Complex Healthcare Interventions Research Articles

Surveying knowledge, practice and attitudes towards intervention fidelity within trials of complex healthcare interventions

BackgroundIntervention fidelity is the degree to which interventions have been implemented as intended by their developers. Assessing fidelity is crucial for accurate interpretation of intervention effectiveness, but fidelity is often poorly addressed within trials of complex healthcare interventions. The reasons for this are unclear, and information on the use of methods to enhance and assess fidelity in trials of complex interventions remains insufficient. This study aimed to explore the knowledge, practice and attitudes towards intervention fidelity amongst researchers, triallists and healthcare professionals involved with the design and conduct of trials of complex healthcare interventions.MethodsAn online survey consisting of closed and open-ended questions exploring four sections (Demographics, Fidelity knowledge, Practice and Attitudes) was conducted. This was an opportunistic sample of individuals with experience of direct involvement in trials of complex healthcare interventions (e.g. design/development, conduct, evaluation).ResultsData from 264 participants representing 15 countries were analysed. The majority (65.9%, n = 174) of participants identified themselves as ‘Researchers’. The majority of participants were familiar with the term “intervention fidelity” (69.7%, n = 184) and indicated that fidelity is important (89.7%, n = 236). Mean self-reported understanding of fidelity was moderate. Although 68% (n = 182) had previously used strategies to assess (e.g. audio/video-recording sessions) and enhance (e.g. training manual) fidelity in trials of complex interventions, only a limited proportion of participants indicated always reporting these strategies in subsequent publications (30.9%, n = 56). Poor knowledge or understanding was the most commonly cited barrier to addressing intervention fidelity in trials (77.4%, n = 202). Over half of respondents (52.1%, n = 137) had never completed specific fidelity training or research, and the vast majority (89.7%, n = 236) would welcome specific training in this area.ConclusionDespite good awareness of intervention fidelity and its importance, poor knowledge and understanding appears to be a key factor limiting how intervention fidelity is addressed in trials of complex interventions. Participants identified a need for further training and education in this area. Additionally, clarification of the terminology, definition and components of intervention fidelity would facilitate better understanding of the concept. A discrepancy between participants’ use of fidelity strategies and subsequent reporting raises concerns around inadequate fidelity reporting in the trials literature.

Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review

BackgroundNormalization Process Theory (NPT) identifies, characterises and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions. A large body of literature that employs NPT to inform feasibility studies and process evaluations of complex healthcare interventions has now emerged. The aims of this review were to review this literature; to identify and characterise the uses and limits of NPT in research on the implementation and integration of healthcare interventions; and to explore NPT’s contribution to understanding the dynamics of these processes.MethodsA qualitative systematic review was conducted. We searched Web of Science, Scopus and Google Scholar for articles with empirical data in peer-reviewed journals that cited either key papers presenting and developing NPT, or the NPT Online Toolkit (www.normalizationprocess.org). We included in the review only articles that used NPT as the primary approach to collection, analysis or reporting of data in studies of the implementation of healthcare techniques, technologies or other interventions. A structured data extraction instrument was used, and data were analysed qualitatively.ResultsSearches revealed 3322 citations. We show that after eliminating 2337 duplicates and broken or junk URLs, 985 were screened as titles and abstracts. Of these, 101 were excluded because they did not fit the inclusion criteria for the review. This left 884 articles for full-text screening. Of these, 754 did not fit the inclusion criteria for the review. This left 130 papers presenting results from 108 identifiable studies to be included in the review. NPT appears to provide researchers and practitioners with a conceptual vocabulary for rigorous studies of implementation processes. It identifies, characterises and explains empirically identifiable mechanisms that motivate and shape implementation processes. Taken together, these mean that analyses using NPT can effectively assist in the explanation of the success or failure of specific implementation projects. Ten percent of papers included critiques of some aspect of NPT, with those that did mainly focusing on its terminology. However, two studies critiqued NPT emphasis on agency, and one study critiqued NPT for its normative focus.ConclusionsThis review demonstrates that researchers found NPT useful and applied it across a wide range of interventions. It has been effectively used to aid intervention development and implementation planning as well as evaluating and understanding implementation processes themselves. In particular, NPT appears to have offered a valuable set of conceptual tools to aid understanding of implementation as a dynamic process.

