Browsing by Subject "Process evaluation"

Now showing 1 - 11 of 11
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    A process evaluation exploring the lay counsellor experience of delivering a task shared psycho-social intervention for perinatal depression in Khayelitsha, South Africa
    (2017) Munodawafa, Memory; Lund, Crick; Schneider, Marguerite
    BACKGROUND: Task sharing of psycho-social interventions for perinatal depression has been shown to be feasible, acceptable and effective in low and middle-income countries. This study conducted a process evaluation exploring the perceptions of counsellors who delivered a task shared psycho-social counselling intervention for perinatal depression in Khayelitsha, Cape Town together with independent fidelity ratings. METHODS: Post intervention qualitative semi-structured interviews were conducted with six counsellors from the AFrica Focus on Intervention Research for Mental health (AFFIRM-SA) randomised controlled trial on their perceptions of delivering a task shared psycho-social intervention for perinatal depression. Themes were identified using the framework approach and were coded and analysed using Nvivo v11. These interviews were supplemented with fidelity ratings for each counsellor and supervision notes. RESULTS: Facilitating factors in the delivery of the intervention included intervention related factors such as: the content of the intervention, ongoing training and supervision, using a counselling manual, conducting counselling sessions in the local language (isiXhosa) and fidelity to the manual; counsellor factors included counsellors' confidence and motivation to conduct the sessions; participant factors included older age, commitment and a desire to be helped. Barriers included contextual factors such as poverty, crime and lack of space to conduct counselling sessions and participant factors such as the nature of the participant's problem, young age, and avoidance of contact with counsellors. Fidelity ratings and dropout rates varied substantially between counsellors. CONCLUSION: These findings show that a variety of intervention, counsellor, participant and contextual factors need to be considered in the delivery of task sharing counselling interventions. Careful attention needs to be paid to ongoing supervision and quality of care if lay counsellors are to deliver good quality task shared counselling interventions in under-resourced communities. TRIAL REGISTRATION: Clinical Trials: NCT01977326 , registered on 24/10/2013; Pan African Clinical Trials Registry: PACTR201403000676264 , registered on 11/10/2013.
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    A process evaluation exploring the lay counsellor experience of delivering a task shared psycho-social intervention for perinatal depression in Khayelitsha, South Africa
    (BioMed Central, 2017) Munodawafa, Memory; Lund, Crick; Schneider, Marguerite
    Background: Task sharing of psycho-social interventions for perinatal depression has been shown to be feasible, acceptable and effective in low and middle-income countries. This study conducted a process evaluation exploring the perceptions of counsellors who delivered a task shared psycho-social counselling intervention for perinatal depression in Khayelitsha, Cape Town together with independent fidelity ratings. Methods: Post intervention qualitative semi-structured interviews were conducted with six counsellors from the AFrica Focus on Intervention Research for Mental health (AFFIRM-SA) randomised controlled trial on their perceptions of delivering a task shared psycho-social intervention for perinatal depression. Themes were identified using the framework approach and were coded and analysed using Nvivo v11. These interviews were supplemented with fidelity ratings for each counsellor and supervision notes. Results: Facilitating factors in the delivery of the intervention included intervention related factors such as: the content of the intervention, ongoing training and supervision, using a counselling manual, conducting counselling sessions in the local language (isiXhosa) and fidelity to the manual; counsellor factors included counsellors’ confidence and motivation to conduct the sessions; participant factors included older age, commitment and a desire to be helped. Barriers included contextual factors such as poverty, crime and lack of space to conduct counselling sessions and participant factors such as the nature of the participant’s problem, young age, and avoidance of contact with counsellors. Fidelity ratings and dropout rates varied substantially between counsellors. Conclusion: These findings show that a variety of intervention, counsellor, participant and contextual factors need to be considered in the delivery of task sharing counselling interventions. Careful attention needs to be paid to ongoing supervision and quality of care if lay counsellors are to deliver good quality task shared counselling interventions in under-resourced communities. Trial registration: Clinical Trials: NCT01977326, registered on 24/10/2013; Pan African Clinical Trials Registry: PACTR201403000676264, registered on 11/10/2013.
