scholarly journals Embedding mentoring to support trial processes and implementation fidelity in a randomised controlled trial of vocational rehabilitation for stroke survivors

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kristelle Craven ◽  
Jain Holmes ◽  
Katie Powers ◽  
Sara Clarke ◽  
Rachel L. Cripps ◽  
...  

Abstract Background Little guidance exists regarding how best to upskill and support those delivering complex healthcare interventions to ensure robust trial outcomes and implementation fidelity. Mentoring was provided to occupational therapists (OTs) delivering a complex vocational rehabilitation (VR) intervention to stroke survivors. This study aimed to explore mentors’ roles in supporting OTs with intervention delivery and fidelity, and to describe factors affecting the mentoring process and intervention delivery. Methods Quantitative data (duration, mode and total time of mentoring support) was extracted from mentoring records and emails between mentors and OTs, alongside qualitative data on barriers and facilitators to intervention delivery. Semi-structured interviews with mentors (n = 6) and OTs (n = 19) explored experiences and perceptions of intervention training, delivery and the mentoring process. Mean total and monthly time spent mentoring were calculated per trial site. Qualitative data were analysed thematically. Results Forty-one OTs across 16 sites were mentored between March 2018 and April 2020. Most mentoring was provided by phone or Microsoft Teams (range: 88.6–100%), with the remainder via email and SMS (Short Message Service) text messages. Mentors suggested strategies to enhance trial recruitment, improved OTs’ understanding of- and adherence to trial processes, intervention delivery and fidelity, and facilitated independent problem-solving. Barriers to mentoring included OT non-attendance at mentoring sessions and mentors struggling to balance mentoring with clinical roles. Facilitators included support from the trial team and mentors having protected time for mentoring. Conclusions Mentoring supported mentee OTs in various ways, but it remains unclear to what extent the OTS would have been able to deliver the intervention without mentoring support, or how this might have impacted fidelity. Successful implementation of mentoring alongside new complex interventions may increase the likelihood of intervention effectiveness being observed and sustained in real-life contexts. Further research is needed to investigate how mentors could be selected, upskilled, funded and mentoring provided to maximise impact. The clinical- and cost-effectiveness of mentoring as an implementation strategy and its impact on fidelity also requires testing in a future trial. Trial registration ISRCTN, ISRCTN12464275. Registered on 13th March 2018.

2021 ◽  
Author(s):  
Kristelle Craven ◽  
Jain Holmes ◽  
Katie Powers ◽  
Sara Clarke ◽  
Rachel L Cripps ◽  
...  

Abstract Background: Little guidance exists regarding how best to upskill and support those delivering complex healthcare interventions to ensure robust trial outcomes and implementation fidelity. Mentoring was provided to occupational therapists (OTs) delivering a complex vocational rehabilitation (VR) intervention to stroke survivors. This study aimed to explore mentors’ roles in supporting OTs with intervention delivery and fidelity, and to describe factors affecting the mentoring process and intervention delivery.Methods: Quantitative data (duration, mode and total time of mentoring support) was extracted from mentoring records and emails between mentors and OTs, alongside qualitative data on barriers and facilitators to intervention delivery. Semi-structured interviews with mentors (n=6) and OTs (n=19) explored experiences and perceptions of intervention training, delivery and the mentoring process. Mean total and monthly time spent mentoring were calculated per trial site. Qualitative data were analysed thematically.Results: Forty-one OTs across 16 sites were mentored between March 2018 and April 2020. Most mentoring was provided by phone or Microsoft Teams (range: 88.6%-100%), with the remainder via email and SMS (Short Message Service) text messages. Mentors suggested strategies to enhance trial recruitment, improved OTs’ understanding of- and adherence to trial processes, intervention delivery and fidelity, and facilitated independent problem-solving. Barriers to mentoring included OT non-attendance at mentoring sessions and mentors struggling to balance mentoring with clinical roles. Facilitators included support from the trial team and mentors having protected time for mentoring. Conclusions: Mentoring supported mentee OTs in various ways, but it remains unclear to what extent the OTS would have been able to deliver the intervention without mentoring support, or how this might have impacted fidelity. Successful implementation of mentoring alongside new complex interventions may increase the likelihood of intervention effectiveness being observed and sustained in real-life contexts. Further research is needed to investigate how mentors could be selected, upskilled, funded and mentoring provided to maximise impact. The clinical- and cost-effectiveness of mentoring as an implementation strategy and its impact on fidelity also requires testing in a future trial.Trial registration: ISRCTN, ISRCTN12464275. Registered on 13th March 2018.


