Parallel Process Evaluation Research Articles

The ASK trial: a randomised controlled feasibility trial and process evaluation of a complex multicomponent intervention to improve AccesS to living-donor Kidney transplantation

Background Following identification of barriers to living-donor kidney transplantation, and subsequent development of a multicomponent intervention, we undertook a feasibility trial of the intervention. Trial design Two-arm, parallel group, pragmatic, individually-randomised, controlled, feasibility trial, comparing the new intervention with usual care, with a mixed-methods parallel process evaluation. Based at two UK hospitals. Participants Individuals were eligible if ≥18 years old, active on the kidney transplant waiting list or had been referred for transplant listing without a contraindication to transplantation. Individuals with a living-donor undergoing surgical assessment were excluded. Intervention i) A meeting between a home educator for a dedicated discussion about living-donor kidney transplantation, living kidney donation and potential donors; ii) A standardized letter from a healthcare professional to a candidate’s potential donors; iii) A home-based education and family engagement session undertaken by a living kidney donor and a nurse specialist. Objective To establish the acceptability and feasibility i) of delivering the developed intervention in existing care pathways, and ii) of undertaking a randomised controlled trial of the intervention. Primary outcomes Recruitment and retention. Randomisation Participants were randomly allocated 1:1 to i) the intervention or ii) usual care, stratified by site. Minimisation was used to ensure balance in sex, age group, and socioeconomic strata, with probability weighting of 0.8. Results 183 people were invited to participate. 62 people (34% recruitment) were randomised. 62/62 (100%) completed nurse assessed follow-up at 6 weeks. 51/62 (82%) completed follow-up questionnaires. 3/30 (10%) in the usual care arm and 9/32 (28%) in the intervention arm had individuals ask to be tested for living kidney donation following recruitment to the trial. Conclusions Intervention and trial delivery are feasible and acceptable. Findings have informed the design of an effectiveness and cost-effectiveness trial. Trial registration ISRCTN Registry ISRCTN10989132 https://doi.org/10.1186/ISRCTN10989132. The trial was registered on 6/11/2020.

Remote monitoring of rheumatoid arthritis (REMORA): study protocol for a stepped wedge cluster randomized trial and process evaluation of an integrated symptom tracking intervention

BackgroundManagement of rheumatoid arthritis (RA) relies on symptoms reported by patients during infrequent outpatient clinic visits. These reports are often incomplete and inaccurate due to poor recall, leading to suboptimal treatment decisions and outcomes. Asking people to track symptoms in-between visits and integrating the data into clinical pathways may improve this. However, knowledge on how to implement this into practice and its impact on services and outcomes remains scarce in RA. Therefore, we evaluate the comparative effectiveness and cost-effectiveness of integrated symptom tracking in people with RA over and above usual care, while generating insights on factors for successful implementation.MethodsIn this superiority stepped wedge cluster-randomized controlled trial with continuous recruitment short exposure design, 16 rheumatology outpatient departments (clusters) recruit a total of 732 people with active RA. They initially offer clinic visits according to standard of care before switching in pairs to visits with integrated symptom tracking. Clusters switch in randomized order every 3 weeks. Integrated symptom tracking consists of (1) a mobile app for patients to track their symptoms daily and other RA aspects weekly/monthly, and (2) an interactive dashboard visualizing the app data, which healthcare professionals access from their electronic health record system. Clinic visits happen according to usual practice, with tracked symptom data only reviewed during visits. Our primary outcome is a difference in marginal mean disease activity score at 12 ± 3 months between standard of care and integrated symptom tracking, after accounting for baseline values, cluster, and other covariates. Secondary outcomes include patient-reported disease activity, quality of life and quality-adjusted life-years, medication/resource use, consultation and decision-making experience, self-management, and illness perception. We also conduct interviews and observations as part of a parallel process evaluation to gather information on implementation.DiscussionOur trial will generate high-quality evidence of comparative and cost-effectiveness of integrated symptom tracking compared to standard of care in people with RA, with our process evaluation delivering knowledge on successful implementation. This optimizes the chances of integrated symptom tracking being adopted more widely if we find it is (cost-) effective.Trial registrationRegistered 4-Jun-2024 on https://www.isrctn.com/, ISRCTN51539448.Trial open science framework repositoryhttps://osf.io/sj9ha/.

