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Implementation fidelity in a complex intervention promoting psychosocial well-being following stroke: an explanatory sequential mixed methods study.

ABSTRACT: BACKGROUND:Evaluation of complex interventions should include a process evaluation to give evaluators, researchers, and policy makers greater confidence in the outcomes reported from RCTs. Implementation fidelity can be part of a process evaluation and refers to the degree to which an intervention is delivered according to protocol. The aim of this implementation fidelity study was to evaluate to what extent a dialogue-based psychosocial intervention was delivered according to protocol. A modified conceptual framework for implementation fidelity was used to guide the analysis. METHODS:This study has an explanatory, sequential two-phase mixed methods design. Quantitative process data were collected longitudinally along with data collection in the RCT. Qualitative process data were collected after the last data collection point of the RCT. Descriptive statistical analyses were conducted to describe the sample, the intervention trajectories, and the adherence measures. A scoring system to clarify quantitative measurement of the levels of implementation was constructed. The qualitative data sources were analyzed separately with a theory-driven content analysis using categories of adherence and potential moderating factors identified in the conceptual framework of implementation fidelity. The quantitative adherence results were extended with the results from the qualitative analysis to assess which potential moderators may have influenced implementation fidelity and in what way. RESULTS:The results show that the core components of the intervention were delivered although the intervention trajectories were individualized. Based on the composite score of adherence, results show that 80.1% of the interventions in the RCT were implemented with high fidelity. Although it is challenging to assess the importance of each of the moderating factors in relation to the other factors and to their influence on the adherence measures, participant responsiveness, comprehensiveness of policy description, context, and recruitment appeared to be the most prominent moderating factors of implementation fidelity in this study. CONCLUSIONS:This evaluation of implementation fidelity and the discussion of what constitutes high fidelity implementation of this intervention are crucial in understanding the factors influencing the trial outcome. The study also highlights important methodological considerations for researchers planning process evaluations and studies of implementation fidelity. TRIAL REGISTRATION:ClinicalTrials.gov , NCT02338869; registered 10/04/2014.

SUBMITTER: Bragstad LK

PROVIDER: S-EPMC6419826 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Implementation fidelity in a complex intervention promoting psychosocial well-being following stroke: an explanatory sequential mixed methods study.

Bragstad Line Kildal LK Bronken Berit Arnesveen BA Sveen Unni U Hjelle Ellen Gabrielsen EG Kitzmüller Gabriele G Martinsen Randi R Kvigne Kari J KJ Mangset Margrete M Kirkevold Marit M

BMC medical research methodology 20190315 1

<h4>Background</h4>Evaluation of complex interventions should include a process evaluation to give evaluators, researchers, and policy makers greater confidence in the outcomes reported from RCTs. Implementation fidelity can be part of a process evaluation and refers to the degree to which an intervention is delivered according to protocol. The aim of this implementation fidelity study was to evaluate to what extent a dialogue-based psychosocial intervention was delivered according to protocol. ...[more]

PMID: 30876403

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Project description:Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia.The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity.The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex interventions. It combines classical effectiveness evaluation with a thorough process evaluation. The results from this study may inform the development of further trials aimed at promoting psychosocial well-being following stroke as well as inform the psychosocial follow up of stroke patients living at home.NCT02338869 ; registered 10/04/2014 (On-going trial).

