Acceptability of a nurse-led non-pharmacological complex intervention for knee pain: Nurse and patient views and experiences

Objectives The overall purpose of this research programme is to develop and test the feasibility of a complex intervention for knee pain delivered by a nurse, and comprising both non-pharmacological and pharmacological interventions. In this first phase, we examined the acceptability of the non-pharmacological component of the intervention; issues faced in delivery, and resolved possible challenges to delivery. Methods Eighteen adults with chronic knee pain were recruited from the community. The intervention comprised holistic assessment, education, exercise, weight-loss advice (where appropriate) and advice on adjunctive treatments such as hot/cold treatments, footwear modification and walking aids. After nurse training, the intervention was delivered in four sessions spread over five weeks. Participants had one to one semi-structured interview at the end of the intervention. The nurse was interviewed after the last visit of the last participant. These were audio recorded and transcribed verbatim. Themes were identified by one author through framework analysis of the transcripts, and cross-checked by another. Results Most participants found the advice from the nurse easy to follow and were satisfied with the package, though some felt that too much information was provided too soon. The intervention changed their perception of managing knee pain, learning that it can be improved with self-management. However, participants thought that the most challenging part of the intervention was fitting the exercise regime into their daily routine. The nurse found discussion of goal setting to be challenging. Conclusion The nurse-led package of care is acceptable within a research setting. The results are promising and will be applied in a feasibility randomised-controlled trial.

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.

Integrating Hepatitis C Care for opioid substitution treatment patients attending general practice: Feasibility, Clinical and Cost Effectiveness (Preprint)

BACKGROUND Hepatitis C (HCV) infection is common among people who inject drugs (PWID), yet well described barriers mean that a minority have accessed HCV treatment. OBJECTIVE The aim of this study was to examine feasibility, acceptability, clinical and cost effectiveness of an integrated model of HCV care for opioid substitution treatment (OST) patients in general practice. METHODS A pre-and-post intervention design with an embedded economic analysis was used to establish the feasibility, acceptability, clinical and cost effectiveness of a complex intervention to optimise HCV identification and linkage to HCV treatment among patients prescribed methadone in primary care. The ‘complex intervention’ comprised General Practitioner (GP) / practice staff education, nurse-led clinical support, and enhanced community-based HCV assessment of patients. General practices in North Dublin were recruited from the professional networks of the research team and from GPs who attended educational sessions. RESULTS Fourteen practices, 135 patients participated. Follow-up data was collected six-months post-intervention on 131(97.0%) patients. With regards to clinical effectiveness, among HCV antibody-positive patients, there was a significant increase in the proportions of who had a liver fibroscan (17/101(16.8%) vs 52/100 (52.0%); p<0.001), had attended hepatology/infectious diseases services (51/101(50.5%) vs 61/100 (61.0%); p=0.002), and initiated treatment (20/101(19.8%) vs 30/100 (30.0%); p=0.004). The mean incremental cost-effectiveness ratio of the intervention was €13,255 per quality adjusted life year gained at current full drug list price (€39,729 per course), which would be cost saving if these costs are reduced by 88%. CONCLUSIONS The complex intervention involving clinical support, access to assessment and practitioner education has the potential to enhance patient care, improving access to assessment and treatment in a cost effective manner.

A complex intervention to promote prevention of delirium in older adults by targeting caregiver’s participation during and after hospital discharge – study protocol of the TRAnsport and DElirium in older people (TRADE) project

Background Among potentially modifiable risk factors for delirium, transfers between wards, hospitals and other facilities have been mentioned with low evidence. TRADE (TRAnsport and DElirium in older people) was set up to investigate i) the impact of transfer and/or discharge on the onset of delirium in older adults and ii) feasibility and acceptance of a developed complex intervention targeting caregiver’s participation during and after hospital discharge or transfer on cognition and the onset of delirium in older adults. Methods The study is designed according to the guidelines of the UK Medical Research Council (MRC) for development and evaluation of complex interventions and comprises two steps: development and feasibility/piloting. The development phase includes i) a multicenter observational prospective cohort study to assess delirium incidence and cognitive decline associated with transfer and discharge, ii) a systematic review of the literature, iii) stakeholder focus group interviews and iv) an expert workshop followed by a Delphi survey. Based on this information, a complex intervention to better and systematically involve family caregivers in discharge and transport was developed. The intervention will be tested in a pilot study using a stepped wedge design with a detailed process and health economic evaluation. The study is conducted at four acute care hospitals in southwest Germany. Primary endpoints are the delirium incidence and cognitive function. Secondary endpoints include prevalence of caregiver companionship, functional decline, cost and cost effectiveness, quality of discharge management and quality of admission management in admitting hospitals or nursing homes. Data will be collected prior to discharge as well as after 3, 7 and 90 days. Discussion TRADE will help to evaluate transfer and discharge as a possible risk factor for delirium. In addition, TRADE evaluates the impact and modifiability of caregiver’s participation during patient’s transfer or discharge on delirium incidence and cognitive decline providing the foundation for a confirmatory implementation study. Trial registration DRKS (Deutsches Register für klinische Studien) DRKS00017828. Registered on 17th September 2019. Retrospectively registered.