A Systematic Review of Dental Antibiotic Stewardship Interventions.

Antimicrobial resistance is a significant threat to global health. Antimicrobial stewardship is reducing inappropriate antimicrobial prescribing to counter it. Dentists prescribe ~10% of all antibiotics worldwide, yet up to 90% of antibiotic prescriptions by dentists are inappropriate. The aim of this systematic review was to update a 2017 review evaluating the effects of antibiotic stewardship interventions in dental settings, using the international consensus on core outcomes for dental antibiotic stewardship. Systematic database searches were undertaken in April 2023, of the: Cochrane Oral Health Group Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE via OVID, EMBASE via OVID, Dentistry and Oral Sciences Source, the US National Institutes of Health Trials Register, the World Health Organisation International Clinical Trials Registry Platform and the ISRCTN registry databases. Randomised controlled trials (or non-randomised studies with clearly reported mechanism of group formation and inclusion criteria) of interventions to optimise and/or reduce dental antibiotic prescribing were eligible for inclusion. Two authors independently screened for eligible studies. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool, certainty of evidence assessed using GRADE. Meta-analysis was planned whether the results of studies reported similar outcomes, otherwise narrative synthesis was undertaken. Three eligible studies randomising 2148 participants were included. The interventions were combinations of education, audit and feedback and written behaviour change messages, guideline summary, practice visits and patient leaflets. None of the control groups received an intervention. All three included studies measured the quantity of antibiotics prescribed and two measured the appropriateness of prescribing. None measured patient-reported or adverse outcomes. Two included studies were assessed as 'high risk' and one with 'low risk' of bias. There was high-certainty evidence that audit and personalised feedback with individualised behaviour change messages can be effective. Evidence for in-person education was low-certainty. Guideline dissemination alone was ineffective at improving antibiotic prescribing. Due to different outcomes reported, meta-analysis was inappropriate. Although various dental antibiotic stewardship interventions have been reported in the literature, none provided high-certainty evidence of effectiveness and only three have been evaluated using a randomised design. To strengthen the body of evidence, well-powered, robust, randomised controlled trials are required, with adequate follow-up, reporting the internationally-agreed core outcomes and including a parallel process evaluation is recommended. PROSPERO (CRD42023411476).

Experiences with implementing advance care planning (ACP-GP) in Belgian general practice in the context of a cluster RCT: a process evaluation using the RE-AIM framework

BackgroundGeneral practice is often recommended as an ideal setting to initiate advance care planning (ACP), but uptake of ACP in this setting is low. ACP-GP is a complex intervention to facilitate ACP for patients with chronic, life-limiting illness in Belgian general practice. It aims to increase patient ACP engagement and general practitioner (GP) ACP self-efficacy. In a cluster-randomized controlled trial, the intervention was not superior to control in increasing these outcomes. A parallel process evaluation aimed to enhance understanding of how the intervention was implemented, and which factors might have influenced trial results.MethodsWe conducted a mixed-methods process evaluation following the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources include recruitment and implementation monitoring, questionnaires for patients and GPs, and semi-structured (focus group) interviews with patients and GPs. Questionnaire data were analyzed descriptively. Qualitative data were first analyzed inductively; themes were then assigned deductively to RE-AIM dimensions.ResultsThirty-five GPs and 95 patients were recruited to the trial; GP reach was low. Sixteen GPs and 46 patients provided questionnaire data at 3 months post-baseline; qualitative data were transcribed for 14 GPs and 11 patients. Adoption of intervention components was moderate to good, with the exception of the documentation template for GPs. Interviews revealed varying patient attitudes towards ACP, but patients nonetheless emphasized that conversations made them feel reassured. GPs especially valued a positive framing of ACP. When adopted, the intervention was well-implemented and participant satisfaction was high. However, intention for maintenance was moderate, with GPs raising questions of how to sustainably implement ACP conversations in the future.ConclusionsImplementing the complex ACP-GP intervention in general practice is feasible, and can be successful. However, the implementation process is challenging and the sustainability is suboptimal. Our findings will guide future research and recommendations for facilitating and implementing ACP in general practice.Trial registrationISRCTN12995230; prospectively registered on 19/06/2020.

