Complex Intervention Research Research Articles

Pacific Peoples Perspectives of Integrated Care Services

Introduction : For patients with complex health and social needs, improved integration of primary health and community and social services has emerged as a policy solution to improving access to care and health status (1,2). However there is little known about how integrated care can improve health outcomes for disadvantaged populations, including for Pacific people (3-6). This paper discusses the insights gained from various organisational and service improvement projects undertaken with providers of integrated care services for Pacific people. These projects have incorporated research in to patients and their families’ experiences of services, their perspectives and lived reality. This paper outlines how we are proceeding with research aimed at providing in-depth understanding of these complex issues and how this can assist with achieving patient centred integrated care for Pacific people in New Zealand. Methods : A critical realist approach provides the overarching methodological framework for our focus on Pacific peoples’ experiences of integrated care. Critical realism enables research in to the structures, culture and generative mechanisms at the macro (planning and funding), meso (organisational or professional) and micro (service and personal) levels that are identified in the framework for effective action to achieve integrated care (3,7). Our qualitative research methods incorporate Pacific methodologies for engaging diverse Pacific communities (8). Results : The problems associated with ethnicity, CALD and poverty and the pathways to poor health or indeed wellness and well-being, need to be better understood in order to determine whether integrated care interventions do in fact make a difference. Discussion : Pacific people like other culturally and linguistically diverse (CALD) populations in developed countries, face complex social problems; have high rates of chronic conditions and multimorbidity, and experience many barriers to obtaining the services they need (9-11). Government policy has supported targeted integrated care programmes for Pacific people (12). These programmes place patients at the centre of services, are mainly delivered by Pacific health clinicians, allied health workers or lay health workers; with the aim of improving access to, and coordination between services. Key findings include the diversity of groups that are included in the umbrella term Pacific and the requirement for better understanding of intragroup differences and patterns of unmet need. There is also need for a ‘family’ model of care that responds to the specific social and economic circumstances of families and provides coordinated care to the family unit as a whole. Overall, we found a gap between the aims and theories underpinning these services and the aspirations, expectations, worldviews and service experiences of diverse Pacific groups. Conclusion : Our research uses the largely untapped resource of the experiences of Pacific patients and their families to understand if integrated care interventions are making a difference. Limitations : This is complex intervention research which requires innovation, iteration and responsiveness to emergent issues. Our multidisciplinary team drew on Pacific cultural protocols and diverse networks to build and maintain relationships with multiple stakeholders including research participants, provider organisations and research funders, while also producing robust evidence to inform policy and practice.

Developing, delivering and evaluating primary mental health care: the co-production of a new complex intervention.

BackgroundHealth services face the challenges created by complex problems, and so need complex intervention solutions. However they also experience ongoing difficulties in translating findings from research in this area in to quality improvement changes on the ground. BounceBack was a service development innovation project which sought to examine this issue through the implementation and evaluation in a primary care setting of a novel complex intervention.MethodsThe project was a collaboration between a local mental health charity, an academic unit, and GP practices. The aim was to translate the charity’s model of care into practice-based evidence describing delivery and impact. Normalisation Process Theory (NPT) was used to support the implementation of the new model of primary mental health care into six GP practices. An integrated process evaluation evaluated the process and impact of care.ResultsImplementation quickly stalled as we identified problems with the described model of care when applied in a changing and variable primary care context. The team therefore switched to using the NPT framework to support the systematic identification and modification of the components of the complex intervention: including the core components that made it distinct (the consultation approach) and the variable components (organisational issues) that made it work in practice. The extra work significantly reduced the time available for outcome evaluation. However findings demonstrated moderately successful implementation of the model and a suggestion of hypothesised changes in outcomes.ConclusionsThe BounceBack project demonstrates the development of a complex intervention from practice. It highlights the use of Normalisation Process Theory to support development, and not just implementation, of a complex intervention; and describes the use of the research process in the generation of practice-based evidence. Implications for future translational complex intervention research supporting practice change through scholarship are discussed.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1726-6) contains supplementary material, which is available to authorized users.

Behavioural activation written self-help to improve mood, wellbeing and quality of life in people with dementia supported by informal carers (PROMOTE): a study protocol for a single-arm feasibility study.