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    Addressing the quality of paediatric primary care: health worker and caregiver perspectives from a process evaluation of PACK child, a health systems intervention in South Africa
    (2021-01-28) Curran, Robyn; Murdoch, Jamie; Bachmann, Max; Bateman, Eric; Cornick, Ruth; Picken, Sandra; Simelane, Makhosazana L; Fairall, Lara
    Background The WHO’s Integrated Management of Childhood Illness (IMCI) has resulted in progress in addressing infant and child mortality. However, unmet needs of children continue to present a burden upon primary healthcare services. The capacity of services and quality of care offered require greater support to address these needs by extending and integrating curative and preventive care for the child with a long-term health condition and the child older than 5, not prioritised in IMCI. In response to these needs, the PACK Child intervention was developed and piloted in October 2017–February 2019 in the Western Cape Province of South Africa. We report health worker and caregiver perspectives of the existing paediatric primary care context as well as the extent to which PACK Child functions to address perceived problems within the current local healthcare system. Methods This process evaluation involved 52 individual interviews with caregivers, 10 focus group discussions with health workers, 3 individual interviews with trainers, and 31 training observations. Interviews and focus groups explored participants’ experiences of paediatric primary care, perspectives of the PACK Child intervention, and tensions with implementation in each context. Inductive thematic analysis was used to analyse verbatim interview and discussion transcripts. Results Perspectives of caregivers and health workers suggest an institutionalised focus of paediatric primary care to treating children’s symptoms as acute episodic conditions. Health workers’ reports imply that this focus is perpetuated by interactions between contextual features such as, IMCI policy, documentation-driven consultations, overcrowded clinics and verticalised care. Whilst these contextual conditions constrained health workers’ ability to translate skills developed within PACK Child training into practice, the intervention initiated expanded care of children 0–13 years and those with long-term health conditions, enhanced professional competence, improved teamwork and referrals, streamlined triaging, and facilitated probing for psychosocial risk. Conclusion PACK Child appears to be catalysing paediatric primary care to address the broader needs of children, including long-term health conditions and the identification of psychosocial problems. However, to maximise this requires primary care to re-orientate from risk minimisation on the day of attendance towards a view of the child beyond the day of presentation at clinics.
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    Can public sector community health workers deliver a nurturing care intervention in South Africa? The Amagugu Asakhula feasibility study
    (2021-02-27) Klingberg, Sonja; van Sluijs, Esther M F; Jong, Stephanie T; Draper, Catherine E
    Background Nurturing care interventions have the potential to promote health and development in early childhood. Amagugu Asakhula was designed to promote developmentally important dietary and movement behaviours among children of preschool age (3–5 years) in South Africa. An initial formative study in Cape Town found the intervention to be feasible and acceptable when delivered by community health workers (CHWs) linked to a community-based organisation. This study evaluated the delivery of the Amagugu Asakhula intervention by CHWs linked to a public sector primary health care facility in Soweto, as this mode of delivery could have more potential for sustainability and scalability. Methods A qualitative design was utilised to assess feasibility, acceptability, adoption, appropriateness, implementation, fidelity and context. CHWs (n = 14) delivered the intervention to caregivers (n = 23) of preschool-age children in Soweto over 6 weeks. Following the completion of the intervention, focus group discussions were held with CHWs and caregivers. Further data were obtained through observations, study records and key informant interviews (n = 5). Data were analysed using deductive thematic analysis guided by a process evaluation framework. Results The delivery of the Amagugu Asakhula intervention through CHWs linked to a primary health care facility in Soweto was not found to be feasible due to contextual challenges such as late payment of salaries influencing CHW performance and willingness to deliver the intervention. CHWs expressed dissatisfaction with their general working conditions and were thus reluctant to take on new tasks. Despite barriers to successful delivery, the intervention was well received by both CHWs and caregivers and was considered a good fit with the CHWs’ scope of work. Conclusions Based on these findings, delivery of the Amagugu Asakhula intervention is not recommended through public sector CHWs in South Africa. This feasibility study informs the optimisation of implementation and supports further testing of the intervention’s effectiveness when delivered by CHWs linked to community-based organisations. The present study further demonstrates how implementation challenges can be identified through qualitative feasibility studies and subsequently addressed prior to large-scale trials, avoiding the wasting of research and resources.