The direct cost of epilepsy in children: Evidence from the Medical Expenditure Panel Survey, 2003–2014

IntroductionEpilepsy is frequent in children and often requires complex healthcare interventions. There is a paucity of recent and detailed healthcare expenditures among children with epilepsy in the United States (US). MethodsData on children (aged ≤17years) from the Medical Expenditure Panel Survey-Household Component (MEPS-HC) from 2003 to 2014 were analyzed. Unadjusted overall and specific cost components were compared between children with epilepsy and those without epilepsy. We used a two-part model with gamma distribution and log link for the estimation of independent incremental cost incurred by epilepsy in children. Unadjusted and adjusted mean expenditures and aggregate burden of epilepsy were estimated. ResultsOut of 54,393,387 (weighted) US children, 457,873 (0.84%) had epilepsy. Children with epilepsy had nearly six times higher healthcare expenditure than those without epilepsy ($2024 [95% confidence interval (CI): 1917–2130] vs. $12,577 [95% CI: 7922–17,231]). Unadjusted inpatient expenditure for epilepsy ($4418 [95% CI: 1550–7285) was ten times higher than that for children without epilepsy, representing more than one-third of unadjusted total direct cost. The adjusted difference in medical expenditure between children with and those without epilepsy was $8317 (95% CI: 3701–13,363). The annual unadjusted aggregate cost of epilepsy in children was approximately $5.8 billion. The annual adjusted difference in cost of epilepsy between children with and those without epilepsy was $3.8 billion. ConclusionUnadjusted and adjusted medical expenditure among children with epilepsy is high. The high expenditure is essentially driven not only by inpatient expenditure but also by home healthcare, outpatient, and medication healthcare expenditures.

Overcoming Challenges In Codifying And Replicating Complex Health Care Interventions.

The complex nature of many health care interventions poses challenges for successful replication. This article presents insights on tackling these challenges primarily drawn from recent research and programs in the UK. These insights include the need to codify complex interventions in ways that reflect their social, context-sensitive, and dynamic nature; to capture learning as the intervention is implemented in new contexts; and to design programs in ways that respect adopters' role in the spread process. We argue that program leaders should have familiarity with theoretical approaches for conceptualizing complex interventions, that a discrete testing-and-revision phase should be recognized as part of the spread process, and that programs should be designed in ways that build and sustain adopter commitment. These perspectives complement the traditional focus on the innovator in models of spread by highlighting the role adopters play in adapting interventions and generating learning, and they have implications for the design of programs to spread innovation.

Evidence-Based Evaluation of Practice and Innovation in Physical Therapy Using the IDEAL-Physio Framework.

The IDEAL framework is an established method for initial and ongoing evaluations of innovation and practice for complex health care interventions. First derived for surgical sciences and embedded at a global level for evaluating surgery/surgical devices, the IDEAL framework is based on the principle that innovation and evaluation in clinical practice can, and should, evolve together in an ordered manner: from conception to development and then to validation by appropriate clinical studies and, finally, longer-term follow-up. This framework is highly suited to other complex, nonpharmacological interventions, such as physical therapist interventions. This perspective outlines the application of IDEAL to physical therapy in the new IDEAL-Physio framework. The IDEAL-Physio framework comprises 5 stages. In stage 1, the idea phase, formal data collection should begin. Stage 2a is the phase for iterative improvement and adjustment with thorough data recording. Stage 2b involves the onset of formal evaluation using systematically collected group or cohort data. Stage 3 is the phase for formal comparative assessment of treatment, usually involving randomized studies. Stage 4 involves long-term follow-up. The IDEAL-Physio framework is recommended as a method for guiding and evaluating both innovation and practice in physical therapy, with the overall goal of providing better evidence-based care.

