates from researchers; (4) Unique challenges for people living with dementia: memory problems presented challenges in engaging with substantial information, and within a large group. Discussion and implications We reflect on the importance of providing accessible, regular updates, managing power imbalances between co-design group members with lived and professional experiences; and ensuring needs and voices of people living with dementia are prioritised. We encourage future studies to incorporate evaluations of co-design processes into study design.

NOT JUST CALORIC RESTRICTION: A COMPLEX APPROACH TO PROLONG LIFESPAN AND IMPROVE QUALITY OF LIFE

Aging is an urgent healthcare issue in view of the rapid growth of the proportion of older persons. Searching for reliable aging biomarkers and prolonging lifespan are increasingly important scientific directions. Experimental gerontology helps to explore fundamental facts which are not always applicable in clinical scenarios. As an example, caloric restriction is one of the key interventions that prolongs laboratory animals’ lifespan and ameliorates some, but not all, aging biomarkers in humans. Consequences of overeating such as obesity, insulin resistance, type 2 diabetes, and metabolic syndrome are taking their toll with aging, making caloric restriction a hot topic in gerontology and geriatrics. Nevertheless, caloric restriction is not widely applicable in view of poor adherence to and limitations of strict diets. Drugs mimicking caloric restrictions, the so-called caloric restriction mimetics, are developed to overcome these limitations. Caloric restriction alone is not a panacea since metabolic pathways are complex and not responsive to a single intervention. Fasting and exercising are additional options for reducing effects of excessive intake of calories. Arguably, physical activity significantly improves the quality of life at old age and delays the onset of overt insulin resistance and associated diseases. Thus, developing optimal fasting and exercising schemes is becoming increasingly important. Such interventions are confounded by a number of factors, including circadian and other biorhythms and baseline metabolic activity. It is justifiable to test fasting and exercising in experimental animals to reveal numerous confounding factors. A hypothesis in this article points to the role of complex interventions such as moderate and balanced diet, intermittent fasting, and physical exercise adjusted to circadian rhythms for prolonging life and improving quality of life. The hypothesis may shed light on fundamental mechanisms of aging and perspectives of anti-aging drug therapies.

Evaluating the Benefits of a SNAP-Ed-Funded Community Garden Intervention Using Ripple Effect Mapping

In North Carolina, rural communities experience high rates of chronic illness due to health inequities exacerbated by the decline of major industries. Community gardens increase access to fresh produce and opportunities for physical activity and may offer additional benefits. These benefits can be difficult to measure as they are often unplanned or unintended. This article describes how we utilized Ripple Effect Mapping (REM), a participatory approach for evaluating complex interventions, to understand the impact of a SNAP-Ed-funded program. We purposively selected six community gardens to participate in 2-hour, facilitated REM sessions. On average, 15 people participated in each session. Participants developed a map of benefits using Appreciative Inquiry, mind mapping, and consensus-building methods. The map organized benefits across three levels: first ripple (individual), second ripple (interpersonal), and third ripple (community). In addition, participants coded benefits using the Community Capitals Framework. After the sessions, the research team extracted identified impacts into a matrix, aligned them with the SNAP-Ed Evaluation Framework, and developed digitized maps. These data corroborated findings from previous evaluations and offered insight into community-identified benefits not previously documented, including other types of capital generated by community gardens in rural communities. In addition, REM was an effective approach to measure and report several SNAP-Ed evaluation indicators, including LT11: Unexpected Benefits. Ultimately, the research team found REM to be an effective community-engaged method for understanding a complex intervention’s benefits while centering participant community voices and transferring ownership of the data to community partners, a key principle in equitable evaluation.

Process facilitators shifting between the support and expert roles in a complex work environment intervention in the Swedish healthcare sector

