Complex Interventions Framework Research Articles

Assessing the Acceptability of a Preschool-Based Multi-Component Physical Activity Intervention Entitled "I'm an Active Hero" (IAAH): Process Evaluation of a Feasibility Trial.

Interventions within preschool settings have gained prominence due to the need to increase physical activity (PA) in early childhood. We first developed a 10-week preschool-based behaviour change intervention, guided by the UK Medical Research Council's framework for complex interventions. We then conducted a cluster feasibility randomised controlled trial (RCT) among young children. This process evaluation was embedded within the cluster feasibility RCT and aimed to assess the acceptability of the 10-week IAAH intervention among both preschool staff and parents. The study utilised a mixed method, involving post-intervention questionnaires completed by preschool staff (n = 4) and children's parents/caregivers (n = 9) and focus groups with preschool staff (n = 3) and parents/caregivers (n = 7). Quantitative data were analysed using SPSS to calculate acceptability scores, while qualitative data underwent thematic analysis using NVivo 12. The intervention was well-received, with preschool staff reporting a 94.5% acceptability rate (mean score of 10.4 out of 11) and parents/caregivers indicating an 86% acceptance rate (mean score of 5.2 out of 6). Thematic analysis of focus group discussions revealed facilitators to intervention delivery, such as user-friendly materials and alignment with preschool curricula, and identified barriers, including time constraints, spatial limitations, and policy conflicts. Parental engagement was hindered by time restrictions, although the intervention materials were praised for their clarity and visual appeal. The findings suggest that the IAAH programme was acceptable to both preschool staff and parents. However, the identified barriers to intervention delivery and engagement should be addressed in the planning of a future cluster RCT to evaluate the efficacy of the intervention.

A Conceptual Study on Characterizing the Complexity of Nutritional Interventions for Malnourished Older Adults in Hospital Settings: An Umbrella Review Approach.

Malnutrition is a widespread and intricate issue among hospitalized adults, necessitating a wide variety of nutritional strategies to address its root causes and repercussions. The primary objective of this study is to systematically categorize nutritional interventions into simple or complex, based on their resource allocation, strategies employed, and predictors of intervention complexity in the context of adult malnutrition in hospital settings. A conceptual evaluation of 100 nutritional intervention studies for adult malnutrition was conducted based on data from a recent umbrella review (patient population of mean age > 60 years). The complexity of interventions was categorized using the Medical Research Council 2021 Framework for Complex Interventions. A logistic regression analysis was employed to recognize variables predicting the complexity of interventions. Interventions were divided into three principal categories: education and training (ET), exogenous nutrient provision (EN), and environment and services (ES). Most interventions (66%) addressed two or more of these areas. A majority of interventions were delivered in a hospital (n = 75) or a hospital-to-community setting (n = 25), with 64 studies being classified as complex interventions. The logistic regression analysis revealed three variables associated with intervention complexity: the number of strategies utilized, the targeted areas, and the involvement of healthcare professionals. Complex interventions were more likely to be tailored to individual needs and engage multiple healthcare providers. The study underlines the importance of considering intervention complexity in addressing adult malnutrition. Findings advocate for a comprehensive approach to characterizing and evaluating nutritional interventions in future research. Subsequent investigations should explore optimal balances between intervention complexity and resource allocation, and assess the effectiveness of complex interventions across various settings, while considering novel approaches like telehealth.

The effect of contextual factors on a health intervention against podoconiosis in Ethiopia