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    Facilitators of and barriers to reducing thirty-day readmissions and improving patient-reported outcomes after surgical aortic valve replacement: a process evaluation of the AVRre trial
    (2020-03-27) Danielsen, Stein O; Moons, Philip; Leegaard, Marit; Solheim, Svein; Tønnessen, Theis; Lie, Irene
    Abstract Background The Aortic Valve Replacement Readmission (AVRre) randomized control trial tested whether a telephone intervention would reduce hospital readmissions following surgical aortic valve replacement (SAVR). The telephone support provided 30 days of continuous phone-support (hotline) and two scheduled phone-calls from the hospital after discharge. The intervention had no effect on reducing 30-day all-cause readmission rate (30-DACR) but did reduce participants’ anxiety compared to a control group receiving usual care. Depression and participant-reported health state were unaffected by the intervention. To better understand these outcomes, we conducted a process evaluation of the AVRre trial to gain insight into the (1) the dose and fidelity of the intervention, (2) mechanism of impacts, and (3) contextual factors that may have influenced the outcomes. Methods The process evaluation was informed by the Medical Research Council framework, a widely used set of guidelines for evaluating complex interventions. A mix of quantitative (questionnaire and journal records) and qualitative data (field notes, memos, registration forms, questionnaire) was prospectively collected, and retrospective interviews were conducted. We performed descriptive analyses of the quantitative data. Content analyses, assisted by NVivo, were performed to evaluate qualitative data. Results The nurses who were serving the 24/7 hotline intervention desired to receive more preparation before intervention implementation. SAVR patient participants were highly satisfied with the telephone intervention (58%), felt safe (86%), and trusted having the option of calling in for support (91%). The support for the telephone hotline staff was perceived as a facilitator of the intervention implementation. Content analyses revealed themes: “gap in the care continuum,” “need for individualized care,” and “need for easy access to health information” after SAVR. Differences in local hospital discharge management practices influenced the 30-DACR incidence. Conclusions The prospective follow-up of the hotline service during the trial facilitated implementation of the intervention, contributing to high participant satisfaction and likely reduced their anxiety after SAVR. Perceived less-than-optimal preparations for the hotline could be a barrier to AVRre trial implementation. Integrating user experiences into a mixed-methods evaluation of clinical trials is important for broadening understanding of trial outcomes, the mechanism of impact, and contextual factors that influence clinical trials. Trial registration ClinicalTrials.gov, NCT02522663. Registered on 11 August 2015.
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    Factors affecting adolescents’ participation in randomized controlled trials evaluating the effectiveness of healthcare interventions: the case of the STEPSTONES project
    (2020-08-03) Saarijärvi, Markus; Wallin, Lars; Moons, Philip; Gyllensten, Hanna; Bratt, Ewa-Lena
    Abstract Background Recruitment of adolescents to intervention studies is a known challenge. For randomized controlled trials (RCT) to be generalizable, reach must be assessed, which means ascertaining how many of the intended population actually participated in the trial. The aim of this study was to evaluate the reach and representativeness of an RCT evaluating the effectiveness of a complex intervention for adolescents with chronic conditions. Methods A mixed methods sequential explanatory design was employed. Firstly, quantitative cross-sectional data from the RCT, patient registries and medical records were collected and analysed regarding baseline differences between participants and non-participants in the trial. Secondly, qualitative data on their reasons for participating or not were collected and analysed with content analysis to explain the quantitative findings. Results Participants showed larger differences in effect sizes and a significantly more complex chronic condition than non-participants. No other statistically significant differences were reported, and effect sizes were negligible. Reasons for declining or accepting participation were categorized into three main categories: altruistic reasons, personal reasons and external reasons and factors. Conclusions Integration of quantitative and qualitative findings showed that participation in the RCT was affected by disease complexity, the perceived need to give back to healthcare and research and the adolescents’ willingness to engage in their illness. To empower adolescents with chronic conditions and motivate them to participate in research, future intervention studies should consider developing tailored recruitment strategies and communications with sub-groups that are harder to reach.