Project description:BACKGROUND:Workplace programs designed to improve the health and psychological well-being of employees are becoming increasingly popular. However, there are mixed reports regarding the effectiveness of such programs and little analysis of what helps people to engage with such programs. OBJECTIVE:This evaluation of a particularly broad, team-based, digital health and well-being program uses mixed methods to identify the elements of the program that reduce work stress and promote psychological well-being, sleep quality, and productivity of employees. METHODS:Participation in the Virgin Pulse Global Challenge program during May to September 2016 was studied. Self-reported stress, sleep quality, productivity, and psychological well-being data were collected both pre- and postprogram. Participant experience data were collected through a third final survey. However, the response rates for the last 2 surveys were only 48% and 10%, respectively. A random forest was used to estimate the probability of the completion of the last 2 surveys based on the preprogram assessment data and the demographic data for the entire sample (N=178,350). The inverse of these estimated probabilities were used as weights in hierarchical linear models in an attempt to address any estimation bias caused by the low response rates. These linear models described changes in psychological well-being, stress, sleep, and productivity over the duration of the program in relation to gender and age, engagement with each of the modules, each of the program features, and participant descriptions of the Virgin Pulse Global Challenge. A 0.1% significance level was used due to the large sample size for the final survey (N=18,653). RESULTS:The final analysis suggested that the program is more beneficial for older people, with 2.9% greater psychological well-being improvements observed on average in the case of women than men (P<.001). With one exception, all the program modules contributed significantly to the outcome measures with the following average improvements observed: psychological well-being, 4.1%-6.0%; quality of sleep, 3.2%-6.9%; work-related stress, 1.7%-6.8%; and productivity, 1.9%-4.2%. However, only 4 of the program features were found to have significant associations with the outcome measures with the following average improvements observed: psychological well-being, 3.7%-5.6%; quality of sleep, 3.4%-6.5%; work-related stress, 4.1%-6.4%; and productivity, 1.6%-3.2%. Finally, descriptions of the Virgin Pulse Global Challenge produced 5 text topics that were related to the outcome measures. Healthy lifestyle descriptions showed a positive association with outcomes, whereas physical activity and step count tracking descriptions showed a negative association with outcomes. CONCLUSIONS:The complementary use of qualitative and quantitative survey data in a mixed-methods analysis provided rich information that will inform the development of this and other programs designed to improve employee health. However, the low response rates and the lack of a control group are limitations, despite the attempts to address these problems in the analysis.

Project description:BackgroundImproved treatment options for congenital heart disease (CHD) lead to a growing number of women with CHD at reproductive age. Due to physical and psychological burden, pregnancies in women with CHD often count for high-risk. Resulting emotional distress can adversely impact pregnancy, motherhood and fetal health. The present study aims to retrospectively investigate mental outcomes and indices of adjustment in women with CHD before, during and after pregnancy. The novel concept of illness identity is applied to explain how patients experience and integrate their CHD into their identities.MethodsPatient-reported outcome measures on mental functioning and illness identity were assessed in a sample of 121 postpartum women with CHD [mean age: 42.7±9.2 (range, 27-81) years] at the German Heart Centre Munich between August and November 2021 in a cross-sectional design. Descriptive analyses, correlations and linear regression models were calculated.ResultsRetrospectively assessed prevalence of emotional distress before giving birth was high (47.0%) and peaked shortly after childbirth in terms of elevated symptoms of postpartum depression and trauma. During the course of maternity, emotional distress decreased significantly (24.1%, P<0.001). Overall, postpartum women demonstrated high scores in functional illness identity states (i.e., acceptance and enrichment) and low scores in dysfunctional states (i.e., rejection and engulfment). CHD severity was not directly associated with mental outcomes (P>0.05), whereas maternal cardiovascular risk, according to the WHO classification, was significantly associated with a higher prevalence of postpartum trauma (t=2.485, P=0.015).ConclusionsPostpartum mental health problems, such as (postpartum) depression, anxiety, and posttraumatic stress can become a serious burden which might be detrimental to the mother's well-being and her infant's development. Present findings emphasise the urgent need for a holistic approach focusing on pregnant women with CHD starting at the prepartum stage to prevent adverse consequences and promote maternal well-being. Illness identity might become an important target construct for clinical practice as it may positively and enduringly influence mental well-being of pregnant women with CHD.