IntroductionUnderstanding contextual factors that influence the implementation and outcome of interventions is crucial to improving them. Outcome and process evaluation studies have to date focused on the successes and limitations of interventions with little consideration of external factors that could either facilitate or impede them. Guided by the Context and Implementation of Complex Intervention (CICI) framework, we evaluated the effect of contextual factors on a health intervention implemented against the neglected tropical disease (NTD) podoconiosis in Ethiopia.MethodWe purposefully selected a health intervention jointly implemented by two NGOs in podoconiosis-endemic districts in Northwestern Ethiopia. We employed an exploratory mixed methods approach, and data were collected between April and July 2022. We first conducted document analysis, observations, 4 focus group discussions, 32 in-depth interviews and 19 key informant interviews. Subsequently, we administered a survey to 369 rural residents, of whom 42 were affected by podoconiosis. The qualitative data were managed with NVivo version 12 software. The quantitative data were analyzed using Stata version 15 software.ResultsMost project activities were implemented as per the initial plan and the intervention reached patients that never had access to treatment services before. Contextual factors (geographical, epidemiological, socio-economic, socio-cultural, ethical, legal and political) and lived experience of patients influenced the implementation and outcome of the intervention. Most of the contextual factors pose constraints on implementation and affected the acceptability and sustainability of project activities. On the other hand, political context such the commitment of the government to rollout national programs and set up NTD structures at district level positively influenced the implementation of the intervention.ConclusionHealth intervention implementors should be aware of the interactive effects of contextual factors wherein interventions are put into practice. Minimizing the constraining effects of these contextual factors while utilizing opportunities presented by them might help implement optimal strategies to improve the lives of individuals affected by podoconiosis and similar NTDs.

Patients’ experience of a novel interdisciplinary nurse-led self-management intervention (INSELMA)—a qualitative evaluation

BackgroundDespite continuous improvements in anti-rheumatic pharmacological treatment, people with chronic inflammatory arthritis still report substantial disease impact. Based on the framework for complex interventions, we thus developed INSELMA, a novel nurse-coordinated multidisciplinary self-management intervention for patients with rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis. Based on individual biopsychosocial assessments, a rheumatology nurse facilitated goal setting and coordinated interdisciplinary support. The aim of this study was to explore the patients’ experience of participating in the six-months INSELMA intervention.MethodsIndividual semi-structured interviews were conducted with 15 of the participants after their final follow-up. Thematic analysis was applied.ResultsThe analysis derived four overall themes. (1) A new opportunity at the right time. The participants’ disease impacted all areas of daily life. Participation in INSELMA was experienced as an opportunity to improve symptoms and together reduce long-held challenges they had fought alone, until now. (2) The importance of person-centred goals. The participants found it meaningful to work with their individual goals, which encompassed physical, psychological, and social factors. Having time between consultations to work with goals at home was important. (3) Empathy, partnership and a little nudging from health professionals are essential. The empathic nurses’ continuous support and coaching helped participants become aware of their own resources. The participants highlighted having access to support from a physiotherapist and occupational therapist with rheumatology experience as important. (4) I got more than I could have hoped for. Most of the participants experienced decreased symptom load and improvement in physical strength, mobility, sleep, and mood as well as increased energy, knowledge, and self-management ability. The participants expressed new hope for the future with an improved ability to manage their symptoms and work towards new goals.ConclusionThe participants found the INSELMA intervention meaningful and feasible. They experienced decreased disease impact and increased activity levels, facilitated by empathy and self-management support from health professionals.

Quality criteria of nature-based interventions in healthcare facilities: a scoping review.

Implementing integrated nature-based interventions that simultaneously serve human health and the restoration of biodiversity in healthcare facilities is considered a promising strategy. As an emerging field of research and practice in healthcare, identification of quality criteria is necessary to support desired outcomes related to biodiversity, human health and intervention processes. This study is part of a larger research project in collaboration with the Flemish Agency of Nature and Forest in Belgium. A scoping review was conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews, in PubMed, Medline, Web of Science and Scopus. A step-by-step tabular screening process was conducted to identify relevant studies and reviews of nature-based interventions, published in English between January 2005 and April 2023. A qualitative content analysis was conducted and the results were then presented to the project steering group and a panel of stakeholders for refinement. After filtering on the eligibility criteria, and with focus on healthcare facilities, 14 articles were included in this study. A preliminary nature-based interventions quality framework with a set of quality indicators has been developed. When designing integrated nature-based interventions, a needs analysis of users and the outdoor environment should be conducted. Next, the integration of a One Health and biodiversity perspective and the application of a complex intervention framework, could support the quality of the design and implementation of nature-based interventions in healthcare facilities and facilitate their assessment. In future work, more rigorous research into the design and implementation of integrated nature-based interventions is needed to test and refine the quality criteria in practice.