Evaluation of the effectiveness of complex health care interventions: the example of case management

Introduction: The aim is to present the evaluation of effectiveness of case management interventions, designed from the bottom-up, which have been implemented in Belgium since 2010 to support dependent elderly people at home. This type of intervention is an integrated care process which combines prevention, evaluation, custom designed multidisciplinary care plan, coordination of services and follow-up. Mixed methods are necessary for covering the indispensable steps of the analysis of effectiveness which includes the specific description of the interventions, the identification of the target populations, the building of a control group, the tracking of pertinent indicators, and the choice of a quantitative approach bearing in mind the implementation process of the interventions. Methods: The quantitative analysis of effectiveness has been guided by the results of the implementation analysis, a qualitative approach which provides the description of essential components of the interventions. Two quantitative databases are available for the beneficiaries and the control group (not benefiting from interventions and recruited by home care organisations, thus reflecting “usual care”): (1) a prospective data collection through a validated comprehensive geriatric instrument (the interRAI Home Care instrument) including clinical variables and data related to the informal caregivers, and (2) the administrative database of the reimbursed health care consumption (routinely recorded by the health care insurance). The different types of dependency are defined through a clustering analysis grouping beneficiaries according to functional and cognitive limitations. Thereafter, each P3 beneficiary is matched by using a propensity score method with one individual of the control group having similar health characteristics and similar levels of presence of informal caregiver (without, non-cohabitant, cohabitant). Finally, the different variables for assessing effectiveness are tested between beneficiaries and the control group. Results: Case management interventions are grouped according to three criteria: (1) the feedback to a general practitioner, (2) the psychological support, and (3) the intensity of the intervention. Beneficiaries are divided into five dependency types (low limitations; important IADL limitations; important ADL and IADL limitations; significant cognitive and functional deficiencies; and people cumulating significant cognitive, functional and behavioural problems). The results are presented for each of the above subgroups in the form of a “dashboard” including the different essential indicators for the evaluation of the impact of the intervention: indicators of health care consumption (i.e. nursing care at home, visits to a medical specialist), indicators identifying the stress on the health system (i.e. unexpected hospitalisation, visits to emergency service) and clinical outcomes (i.e. functional, cognitive, and depressive status, quality of life, informal caregiver’s perceived burden). Discussion: The analysis of the data collected through the questionnaires filled out by both the care recipients and their main informal caregivers linked to the administrative database of health care consumption provides a comprehensive evaluation of the effectiveness of a complex intervention. Both clinical and use of resources outcomes are analyzed for the dyads of care recipients/informal caregivers and allow for comprehensively and accurately describing the consequences of case management interventions according to various types of situations at home.

A robust interrupted time series model for analyzing complex health care intervention data.

Current health policy calls for greater use of evidence-based care delivery services to improve patient quality and safety outcomes. Care delivery is complex, with interacting and interdependent components that challenge traditional statistical analytic techniques, in particular, when modeling a time series of outcomes data that might be "interrupted" by a change in a particular method of health care delivery. Interrupted time series (ITS) is a robust quasi-experimental design with the ability to infer the effectiveness of an intervention that accounts for data dependency. Current standardized methods for analyzing ITS data do not model changes in variation and correlation following the intervention. This is a key limitation since it is plausible for data variability and dependency to change because of the intervention. Moreover, present methodology either assumes a prespecified interruption time point with an instantaneous effect or removes data for which the effect of intervention is not fully realized. In this paper, we describe and develop a novel robust interrupted time series (robust-ITS) model that overcomes these omissions and limitations. The robust-ITS model formally performs inference on (1) identifying the change point; (2) differences in preintervention and postintervention correlation; (3) differences in the outcome variance preintervention and postintervention; and (4) differences in the mean preintervention and postintervention. We illustrate the proposed method by analyzing patient satisfaction data from a hospital that implemented and evaluated a new nursing care delivery model as the intervention of interest. The robust-ITS model is implemented in an R Shiny toolbox, which is freely available to the community.