Clinical effectiveness and cost-effectiveness of Structured Psychological Support for people with probable personality disorder in mental health services in England: study protocol for a randomised controlled trial

IntroductionEvidence-based psychological treatments for people with personality disorder usually involve attending group-based sessions over many months. Low-intensity psychological interventions of less than 6 months duration have been developed, but their...

Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation

BackgroundUK national clinical guidance recommends that men with prostate cancer on androgen deprivation therapy are offered twice weekly supervised aerobic and resistance exercise to address iatrogenic harm caused by treatment. Very few NHS trusts have established adequate provision of such services. Furthermore, interventions fail to demonstrate sustained behaviour change. The STAMINA lifestyle intervention offers a system-level change to clinical care delivery addressing barriers to long-term behaviour change and implementation of new prostate cancer care pathways. This trial aims to establish whether STAMINA is clinically and cost-effective in improving cancer-specific quality of life and/or reducing fatigue compared to optimised usual care. The process evaluation aims to inform the interpretation of results and, if the intervention is shown to benefit patients, to inform the implementation of the intervention into the NHS.MethodsMen with prostate cancer on androgen deprivation therapy (n = 697) will be identified from a minimum of 12 UK NHS trusts to participate in a multi-centre, two-arm, individually randomised controlled trial. Consenting men will have a ‘safety to exercise’ check and be randomly allocated (5:4) to the STAMINA lifestyle intervention (n = 384) or optimised usual care (n = 313). Outcomes will be collected at baseline, 3-, 6- and 12-month post-randomisation. The two primary outcomes are cancer-specific quality of life and fatigue. The parallel process evaluation will follow a mixed-methods approach to explore recruitment and aspects of the intervention including, reach, fidelity, acceptability, and implementation. An economic evaluation will estimate the cost-effectiveness of the STAMINA lifestyle intervention versus optimised usual care and a discrete choice experiment will explore patient preferences.DiscussionThe STAMINA lifestyle intervention has the potential to improve quality of life and reduce fatigue in men on androgen deprivation therapy for prostate cancer. Embedding supervised exercise into prostate cancer care may also support long-term positive behaviour change and reduce adverse events caused by treatment. Findings will inform future clinical care and could provide a blueprint for the integration of supervised exercise and behavioural support into other cancer and/or clinical services.Trial registrationISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.

Setting the context for a complex dental intervention of role substitution in care homes: Initial process evaluation findings.

SENIOR (uSing rolE-substitutioN In care homes to improve oRal health) is a randomised controlled trial designed to determine whether role substitution could improve oral health for this population. A parallel process evaluation was undertaken to understand context. This paper reports on the first phase of the process evaluation. The oral health and quality-of-life of older adults residing in care homes is poorer than those in the community. Oral health care provision is often unavailable and a concern and challenge for managers. The use of Dental Therapists and Dental Nurses rather than dentists could potentially meet these needs. Semi-structured interviews were conducted with 21 key stakeholders who either worked or had experience of dependent care settings. Questions were theoretically informed by the: Promoting Action on Research Implementation in Health Services (PAHRIS) framework. The focus was on contextual factors that could influence adoption in practice and the pathway-to-impact. Interviews were fully transcribed and analysed thematically. Three themes (receptive context, culture, and leadership) and 11 codes were generated. Data show the complexity of the setting and contextual factors that may work as barriers and facilitators to intervention delivery. Managers are aware of the issues regarding oral health and seek to provide best care, but face many challenges including staff turnover, time pressures, competing needs, access to services, and financial constraints. Dental professionals recognise the need for improvement and view role substitution as a viable alternative to current practice. Although role substitution could potentially meet the needs of this population, an in-depth understanding of contextual factors appeared important in understanding intervention delivery and implementation.

