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Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

ABSTRACT: To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams.Process evaluation nested within a cluster randomised controlled trial (RCT).28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports.14 community-based mental health teams in two UK sites (one urban, one semi-rural) who received the intervention.The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles.Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research expenditure.Controlled-Trials.com ISRCTN02507940.

SUBMITTER: Leamy M

PROVIDER: S-EPMC4038471 | biostudies-other | 2014

REPOSITORIES: biostudies-other

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Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

Leamy Mary M Clarke Eleanor E Le Boutillier Clair C Bird Victoria V Janosik Monika M Sabas Kai K Riley Genevieve G Williams Julie J Slade Mike M

PloS one 20140529 5

<h4>Objective</h4>To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams.<h4>Design</h4>Process evaluation nested within a cluster randomised controlled trial (RCT).<h4>Participants</h4>28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written t ...[more]

PMID: 24875748

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Project description:BackgroundTo improve the translation of public health evidence into practice, there is a need to increase practitioner involvement in initiative development, to place greater emphasis on contextual knowledge, and to address intervention processes and outcomes. Evidence that demonstrates the need to reduce childhood fire-related injuries is compelling but its translation into practice is inconsistent and limited. With this knowledge the Keeping Children Safe programme developed an "Injury Prevention Briefing (IPB)" using a 7 step process to combine scientific evidence with practitioner contextual knowledge. The IPB was designed specifically for children's centres (CCs) to support delivery of key fire safety messages to parents. This paper reports the findings of a nested qualitative study within a clustered randomised controlled trial of the IPB, in which staff described their experiences of IPB implementation to aid understanding of why or how the intervention worked.MethodsInterviews were conducted with key staff at 24 CCs participating in the two intervention arms: 1) IPB supplemented by initial training and regular facilitation; 2) IPB sent by post with no facilitation. Framework Analysis was applied to these interview data to explore intervention adherence including; exposure or dose; quality of delivery; participant responsiveness; programme differentiation; and staff experience of IPB implementation. This included barriers, facilitators and suggested improvements.Results83% of CCs regarded the IPB as a simple, accessible tool which raised awareness, and stimulated discussion and behaviour change. 15 CCs suggested minor modifications to format and content. Four levels of implementation were identified according to content, frequency, duration and coverage. Most CCs (75%) achieved 'extended' or 'essential' IPB implementation. Three universal factors affected all CCs: organisational change and resourcing; working with hard to engage groups; additional demands of participating in a research study. Six specific factors were associated with the implementation level achieved: staff engagement and training; staff continuity; adaptability and flexibility; other agency support; conflicting priorities; facilitation. CCs achieving high implementation levels increased from 58% (no facilitation) to 92% with facilitation.ConclusionIncorporating service provider perspectives and scientific evidence into health education initiatives enhances potential for successful implementation, particularly when supplemented by ongoing training and facilitation.

Project description:INTRODUCTION:On average women retain 5 to 9?kg 1?year after giving birth which can increase the risk of later obesity and chronic diseases. Some previous trials in this population have been effective in reducing weight, but are too intensive and costly to deliver at scale. There is a need for low-cost interventions to facilitate weight loss in this population. METHODS AND ANALYSIS:The primary aim is to assess the feasibility of delivering a weight management intervention for overweight/obese postnatal women within child immunisation appointments. We will conduct a randomised controlled cluster feasibility trial with a nested qualitative study to assess study recruitment and acceptability of the intervention. General practitioner practice (cluster) will be the unit of randomisation, with practices randomised to offer usual care plus the intervention or usual care only. Eighty women will be recruited. The intervention group will be offered brief support that encourages self-management of weight when attending child immunisation appointments. Practice nurses will encourage women to weigh themselves weekly and record this, and to make healthy lifestyle choices through using an online weight management programme. Women will be advised to aim for 0.5 to 1?kg/week weight loss. At each child immunisation the nurse will assess progress by weighing women. The comparator group will receive a healthy lifestyle leaflet. Data on weight, body fat, depression, anxiety, body image, eating behaviours and physical activity will be collected at baseline and follow-up. Women and nurses will be interviewed to ascertain their views about the intervention. The decision to proceed to the phase III trial will be based on prespecified stop-go criteria. ETHICS AND DISSEMINATION:Data will be stored securely at the University of Birmingham. Results will be disseminated through academic publications and presentations and will inform a possible phase III trial. The National Research Ethics Committee approved the study protocol. TRIAL REGISTRATION NUMBER:ISRCTN12209332.