AHRQ series on complex intervention systematic reviews—paper 6: PRISMA-CI extension statement and checklist

BackgroundComplex interventions are widely used in health systems, public health, education, and communities and are increasingly the subject of systematic reviews. Oversimplification and inconsistencies in reporting about complex interventions can limit the usability of review findings. RationaleAlthough guidance exists to ensure that reports of individual studies and systematic reviews adhere to accepted scientific standards, their design-specific focus leaves important reporting gaps relative to complex interventions in health care. This paper provides a stand-alone extension to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting tool for complex interventions—PRISMA-CI—to help authors, publishers, and readers understand and apply to systematic reviews of complex interventions. DiscussionPRISMA-CI development followed the Enhancing the QUAlity and Transparency Of health Research Network guidance for extensions and focused on adding or modifying only essential items that are truly unique to complex interventions and are not covered by broader interpretation of current PRISMA guidance. PRISMA-CI provides an important structure and guidance for systematic reviews and meta-analyses for the highly prevalent and dynamic field of complex interventions.

Paediatric early warning systems for detecting and responding to clinical deterioration in children: a systematic review

ObjectiveTo systematically review the available evidence on paediatric early warning systems (PEWS) for use in acute paediatric healthcare settings for the detection of, and timely response to, clinical deterioration in...

Testing a systematic approach to identify and prioritise barriers to successful implementation of a complex healthcare intervention

BackgroundMultiple barriers may inhibit the adoption of clinical interventions and impede successful implementation. Use of standardised methods to prioritise barriers to target when selecting implementation interventions is an understudied area of implementation research. The aim of this study was to describe a method to identify and prioritise barriers to the implementation of clinical practice elements which were used to inform the development of the T3 trial implementation intervention (Triage, Treatment [thrombolysis administration; monitoring and management of temperature, blood glucose levels, and swallowing difficulties] and Transfer of stroke patients from Emergency Departments [ED]).MethodsA survey was developed based on a literature review and data from a complementary trial to identify the commonly reported barriers for the nine T3 clinical care elements. This was administered via a web-based questionnaire to a purposive sample of Australian multidisciplinary clinicians and managers in acute stroke care. The questionnaire addressed barriers to each of the nine T3 trial clinical care elements. Participants produced two ranked lists: on their perception of: firstly, how influential each barrier was in preventing clinicians from performing the clinical care element (influence attribute); and secondly how difficult the barrier was to overcome (difficulty attribute). The rankings for both influence and difficulty were combined to classify the barriers according to three categories (‘least desirable’, desirable’ or ‘most desirable’ to target) to assist interpretation.ResultsAll invited participants completed the survey; (n = 17; 35% medical, 35% nursing, 18% speech pathology, 12% bed managers). The barriers classified as most desirable to target and overcome were a ‘lack of protocols for the management of fever’ and ‘not enough blood glucose monitoring machines’.ConclusionsA structured decision-support procedure has been illustrated and successfully applied to identify and prioritise barriers to target within an implementation intervention. This approach may prove to be a useful in other studies and as an adjunct to undertaking barrier assessments within individual sites when planning implementation interventions.

Trends in clinical characteristics and outcomes of Pre-ART care at a large HIV clinic in Nairobi, Kenya: a retrospective cohort study.

