scholarly journals Assessing Adherence, Competence and Differentiation in a Stepped-Wedge Randomised Clinical Trial of a Complex Behaviour Change Intervention

Nutrients ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 2332
Author(s):  
Alison Kate Beck ◽  
Amanda L. Baker ◽  
Gregory Carter ◽  
Chris Wratten ◽  
Judith Bauer ◽  
...  
Keyword(s):  
Behaviour Change ◽  
Real World ◽  
Best Practice ◽  
Research Question ◽  
Randomised Clinical Trial ◽  
Routine Care ◽  
Stepped Wedge ◽  
Behaviour Change Intervention ◽  
Complex Behaviour ◽  
Behaviour Change Counselling

Background: A key challenge in behavioural medicine is developing interventions that can be delivered adequately (i.e., with fidelity) within real-world consultations. Accordingly, clinical trials should (but tend not to) report what is actually delivered (adherence), how well (competence) and the distinction between intervention and comparator conditions (differentiation). Purpose: To address this important clinical and research priority, we apply best practice guidelines to evaluate fidelity within a real-world, stepped-wedge evaluation of “EAT: Eating As Treatment”, a new dietitian delivered health behaviour change intervention designed to reduce malnutrition in head and neck cancer (HNC) patients undergoing radiotherapy. Methods: Dietitians (n = 18) from five Australian hospitals delivered a period of routine care and following a randomly determined order each site received training and began delivering the EAT Intervention. A 20% random stratified sample of audio-recorded consultations (control n = 196; intervention n = 194) was coded by trained, independent, raters using a study specific checklist and the Behaviour Change Counselling Inventory. Intervention adherence and competence were examined relative to apriori benchmarks. Differentiation was examined by comparing control and intervention sessions (adherence, competence, non-specific factors, and dose), via multiple linear regression, logistic regression, or mixed-models. Results: Achievement of adherence benchmarks varied. The majority of sessions attained competence. Post-training consultations were clearly distinct from routine care regarding motivational and behavioural, but not generic, skills. Conclusions: Although what level of fidelity is “good enough” remains an important research question, findings support the real-world feasibility of integrating EAT into dietetic consultations with HNC patients and provide a foundation for interpreting treatment effects.

scholarly journals Is fidelity to a complex behaviour change intervention associated with patient outcomes? Exploring the relationship between dietitian adherence and competence and the nutritional status of intervention patients in a successful stepped-wedge randomised clinical trial of eating as treatment (EAT)

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Alison K. Beck ◽  
Amanda L. Baker ◽  
Gregory Carter ◽  
Laura Robinson ◽  
Kristen McCarter ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Nutritional Status ◽  
Behaviour Change ◽  
Trial Registration ◽  
Stepped Wedge ◽  
Behaviour Change Intervention ◽  
Intervention Effects ◽  
Complex Behaviour ◽  
Behaviour Change Counselling ◽  
The Relationship

AbstractBackgroundBehavioural medicine is characterised by findings for the effectiveness and efficacy of complex behaviour change interventions. Comparatively, scant attention has been paid to key intervention components or mechanisms of action. Evaluating relationships between process variables (fidelity) and intervention effects is central to addressing this imbalance. Accordingly, in the current study, we sought to explore the magnitude and direction of effect between fidelity predictors (dietitian adherence and competence) and intervention effects (patient nutritional status) during the intervention phase of a real-world, stepped-wedge evaluation of ‘EAT: Eating As Treatment’.MethodsThe EAT clinical trial was conducted within five major Australian hospitals located in Queensland, Western Australia, Victoria and South Australia between 2013 and 2016. EAT is a dietitian-delivered health behaviour change intervention designed to reduce malnutrition in head and neck cancer (HNC) patients undergoing radiotherapy. Dietitian adherence and competence ratings were derived from a 20% random sample of audio-recorded dietetic consultations (n=194) conducted after dietitians (n=18) were trained in EAT. Sessions were coded by trained, independent, coders using a study checklist, the Behaviour Change Counselling Index (BECCI) and items from the Cognitive Therapy Scale-Revised (CTS-R). Patient nutritional status was measured using the Patient-Generated Subjective Global Assessment (PGSGA).ResultsDietitian adherence to a written nutrition plan (β=7.62, 95% CI=0.65 to 14.58,p=0.032), dietitian adherence to behaviour change counselling (β=0.69, 95% CI =0.02 to 1.38,p=0.045) and competence in delivering behaviour change counselling (β=3.50, 95% CI =0.47 to 6.53,p=0.024) were significant predictors of patient nutritional status. Dietitian adherence and competence ratings were higher during consultations with intervention patients at greater risk of malnutrition.ConclusionsThis study contributes new insights into the relationship between fidelity and treatment outcome by demonstrating that dietitian adherence and competence is greater when working with more challenging patients. This is likely central to the demonstrated success of the EAT intervention in reducing malnutrition and highlights the importance of ensuring that providers are adequately equipped to flexibly integrate intervention elements according to patient need.Trial registrationThis study is a process analysis of a stepped-wedge randomised controlled trial prospectively registered on the Australian New Zealand Clinical Trials Registry (ACTRN12613000320752; Date of registration 21/03/2013).

