Staff’s views on delivering patient-led therapy during inpatient stroke rehabilitation: a focus group study with lessons for trial fidelity

Background; Fidelity to the treatment protocol is key to successful trials but often problematic. This article reports the staff’s views on delivering a complex rehabilitation intervention: patient-led therapy during inpatient stroke care. Methods; An exploratory qualitative study using focus groups with staff involved in a multicenter (n = 12) feasibility trial of patient-led therapy (the MAESTRO trial) was undertaken as part of the evaluation process. Purposive sampling ensured that participants represented all recruiting sites, relevant professions and levels of seniority. Data analysis used a Framework Approach. Results; Five focus groups were held involving 30 participants. Five main themes emerged: the effect of the interventions, practical problems, patient-related factors, professional dilemmas, and skills. Staff felt the main effect of the therapies was on patients’ autonomy and occupation; the main practical problems were the patients’ difficulties in achieving the correct position and a lack of space. Staff clearly identified characteristics that made patient-led therapy unsuitable for some patients. Most staff experienced dilemmas over how to prioritize the trial interventions compared to their usual therapy and other clinical demands. Staff also lacked confidence about how to deliver the interventions, particularly when adapting the interventions to individual needs. For each barrier to implementation, possible solutions were identified. Of these, involving other people and establishing a routine were the most common. Conclusions; Delivering rehabilitation interventions within a trial is complex. Staff require time and support to develop the skills, strategies and confidence to identify suitable patients, deliver new treatments, adapt the new treatments to individuals’ needs and balance the demands of delivering the trial intervention according to the treatment protocol with other clinical and professional priorities

Quality of intervention delivery in a cluster randomised controlled trial : a qualitative observational study with lessons for implementation fidelity

Abstract Background Understanding intervention fidelity is an essential part of the evaluation of complex interventions because fidelity not only affects the validity of trial findings, but also because studies of fidelity can be used to identify barriers and facilitators to successful implementation, and so provide important information about factors likely to impact the uptake of the intervention into clinical practice. Participant observation methods have been identified as being particularly valuable in studies of fidelity, yet are rarely used. This study aimed to use these methods to explore the quality of implementation of a complex intervention (Safewards) on mental health wards during a cluster randomised controlled trial. Specific aims were firstly to describe the different ways in which the intervention was implemented, and secondly to explore the contextual factors moderating the quality of intervention delivery, in order to inform ‘real world’ implementation of the intervention. Methods Safewards was implemented on 16 mental health wards in England. We used Research Assistants (RAs) trained in participant observation to record qualitative observational data on the quality of intervention delivery (n = 565 observations). At the end of the trial, two focus groups were conducted with RAs, which were used to develop the coding framework. Data were analysed using thematic analysis. Results There was substantial variation in intervention delivery between wards. We observed modifications to the intervention which were both fidelity consistent and inconsistent, and could enhance or dilute the intervention effects. We used these data to develop a typology which describes the different ways in which the intervention was delivered. This typology could be used as a tool to collect qualitative observational data about fidelity during trials. Moderators of Safewards implementation included systemic, interpersonal, and individual factors and patient responses to the intervention. Conclusions Our study demonstrates how, with appropriate training in participant observation, RAs can collect high-quality observational data about the quality of intervention delivery during a trial, giving a more complete picture of ‘fidelity’ than measurements of adherence alone. Trial registration ISRCTN registry; IRSCTN38001825 . Registered 29 August 201

Factors contributing to intervention fidelity in a multi-site chronic disease self-management program

BACKGROUND AND OBJECTIVES: Disease self-management programs have been a popular approach to reducing morbidity and mortality from chronic disease. Replicating an evidence-based disease management program successfully requires practitioners to ensure fidelity to the original program design. METHODS: The Florida Health Literacy Study (FHLS) was conducted to investigate the implementation impact of the Pfizer, Inc. Diabetes Mellitus and Hypertension Disease Self-Management Program based on health literacy principles in 14 community health centers in Florida. The intervention components discussed include health educator recruitment and training, patient recruitment, class sessions, utilization of program materials, translation of program manuals, patient retention and follow-up, and technical assistance. RESULTS: This report describes challenges associated with achieving a balance between adaptation for cultural relevance and fidelity when implementing the health education program across clinic sites. This balance was necessary to achieve effectiveness of the disease self-management program. The FHLS program was implemented with a high degree of fidelity to the original design and used original program materials. Adaptations identified as advantageous to program participation are discussed, such as implementing alternate methods for recruiting patients and developing staff incentives for participation. CONCLUSION: Effective program implementation depends on the talent, skill and willing participation of clinic staff. Program adaptations that conserve staff time and resources and recognize their contribution can increase program effectiveness without jeopardizing its fidelity

A conceptual framework for implementation fidelity

<p>Abstract</p> <p>Background</p> <p>Implementation fidelity refers to the degree to which an intervention or programme is delivered as intended. Only by understanding and measuring whether an intervention has been implemented with fidelity can researchers and practitioners gain a better understanding of how and why an intervention works, and the extent to which outcomes can be improved.</p> <p>Discussion</p> <p>The authors undertook a critical review of existing conceptualisations of implementation fidelity and developed a new conceptual framework for understanding and measuring the process. The resulting theoretical framework requires testing by empirical research.</p> <p>Summary</p> <p>Implementation fidelity is an important source of variation affecting the credibility and utility of research. The conceptual framework presented here offers a means for measuring this variable and understanding its place in the process of intervention implementation.</p