BackgroundThe success of antiretroviral therapy in resource-scarce settings is an illustration that complex healthcare interventions can be successfully delivered even in fragile health systems. Documenting the success factors in the scale-up of HIV care and treatment in resource constrained settings will enable health systems to prepare for changing population health needs. This study describes changing demographic and clinical characteristics of adult pre-ART cohorts, and identifies predictors of pre-ART attrition at a large urban HIV clinic in Nairobi, Kenya.MethodsWe conducted a retrospective cohort analysis of data on HIV infected adults (≥15 years) enrolling in pre-ART care between January 2004 and September 2015. Attrition (loss to program) was defined as those who died or were lost to follow-up (having no contact with the facility for at least 6 months). We used Kaplan-Meier survival analysis to determine time to event for the different modes of transition, and Cox proportional hazards models to determine predictors of pre-ART attrition.ResultsOver the 12 years of observation, there were increases in the proportions of young people (age 15 to 24 years); and patients presenting with early disease (by WHO clinical stage and higher median CD4 cell counts), p = 0.0001 for trend. Independent predictors of attrition included: aHR (95% CI): male gender 1.98 (1.69–2.33), p = 0.0001; age 20–24 years 1.80 (1.37–2.37), p = 0.0001), or 25–34 years 1.22 (1.01–1.47), p = 0.0364; marital status single 1.55 (1.29–1.86), p = 0.0001) or divorced 1.41(1.02–1.95), p = 0.0370; urban residency 1.83 (1.40–2.38), p = 0.0001; CD4 count of 0–100 cells/µl 1.63 (1.003–2.658), p = 0.0486 or CD4 count >500 cells/µl 2.14(1.46–3.14), p = 0.0001.ConclusionsIn order to optimize the impact of HIV prevention, care and treatment in resource scarce settings, there is an urgent need to implement prevention and treatment interventions targeting young people and patients entering care with severe immunosuppression (CD4 cell counts <100 cells/µl). Additionally, care and treatment programmes should strengthen inter-facility referrals and linkages to improve care coordination and prevent leakages in the HIV care continuum.

Feasibility, appropriateness, meaningfulness and effectiveness of patient participation at bedside shift reporting: mixed-method research protocol.

To evaluate the feasibility, appropriateness, meaningfulness and effectiveness of bedside shift reporting in a minimum of five interventions and five control wards. Hospitals continually improve their quality of care. Next to improvements in clinical performance, more patient participation is stimulated through different methods. Methods to enhance patient participation such as bedside shift reporting lack rigorously performed research to determine their feasibility, appropriateness, meaningfulness and effectiveness. Small-scale research and a previous pilot study indicate that bedside shift reporting improves patient participation, nurse-nurse communication and nurse-patient communication. The development, implementation and evaluation of bedside shift report are based on the Medical Research Council framework for complex interventions in health care. A matched, controlled, mixed-method, longitudinal study design will be used. The Feasibility-Appropriateness-Meaningfulness-Effectiveness framework will be applied for the quantitative and qualitative evaluation of bedside shift report. A tailored intervention and implementation process for bedside shift report will be developed using diagnostic interviews, co-design and acceptability testing. The intervention will be evaluated before implementation and three times after implementation. Individual and focus group interviews will be performed. Questionnaires, observations and analysis of the medical records and administrative databases will be completed. This study was funded in October 2015. Research Ethics Committee approval was granted in March 2016. There is a pressing need for rigorous research into the effects of interventions for improving patient participation. This study addresses the significance of bedside shift report as an intervention to improve quality of care, communication and patient participation within a large-scale, matched, controlled research design.

Incorporating Budget Impact Analysis in the Implementation of Complex Interventions: A Case of an Integrated Intervention for Multimorbid Patients within the CareWell Study

To develop a framework for the management of complex health care interventions within the Deming continuous improvement cycle and to test the framework in the case of an integrated intervention for multimorbid patients in the Basque Country within the CareWell project. Statistical analysis alone, although necessary, may not always represent the practical significance of the intervention. Thus, to ascertain the true economic impact of the intervention, the statistical results can be integrated into the budget impact analysis. The intervention of the case study consisted of a comprehensive approach that integrated new provider roles and new technological infrastructure for multimorbid patients, with the aim of reducing patient decompensations by 10% over 5 years. The study period was 2012 to 2020. Given the aging of the general population, the conventional scenario predicts an increase of 21% in the health care budget for care of multimorbid patients during the study period. With a successful intervention, this figure should drop to 18%. The statistical analysis, however, showed no significant differences in costs either in primary care or in hospital care between 2012 and 2014. The real costs in 2014 were by far closer to those in the conventional scenario than to the reductions expected in the objective scenario. The present implementation should be reappraised, because the present expenditure did not move closer to the objective budget. This work demonstrates the capacity of budget impact analysis to enhance the implementation of complex interventions. Its integration in the context of the continuous improvement cycle is transferable to other contexts in which implementation depth and time are important.