Clinical and cost-effectiveness of ‘Live Well with Parkinson’s’ self-management intervention versus treatment as usual for improving quality of life for people with Parkinson’s: study protocol for a randomised controlled trial

BackgroundThe Live Well with Parkinson’s Self-Management Toolkit is designed for use in the NHS to support people with Parkinson’s, their carers and health professionals in managing motor and non-motor symptoms and promoting well-being. The Toolkit was developed based on theory-based behaviour change and self-management techniques in consultation with people living with Parkinson’s and health and social care practitioners. There are digital (e-Toolkit) and paper (manual) versions.MethodsSingle-blind two-arm randomised controlled trial RCT of clinical effectiveness and cost-effectiveness of the Toolkit, facilitated by up to six sessions with a trained non-specialist supporter, in improving quality of life. People with Parkinson’s will be assessed at baseline, 6 and 12 months. Assessors will be blind to the treatment group. The primary outcome measure is the Parkinson’s Disease Questionnaire (PDQ-39, Parkinson’s related quality of life) score at 12 months. Secondary outcome measures include the MDS Unified Parkinson’s Disease Rating Scale (Part I, II, III, IV), EQ-5D, and a Client Service Receipt Inventory shortened, adapted for Parkinson’s. Carer outcomes include the Zarit Carer Burden Inventory and Carer Quality of Life Questionnaire for Parkinsonism. A total of 338 people with Parkinson’s, and their carers if appropriate, will be recruited from diverse settings across England. Those with advanced dementia, at end-of-life or with atypical Parkinsonism will be excluded. A parallel mixed methods process evaluation will explore the factors promoting or inhibiting implementation, uptake, use, effectiveness and cost-effectiveness of the Toolkit and sessions.DiscussionIf successful, the Live Well with Parkinson’s Toolkit could be used as a model for other complex long-term disorders, including dementia. This would bridge existing gaps in the NHS (as shown by the national Parkinson’s audit data), by enabling patients and carers to access personalised information, advice and support on symptom management and ‘living well’ with Parkinson’s.Trial registrationISRCTN92831552. Registered on 26th Oct 2021.

Community-based integrated care for patients with diabetes and depression (CIC-PDD): study protocol for a cluster randomized controlled trial

BackgroundManaging the multimorbidity of diabetes and depression remains a clinical challenge for patients and healthcare professionals due to the fragmented healthcare delivery system. To effectively cope with multimorbidity, there is an urgent need for the health system to transform into people-centered integrated care (PCIC) system globally. Therefore, this paper describes the protocol of community-based integrated care for patients with diabetes and depression (CIC-PDD) project, an integrated and shared-care intervention project.Methods/designCIC-PDD project is conducted in two phases, namely “care model development” and “implementation and evaluation.” In the first phase, CIC-PDD model was designed and developed based on the four criteria of collaborative care model (CCM) and was subsequently adjusted to align with the context of China. The second phase entails a pragmatic, two-arm, cluster randomized controlled implementation trial, accompanied by parallel mixed-methods process evaluation and cost-effectiveness analysis.DiscussionWe anticipate CIC-PDD project will facilitate the development and innovation of PCIC model and related theories worldwide, particularly in low- and middle-income countries (LMICs). In addition, CIC-PDD project will contribute to the exploration of primary health care (PHC) in addressing the multimorbidity of physical and mental health issues.Trial registrationClinicalTrials.gov registration ChiCTR2200065608 (China Clinical Trials Registry https://www.chictr.org.cn). Registered on November 9, 2022.