PurposeProcess facilitation as part of a complex intervention for changing or improving practices within workplaces is becoming a common work method. The aim of this study was to investigate what characterizes the process-facilitating role in a complex intervention.Design/methodology/approachThe present study focuses on a complex work environment intervention targeting eight organizational units (workplaces) in the Swedish healthcare sector. The study applies a mixed-method approach and has been carried out in two steps. First, a qualitative process evaluation was performed. Secondly, an evaluation was conducted to see to what extent these identified conditions and mechanisms affected the quantitative intervention effect in term of sickness absence.FindingsThe analysis shows that the facilitating role consisted of three overlapping and partially iterative phases. These phases involved different activities for the facilitating role. Depending on how the facilitating role and the intervention were designed, various supporting conditions were found to significantly affect the outcome of the intervention measured as the total sickness absence.Research limitations/implicationsIt is concluded that the facilitation is not static or fixed during the change process. Instead, the facilitation role develops and emerges through the process of support during the different implementation phases.Practical implicationsThe facilitative role of performing support is based on a combination of support role activities and expert role activities. The support role focuses on support activities, while the expert role includes capacity building through knowledge- and legitimacy-oriented activities.Originality/valueThis study contributes to earlier research by developing a methodological approach for carrying out process facilitation in complex interventions.

Co-Designing a New Yoga-Based Mindfulness Intervention for Survivors of Stroke: A Formative Evaluation

Movement-based mindfulness interventions (MBI) are complex, multi-component interventions for which the design process is rarely reported. For people with stroke, emerging evidence suggests benefits, but mainstream programs are generally unsuitable. We aimed to describe the processes involved and to conduct a formative evaluation of the development of a novel yoga-based MBI designed for survivors of stroke. We used the Medical Research Council complex interventions framework and principles of co-design. We purposefully approached health professionals and consumers to establish an advisory committee for developing the intervention. Members collaborated and iteratively reviewed the design and content of the program, formatted into a training manual. Four external yoga teachers independently reviewed the program. Formative evaluation included review of multiple data sources and documentation (e.g., formal meeting minutes, focus group discussions, researcher observations). The data were synthesized using inductive thematic analysis. Three broad themes emerged: (a) MBI content and terminology; (b) manual design and readability; and (c) barriers and enablers to deliver the intervention. Various perspectives and feedback on essential components guided finalizing the program. The design phase of a novel yoga-based MBI was strengthened by interdisciplinary, consumer contributions and peer review. The 12-week intervention is ready for testing among survivors of stroke.

Evaluating complex interventions in international development

Complex interventions are those that are characterized by multiple components, multiple stakeholders, or multiple target populations. They may also be interventions that incorporate multiple processes of behavioral change. While such interventions are very common and receive a large proportion of development aid budgets, they are rarely subject to rigorous evaluations. The CEDIL Methods Working Paper, Evaluating Complex Interventions in International Development reviews promising methods for the evaluation of complex interventions that are new or have been used in a limited way. It offers a taxonomy of complex interventions in international development and draws on literature to discuss several methods that can be used to evaluate these interventions. The paper focuses its attention on methods that address causality and allow us to state conclusively whether an intervention works or not. It shows that several rigorous methods developed in different disciplines can be adapted and used to evaluate complex interventions in international development.

Development of a Complex Intervention to Support Parents of Chronically Ill Adolescents in Transition From Pediatrics to Adult Care (ParTNer-STEPs)

Background Transfer from pediatric to adult care for chronically ill adolescents is associated with outpatient non-attendance and low treatment adherence in adolescents, and with anxiety and concerns among parents. Recent studies have shown that parent involvement results in better transitions. The aim of this paper was to describe the development, through participatory design, of a brief transition program targeted to parents of chronically ill adolescents.Methods The study was based on the UK Medical Research Council’s (MRC) framework on developing and testing complex interventions. To increase the program’s feasibility and relevance, participatory design was chosen as the overall method. A collaboration group of parents, adolescents and health care professionals (HCP) were actively involved in the development of the program. The program was developed in three development stages, in accordance with the MRC framework: 1) identifying the evidence base, 2) identifying theory, and 3) modelling process and outcomes. Results Together with the collaboration group, we developed a brief transition program targeting parents, by undertaking an iterative process, involving a literature review, individual interviews, workshops, online brainstorms and multiple pilot tests. The program, called ParTNer-STEPs (Parents in Transition – a Nurse-led Support and Transfer Educational Program) comprised three components: 1) an informative website, 2) online educational events for parents, and 3) transfer consultations with providers from both pediatrics and adult care.Conclusions The MRC framework was successfully applied to develop a brief transition program targeting parents of chronically ill adolescents. By incorporating the principles of participatory design in the development phase, we ensured that both parents’ and adolescents’ needs were represented and addressed in the program. Furthermore, the involvement of HCPs ensured the feasibility and relevance of the intervention in clinical practice and will increase the chances of successful implementation.Trial registration ClinicalTrials.gov ID NCT04969328