Oral health educational interventions for nursing home staff and residents.

Associations between nursing home residents' oral health status and quality of life, respiratory tract infections, and nutritional status have been reported. Educational interventions for nurses or residents, or both, focusing on knowledge and skills related to oral health management may have the potential to improve residents' oral health. To assess the effects of oral health educational interventions for nursing home staff or residents, or both, to maintain or improve the oral health of nursing home residents. We searched the Cochrane Oral Health Trials Register (to 18 January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2015, Issue 12), MEDLINE Ovid (1946 to 18 January 2016), Embase Ovid (1980 to 18 January 2016), CINAHL EBSCO (1937 to 18 January 2016), and Web of Science Conference Proceedings (1990 to 18 January 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials to 18 January 2016. In addition, we searched reference lists of identified articles and contacted experts in the field. We placed no restrictions on language or date of publication when searching the electronic databases. Randomised controlled trials (RCTs) and cluster-RCTs comparing oral health educational programmes for nursing staff or residents, or both with usual care or any other oral healthcare intervention. Two review authors independently screened articles retrieved from the searches for relevance, extracted data from included studies, assessed risk of bias for each included study, and evaluated the overall quality of the evidence. We retrieved data about the development and evaluation processes of complex interventions on the basis of the Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2). We contacted authors of relevant studies for additional information. We included nine RCTs involving 3253 nursing home residents in this review; seven of these trials used cluster randomisation. The mean resident age ranged from 78 to 86 years across studies, and most participants were women (more than 66% in all studies). The proportion of residents with dental protheses ranged from 62% to 87%, and the proportion of edentulous residents ranged from 32% to 90% across studies.Eight studies compared educational interventions with information and practical components versus (optimised) usual care, while the ninth study compared educational interventions with information only versus usual care. All interventions included educational sessions on oral health for nursing staff (five trials) or for both staff and residents (four trials), and used more than one active component. Follow-up of included studies ranged from three months to five years.No study showed overall low risk of bias. Four studies had a high risk of bias, and the other five studies were at unclear risk of bias.None of the trials assessed our predefined primary outcomes 'oral health' and 'oral health-related quality of life'. All trials assessed our third primary outcome, 'dental or denture plaque'. Meta-analyses showed no evidence of a difference between interventions and usual care for dental plaque (mean difference -0.04, 95% confidence interval (CI) -0.26 to 0.17; six trials; 437 participants; low quality evidence) or denture plaque (standardised mean difference -0.60, 95% CI -1.25 to 0.05; five trials; 816 participants; low quality evidence). None of the studies assessed adverse events of the intervention. We found insufficient evidence to draw robust conclusions about the effects of oral health educational interventions for nursing home staff and residents. We did not find evidence of meaningful effects of educational interventions on any measure of residents' oral health; however, the quality of the available evidence is low. More adequately powered and high-quality studies using relevant outcome measures are needed.

Framing moving and handling as a complex healthcare intervention within the acute care of older people with osteoporosis: a qualitative study