Reducing the burden of knee osteoarthritis through community pharmacy: Protocol for a randomised controlled trial of the Knee Care for Arthritis through Pharmacy Service.

Knee osteoarthritis (OA) negatively impacts the health outcomes and equity, social and employment participation, and socio-economic wellbeing of those affected. Little community-based support is offered to people with knee OA in Aotearoa New Zealand. Identifying Māori and non-Māori with knee OA in community pharmacy and providing co-ordinated, evidence- and community-based care may be a scalable, sustainable, equitable, effective and cost-effective approach to improve health and wellbeing. Assess whether the Knee Care for Arthritis through Pharmacy Service (KneeCAPS) intervention improves knee-related physical function and pain (co-primary outcomes). Secondary aims assess impacts on health-related quality of life, employment participation, medication use, secondary health care utilisation, and relative effectiveness for Māori. A pragmatic randomised controlled trial will compare the KneeCAPS intervention to the Pharmaceutical Society of New Zealand Arthritis Fact Sheet and usual care (active control) at 12months for Māori and non-Māori who have knee OA. Participants will be recruited in community pharmacies. Knee-related physical function will be measured using the function subscale of the Short Form of the Western Ontario and McMaster Universities Osteoarthritis Index. Knee-related pain will be measured using an 11-point numeric pain rating scale. Primary outcome analyses will be conducted on an intention-to-treat basis using linear mixed models. Parallel within-trial health economic analysis and process evaluation will also be conducted. Ethical approval was obtained from the Central Health and Ethics Committee (2022-EXP-11725). The trial is registered with ANZCTR (ACTRN12622000469718). Findings will be submitted for publication and shared with participants.

Investigating strategies to improve AccesS to Kidney transplantation (the ASK trial): a protocol for a feasibility randomised controlled trial with parallel process evaluation

BackgroundThe UK’s living-donor kidney transplant (LDKT) activity falls behind that of many other countries internationally, with less than 20% of those eligible receiving a LDKT each year. Certain individuals with kidney disease in the UK appear to be particularly disadvantaged in accessing a LDKT; the most socioeconomically deprived people with kidney disease are 60% less likely to receive a LDKT than the least deprived. Improving equity in living-donor kidney transplantation has been highlighted as an international research priority.MethodsThis feasibility trial was designed to determine the feasibility of delivery and acceptability of a multicomponent intervention designed to improve access to living-donor kidney transplantation. The intervention comprises three main components: (i) a meeting between a home educator and the transplant candidate for a dedicated discussion about living-donor kidney transplantation, living kidney donation and potential donors; (ii) a standardized letter from a healthcare professional to a candidate’s potential donors and (iii) a home-based education and family engagement session including two home educators, the transplant candidate and their family. The primary objectives are to establish the feasibility (i) of delivering the developed intervention in existing care pathways and (ii) of undertaking a randomised controlled trial of the intervention. A mixed-methods parallel process evaluation will investigate the acceptability, implementation and mechanisms of impact of the intervention. The trial is based at two UK hospitals: a transplanting hospital and a non-transplanting referral hospital. Individuals are eligible if they are ≥ 18 years old, are active on the kidney transplant waiting list or have been referred for transplant listing and do not have a potential living-donor undergoing surgical assessment. Randomisation will be undertaken with concealed allocation. Participants will be randomly allocated 1:1 to (i) the intervention or (ii) usual care, stratified by site to ensure a balance in terms of local differences. Minimisation will be used to ensure balance in sex, age group and socioeconomic strata, with probability weighting of 0.8 in order to reduce predictability. The primary outcomes are recruitment (% of those eligible and invited who consent to randomisation) and retention (% of participants completing follow-up).DiscussionFindings will inform the design of a future fully powered, randomised controlled trial to formally evaluate the effectiveness of the intervention at improving equitable access to living-donor kidney transplantation.Trial registrationISRCTN Registry ISRCTN10989132 Applied 30/10/20.