scholarly journals Adapted motivational interviewing for brief healthcare consultations: protocol for a systematic review and meta-analysis of treatment fidelity in real-world evaluations of behaviour change counselling

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e028417 ◽  
Author(s):  
Alison K Beck ◽  
Erin Forbes ◽  
Amanda L Baker ◽  
Ben Britton ◽  
Christopher Oldmeadow ◽  
...  
Keyword(s):  
Behaviour Change ◽  
Health Behaviour ◽  
Real World ◽  
Treatment Effects ◽  
Random Effect ◽  
Treatment Fidelity ◽  
Systematic Evaluation ◽  
Complex Behaviour ◽  
Behaviour Change Counselling ◽  
The Impact

IntroductionTreatment fidelity is an important and often neglected component of complex behaviour change research. It is central to understanding treatment effects, especially for evaluations conducted outside of highly controlled research settings. Ensuring that promising interventions can be delivered adequately (ie, with fidelity) by real-world clinicians within real-world settings is an essential step in developing interventions that are both effective and ‘implementable’. Whether this is the case for behaviour change counselling, a complex intervention developed specifically for maximising the effectiveness of real-world consultations about health behaviour change, remains unclear. To improve our understanding of treatment effects, best practice guidelines recommend the use of strategies to enhance, monitor and evaluate what clinicians deliver during patient consultations. There has yet to be a systematic evaluation of whether and how these recommendations have been employed within evaluations of behaviour change counselling, nor the impact on patient health behaviour and/or outcome. We seek to address this gap.Methods and analysisMethods are informed by published guidelines. Ten electronic databases (Medline, PubMed, EMBASE, PsycINFO, CINAHL Complete, ScienceDirect, Taylor and Francis; Wiley, ProQuest and Open Grey) will be searched for published and unpublished articles that evaluate behaviour change counselling within real-world clinical settings (randomised and non-randomised). Eligible papers will be rated against the National Institute of Health fidelity framework. A synthesis, evaluation and critical overview of fidelity practices will be reported and linear regression used to explore change across time. Random-effect meta-regression is planned to explore whether fidelity (outcomes reported and methods used) is associated with the impact of behaviour change counselling. Standardised effect sizes will be calculated using Hedges’ g (continuous outcomes) and ORs (binary/dichotomous outcomes).Ethics and disseminationNo ethical issues are foreseen. Findings will be disseminated via journal publication and conference presentation(s).PROSPERO registration numberCRD42019131169

scholarly journals Addressing fidelity within complex health behaviour change interventions: A protocol of a scoping review of intervention fidelity frameworks and models.

2018 ◽  
Vol 1 ◽  
pp. 25 ◽  
Author(s):  
Rebekah Roy ◽  
Heather Colquhoun ◽  
Molly Byrne ◽  
Fabiana Lorencatto ◽  
Karen Matvienko-Sikar ◽  
...  
Keyword(s):  
Behaviour Change ◽  
Health Behaviour ◽  
Scoping Review ◽  
Research Question ◽  
Future Research ◽  
Intervention Fidelity ◽  
Behaviour Change Intervention ◽  
Behaviour Change Interventions ◽  
Health Behaviour Change ◽  
Review Team