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    Implementation fidelity of a transition program for adolescents with congenital heart disease: the STEPSTONES project
    (2022-02-05) Saarijärvi, Markus; Wallin, Lars; Moons, Philip; Gyllensten, Hanna; Bratt, Ewa-Lena
    Background Although transition programs have been evaluated for adolescents with chronic conditions, these have rarely involved process evaluations. Indeed, outcomes of complex interventions are dependent on how the intervention is implemented in practice and evaluations of implementation process are therefore pivotal. The aim of this study was to evaluate the extent to which a transition program for adolescents with congenital heart disease was delivered as intended. Research questions were 1) to what level of fidelity was the program delivered? and 2) what potential moderating factors affected the delivery of the program and overall fidelity? Methods A mixed methods design was used, where a process evaluation was embedded in the STEPSTONES randomized controlled trial in Sweden. The implementation fidelity framework by Carrol (2007) and Hasson (2010) was used to design, collect and analyze data. Quantitative data consisted of intervention records on adherence and were analyzed with descriptive statistics. Qualitative data on moderators affecting fidelity were collected through interviews, log-books and focus group interviews with healthcare professionals implementing the intervention and participatory observations of the implementation process. Data were analyzed with deductive content analysis. Triangulation was used to integrate quantitative and qualitative data within the fidelity framework. Results Six out of eight components of the transition program were delivered to an extent that adhered to the program theory or achieved a high level of fidelity. However, components involving peer support had a low attendance by the participating sample (32.2%), and the joint transfer meeting was challenging to implement, despite achieving high adherence. Moderators affecting the implementation process were the adolescent’s and healthcare professional’s engagement in the intervention, contextual factors and a lack of standard operating procedures for all components in the program. Conclusion Barriers and facilitators for a future implementation of transition programs have been illuminated in this study. The use of an implementation fidelity framework in the process evaluation proved successful in providing a comprehensive evaluation of factors affecting the implementation process. However, implementation fidelity must be considered in relation to adaptations to the local and personal prerequisites in order to create interventions that can achieve fit.
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    Implementing a provider-initiated testing and counselling (PITC) intervention in Cape town, South Africa: a process evaluation using the normalisation process model
    (BioMed Central Ltd, 2013) Leon, Natalie; Lewin, Simon; Mathews, Catherine
    BACKGROUND:Provider-initiated HIV testing and counselling (PITC) increases HIV testing rates in most settings, but its effect on testing rates varies considerably. This paper reports the findings of a process evaluation of a controlled trial of PITC for people with sexually transmitted infections (STI) attending publicly funded clinics in a low-resource setting in South Africa, where the trial results were lower than anticipated compared to the standard Voluntary Counselling and Testing (VCT) approach.METHOD:This longitudinal study used a variety of qualitative methods, including participant observation of project implementation processes, staff focus groups, patient interviews, and observation of clinical practice. Data were content analysed by identifying the main influences shaping the implementation process. The Normalisation Process Model (NPM) was used as a theoretical framework to analyse implementation processes and explain the trial outcomes. RESULTS: The new PITC intervention became embedded in practice (normalised) during a two-year period (2006 to 2007). Factors that promoted the normalising include strong senior leadership, implementation support, appropriate accountability mechanisms, an intervention design that was responsive to service needs and congruent with professional practice, positive staff and patient perceptions, and a responsive organisational context. Nevertheless, nurses struggled to deploy the intervention efficiently, mainly because of poor sequencing and integration of HIV and STI tasks, a focus on HIV education, tension with a patient-centred communication style, and inadequate training on dealing with the operational challenges. This resulted in longer consultation times, which may account for the low test coverage outcome. CONCLUSION: Leadership and implementation support, congruent intervention design, and a responsive organisational context strengthened implementation. Poor compatibility with nurse skills on the level of the clinical consultation may have contributed to limiting the size of the trial outcomes. A close fit between the PITC intervention design and clinical practices, as well as appropriate training, are needed to ensure sustainability of the programme. The use of a theory-driven analysis promotes transferability of the results, and the findings are therefore relevant to the implementation of HIV testing and to the design and evaluation of complex interventions in other settings.TRIAL REGISTRATION:Current controlled trials ISRCTN93692532
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    Implementing nurse-initiated and managed antiretroviral treatment (NIMART) in South Africa: a qualitative process evaluation of the STRETCH trial
    (BioMed Central Ltd, 2012) Georgeu, Daniella; Colvin, Christopher; Lewin, Simon; Fairall, Lara; Bachmann, Max; Uebel, Kerry; Zwarenstein, Merrick; Draper, Beverly; Bateman, Eric