Methodological challenges and solution strategies during implementation of a midwife-led multicenter randomized controlled trial (RCT) in maternity hospitals

Background Randomized controlled trials (RCTs), especially multicentric, with complex interventions are methodically challenging. Careful planning under everyday conditions in compliance with the relevant international quality standard (Good Clinical Practice [GCP] guideline) is crucial. Specific challenges exist for RCTs conducted in delivery rooms due to various factors that cannot be planned beforehand. Few published RCTs report challenges and problems in implementing complex interventions in maternity wards. In Germany as well as in other countries, midwives and obstetricians have frequently little experience as investigators in clinical trials. Methods The aim is to describe the key methodological and organizational challenges in conducting a multicenter study in maternity wards and the solution strategies applied to them. In particular, project-related and process-oriented challenges for hospital staff are considered. The exemplarily presented randomized controlled trial “BE-UP” investigates the effectiveness of an alternative design of a birthing room on the rate of vaginal births and women-specific outcomes. Results The results are presented in five sectors: 1) Selection of and support for cooperating hospitals: they are to be selected according to predefined criteria, and strategies to offer continuous support in trial implementation must be mapped out. 2) Establishing a process of requesting informed consent: a quality-assured process to inform pregnant women early on must be feasible and effective. 3) Individual digital real-time randomization: In addition to instructing maternity teams, appropriate measures for technical failure must be provided. 4) The standardized birthing room: The complex intervention is to be implemented according to the study protocol yet adapted to the prevailing conditions in the delivery rooms. 5) GCP-compliant documentation: midwives and obstetricians will be instructed in high-quality data collection, supported by external monitoring throughout the trial. Conclusion Since not all potential challenges can be anticipated in the planning of a trial, study teams need to be flexible and react promptly to any problems that threaten recruitment or the implementation of the complex intervention. Thought should be given to the perspectives of midwives and obstetricians as recruiters and how clinic-intern processes could be adapted to correspond with the trial’s requirements. Trial registration The BE-UP study was registered on 07/03/ 2018 in the German Register for Clinical Trials under Reference No. DRKS00012854 and can also be found on the International Clinical Trials Registry Platform (ICTRP) (see https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS0001285).

Hierarchical Representation of Complex Intervention Sequences for Automated Subgroup Analysis in Critical Care Settings

Our understanding of the impact of interventions in critical care is limited by the lack of techniques that represent and analyze complex intervention spaces applied across heterogeneous patient populations. Existing work has mainly focused on selecting a few interventions and representing them as binary variables, resulting in oversimplification of intervention representation. The goal of this study is to find effective representations of sequential interventions to support intervention effect analysis. To this end, we have developed Hi-RISE (Hierarchical Representation of Intervention Sequences), an approach that transforms and clusters sequential interventions into a latent space, with the resulting clusters used for heterogenous treatment effect analysis. We apply this approach to the MIMIC III dataset and identified intervention clusters and corresponding subpopulations with peculiar odds of 28-day mortality. Our approach may lead to a better understanding of the subgroup-level effects of sequential interventions and improve targeted intervention planning in critical care settings.

Research Study Protocol: Using health information systems to address patients concerns in general practice: the COAC Intervention development and feasibility study