Intervention fidelity is crucial to facilitate accurate interpretation of research outcomes, but has been inadequately addressed within complex health behaviour change interventions. Recent research has highlighted a need for practical guidance to improve understanding and use of existing fidelity frameworks and models within complex health behaviour change intervention research. The aim of this paper is to present a protocol for a scoping review of existing intervention fidelity frameworks and models.  In accordance with scoping review guidelines, the following stages will be conducted: (1) identifying the research question, (2) identifying potentially relevant studies of fidelity frameworks and models, (3) study screening and selection, (4) charting and extracting data from identified frameworks and models, (5) collating, summarising and reporting the results and (6) consultation with stakeholders. Two reviewers will independently conduct the screening and extraction stages. Identified frameworks will be collated, summarized and categorized iteratively by one reviewer in consultation with the review team. The findings of this review will provide a useful resource by identifying and comparing existing fidelity frameworks and models. It is intended that increased clarity and understanding in this area will facilitate the appropriate selection and application of fidelity frameworks for complex health behaviour change interventions, inform areas for future research, and ultimately contribute towards improving how intervention fidelity is addressed in this area.

Leadership and school self-evaluation in Irish-medium immersion: A roadmap for success

2021 ◽  
pp. 174114322110152
Author(s):  
TJ Ó Ceallaigh ◽  
Aoife Ní Shéaghdha
Keyword(s):  
Quality Indicators ◽  
Cognitive Skills ◽  
Best Practice ◽  
Research Question ◽  
Evaluation Process ◽  
Successful Implementation ◽  
Language And Literacy ◽  
Evaluation Tool ◽  
Self Evaluation ◽  
Individual Interviews

While research on Irish-medium immersion education (IME) has heralded benefits such as cognitive skills, academic achievement and language and literacy development, many studies have also identified challenges to its successful implementation. Immersion-specific research-validated tools can help school leaders navigate the school self-evaluation journey, critically review and evaluate the quality of aspects of their school’s provision and plan for improvement. This paper reports on one theme, leadership, from a larger study, Quality indicators of best practice in Irish-medium immersion (Ó Ceallaigh and Ní Shéaghdha, 2017). Qualitative in nature, the study was guided by the following research question: What are IME educators’ perceptions of best practices in IME?. The study explored 120 IME educators’ perceptions of best practice in IME to inform the development of IME quality indicators. Individual interviews and focus group interviews were utilised to collect data. Data analysis revealed particular themes related to best IME leadership practices. Findings in turn informed the design of an evidence-informed school self-evaluation tool for IME settings. The various functions of the tool will be explored with a particular emphasis on building teaching and leadership capacity in IME through the school self-evaluation process.

scholarly journals Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine?

2021 ◽  
pp. 026988112110085
Author(s):  
Robin L Carhart-Harris ◽  
Anne C Wagner ◽  
Manish Agrawal ◽  
Hannes Kettner ◽  
Jerold F Rosenbaum ◽  
...  
Keyword(s):  
Real World ◽  
Best Practice ◽  
Digital Health ◽  
Real World Data ◽  
Treatment Protocols ◽  
World Data ◽  
Cost Efficient ◽  
Personalised Treatment ◽  
New Research ◽  
Confirmatory Trials

Favourable regulatory assessments, liberal policy changes, new research centres and substantial commercial investment signal that psychedelic therapy is making a major comeback. Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice. Here we suggest supplementing traditional confirmatory trials with pragmatic trials, real-world data initiatives and digital health solutions to better support the discovery of optimal and personalised treatment protocols and parameters. These recommendations are intended to help support the development of safe, effective and cost-efficient psychedelic therapy, which, given its history, is vulnerable to excesses of hype and regulation.

scholarly journals A behaviour change intervention to reduce home exposure to second hand smoke during pregnancy in India and Bangladesh: a theory and evidence-based approach to development

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Veena A. Satyanarayana ◽  
Cath Jackson ◽  
Kamran Siddiqi ◽  
Prabha S. Chandra ◽  
Rumana Huque ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Behaviour Change ◽  
Delphi Survey ◽  
Behaviour Change Techniques ◽  
Evidence Based ◽  
Behaviour Change Intervention ◽  
Behaviour Change Interventions ◽  
Modified Delphi ◽  
Qualitative Interview Study ◽  
At Home