To investigate healthcare staff's views and experiences of caring for older hospitalised adults (aged 60+) with osteoporosis focusing on moving and handling. Specific objectives were to explore the composition of manual handling risk assessments and interventions in osteoporosis. Osteoporosis is a skeletal disease that reduces bone density and causes increased fracture risk. Incidence rises with age and osteoporotic fractures cause increased morbidity and mortality. It is a major global health problem. In the UK older hospitalised adults are normally screened for falls risk but not necessarily for osteoporosis. As presentation of osteoporosis is normally silent until fractures are evident, it is frequently undiagnosed. Healthcare staff's knowledge of osteoporosis is often suboptimal and specific manual handling implications are under-researched. An exploratory qualitative content analysis research design informed by critical realism. The purposive sample comprised 26 nursing and allied health professionals. Semi-structured interviews addressed topics including knowledge of osteoporosis, implications for acute care, moving and handling and clinical guidelines. Qualitative content data analysis was used. Awareness of osteoporosis prevalence in older populations varies and implications for nursing are indistinct to nonspecialists. In-hospital fractures potentially linked to suboptimal moving and handling seemed rare, but prospective studies are needed. Categories of 'Understanding moving and handling as routine care or as a healthcare intervention', with further categories 'healthcare practitioners' capacities and capabilities for dealing with people with osteoporosis' and 'the structural and organisational context for moving and handling' are reported alongside safety, frailty and dependency dimensions. This study informs moving and handling in higher risk groups such as osteoporosis. Clinical knowledge/expertise is required when adapting generic manual handling guidelines to specific patients/contexts. Patients' experiences of moving and handling have received limited attention. Increased focus on musculoskeletal conditions and moving and handling implications is required.

Process evaluation for complex interventions in health services research: analysing context, text trajectories and disruptions.

BackgroundProcess evaluations assess the implementation and sustainability of complex healthcare interventions within clinical trials, with well-established theoretical models available for evaluating intervention delivery within specific contexts. However, there is a need to translate conceptualisations of context into analytical tools which enable the dynamic relationship between context and intervention implementation to be captured and understood.MethodsIn this paper I propose an alternative approach to the design, implementation and analysis of process evaluations for complex health interventions through a consideration of trial protocols as textual documents, distributed and enacted at multiple contextual levels. As an example, I conduct retrospective analysis of a sample of field notes and transcripts collected during the ESTEEM study - a cluster randomised controlled trial of primary care telephone triage. I draw on theoretical perspectives associated with Linguistic Ethnography to examine the delivery of ESTEEM through staff orientation to different texts. In doing so I consider what can be learned from examining the flow and enactment of protocols for notions of implementation and theoretical fidelity (i.e. intervention delivered as intended and whether congruent with the intervention theory).ResultsImplementation of the triage intervention required staff to integrate essential elements of the protocol within everyday practice, seen through the adoption and use of different texts that were distributed across staff and within specific events. Staff were observed deploying texts in diverse ways (e.g. reinterpreting scripts, deviating from standard operating procedures, difficulty completing decision support software), providing numerous instances of disruption to maintaining intervention fidelity. Such observations exposed tensions between different contextual features in which the trial was implemented, offering theoretical explanations for the main trial findings.ConclusionsThe value of following how trial protocols produce new texts is that we can observe the flow of ‘the intervention as intended’ across a series of events which are enacted to meet specific demands of intervention delivery. Such observations are not solely premised on identifying routines or practices of implementation, but where ‘protocols as intended’ breaks down. In doing so, I discuss whether it is here where we might expose the ‘active ingredients’ of interventions in action.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1651-8) contains supplementary material, which is available to authorized users.

Complex health care interventions: Characteristics relevant for ethical analysis in health technology assessment.

Complexity entails methodological challenges in assessing health care interventions. In order to address these challenges, a series of characteristics of complexity have been identified in the Health Technology Assessment (HTA) literature. These characteristics are primarily identified and developed to facilitate effectiveness, safety, and cost-effectiveness analysis. However, ethics is also a constitutive part of HTA, and it is not given that the conceptions of complexity that appears relevant for effectiveness, safety, and cost-effectiveness analysis are also relevant and directly applicable for ethical analysis in HTA. The objective of this article is therefore to identify and elaborate a set of key characteristics of complex health care interventions relevant for addressing ethical aspects in HTA. We start by investigating the relevance of the characteristics of complex interventions, as defined in the HTA literature. Most aspects of complexity found to be important when assessing effectiveness, safety, and efficiency turn out also to be relevant when assessing ethical issues of a given health technology. However, the importance and relevance of the complexity characteristics may differ when addressing ethical issues rather than effectiveness. Moreover, the moral challenges of a health care intervention may themselves contribute to the complexity. After identifying and analysing existing conceptions of complexity, we synthesise a set of five key characteristics of complexity for addressing ethical aspects in HTA: 1) multiple and changing perspectives, 2) indeterminate phenomena, 3) uncertain causality, 4) unpredictable outcome, and 5) ethical complexity. This may serve as an analytic tool in addressing ethical issues in HTA of complex interventions.