Accentuating patient values in shared decision-making: A mixed methods development of an online value clarification tool and communication training in the context of early phase clinical cancer trials

ObjectiveIn the shared decision-making (SDM) process for potential early phase clinical cancer trial participation, value clarification is highly recommended. However, exploration and discussion of patient values between patients and oncologists remains limited. This study aims to develop an SDM-supportive intervention, consisting of a preparatory online value clarification tool (OnVaCT) and a communication training. MethodsThe OnVaCT intervention was developed and pilot-tested by combining theoretical notions on value clarification, with interview studies with patients and oncologists, focus groups with patient representatives and oncologists, and think aloud sessions with patients, following the Medical Research Council (MRC) framework for complex interventions. These human-centered methodologies enabled a user-centered approach at every step of the development process of the intervention. ResultsThis study shows relevant patient values and oncologists’ perspectives on value exploration and discussion in daily practice. This has been combined with theoretical considerations into the creation of characters based on real-life experiences of patients in the OnVaCT, and how the tool is combined with a communication training for oncologists to improve SDM.

Development of a complex intervention to prevent delirium in older hospitalized patients by optimizing discharge and transfer processes and involving caregivers: A multi-method study

BackgroundDelirium is a common yet challenging condition in older hospitalized patients, associated with various adverse outcomes. Environmental factors, such as room changes, may contribute to the development or severity of delirium. Most previous research has focused on preventing and reducing this condition by addressing risk factors and facilitating reorientation during hospital stay. ObjectiveWe aimed to systematically develop a complex intervention to prevent delirium in older hospitalized patients by optimizing discharge and transfer processes and involving caregivers during and after these procedures. The intervention combines stakeholder and expert opinions, evidence, and theory. This article provides guidance and inspiration to research groups in developing complex interventions according to the recommendations in the Medical Research Council framework for complex interventions. Design and methodsA stepwise multi-method study was conducted. The preparation phase included analysis of the context and current practice via focus groups. Based on these results, an expert workshop was organized, followed by a Delphi survey. Finally, the intervention was modeled and a program theory was developed, including a logic model. ResultsA complex intervention was developed in an iterative process, involving healthcare professionals, delirium experts, researchers, as well as caregiver and patient representatives. The key intervention component is an 8-point-program, which provides caregivers with recommendations for preventing delirium during the transition phase and in the post-discharge period. Information materials (flyers, handbook, videos, posters, defined “Dos and Don'ts”, discharge checklist), training for healthcare professionals, and status analyses are used as implementation strategies. In addition, roles were established for gatekeepers to act as leaders, and champions to serve as knowledge multipliers and trainers for the multi-professional team in the hospitals. ConclusionsThis study serves as an example of how to develop a complex intervention. In an additional step, the intervention and implementation strategies will be investigated for feasibility and acceptability in a pilot study with an accompanying process evaluation. Tweetable abstractDelirium prevention can benefit from optimizing discharge and transfer processes and involving caregivers of older patients in these procedures. Study registrationDRKS00017828, German Register of Clinical Studies, date of registration 17.09.2019.

IMP2ART: development of a multi-level programme theory integrating the COM-B model and the iPARIHS framework, to enhance implementation of supported self-management of asthma in primary care