Abstract Background Home exposure to secondhand smoke (SHS) is highly prevalent amongst pregnant women in low- and middle-income countries like India and Bangladesh. The literature on the efficacy of behaviour change interventions to reduce home exposure to SHS in pregnancy is scarce. Methods We employed a theory and evidence-based approach to develop an intervention using pregnant women as agents of change for their husband’s smoking behaviours at home. A systematic review of SHS behaviour change interventions led us to focus on developing a multicomponent intervention and informed selection of behaviour change techniques (BCTs) for review in a modified Delphi survey. The modified Delphi survey provided expert consensus on the most effective BCTs in reducing home exposure to SHS. Finally, a qualitative interview study provided context and detailed understanding of knowledge, attitudes and practices around SHS. This insight informed the content and delivery of the proposed intervention components. Results The final intervention consisted of four components: a report on saliva cotinine levels of the pregnant woman, a picture booklet containing information about SHS and its impact on health as well strategies to negotiate a smoke-free home, a letter from the future baby to their father encouraging him to provide a smoke-free home, and automated voice reminder and motivational messages delivered to husbands on their mobile phone. Intervention delivery was in a single face-to-face session with a research assistant who explained the cotinine report, discussed key strategies for ensuring a smoke-free environment at home and practised with pregnant women how they would share the booklet and letter with their husband and supportive family members. Conclusion A theory and evidence-based approach informed the development of a multicomponent behaviour change intervention, described here. The acceptability and feasibility of the intervention which was subsequently tested in a pilot RCT in India and Bangladesh will be published later.

scholarly journals Protocol for a two-arm pragmatic stepped-wedge hybrid effectiveness-implementation trial evaluating Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (ENCOMPASS)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marc Kowalkowski ◽  
Tara Eaton ◽  
Andrew McWilliams ◽  
Hazel Tapp ◽  
Aleta Rios ◽  
...  
Keyword(s):  
Usual Care ◽  
Best Practice ◽  
Healthcare Delivery ◽  
Collaborative Management ◽  
High Morbidity ◽  
Type I ◽  
Stepped Wedge ◽  
Sepsis Management ◽  
Sepsis Survivors ◽  
Sepsis Care

Abstract Background Sepsis survivors experience high morbidity and mortality, and healthcare systems lack effective strategies to address patient needs after hospital discharge. The Sepsis Transition and Recovery (STAR) program is a navigator-led, telehealth-based multicomponent strategy to provide proactive care coordination and monitoring of high-risk patients using evidence-driven, post-sepsis care tasks. The purpose of this study is to evaluate the effectiveness of STAR to improve outcomes for sepsis patients and to examine contextual factors that influence STAR implementation. Methods This study uses a hybrid type I effectiveness-implementation design to concurrently test clinical effectiveness and gather implementation data. The effectiveness evaluation is a two-arm, pragmatic, stepped-wedge cluster randomized controlled trial at eight hospitals in North Carolina comparing clinical outcomes between sepsis survivors who receive Usual Care versus care delivered through STAR. Each hospital begins in a Usual Care control phase and transitions to STAR in a randomly assigned sequence (one every 4 months). During months that a hospital is allocated to Usual Care, all eligible patients will receive usual care. Once a hospital transitions to STAR, all eligible patients will receive STAR during their hospitalization and extending through 90 days from discharge. STAR includes centrally located nurse navigators using telephonic counseling and electronic health record-based support to facilitate best-practice post-sepsis care strategies including post-discharge review of medications, evaluation for new impairments or symptoms, monitoring existing comorbidities, and palliative care referral when appropriate. Adults admitted with suspected sepsis, defined by clinical criteria for infection and organ failure, are included. Planned enrollment is 4032 patients during a 36-month period. The primary effectiveness outcome is the composite of all-cause hospital readmission or mortality within 90 days of discharge. A mixed-methods implementation evaluation will be conducted before, during, and after STAR implementation. Discussion This pragmatic evaluation will test the effectiveness of STAR to reduce combined hospital readmissions and mortality, while identifying key implementation factors. Results will provide practical information to advance understanding of how to integrate post-sepsis management across care settings and facilitate implementation, dissemination, and sustained utilization of best-practice post-sepsis management strategies in other heterogeneous healthcare delivery systems. Trial registration NCT04495946. Submitted July 7, 2020; Posted August 3, 2020.

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