Strengthening health systems through the use of process evaluations of complex interventions

Strengthening health systems to provide affordable, effective and accessible care in a lifecourse approach is necessary to address the growing global burden from non-communicable diseases (NCD). To address deficiencies in the health system, researchers have designed and trialled ‘complex interventions’ which are defined as interventions with multiple interacting components, and complexity in its implementation. Process evaluations alongside randomised controlled trials (RCT) of complex interventions are highly valuable. They explore implementation and different stakeholders’ perspectives as to for whom, how and why a complex intervention has an impact

The impact of Vicarious Trauma on Indigenous health researchers

Objective(s): To describe and reflect on an Indigenous researcher’s experience of vicarious trauma arising from a qualitative study of Indigenous women with chronic disease. Design: In-depth semi-structured interviews with thematic analysis were under-taken to explore the psychosocial factors experienced by Indigenous women as they managed their chronic disease. As part of the research process, reflecting on the experience of an Indigenous research team member, an Indigenous woman’s standpoint theoretical approach was adopted to frame discussion of the potential impact of vicarious trauma. Setting: Interviews were conducted with participants from four Aboriginal Medical Services from urban, rural and remote Australia. Analysis of the interviews, and reflection regarding the researcher’s experiences, occurred within the context of a multi-disciplinary team. Participants: Participant selection for the interview study was purposive. Seventy-two participants were selected for this study. The duration of the study was two years and was undertaken between March and December 2014, and finalised in December 2016. Results: n exploring how Indigenous women managed their own health and wellbeing, compelling stories of trauma, domestic violence and generational incarceration were shared with the researcher. Hearing and re-living some of these overwhelming experiences left her feeling iisolated and distressed. These compelling stories contributed to her experience of vicarious trauma. Conclusion: When Indigenous researchers conduct research in Indigenous communities, we should monitor, prepare for and provide appropriate care and support to researchers to address the potential for vicarious trauma. These considerations are paramount if we are to build the capacity of Indigenous and non-Indigenous researchers to conduct Indigenous health research

Editorial : The process evaluation of clinical trials

No abstract available.A Program Grant Fellowship from The George Institute for Global Health.http://frontiersin.org/Medicinedm2022Speech-Language Pathology and Audiolog

Formulating Initial Programme Theories of the Healthy Homes and Neighbourhoods Integrated Care Initiative

Introduction: The Healthy Homes and Neighbourhoods (HHAN) integrated care initiative was designed to break intergenerational cycles of social and health inequalities and enhance access to and engagement with health and social services for vulnerable families in the Sydney Local Health District. We sought to unearth the initial programme theory of the HHAN initiative to inform rollout to other relevant areas. Methods: We conducted a critical realist evaluation using steps. (1) Exploring the events around the HHAN initiative development. (2) Explore consumer experiences. (3) Identifying the entities and associations characterising the HHAN initiative and related outcomes. (4) Searching for different theoretical perspectives and explanations (abduction). (5) Hypothesising the mechanisms and [context] conditions that might have activated the generation of the HHAN outcomes (retroduction). Results: We identified three central mechanisms; trust, buy-in and motivation, and understanding family dynamics operating across consumer, provider and systems levels of the HHAN initiative. Discussion: These programme theories reveal that to achieve the goals of HHAN, interpersonal dynamics, fostering buy-in and ensuring motivation of both the consumers and care workers should be sought and sustained at all levels. Conclusion: The programme theories unveil that integrated care initiatives should foster positive relationships at all levels to ensure favourable consumer outcomes

Exploring the use of economic evidence to inform investment in disease prevention - a qualitative study

Objective: In the context of growing financial pressures on health budgets, cost‐effective prevention strategies are needed to address the burden from non‐communicable disease in Australia. We explored how decision makers use economic evidence to inform such investment and how such evidence generated can more effectively meet the needs of end users.Methods: Thematic analysis of in‐depth interviews with 15 high level stakeholders (Treasury, state health departments and the insurance industry), supplemented by documentary analysis.Results: Types of prevention approaches and economic evidence relevant to decision makers differed by organisational perspective. Capacity building in understanding economic evaluations and research evidence that addresses the differing criteria for investment used by different organisations is needed. The task of determining investment priorities in disease prevention comes with significant challenges including ideological barriers, delayed outcome measures, and implementation uncertainties.Conclusions and Implications for public health: Promoting the greater use of economic evidence in prevention requires more work on two fronts: tailoring the methods used by economists to better match the organisational imperatives of end users; and promoting greater consideration of broader societal and health sector perspectives among end users. This will require significant infrastructure development, monitoring and evaluation, stronger national leadership and a greater emphasis on evidence coproduction.<br /

Process evaluation of complex interventions in chronic and neglected tropical diseases in low- and middle-income countries-a scoping review protocol