BackgroundSupported asthma self-management, incorporating an asthma action plan and annual clinical review, has been recommended by UK/global guidelines for over three decades. However, implementation remains poor, as only around a third of individuals receive basic asthma care, according to the UKs leading respiratory charity Asthma and Lung UK. A systematic review of implementation studies recommended that a whole systems approach targeting patients, healthcare professional education, and organisations is needed to improve implementation of supported asthma self-management in primary care. The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) is a national Hybrid-II implementation cluster randomised controlled trial that aims to evaluate such an approach. This paper describes the development of the implementation strategy for IMP2ART with particular focus on the integration of multiple level theories.MethodsThe Medical Research Council design and evaluation of complex interventions framework and the Person-Based Approach to intervention development were used as guidance for stages of strategy development. Specifically, we (i) set up a multidisciplinary team (including practicing and academic clinicians, health psychologists, public health and patient colleagues), (ii) reviewed and integrated evidence and theory, (iii) developed guiding principles, (iv) developed prototype materials, and (v) conducted a pre-pilot study before final refinement.ResultsThe implementation strategy included resources for patients, team-based and individual healthcare professional education, practice audit and feedback, and an asthma review template, as well as a facilitator role accessible to primary care practices for 12 months. The synthesis of the integrated Promoting Action on Research Implementation in Health Services (iPARIHS) and Capability, Opportunity, Motivation and Behaviour (COM-B) frameworks led to an evolved framework bringing together important implementation and behaviour change elements which will be used as a basis for the study process evaluation.ConclusionsA description of rigorous implementation strategy development for the IMP2ART study is provided along with newly theorised integration of implementation and behaviour change science which may be of benefit to others targeting implementation in primary care.Trial registrationISRCTN15448074. Registered on 2nd December 2019.

Development of an intervention to manage benzodiazepine dependence and high-risk use in the context of escalating drug related deaths in Scotland: an application of the MRC framework

BackgroundScotland has the highest rate of drug related deaths (DRD) in Europe. These are deaths in people who use drugs such as heroin, cocaine, benzodiazepines and gabapentinoids. It is a feature of deaths in Scotland that people use combinations of drugs which increases the chance of a DRD. Many deaths involve ‘street’ benzodiazepines, especially a drug called etizolam. Many of the ‘street’ benzodiazepines are not licensed in the UK so come from illegal sources. People who use opiates can be prescribed a safer replacement medication (e.g., methadone). While guidance on management of benzodiazepines use highlights that there is little evidence to support replacement prescribing, practice and evidence are emerging.AimTo develop an intervention to address ‘street’ benzodiazepines use in people who also use opiates.MethodsThe MRC Framework for Complex Interventions was used to inform research design. Co-production of the intervention was achieved through three online workshops with clinicians, academics working in the area of substance use, and people with lived experience (PWLE). Each workshop was followed by a PWLE group meeting. Outputs from workshops were discussed and refined by the PWLE group and then further explored at the next workshop.ResultsAfter these six sessions, a finalised logic model for the intervention was successfully achieved that was acceptable to clinicians and PWLE. Key components of the intervention were: prescribing of diazepam; anxiety management, sleep, and pain; and harm reduction resources (locked box and a range of tips), personal safety conversations, as well as a virtual learning environment.ConclusionA co-produced intervention was developed for next stage clinical feasibility testing.

BREATHLEssness in INDIA (BREATHE-INDIA)-Study protocol for the co-design of a community breathlessness intervention in India using realist methods and intervention mapping.

Breathlessness that persists despite treatment of causal disease(s) is disabling, associated with high therapy-related costs and poor socioeconomic outcomes. Low resource countries bear a disproportionate burden of respiratory problems, often characterised by disabling breathlessness. Low-cost self-management breathlessness-targeted interventions are effective and deliverable in community settings but have been developed in high-income countries. We aim to understand how breathlessness self-management works in 'real life' populations and cultural contexts, to develop programme theory and co-design a prototype intervention to improve persistent breathlessness management in India. Using a Realist approach, Intervention Mapping and the Medical Research Council Complex Intervention Framework we will undertake two phases of work supported by our Expert Group (of respiratory, primary, palliative care physicians) and key stakeholder groups (opinion leader clinicians, community health workers and people with lived experiences of breathlessness). 1) Realist review and evaluation to identify and refine evidence and theory for breathlessness self-management, producing intervention and implementation programme theory. We will identify literature through our Expert Group, scoping searches and systematic searches (Medline, Ebscohost, CINAHL, Scopus, Psychinfo). We will map intervention components to 'what works, for whom, and where.' 2) Intervention development using Intervention Mapping to map intervention and implementation programme theory to intervention components, develop materials to support intervention delivery, and co-design a prototype educational intervention ready for early acceptability and delivery-feasibility testing and evaluation planning in India. Use of stakeholder groups is to allow people with experience of breathlessness and/or its management to contribute their views on content developed by our team based upon review of secondary data sources. Experts and Stakeholders are therefore not research subjects but are included as extended members of the study team and will not follow informed consent procedures. Experts and stakeholders will be acknowledge in outputs arising from our project if they wish to be. Our review conduct will be consistent with RAMESES quality standards. At the conclusion of our study, we will have co-designed a breathlessness intervention for use in the community setting in India ready for further evaluation of: effectiveness, socioeconomic outcomes, acceptability and transferability to other low resource settings.