Project description:BACKGROUND:Neonatal seizures are difficult to diagnose and, when they are, tradition dictates first line treatment is phenobarbital. There is little data on how consultants diagnose neonatal seizures, choose when to treat or how they choose aetiological investigations or drug treatments. The purpose of this study was to assess the variation across the UK in the management of neonatal seizures and explore paediatricians' views on their diagnosis and treatment. METHODS:An explanatory sequential mixed methods approach was used (QUAN?QUAL) with equal waiting between stages. We collected quantitative data from neonatology staff and paediatric neurologists using a questionnaire sent to neonatal units and via emails from the British Paediatric Neurology Association. We asked for copies of neonatal unit guidelines on the management of seizures. The data from questionnaires was used to identify16 consultants using semi-structured interviews. Thematic analysis was used to interpret qualitative data, which was triangulated with quantitative questionnaire data. RESULTS:One hundred questionnaires were returned: 47.7% thought levetiracetam was as, or equally, effective as phenobarbital; 9.2% thought it was less effective. 79.6% of clinicians had seen no side effects in neonates with levetiracetam. 97.8% of unit guidelines recommended phenobarbital first line, with wide variation in subsequent drug choice, aetiological investigations, and advice on when to start treatment. Thematic analysis revealed three themes: 'Managing uncertainty with neonatal seizures', 'Moving practice forward' and 'Multidisciplinary team working'. Consultants noted collecting evidence on anti-convulsant drugs in neonates is problematic, and recommended a number of solutions, including collaboration to reach consensus guidelines, to reduce diagnostic and management uncertainty. CONCLUSIONS:There is wide variation in the management of neonatal seizures and clinicians face many uncertainties. Our data has helped reveal some of the reasons for current practice and decision making. Suggestions to improve certainty include: educational initiatives to improve the ability of neonatal staff to describe suspicious events, greater use of video, closer working between neonatologists and neurologists, further research, and a national discussion to reach a consensus on a standardised approach to managing neonatal epileptic seizures.

Project description:Background: With the purpose of preventing SARS-Cov-2 traveling with the troops, pre-deployment and post-deployment quarantine are mandatory for the German military. This study investigates which factors could be addressed in order to facilitate adherence and mental health during isolation. Method: Six hundred three soldiers completed questionnaires at the beginning and at the end of pre-deployment quarantine: Mini-SCL (BSI), Perceived Social Support (FSozU-K22), Unit Cohesion, Military Quarantine Adherence Questionnaire (MQAQ), and quarantine-associated factors including informedness about Covid-19, perceived individual risk, benefit of quarantine, clarity of quarantine protocol, need of intimacy, social norms, stigma, practicality of the quarantine, financial disadvantages, boredom, and health promoting leadership. Results: Using stepwise regression analyses, up to 57% of the quarantine adherence was explained by social norms, boredom, perceived benefit/effectiveness of the quarantine, clear communication of the quarantine protocol and perceived risk of an infection, with social norms explaining 43%. In respect to mental health (Mini-SCL) at the beginning of quarantine, only 15% is explained by being in a partnership, (un)fulfilled need for bonding/intimacy, perceived unit cohesion, and perceived social support. Up to 20 % of the variance in mental health at the end of quarantine is explained by accumulated days of isolation before pre-deployment quarantine, age, clear communication of the quarantine protocol, perceived social support, fulfilled need for bonding/intimacy and perceived stigma. Mental health and quarantine adherence did correlate significantly, but to a slight extent. No differences between the beginning and the end of pre-deployment quarantine were found for the overall group in respect to mental health, quarantine adherence, perceived social support and perceived unit cohesion, while their trajectories differed for different subgroups including age, gender, rank, and accumulated days of quarantine: With increasing accumulated days of isolation prior to pre-deployment quarantine, mental health declined over the course of quarantine, though to a small degree. Conclusion: Findings suggest that addressing the norms of fellow soldiers and dependents alike could contribute to quarantine adherence in pre-deployment quarantine. Ongoing research should examine long-term effects on mental health, including these of accumulated days of quarantine, also taking into account post-deployment quarantine.

Dataset Information

Implementation fidelity in a complex intervention promoting psychosocial well-being following stroke: an explanatory sequential mixed methods study.

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Implementation fidelity in a complex intervention promoting psychosocial well-being following stroke: an explanatory sequential mixed methods study.

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