Project description:ObjectivesTo examine care home resident and staff perceptions of the acceptability of participating in a feasibility trial evaluating nutritional interventions in the treatment of malnutrition.DesignExploratory qualitative methodology was used to gather descriptions of resident and staff perceptions of trial procedures, using semi-structured interviews with residents and focus groups with staff. The interviews were used to explore individual perceptions of the acceptability of the assigned intervention and the outcomes measured. Focus groups were used to explore staff experiences of trial participation and perspectives of nutritional support interventions.SettingThe study was embedded within a cluster randomised feasibility trial, which randomised six care homes to provide standard care (SC), food-based (FB) intervention or oral nutritional supplement (ONS) intervention to residents with, or at risk of, malnutrition.ParticipantsResidents in the trial with capacity to consent (n=7) formed the sampling frame for inclusion. Four agreed to be approached by the researcher and to take part in the individual interviews. All were women, representing two arms of the trial (ONS and SC). Twelve staff participated in six focus groups, one at each care home. All participants were women, representing all three arms of the trial.ResultsMajor themes that emerged from both interviews and focus groups included the perceived acceptability of trial involvement, the value of residents completing participant-reported outcome measures and the challenges associated with outcomes measurement in this setting. Themes that emerged from the focus groups alone, included the importance of individualising an intervention, and the perceived value of FB and ONS interventions and dietetic input.ConclusionsResidents and staff perceived involvement in a trial evaluating nutritional interventions to be acceptable, although the challenges associated with research in this setting were acknowledged. Resident preferences were highlighted by staff as an important consideration when implementing a nutrition support plan.Trial registration numberISRCTN38047922.

Project description:IntroductionDepression and pain frequently occur together and impact on outcomes of existing treatment for depression. Additional treatment options are required. This study aimed to explore patients' experiences of depression, the processes of change within acupuncture and counselling, and the elements that contributed to longer-term change.MethodsIn a substudy nested within a randomised controlled trial of acupuncture or counselling compared with usual care alone for depression, semistructured interviews of 52 purposively sampled participants were conducted and analysed using thematic analysis.ResultsDifferences were reported by participants regarding their experience of depression with comorbid pain compared with depression alone. Along with physical symptoms often related to fatigue and sleep, participants with depression and comorbid pain generally had fewer internal and external resources available to manage their depression effectively. Those who had physical symptoms and were receiving acupuncture commonly reported that these were addressed as part of the treatment. For those receiving counselling, there was less emphasis on physical symptoms and more on help with gaining an understanding of themselves and their situation. Over the course of treatment, most participants in both groups reported receiving support to cope with depression and pain independently of treatment, with a focus on relevant lifestyle and behaviour changes. The establishment of a therapeutic relationship and their active engagement as participants were identified as important components of treatment.ConclusionsParticipants with and without comorbid pain received acupuncture or counselling for depression, and reported specific identifiable treatment effects. The therapeutic relationship and participants' active engagement in recovery may play distinct roles in driving long-term change. Patients who present with depression and physical symptoms of care may wish to consider a short course of acupuncture to relieve symptoms prior to a referral for counselling if needed.Trial registration numberISRCTN63787732.