Use of the 2021 UK Medical Research Council guidance to refine the Women's Wellness with Type 2 Diabetes Programme: a mixed-methods study

BackgroundThe Women's Wellness with Type 2 Diabetes Programme (WWDP) is an online behavioural intervention for midlife women living with type 2 diabetes. The gender-specific intervention fosters self-efficacy, encouraging positive wellbeing behaviours to enhance diabetes and menopause outcomes. In 2016, We co-led a feasibility trial and process evaluation with 70 women aged 45–50 years from the UK and Australia. The intervention comprised an e-book, a website, and nurse consultations. The WWDP seemed to improved diabetes distress, self-efficacy, and menopausal symptoms, but with impactful, costly, diabetes nurse input, compromising feasibility and delivery by the NHS. We report WWDP refinement using the 2021 Medical Research Council (MRC) framework for complex interventions to optimise future implementation. MethodsIntervention refinement was guided by six core MRC elements of context, programme theory, stakeholder engagement, key uncertainties, intervention refinement, and economic considerations. Critical analysis of quantitative and qualitative feasibility data, informed by self-efficacy theory, provided a deeper understanding of how the intervention was used. Eight PPI consultations took place between Sept 1, 2021, and Dec 31, 2022, with three women from diverse cultural and socioeconomic backgrounds and three female diabetes professionals to strengthen the e-book and methods of support for women undertaking the programme. FindingsContext was improved by the feasibility study and the PPI consultations, making the e-book relevant to UK health care. Understanding that self-efficacy was supported through primary use of peer group, and goal setting components supported the existing programme theory. Stakeholder engagement shaped the structure of the online peer support group. The feasibility study revealed uncertainties around goal settings. These uncertainties were addressed by introducing individualised goals focusing on aspects like medication adherence. The nurse support in the intervention was replaced with peer support, which might lead to greater economic feasibility of the programme. An optimised website and individualised goal setting underpin the WWDP. InterpretationThe MRC Framework provides intervention refinement structure, allowing adaptive adjustments based on emerging evidence, feedback, and contextual nuances. Limitations exist. Intervention refinements, including peer support, might affect adherence and unexpected interactions. New components could influence long-term efficacy. FundingTurkish Ministry of National Education.

Ukraine Trauma Project: the feasibility of introducing advanced trauma-care skills to frontline emergency medical services responders

ObjectivesTo design, develop, deliver and assess a training initiative on haemorrhage control for emergency medical services (EMS) staff in Ukraine, in an active wartime setting.DesignUsing the Medical Research Council framework...

Health Catch-UP!: process evaluation of a migrant multi-disease screening and vaccination tool