Drug education in victorian schools (DEVS): the study protocol for a harm reduction focused school drug education trial

<p>Abstract</p> <p>Background</p> <p>This study seeks to extend earlier Australian school drug education research by developing and measuring the effectiveness of a comprehensive, evidence-based, harm reduction focused school drug education program for junior secondary students aged 13 to 15 years. The intervention draws on the recent literature as to the common elements in effective school curriculum. It seeks to incorporate the social influence of parents through home activities. It also emphasises the use of appropriate pedagogy in the delivery of classroom lessons.</p> <p>Methods/Design</p> <p>A cluster randomised school drug education trial will be conducted with 1746 junior high school students in 21 Victorian secondary schools over a period of three years. Both the schools and students have actively consented to participate in the study. The education program comprises ten lessons in year eight (13-14 year olds) and eight in year nine (14-15 year olds) that address issues around the use of alcohol, tobacco, cannabis and other illicit drugs. Control students will receive the drug education normally provided in their schools. Students will be tested at baseline, at the end of each intervention year and also at the end of year ten. A self completion questionnaire will be used to collect information on knowledge, patterns and context of use, attitudes and harms experienced in relation to alcohol, tobacco, cannabis and other illicit drug use. Multi-level modelling will be the method of analysis because it can best accommodate hierarchically structured data. All analyses will be conducted on an Intent-to-Treat basis. In addition, focus groups will be conducted with teachers and students in five of the 14 intervention schools, subsequent to delivery of the year eight and nine programs. This will provide qualitative data about the effectiveness of the lessons and the relevance of the materials.</p> <p>Discussion</p> <p>The benefits of this drug education study derive both from the knowledge gained by trialling an optimum combination of innovative, harm reduction approaches with a large, student sample, and the resultant product. The research will provide better understanding of what benefits can be achieved by harm reduction education. It will also produce an intervention, dealing with both licit and illicit drug use that has been thoroughly evaluated in terms of its efficacy, and informed by teacher and student feedback. This makes available to schools a comprehensive drug education package with prevention characteristics and useability that are well understood.</p> <p>Trial registration</p> <p>Australia and New Zealand Clinical Trials Register (ANZCTR): <a href="http://www.anzctr.org.au/ACTRN12612000079842.aspx">ACTRN12612000079842</a></p

Study design of 'FRIENDS for Life': process and effect evaluation of an indicated school-based prevention programme for childhood anxiety and depression

Background: Anxiety disorders and depression are highly prevalent in children and affect their current and future functioning. 'FRIENDS for Life' is a cognitive-behavioural programme teaching children skills to cope more effectively with feelings of anxiety and depression. Although 'FRIENDS for Life' is increasingly being implemented at Dutch schools, its effectiveness as a preventive intervention in Dutch schools has never been investigated. The aim of the study is to evaluate the effectiveness of 'FRIENDS for Life' as an indicated school-based prevention programme for children with early or mild signs of anxiety or depression. Methods/Design. This study is a controlled trial with one pre-intervention and three post-intervention measurements (directly after, and 6 and 12 months after the end of the programme). The study sample consists of children aged 10-12 years (grades 6, 7 and 8 of Dutch primary schools), who show symptoms of anxiety or depressive disorder. Data are collected through self-report, teacher report and peer nomination. A process evaluation is conducted to investigate programme integrity (whether the programme has been executed according to protocol) and to evaluate children's and parents' opinions about 'FRIENDS for Life' using online focus groups and interviews. Discussion. The present study will provide insight into the effectiveness of 'FRIENDS for Life' as an indicated school-based prevention programme for children with early or mild signs of anxiety or depression

Effects of a parental program for preventing underage drinking - The NGO program strong and clear

<p>Abstract</p> <p>Background</p> <p>The present study is an evaluation of a 3-year parental program aiming to prevent underage drinking. The intervention was implemented by a non-governmental organization and targeted parents with children aged 13-16 years old and included recurrent activities during the entire period of secondary school. The program consisted of four different types of group and self-administered activities: parent meetings, family dialogues, friend meetings, and family meetings.</p> <p>Methods</p> <p>A quasi-experimental design was used following parents and children with questionnaires during the three years of secondary school. The analytic sample consisted of 509 dyads of parents and children. Measures of parental attitudes and behaviour concerning underage drinking and adolescents' lifetime alcohol consumption and drunkenness were used. Three socio-demographic factors were included: parental education, school, and gender of the child. A Latent Growth Modelling (LGM) approach was used to examine changes in parental behaviour regarding youth drinking and in young people's drinking behaviour. To test for the pre-post test differences in parental attitudes repeated measures ANOVA were used.</p> <p>Results</p> <p>The results showed that parents in the program maintained their restrictive attitude toward underage drinking to a higher degree than non-participating parents. Adolescents of participants were on average one year older than adolescents with non-participating parents when they made their alcohol debut. They were also less likely to have ever been drunk in school year 9.</p> <p>Conclusion</p> <p>The results of the study suggested that Strong and Clear contributed to maintaining parents' restrictive attitude toward underage drinking during secondary school, postponing alcohol debut among the adolescents, and significantly reducing their drunkenness.</p