BackgroundIncreases in life expectancy have resulted in a global rise in dementia prevalence. Dementia is associated with poor wellbeing, low quality of life and increased incidence of mental health difficulties such as low mood or depression. However, currently, there is limited access to evidence-based psychological interventions for people with dementia experiencing low mood and poor wellbeing. Behavioural activation-based self-help, supported by informal carers and guided by mental health professionals, may represent an effective and acceptable solution.Methods/designThe present study is a phase II (feasibility) single-arm trial informed by the Medical Research Council complex interventions research methods framework. Up to 50 dementia participant/informal carer dyads will be recruited from a variety of settings including primary care, dementia-specific health settings and community outreach. People living with dementia will receive behavioural activation-based self-help and be supported by their informal carer who has received training in the skills required to support the self-help approach. In turn, during the use of the intervention, the informal carer will be guided by mental health professionals to help them work through the materials and problem solve any difficulties. Consistent with the objectives of feasibility studies, outcomes relating to recruitment from different settings, employment of different recruitment methods, attrition, data collection procedures, clinical delivery and acceptability of the intervention will be examined. Clinical outcomes for people with dementia (symptoms of depression and quality of life) and informal carers (symptoms of depression and anxiety, carer burden and quality of life) will be measured pre-treatment and at 3 months post-treatment allocation.DiscussionThis study will examine the feasibility and acceptability of a novel behavioural activation-based self-help intervention designed to promote wellbeing and improve low mood in people living with dementia, alongside methodological and procedural uncertainties associated with research-related procedures. As determined by pre-specified progression criteria, if research procedures and the new intervention demonstrate feasibility and acceptability, results will then be used to inform the design of a pilot randomised controlled trial (RCT) to specifically examine remaining methodological uncertainties associated with recruitment into a randomised controlled design.Trial registrationCurrent Controlled Trials ISRCTN42017211

Icons: identifying continence options after stroke trial: utility of a logic model in the design and implementation of a process evaluation

Background: ICONS is a cluster randomised controlled pilot trial designed to provide preliminary evidence of the effectiveness of a systematic voiding programme (SVP) for the management of continence after stroke. Stroke services were randomised to receive the SVP, the SVP plus supported implementation, or usual care. Process evaluations are designed to evaluate fidelity and provide explanatory evidence around trial outcomes; these need to be underpinned by a theoretical framework to explain linkages between intervention processes and outcomes. Process evaluation: We conducted an evaluation to describe SVP implementation and assist in explaining intervention outcomes. Reflecting best practice in complex intervention research, we developed a logic model to underpin the evaluation representing practitioners’ implementation activities. To increase explanatory power of the model, we synthesised principles from theoretical frameworks underpinning the study (e.g. the Normalisation Process Model) into mechanisms of action to explain conditions necessary for activities to impact on outcomes. Mechanisms were: • Understanding and agreeing: conceptual work associated with the SVP, e.g. increasing awareness. • Driving and aligning: organising systems or processes to align and drive new practice. • Building and supporting: enacting the SVP. • Learning and evaluation: reflecting on performance and progress. Findings: We will discuss the utility of the logic model in explaining conditions necessary for the intervention to work, the success of implementation strategies adopted and variations in patient outcome across trial arms. We will also consider the challenges of synthesising across multiple data sources to understand variation in intervention delivery, maintenance and outcome in cluster trials.

Using documents to investigate links between implementation and sustainability in a complex community intervention: The PRISM study

The increasing imperative to find what works in health services has meant a rise in research trialing interventions deemed ‘complex’. While the strength of these interventions comes from taking a ‘whole of problem’ approach using multiple and inter-linking strategies, ways of examining implementation are under-explored. Building sustainability is an important part of implementing complex intervention research, but this too has received little exploration in the implementation literature. This paper explores issues of implementation and sustainability by examining the case of PRISM (Program of Resources, Information and Support for Mothers), a community randomised trial in Victoria, Australia aimed at improving maternal health and wellbeing. It examines documents placed on the project website. Three groups of documents relating to implementation of the intervention were examined – implementation reports, media reports and community newsletters. Analysing these documents allowed a focus on the ‘work’ of the intervention – who does the work and what activities comprise the work – in order to examine implementation as it relates to sustainability. Document analysis provides a useful way of considering implementation and sustainability of complex intervention research. It can ‘value add’ to findings from process evaluation and extend our understanding of an intervention beyond outcome measures. Analysis of the documents in this case provides insights into why sustainability of an intervention may be difficult to achieve during implementation.

RCTs in complex nursing interventions and laboratory experimental studies

The randomised controlled trial (RCT) is at the heart of the evidence-based medicine movement and by implication should also be central to evidence-based nursing. One objection to RCTs in nursing science is that nursing is too complex an activity to be subjected to a carefully controlled experimental paradigm. We suggest that this argument is false and use examples from complex interventions research in nursing and experimental laboratory methods to demonstrate that RCTs can bring much needed clarity to the search for nursing knowledge.

Causality in complex interventions

In this paper I look at causality in the context of intervention research, and discuss some problems faced in the evaluation of causal hypotheses via interventions. I draw attention to a simple problem for evaluations that employ randomized controlled trials. The common alternative to randomized trials, the observational study, is shown to face problems of a similar nature. I then argue that these problems become especially acute in cases where the intervention is complex (i.e. that involves intervening in a complex system). Finally, I consider and reject a possible resolution of the problem involving the simulation of complex interventions. The conclusion I draw from this is that we need to radically reframe the way we think about causal inference in complex intervention research.