Abstract Background European migrants face a disproportionate burden of infection (tuberculosis, HIV, hepatitis B/C and parasites), are at-risk of underdiagnosis of non-communicable diseases and are an under-immunised group. Reducing these health inequities is a key public health priority, with the ECDC calling for innovative strategies to deliver multi-disease screening to at-risk migrants. Current strategies in the UK to screen migrants report low uptake despite clear health and cost benefits. Health Catch-UP! is a collaboratively produced innovative digital tool applying UK guidance to identify screening and vaccination requirements of migrants based on country-of-origin. (https://emishealth.vids.io/videos/a49ad1bb1a18e4c72c/health-catch-up-with-requested-editsmp4 Methods We did a mixed methods process evaluation of the Health Catch UP! tool in two GP practices, using the Medical Research Council framework for complex interventions. We recorded data on demographics, patients screened, disease detection and catch-up vaccination rates. We conducted qualitative interviews with staff and migrants to explore barriers and facilitators. Results Outcomes data were extracted for 99 migrants, predominantly from Asia (31.3%), and Sub-Saharan Africa (26.1%). 61.6% of participants were recommended screening, uptake of screening was high with 86.9% were screened for at least one health problem. New diagnoses included: one case of hepatitis C, 6 hypercholesteremia, 4 pre-diabetes and one diabetes. Catch-up vaccination uptake was poor (2.0%). Qualitative data strongly supported the acceptability and feasibility of the tool but recommended clear laboratory and management pathways, financial incentives, and a staff and patient information and training implementation package. Conclusions Innovative primary care digital tools like Health Catch-UP! have potential to significantly improve disease detection and effective implementation of screening guidance but require robust testing and resourcing. Key messages • Migrants face disproportionate burden of infectious diseases, screening and vaccination innovations are required to reduce health inequity. • Digital clinical support tools in primary care have potential to improve disease detection and implementation of migrant screening guidance.

Adapting family-based treatment for adolescent anorexia nervosa delivered in the home: A novel approach for improving access to care and generalizability of skill acquisition

BackgroundAnorexia nervosa (AN) is a serious mental illness associated with high rates of morbidity and mortality. Family-based treatment (FBT) is a well-established treatment for adolescent AN, yet it is underutilized in community settings and is unavailable to many families, particularly those from lower income and racial and ethnic minority backgrounds. Furthermore, some families do not respond optimally to FBT, possibly because of challenges translating skills acquired in office-based treatment settings to naturalistic settings. Home-based treatment could reduce barriers to access and enhance generalization of newly learned treatment skills. Home-based models demonstrate initial feasibility, acceptability, and efficacy for adolescent AN, however, FBT principles have yet to be applied as a stand-alone intervention in a home-based level of care. This paper describes the rationale for and process of adapting FBT principles/interventions to improve fit within a home-based model delivered in the context of community mental health, and discusses potential strengths and opportunities associated with this approach.ResultsAdaptations were made through consultation with collaborating community agencies and were guided by the complex interventions framework. The primary modifications included: (1) altered dose; (2) multiple family meals; (3) additional support for meal preparation and supervision; (4) clinician attendance at medical appointments; (5) cultural adaptation; and (6) introduction of distress tolerance and emotion regulation skills.ConclusionsImplementing FBT in the home may present one promising and novel approach to enhance engagement and treatment outcomes for adolescents with restrictive eating disorders, particularly those who are underserved, but evaluation of efficacy/effectiveness is needed.

Development of the HT&Me intervention to support women with breast cancer to adhere to adjuvant endocrine therapy and improve quality of life.

Breast cancer is the most common cancer in women worldwide. Approximately 80% of breast cancers are oestrogen receptor positive (ER+). Patients treated surgically are usually recommended adjuvant endocrine therapy (AET) for 5-10 years. AET significantly reduces recurrence, but up to 50% of women do not take it as prescribed. To co-design and develop an intervention to support AET adherence and improve health-related quality-of-life (QoL) in women with breast cancer. Design and development of the HT&Me intervention took a person-based approach and was guided by the Medical Research Council framework for complex interventions, based on evidence and underpinned by theory. Literature reviews, behavioural analysis, and extensive key stakeholder involvement informed 'guiding principles' and the intervention logic model. Using co-design principles, a prototype intervention was developed and refined. The blended tailored HT&Me intervention supports women to self-manage their AET. It comprises initial and follow-up consultations with a trained nurse, supported with an animation video, a web-app and ongoing motivational 'nudge' messages. It addresses perceptual (e.g. doubts about necessity, treatment concerns) and practical (e.g. forgetting) barriers to adherence and provides information, support and behaviour change techniques to improve QoL. Iterative patient feedback maximised feasibility, acceptability, and likelihood of maintaining adherence; health professional feedback maximised likelihood of scalability. HT&Me has been systematically and rigorously developed to promote AET adherence and improve QoL, and is complemented with a logic model documenting hypothesized mechanisms of action. An ongoing feasibility trial will inform a future randomised control trial of effectiveness and cost-effectiveness.