    BACKGROUND:Task-shifting is promoted widely as a mechanism for expanding antiretroviral treatment (ART) access. However, the evidence for nurse-initiated and managed ART (NIMART) in Africa is limited, and little is known about the key barriers and enablers to implementing NIMART programmes on a large scale. The STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV) programme was a complex educational and organisational intervention implemented in the Free State Province of South Africa to enable nurses providing primary HIV/AIDS care to expand their roles and include aspects of care and treatment usually provided by physicians. STRETCH used a phased implementation approach and ART treatment guidelines tailored specifically to nurses. The effects of STRETCH on pre-ART mortality, ART provision, and the quality of HIV/ART care were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of factors affecting the implementation of the programme. METHODS: This study was a qualitative process evaluation using in-depth interviews and focus group discussions with patients, health workers, health managers, and other key informants as well as observation in clinics. Research questions focused on perceptions of STRETCH, changes in health provider roles, attitudes and patient relationships, and impact of the implementation context on trial outcomes. Data were analysed collaboratively by the research team using thematic analysis. RESULTS: NIMART appears to be highly acceptable among nurses, patients, and physicians. Managers and nurses expressed confidence in their ability to deliver ART successfully. This confidence developed slowly and unevenly, through a phased and well-supported approach that guided nurses through training, re-prescription, and initiation. The research also shows that NIMART changes the working and referral relationships between health staff, demands significant training and support, and faces workload and capacity constraints, and logistical and infrastructural challenges. CONCLUSIONS: Large-scale NIMART appears to be feasible and acceptable in the primary level public sector health services in South Africa. Successful implementation requires a comprehensive approach with: an incremental and well supported approach to implementation; clinical guidelines tailored to nurses; and significant health services reorganisation to accommodate the knock-on effects of shifts in practice.TRIAL REGISTRATION:ISRCTN46836853
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    A stitch in time saves nine? A repeated cross-sectional case study on the implementation of the intersectoral community approach Youth At a Healthy Weight
    (BioMed Central Ltd, 2015) van der Kleij, Rianne; Crone, Mathilde R; Paulussen, Theo; van de Gaar, Vivan; Reis, Ria
    BACKGROUND: The implementation of programs complex in design, such as the intersectoral community approach Youth At a Healthy Weight (JOGG), often deviates from their application as intended. There is limited knowledge of their implementation processes, making it difficult to formulate sound implementation strategies. METHODS: For two years, we performed a repeated cross-sectional case study on the implementation of a JOGG fruit and water campaign targeting children age 0-12. Semi-structured observations, interviews, field notes and professionals' logs entries were used to evaluate implementation process. Data was analyzed via a framework approach; within-case and cross-case displays were formulated and key determinants identified. Principles from Qualitative Comparative Analysis (QCA) were used to identify causal configurations of determinants per sector and implementation phase. RESULTS: Implementation completeness differed, but was highest in the educational and health care sector, and higher for key than additional activities. Determinants and causal configurations of determinants were mostly sector- and implementation phase specific. High campaign ownership and possibilities for campaign adaptation were most frequently mentioned as facilitators. A lack of reinforcement strategies, low priority for campaign use and incompatibility of own goals with campaign goals were most often indicated as barriers.DISCUSSION:We advise multiple 'stitches in time'; tailoring implementation strategies to specific implementation phases and sectors using both the results from this study and a mutual adaptation strategy in which professionals are involved in the development of implementation strategies. CONCLUSION: The results of this study show that the implementation process of IACOs is complex and sustainable implementation is difficult to achieve. Moreover, this study reveals that the implementation process is influenced by predominantly sector and implementation phase specific (causal configurations of) determinants.
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    Unravelling the factors decisive to the implementation of EPODE-derived community approaches targeting childhood obesity: a longitudinal, multiple case study
    (2016) van der Kleij, Maria Rianne; Crone, Mathilde; Reis, Ria; Paulussen, Theo
    Abstract Background Implementation of intersectoral community approaches often fails due to a translational gap between the approach as intended and the approach as implemented in practice. Knowledge about the implementation determinants of such approaches is needed to facilitate future implementation processes. Methods The implementation of five EPODE-derived intersectoral community approaches was studied longitudinally. Semi-structured interviews were held with 189 community stakeholders from four sectors to elucidate which determinants influenced implementation, and if an to which extent determinants differed across communities, sectors and over time. A framework approach was used to analyze our data. Results Twenty-two key determinants of implementation were identified. Facilitators named were mostly proximal (stakeholder level), and barriers were mostly distal (context level). Key determinants varied greatly across sectors and over time, especially between the educational & health care sector and the private, welfare & sports sector. Only ‘perceived importance of IACO goals’ was identified as an universal implementation facilitator. Conclusions Striking differences in determinants were found across sectors and over time. Also, stakeholders expressed that possibilities to adapt the approach to the local context were needed to improve implementation. We therefore propose to develop sector- and time specific leads for implementation, which should be approved and amended (over time) by stakeholders. This so-called ‘mutual adaptation’ allows for the use of both scientific insights and practice-based knowledge, enabling program management and community stakeholders to collaboratively improve their implementation efforts.