Project description:IntroductionThe National Institute for Health and Clinical Excellence guidelines recommend acupuncture as a clinically effective treatment for chronic back pain. However, there is insufficient knowledge of what factors contribute to patients' positive and negative experiences of acupuncture, and how those factors interact in terms of the acceptability of treatment. This study used patient interviews following acupuncture treatment for back pain to identify, understand and describe the elements that contribute or detract from acceptability of treatment.MethodsThe study used semi-structured interviews. Twelve patients were interviewed using an interview schedule as a sub-study nested within a randomised controlled trial of acupuncture for chronic back pain. The interviews were analysed using thematic analysis.Results and discussionThree over-arching themes emerged from the analysis. The first entitled facilitators of acceptability contained five subthemes; experience of pain relief, improvements in physical activity, relaxation, psychological benefit, reduced reliance on medication. The second over-arching theme identified barriers to acceptability, which included needle-related discomfort and temporary worsening of symptoms, pressure to continue treatment and financial cost. The third over-arching theme comprised mediators of acceptability, which included pre-treatment mediators such as expectation and previous experience, and treatment-related mediators of time, therapeutic alliance, lifestyle advice and the patient's active involvement in recovery. These themes inform our understanding of the acceptability of acupuncture to patients with low back pain.ConclusionThe acceptability of acupuncture treatment for low back pain is complex and multifaceted. The therapeutic relationship between the practitioner and patient emerged as a strong driver for acceptability, and as a useful vehicle to develop the patients' self-efficacy in pain management in the longer term. Unpleasant treatment related effects do not necessarily detract from patients' overall perception of acceptability.

Project description:BackgroundFor people with long-term conditions, social networks provide a potentially central means of mobilising, mediating and accessing support for health and well-being. Few interventions address the implementation of improving engagement with and through social networks. This paper describes the development and implementation of a web-based tool which comprises: network mapping, user-centred preference elicitation and need assessment and facilitated engagement with resources. The study aimed to determine whether the intervention was acceptable, implementable and acted to enhance support and to add to theory concerning social networks and engagement with resources and activities.MethodsA longitudinal design with 15 case studies used ethnographic methods comprising video, non-participant observation of intervention delivery and qualitative interviews (baseline, 6 and 12 months). Participants were people with type 2 diabetes living in a marginalised island community. Facilitators were local health trainers and care navigators. Analysis applied concepts concerning implementation of technology for self-management support to explain how new practices of work were operationalised and how the technology impacted on relationships fit with everyday life and allowed for visual feedback.ResultsMost participants reported identifying and taking up new activities as a result of using the tool. Thematic analysis suggested that workability of the tool was predicated on disruption and reconstruction of networks, challenging/supportive facilitation and change and reflection over time concerning network support. Visualisation of the network enabled people to mobilise support and engage in new activities. The tool aligned synergistically with the facilitators' role of linking people to local resources.ConclusionsThe social network tool works through a process of initiating positive disruption of established self-management practice through mapping and reflection on personal network membership and support. This opens up possibilities for reconstructing self-management differently from current practice. Key facets of successful implementation were: the visual maps of networks and support options; facilitation characterised by a perceived lack of status difference which assisted engagement and constructive discussion of support and preferences for activities; and background work (a reliable database, tailored preferences, option reduction) for facilitator and user ease of use.

Project description:BackgroundWomen's experience of domestic violence and abuse (DVA) is associated with mental illness which may not be addressed by domestic violence advocacy. The study aimed to compare the experiences of women receiving a psychological intervention with women receiving usual advocacy in a randomized controlled trial (PATH: Psychological Advocacy Towards Healing), to illuminate the trial results by exploring women's experiences of benefits and difficulties.MethodsA qualitative study nested within the PATH trial, based in two DVA agencies in the UK. A purposive sample of thirty-one intervention and usual care participants were interviewed up to three interviews over a year. Thematic analysis was carried out, incorporating concepts from the Trans-Theoretical Model of change.FindingsThe PATH trial reports a clinically relevant improvement in mental health outcomes for women receiving the intervention compared to usual advocacy. The qualitative study reveals which elements of the intervention were beneficial or problematic, which outcomes were most meaningful and relevant to participants and highlights reasons for variations in adherence. Women valued the educational, psychological and emotional elements of the intervention, they felt safe to explore repressed emotions for the first time and experienced a reduction in self-blame, improved sense of identity and greater self-esteem. They also incorporated new skills and self-help techniques to enable sustainable change. Women receiving usual advocacy reported un-met needs for psychological and emotional support. Adherence was affected by women's 'psychological 'readiness' to engage, the competing demands of practical issues such as housing insecurity, legal proceedings or the availability of child care, and breaks in the continuity of professional care.ConclusionsContinuity and regularity of sessions with a trained specialist worker was key to women's recovery. Individual assessment of 'readiness' would optimise the timing of delivery to maximise adherence and benefit.

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Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

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Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

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