Patient involvement interventions for patients with kidney failure making end-of-life care decisions: a scoping review.

The objective of this review was to investigate and map empirical evidence of patient involvement interventions to support patients with kidney failure making end-of-life care decisions in kidney services. Clinical guidance integrating end-of-life care within kidney failure management pathways varies. Advance care planning interventions aimed at involving patients with kidney failure in their end-of-life care planning are established in some countries. However, there is limited evidence of the other types of patient involvement interventions integrated within services to support patients with kidney failure in making decisions about their end-of-life care. This scoping review included studies exploring patient involvement interventions evaluated for patients with kidney failure considering end-of-life care, their relatives, and/or health professionals in kidney services. Studies of children under the age of 18 years were excluded. The review was informed by JBI methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review guidelines. MEDLINE, Scopus, Embase, and CINAHL were searched for full-text studies in English, Danish, German, Norwegian, or Swedish. Two independent reviewers assessed the literature against the inclusion criteria. A relational analysis framework was used to synthesize the data extracted from the included studies, and to investigate and map different patient involvement interventions. The search identified 1628 articles, of which 33 articles met the inclusion criteria. A total of 23 interventions were described. Interventions targeted patients (n=3); health professionals (n=8); patients and health professionals (n=5); and patients, relatives, and health professionals (n=7). Intervention components included patient resources (eg, information, patient decision aids), consultation resources (eg, advance care planning, shared decision-making), and practitioner resources (eg, communication training). Patient involvement interventions were delivered within hospital-based kidney services. The review identified several ways to support patients with kidney failure to be involved in end-of-life care decisions. Future interventions may benefit from adopting a complex intervention framework to engage multiple stakeholders in the research and design of an intervention for shared decision-making between patients with kidney failure, their relatives, and health professionals about integrating end-of-life care options into their kidney disease management pathway.

Contextual factors influencing the roles of patent medicine vendors in the provision of injectable contraception services in Nigeria

BackgroundPatent medicine vendors (PMVs) play vital roles in the delivery of family planning services in Nigeria and other developing countries. There is a growing recognition of the need to integrate them into the formal health care system as a strategy to increase the contraceptive prevalence rate and achieve universal health coverage. Though promising, the success of this proposition is largely dependent on a critical analysis of the factors which influence their operations. This study was designed to identify the contextual factors influencing the provision of injectable contraceptive services by PMVs and the broader effects of their activities on the health system to inform similar interventions in Nigeria.MethodsThis was a qualitative study guided by the UK Medical Research Council’s Framework for Complex Interventions. Twenty-seven in-depth interviews were conducted among officials of the association of PMVs, health workers, government regulatory officers and programme implementers who participated in a phased 3-year (2015–2018) intervention designed to enhance the capacity of PMVs to deliver injectable contraceptive services. The data were transcribed and analyzed thematically using NVIVO software.ResultsThe contextual factors which had implications on the roles of PMVs were socio-cultural and religious, the failing Nigerian health system coupled with government regulatory policies. Other factors were interprofessional tensions and rivalry between the PMVs and some categories of health care workers and increasing donors’ interest in exploring the potentials of PMVs for expanded healthcare service provision. According to the respondents, the PMVs bridged the Nigerian health system service delivery gaps serving as the first point of contact for injectable contraceptive services and this increased contraceptive uptake in the study sites. A negative effect of their operation is the tendency to exceed their service provision limits, which has spurred a planned tiered PMV accreditation system.ConclusionsThis study has highlighted the contextual factors which define the roles and scope of practice of PMVs involved in injectable contraceptive service provision. Strategies and interventions aimed at expanding the healthcare delivery roles of PMVs must be encompassing to address the broader contextual factors which underpin their capacities and functions.

A complex intervention to support breastfeeding: A feasibility and acceptability study.