Navigator programme for hospitalised adults experiencing homelessness: protocol for a pragmatic randomised controlled trial

IntroductionPeople experiencing homelessness suffer from poor outcomes after hospitalisation due to systemic barriers to care, suboptimal transitions of care, and intersecting health and social burdens. Case management programmes have been...

Pharmacist and Homeless Outreach Engagement and Non-medical Independent prescribing Rx (PHOENIx): a study protocol for a pilot randomised controlled trial

IntroductionThe number of people experiencing homelessness (PEH) is increasing worldwide. Systematic reviews show high levels of multimorbidity and mortality. Integrated health and social care outreach interventions may improve outcomes. No...

Protocol for the Feasibility Randomised Controlled Trial of Being a Parent- Enjoying Family Life (BAP-EFL): A peer-led group intervention for parents and caregivers with significant emotional and interpersonal difficulties

Group-format parenting interventions are well-established at reducing challenging child behavior and risk for psychopathology. However, there is significantly less evidence about the performance of these interventions for parents with significant emotional and interpersonal difficulties, including personality disorder. This protocol presents the rationale and design of a two-arm parallel group feasibility Randomised Controlled Trial and nested process evaluation of Being a Parent (BaP)- Enjoying Family Life, a novel peer-led intervention. The trial compares BaP-Enjoying Family Life to the well-established Empowering Parents Empowering Communities-Being a Parent (EPEC-Being a Parent) in a sample of parents who experience significant emotional and interpersonal difficulties and who are concerned about their child's, aged 2–11 years, behavior. 72 parents will be recruited and randomised to receive either BaP-Enjoying Family Life or EPEC-Being a Parent group-format interventions. The primary aim of this study is to examine the feasibility and acceptability of BaP-Enjoying Family Life and the proposed trial methods. Secondary clinical outcomes include child behavioral difficulties, parenting, parental reflective function, parent wellbeing, satisfaction and self-efficacy. An observational assessment of parent and index child will also assess changes in the home environment. Outcome measures will be collected pre-intervention, post-intervention and at 6-month follow up. A parallel process evaluation will use qualitative data from interviews to assess parents' experience of the intervention delivery and trial methods. Findings will be evaluated against pre-determined feasibility criteria. The results will be used to determine the planning of a definitive clinical trial. The wider methodological and clinical implications are also discussed.

Induction of labour for predicted macrosomia: study protocol for the ‘Big Baby’ randomised controlled trial

IntroductionLarge-for-gestational age (LGA) fetuses have an increased risk of shoulder dystocia. This can lead to adverse neonatal outcomes and death. Early induction of labour in women with a fetus suspected...

USing rolE-substitutioN In care homes to improve ORal health (SENIOR): a study protocol