Examination of England's New Medicine Service (NMS) of complex health care interventions in community pharmacy.

Community pharmacies are increasingly commissioned to deliver new, complex health interventions in response to the growing demands on family doctors and secondary health care services. Little is known about how these complex interventions are being accommodated and translated into the community pharmacy setting and whether their aims and objectives are realized in practice. The New Medicine Service (NMS) is a complex medicine management intervention that aims to support patients' adherence to newly prescribed medicines for a long-term condition. This study explores the recent implementation of the NMS in community pharmacies across England. It also seeks to understand how the service is becoming manifest in practice and what lessons can be learned for future service implementation. Structured, organizational ethnographic observations and in situ workplace interviews with pharmacists and support staff were undertaken within 23 English community pharmacies. Additionally, one-to-one, semi-structured interviews were carried out with 47 community pharmacists and 11 general practitioners (GPs). Observational and interview data were transcribed and analyzed thematically and guided by Damschroder's consolidated framework for implementation research. The NMS workload had been implemented and absorbed into pharmacists' daily routines alongside existing responsibilities with no extra resources and little evidence of reduction in other responsibilities. Pharmacists were pragmatic, simplifying, and adapting the NMS to facilitate its delivery and using discretion to circumvent perceived non-essential paperwork. Pharmacist understanding of the NMS was found to impact on what they believed should be achieved from the service. Despite pharmacists holding positive views about the value of the NMS, not all were convinced of its perceived benefits and necessity, with reports that many consultations did not identify any problems with the patients' medicines. GPs were generally supportive of the initiative but were unaware of the service or potential benefits. Poorly developed existing pharmacist-GP relationships impeded implementation. This study identifies the multifaceted and complex processes involved in implementing a new community pharmacy service in England. Community pharmacy workflow, infrastructure, and public and professional relationships all affect NMS implementation. Greater prior engagement with the pharmacy workforce and GPs, robust piloting and a phased rollout together with ongoing support and updates, are potentials strategies to ensure future implementation of pharmacy services meet their intended aims in practice.

All Wales Injury Surveillance System revised: development of a population-based system to evaluate single-level and multilevel interventions

BackgroundInjury surveillance has been established since the 1990s, but is still largely based upon single-source data from sentinel sites. The growth of electronic health records and developments in privacy protecting...

Using conversation analytic methods to explore the content, delivery and receipt of complex healthcare interventions

The majority of healthcare interventions rely on communication of one kind or another. In some trials, the main intervention elements are communication-based, involving multiple parties. However there has been little research on the content, delivery or receipt, or on the communication outcomes (i.e. the interactional consequences) of such complex interventions. In this paper we demonstrate the benefits of such an approach in three separate case studies where conversation analytic (CA) methods have been used in primary care trials. CA is a well-established qualitative method that affords opportunities for the identification, and distributional analyses, of communication practices of interest, providing evidence for the interactional consequences of communication-based interventions. Case study 1 explored interactions between patients and practitioners in a follow-up study to a trial of online cognitive behavioural therapy for depression. Case study 2 compared interaction in nurse-led vs GP-led telephone triage for same-day appointment requests in a sub-study to a trial evaluating effectiveness and cost effectiveness. Case study 3, explored GP’s fidelity to communication training in a feasibility study of a consultation-level intervention for the management of frequent attenders with clinically inexplicable symptoms. Understanding how both patient and practitioner communication behaviours can influence the content, delivery and receipt of an intervention is important. Without an understanding of how communication can be consequential, we are left with idealisations about how an intervention should work, drawing on formal theories alone, as opposed to opening a window on the similarities, gaps or differences between an intervention-as-designed and how it plays out in practice.