The aims of this study are to assess the acceptability and feasibility of a multicomponent intervention to support breastfeeding women and their families and explore its effectiveness. A pilot study with control and intervention groups was conducted using the complex intervention framework in two primary healthcare centres. Overall, 44 childbearing women, their partners/relatives and 20 healthcare professionals participated in the study. The intervention's feasibility and acceptability were measured. The percentage of exclusive breastfeeding rates and women's self-efficacy were measured at pre-intervention, at 10 days postpartum, and again at 2, 4 and 6 months postpartum. Postpartum depression risk was measured at 2 and 6 months postpartum. Professional self-efficacy was measured at pre-intervention and 3 months later. The intervention was feasible and acceptable. No difference in self-efficacy existed between the intervention and control groups. Preliminary effects of the intervention were found in exclusive breastfeeding percentage and postpartum depression risk in the intervention group. The intervention is feasible and acceptable. The results are promising not only for breastfeeding maintenance but also for preventing postpartum depression and recovering exclusive breastfeeding during pandemics. ClinicalTrials.gov ID: NCT03944642.

Development of an online intervention for the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) trial.

Up to half of people hospitalised with COVID-19 report diverse and persistent symptoms affecting quality of life for months and sometimes years after discharge (long-COVID). We describe the development of an online group exercise and behavioural support intervention for people who continue to experience such physical and/or emotional health problems more than three months after hospital discharge. Intervention development was informed by the Medical Research Council framework for complex interventions. Our multidisciplinary team of academics, clinicians, and people with long-COVID, had collective expertise in the development and testing of complex interventions. We integrated a bio-psycho-social model of care drawing on rehabilitation literature for long-term health conditions and experiences from our pre-pilot study. Multiple stakeholder meetings were held to refine the intervention which was designed to be deliverable within the UK National Health Service. We adhere to TIDieR guidance for transparent and explicit reporting of telehealth interventions. The final REGAIN online exercise and behavioural support intervention consisted of an initial 1:1 consultation with a trained practitioner, followed by eight online group exercise, and six group support, sessions delivered over eight weeks. Participants could also access an online library of on-demand exercise and support videos. The final REGAIN intervention, combining exercise and behavioural support, is fully manualised with clear pathways to delivery and implementation. It is currently being tested in a randomised controlled trial. The intervention, developed with extensive patient and stakeholder engagement, could be incorporated into existing NHS rehabilitation programmes, should it prove to be clinically and cost-effective for people with long-COVID. International Standard Randomised Controlled Trial Number (ISRCTN) 11466448: Rehabilitation exercise and psychological support after COVID-19 infection: REGAIN.

Development of theoretically informed audit and feedback: An exemplar from a complex implementation strategy to improve asthma self-management in UK primary care.

Audit and feedback is an evidence-based implementation strategy, but studies reporting the use of theory to guide design elements are limited. Within the context of a programme of research aiming to improve the implementation of supported asthma self-management in UK primary care (IMPlementing IMProved Asthma self-management as RouTine [IMP2 ART]), we aimed to design and develop theoretically-informed audit and feedback that highlighted supported asthma self-management provision and areas for improvement in primary care general practices. Aligned with the Medical Research Council (MRC) complex intervention framework, the audit and feedback was developed in three phases: (1) Development: literature and theory exploration, and prototype audit and feedback design; (2) Feasibility: eliciting feedback on the audit and feedback from general practice staff (n = 9); (3) Prepiloting: delivering the audit and feedback within the IMP2 ART implementation strategy (incorporating patient and professional resources and an asthma review template) and eliciting clinician feedback (n = 9). Audit and feedback design was guided by and mapped to existing literature suggestions and theory (e.g., Theoretical Domains Framework, Behaviour Change Technique Taxonomy). Feedback on the prototype audit and feedback confirmed feasibility but identified some refinements (a need to highlight supporting self-management and importance of asthma action plans). Prepiloting informed integration with other IMP2 ART programme strategies (e.g., patient resources and professional education). We conclude that a multistage development process including theory exploration and mapping, contributed to the design and delivery of the audit and feedback. Aligned with the MRC framework, the IMP2 ART strategy (incorporating the audit and feedback) is now being tested in a UK-wide cluster randomised controlled trial.