BackgroundProblems are missed in up to 50% of primary care consultations. This is costly for the NHS, both in terms of reconsultation rates and in missed opportunities to increase patient empowerment. Research suggests that interventions at each end of the consultation can help to address patient concerns. At consultation initiation, sharing the results from electronic patient-reported outcome measures (ePROMs) with clinicians can help to elicit concerns. At consultation closure, providing the patient with written information to supplement spoken can improve recall and adherence.Aims and ObjectivesAim: To develop and test a complex intervention designed to more comprehensively address patients’ concerns in general practice, thereby reducing re-consultation rates, improving patients’ well-being and health knowledge, reducing health concerns and increasing patients’ confidence in their health provision and health plan. The aims will be achieved through two studies. Firstly a complex intervention will be designed, which uses an ePROM at consultation opening and a report printed or texted at consultation closure. Secondly, this intervention will be tested to establish the feasibility both of the intervention and of a randomised control trial (RCT) of the intervention.Methods1. Intervention Design Study: This will involve:1. Design of an online questionnaire system using practice SMS/email systems and online survey software to allow patient self-completion of a pre-consultation questionnaire and a report showing low-scoring questionnaire items, which is shared with GPs or nurses.2. Testing the pre-consultation system with 45 patients in 3 rounds, using a person-based approach, with iterative adjustments made based on patient, administrator, receptionist, nurse and GP feedback after each round.3. Design of an electronic template, integrated with the patient record, to provide a printable consultation-closure report to patients on issues raised in the consultation, advice given, treatment, follow-up and safety-netting.4. Testing the consultation-closure report iteratively with 45 patients in 3 rounds, using a person-based approach, with iterative adjustments made based on patient and GP/nurse feedback after each round.2. Feasibility Study: The intervention will be tested in a cluster-randomised framework as follows:1. Refinement of the intervention and update to programme theory.2. Randomisation of six practices: four randomised to intervention, and two to control.3. Recruitment of 30 patients per practice: 120 intervention and 60 control.4. Data Collection of quantitative data via GP/nurse-report, patient-report and health records. Interview of GPs, nurses, practice manager, administrators and receptionists and up to 30 patients.5. Realist evaluation of the data to identify and understand the mechanisms by which outcomes have occurred within the programme theory.6. Data analysis of recruitment rates, follow-up rates, data completeness, re-consultation rates within one/three months and other outcomes measures to assess feasibility of a future RCT.7. Evaluation of pre-agreed success criteria to decide whether to continue to RCT, stop, or modify the intervention.Timelines for deliveryStudy 1 will be completed from October 2019 – March 2021 and study 2 from April 2021 – April 2022.Anticipated impact and disseminationResults will be disseminated through targeted communications in social media, the University of Bristol website, policy briefings, academic papers, patient participation groups, community associations and seminars and conferences. The study output resources will be made available for immediate use. If progression criteria are met, we will aim to complete a randomised control trial within five years.

Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update

Background The Medical Research Council published the second edition of its framework in 2006 on developing and evaluating complex interventions. Since then, there have been considerable developments in the field of complex intervention research. The objective of this project was to update the framework in the light of these developments. The framework aims to help research teams prioritise research questions and design, and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. Methods There were four stages to the update: (1) gap analysis to identify developments in the methods and practice since the previous framework was published; (2) an expert workshop of 36 participants to discuss the topics identified in the gap analysis; (3) an open consultation process to seek comments on a first draft of the new framework; and (4) findings from the previous stages were used to redraft the framework, and final expert review was obtained. The process was overseen by a Scientific Advisory Group representing the range of relevant National Institute for Health Research and Medical Research Council research investments. Results Key changes to the previous framework include (1) an updated definition of complex interventions, highlighting the dynamic relationship between the intervention and its context; (2) an emphasis on the use of diverse research perspectives: efficacy, effectiveness, theory-based and systems perspectives; (3) a focus on the usefulness of evidence as the basis for determining research perspective and questions; (4) an increased focus on interventions developed outside research teams, for example changes in policy or health services delivery; and (5) the identification of six ‘core elements’ that should guide all phases of complex intervention research: consider context; develop, refine and test programme theory; engage stakeholders; identify key uncertainties; refine the intervention; and economic considerations. We divide the research process into four phases: development, feasibility, evaluation and implementation. For each phase we provide a concise summary of recent developments, key points to address and signposts to further reading. We also present case studies to illustrate the points being made throughout. Limitations The framework aims to help research teams prioritise research questions and design and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. In many of the areas of innovation that we highlight, such as the use of systems approaches, there are still only a few practical examples. We refer to more specific and detailed guidance where available and note where promising approaches require further development. Conclusions This new framework incorporates developments in complex intervention research published since the previous edition was written in 2006. As well as taking account of established practice and recent refinements, we draw attention to new approaches and place greater emphasis on economic considerations in complex intervention research. We have introduced a new emphasis on the importance of context and the value of understanding interventions as ‘events in systems’ that produce effects through interactions with features of the contexts in which they are implemented. The framework adopts a pluralist approach, encouraging researchers and research funders to adopt diverse research perspectives and to select research questions and methods pragmatically, with the aim of providing evidence that is useful to decision-makers. Future work We call for further work to develop relevant methods and provide examples in practice. The use of this framework should be monitored and the move should be made to a more fluid resource in the future, for example a web-based format that can be frequently updated to incorporate new material and links to emerging resources. Funding This project was jointly funded by the Medical Research Council (MRC) and the National Institute for Health Research (Department of Health and Social Care 73514).