BACKGROUND: The use of process evaluations is a growing area of interest in research groups working on complex interventions. This methodology tries to understand how the intervention was implemented to inform policy and practice. A recent systematic review by Liu et al. on process evaluations of complex interventions addressing non-communicable diseases found few studies in low- and middle- income countries (LMIC) because it was restricted to randomized controlled trials, primary healthcare level and non-communicable diseases. Yet, LMICs face different barriers to implement interventions in comparison to high-income countries such as limited human resources, access to health care and skills of health workers to treat chronic conditions especially at primary health care level. Therefore, understanding the challenges of interventions for non-communicable diseases and neglected tropical diseases (diseases that affect poor populations and have chronic sequelae) will be important to improve how process evaluation is designed, conducted and used in research projects in LMICs. For these reasons, in comparison to the study of Liu et al., the current study will expand the search strategy to include different study designs, languages and settings. OBJECTIVE: Map research using process evaluation in the areas of non-communicable diseases and neglected tropical diseases to inform the gaps in the design and conduct of this type of research in LMICs. METHODS: Scoping review of process evaluation studies of randomized controlled trials (RCTs) and non-RCTs of complex interventions implemented in LMICs including participants with non-communicable diseases or neglected tropical diseases and their health care providers (physicians, nurses, technicians and others) related to achieve better health for all through reforms in universal coverage, public policy, service delivery and leadership. The aspects that will be evaluated are as follows: (i) available evidence of process evaluation in the areas of non-communicable diseases and neglected tropical diseases such as frameworks and theories, (ii) methods applied to conduct process evaluations and (iii) gaps between the design of the intervention and its implementation that were identified through the process evaluation. Studies published from January 2008. Exclusion criteria are as follows: not peer reviewed articles, not a report based on empirical research, not reported in English or Spanish or Portuguese or French, reviews and non-human research. DISCUSSION: This scoping review will map the evidence of process evaluations conducted in LMICs. It will also identify the methods they used to collect and interpret data, how different theories and frameworks were used and lessons from the implementation of complex interventions. This information will allow researchers to conduct better process evaluations considering special characteristics from countries with limited human resources, scarce data available and limited access to health care

Family-led rehabilitation after stroke in India: a randomised controlled trial

Background: Most people with stroke in India have no access to organised rehabilitation services. The effectiveness of training family members to provide stroke rehabilitation is uncertain. Our primary objective was to determine whether family-led stroke rehabilitation, initiated in hospital and continued at home, would be superior to usual care, in a low resource setting. Methods: The Family-led Rehabilitation after Stroke in India (ATTEND) trial was a prospectively randomised open trial with blinded endpoints (PROBE) conducted across 14 hospitals in India. Patients (and their caregivers) were randomised to intervention or usual care by site Coordinators, using a secure web-based system, with minimisation by site and stroke severity. The intervention group received additional structured rehabilitation training, commenced in hospital and continued at home for up to 2 months. The primary outcome was death or dependency, defined by scores 3 to 6 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) as assessed by blinded observers at six months. Secondary outcomes included any serious adverse event, hospital length of stay, activities of daily living, health-related quality of life, anxiety and depression, and caregiver strain. All analyses were intention to treat. Registration: Clinical Trials Registry-India (CTRI/2013/04/003557); Australian New Zealand Clinical Trials Registry (ACTRN12613000078752); and Universal Trial Number (U1111-1138-6707) Findings: A total of 1,250 patients were randomised (623 intervention and 627 control) between 13 January 2014 and 12 February 2016. At six months, 285 of 607 (47·0%) participants in the intervention group were dead or dependent compared to 287 of 605 (47·4%) in the control group (odds ratio 0·98; 95% confidence Interval 0·78 to 1·23, P = 0·87). No significant differences were observed in any of the secondary or safety outcomes. Interpretation: Family-led rehabilitation did not reduce death or dependency after stroke

INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4) : study protocol for a randomized controlled trial

Background: Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4). Methods: A multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of < 140 mmHg within 30 min, or guideline-recommended BP management according to local protocols. After the collection of in-hospital clinical and management data and 7-day outcomes, trained blinded assessors conduct telephone or face-to-face assessments of physical function and health-related quality of life in participants at 90 days. The primary outcome is the physical function on the modified Rankin scale at 90 days, analyzed as an ordinal outcome with 7 categories. The sample size was estimated to provide 90% power (α = 0.05) to detect a 22% reduction in the odds of a worse functional outcome using ordinal logistic regression. Discussion: INTERACT4 is a pragmatic clinical trial to provide reliable evidence on the effectiveness and safety of ambulance-delivered hyperacute BP lowering in patients with suspected acute stroke. Trial registration: ClinicalTrials.gov NCT03790800. Registered on 2 January 2019; Chinese Trial Registry ChiCTR1900020534. Registered on 7 January 2019. All items can be found in this protocol paper

Family-led rehabilitation in India (ATTEND)—Findings from the process evaluation of a randomized controlled trial

Background Training family carers to provide evidence-based rehabilitation to stroke patients could address the recognized deficiency of access to stroke rehabilitation in low-resource settings. However, our randomized controlled trial in India (ATTEND) found that this model of care was not superior to usual care alone. Aims This process evaluation aimed to better understand trial outcomes through assessing trial implementation and exploring patients’, carers’, and providers’ perspectives. Methods Our mixed methods study included process, healthcare use data and patient demographics from all sites; observations and semi-structured interviews with participants (22 patients, 22 carers, and 28 health providers) from six sampled sites. Results Intervention fidelity and adherence to the trial protocol was high across the 14 sites; however, early supported discharge (an intervention component) was not implemented. Within both randomized groups, some form of rehabilitation was widely accessed. ATTEND stroke coordinators provided counseling and perceived that sustaining patients’ motivation to continue with rehabilitation in the face of significant emotional and financial stress as a key challenge. The intervention was perceived as an acceptable community-based package with education as an important component in raising the poor awareness of stroke. Many participants viewed family-led rehabilitation as a necessary model of care for poor and rural populations who could not access rehabilitation. Conclusion Difficulty in sustaining patient and carer motivation for rehabilitation without ongoing support, and greater than anticipated access to routine rehabilitation may explain the lack of benefit in the trial. Nonetheless, family-led rehabilitation was seen as a concept worthy of further development