BackgroundDental service provision in the care home sector is poor, with little emphasis on prevention. Emerging evidence suggests that the use of Dental Care Professionals (dental therapists and dental nurses) as an alternative to dentists has the potential to improve preventive advice, the provision of care and access to services within care homes. However, robust empirical evidence from definitive trials on how to successfully implement and sustain these interventions within care homes is currently lacking. The aim of the study is to determine whether Dental Care Professionals could reduce plaque levels of dentate older adults (65 + years) residing in care homes.MethodsThis protocol describes a two-arm cluster-randomised controlled trial that will be undertaken in care homes across Wales, Northern Ireland and England. In the intervention arm, the dental therapists will visit the care homes every 6 months to assess and then treat eligible residents, where necessary. All treatment will be conducted within their Scope of Practice. Dental nurses will visit the care homes every month for the first 3 months and then three-monthly afterwards to promulgate advice to improve the day-to-day prevention offered to residents by carers. The control arm will be ‘treatment as usual’.Eligible care homes (n = 40) will be randomised based on a 1:1 ratio (20 intervention and 20 control), with an average of seven residents recruited in each home resulting in an estimated sample of 280. Assessments will be undertaken at baseline, 6 months and 12 months and will include a dental examination and quality of life questionnaires. Care home staff will collect weekly information on the residents’ oral health (e.g. episodes of pain and unscheduled care). The primary outcome will be a binary classification of the mean reduction in Silness-Löe Plaque Index at 6 months. A parallel process evaluation will be undertaken to explore the intervention’s acceptability and how it could be embedded in standard practice (described in a separate paper), whilst a cost-effectiveness analysis will examine the potential long-term costs and benefits of the intervention.DiscussionThis trial will provide evidence on how to successfully implement and sustain a Dental Care Professional-led intervention within care homes to promote access and prevention.Trial registrationISRCTN16332897. Registered on 3 December 2021.

Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb post Stroke (RHOMBUS II): protocol of a feasibility randomised controlled trial

IntroductionUpper limb (UL) rehabilitation is most effective early after stroke, with higher doses leading to improved outcomes. For the stroke survivor, the repetition may be monotonous. For clinicians, providing a...

Improving emergency treatment for patients with acute stroke: the PEARS research programme, including the PASTA cluster RCT

Improving emergency treatment for patients with acute stroke: the PEARS research programme, including the PASTA cluster RCT

Using routine healthcare data to evaluate the impact of the Medicines at Transitions Intervention (MaTI) on clinical outcomes of patients hospitalised with heart failure: protocol for the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) cluster randomised controlled trial with embedded process evaluation, health economics evaluation and internal pilot

IntroductionHeart failure affects 26 million people globally, approximately 900 thousand people in the UK, and is increasing in incidence. Appropriate management of medicines for heart failure at the time of...

Multi-level barriers and facilitators to implementing a parenting intervention in prison, perceptions from deliverers and responsible managers: a mixed-methods study

BackgroundChildren of incarcerated parents run a high risk of poor health and own delinquency and positive parenting is vital for their healthy development. Internationally, parenting interventions for incarcerated parents suggest impacts on parenting and child behaviour outcomes. The intervention For Our Children’s Sake (FOCS), was developed for incarcerated parents in Sweden and evaluated in a controlled trial with a parallel process evaluation during 2019–2021. This study constitutes part of the process evaluation and aims to describe barriers and facilitators for the implementation of FOCS, and how the intervention targets parents’ needs, as perceived by delivering group leaders and responsible correctional inspectors.MethodsIn this mixed-methods study, group leaders (n = 23) and correctional inspectors (n = 12) in both intervention and control group of the FOCS trial responded to a quantitative questionnaire regarding factors of importance for intervention implementation. Group leaders (n = 12) and correctional inspectors (n = 6) in the intervention group also participated in qualitative interviews. Quantitative data were analysed using descriptive statistics and comparison of means. Qualitative data were analysed inductively using qualitative content analysis.ResultsA synthesis of the quantitative and qualitative results showed that the topic of parenting and child issues in general was perceived as highly important to work with in prison, and FOCS to be an important programme in specific. At the same time, the implementation of FOCS was perceived as reliant on the individual engagement of group leaders and correctional inspectors and implementation was described as a struggle due to the scarce resources that were allowed for FOCS. Thus, additional resources and support from the Prison and Probation Service’s management were called for to facilitate implementation of FOCS, and to make it an automatic part of prison activities.ConclusionThis study showed that there was high engagement among deliverers and managers for working with parenting in prison, where the need among parents has been described as great. Additional resources and support within the overall Prison and Probation Service, is vital to facilitate implementation of FOCS and make it sustainable within the prisons. The findings can be used to refine an implementations structure for similar interventions in the prison or similar settings.