2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Jain Anne Holmes ◽  
Philippa Logan ◽  
Richard Morris ◽  
Kathryn Radford

Abstract Background Rehabilitation research does not always improve patient outcomes because of difficulties implementing complex health interventions. Identifying barriers and facilitators to implementation fidelity is critical. Not reporting implementation issues wastes research resources and risks erroneously attributing effectiveness when interventions are not implemented as planned, particularly progressing from single to multicentre trials. The Consolidated Framework for Implementation Research (CFIR) and Conceptual Framework for Implementation Fidelity (CFIF) facilitate identification of barriers and facilitators. This review sought to identify barriers and facilitators (determinants) affecting implementation in trials of complex rehabilitation interventions for adults with long-term neurological conditions (LTNC) and describe implementation issues. Methods Implementation, complex health interventions and LTNC search terms were developed. Studies of all designs were eligible. Searches involved 11 databases, trial registries and citations. After screening titles and abstracts, two reviewers independently shortlisted studies. A third resolved discrepancies. One reviewer extracted data in two stages; 1) descriptive study data, 2) units of text describing determinants. Data were synthesised by (1) mapping determinants to CFIF and CFIR and (2) thematic analysis. Results Forty-three studies, from 7434 records, reported implementation determinants; 41 reported both barriers and facilitators. Most implied determinants but five used implementation theory to inform recording. More barriers than facilitators were mapped onto CFIF and CFIR constructs. “Patient needs and resources”, “readiness for implementation”, “knowledge and beliefs about the intervention”, “facilitation strategies”, “participant responsiveness” were the most frequently mapped constructs. Constructs relating to the quality of intervention delivery, organisational/contextual aspects and trial-related issues were rarely tapped. Thematic analysis revealed the most frequently reported determinants related to adherence, intervention perceptions and attrition. Conclusions This review has described the barriers and facilitators identified in studies implementing complex interventions for people with LTNCs. Early adoption of implementation frameworks by trialists can simplify identification and reporting of factors affecting delivery of new complex rehabilitation interventions. It is vital to learn from previous experiences to prevent unnecessary repetitions of implementation failure at both trial and service provision levels. Reported facilitators can provide strategies for overcoming implementation issues. Reporting gaps may be due to the lack of standardised reporting methods, researcher ignorance and historical reporting requirements. Systemic review registration PROSPERO CRD42015020423


2020 ◽  
Author(s):  
Jain Anne Holmes ◽  
Joanna Clare Fletcher-Smith ◽  
Jose Antionio Merchán-Baeza ◽  
Julie Phillips ◽  
Kathryn Radford

Abstract Background:Determining whether complex rehabilitation interventions are delivered with fidelity is important as differences can occur between sites, therapists delivering the intervention and over time; threatening trial outcomes and increasing the risk of Type II and Type III errors. Aims: to (1) evaluate implementation fidelity of vocational rehabilitation delivered in FRESH, a multi-centre feasibility randomised controlled trial; and (2) understand factors affecting delivery. Methods:Mixed methods evaluation. Fidelity was measured quantitatively using intervention case report forms, fidelity checklists and clinical records. Qualitative data from mentoring records, interviews with the intervention therapists, participants and their employers and NHS staff at each site explored moderators of implementation fidelity. The quantitative and qualitativedata informed data collection tools and analysis. Data were examined against a logic model and benchmarked against an earlier cohort study. Results:Analysis of 38 clinical records (one per participant), 699 content CRFs (42-248 per therapist) and 12 fidelity checklists suggest intervention was delivered as intended. The core intervention process was followed in each case despite therapist variation. Qualitative data from clinical records, fidelity checklists, 183 mentoring records and 38 interviews (4 therapists, 15 trial participants, 6 employers and 13 NHS staff) explained factors affecting intervention fidelity. Fidelity moderators were similar across sites. Facilitators included therapists’ community rehabilitation experience, expert mentoring, and ability to individually tailor intervention. Barriers involved a lack of access to NHS systems no backfill and limited line-manager support. Factors that both helped or hindered intervention delivery were effective communication with participants, intervention acceptability, participants’ changing needs and interagency working. Different fidelity measures answered different questions. Fidelity checklists determined whether intervention processes were followed and explained moderators. Interviews provided insights into acceptability. Adherence was determined by content forms. Mentoring records described implementation barriers and how they were overcome.Conclusions:Mixed methods fidelity assessments enable trialists to identify factors likely to affect intervention fidelity in a definitive trial and longer-term clinical implementation. Mentoring provided insight into engagement and fidelity deviations that could be addressed in real-time, facilitating fidelity and offering a window on trial processesTrial registration: ISRCTN Registry, ISRCTN38581822 (Registered: 02/01/2014) (https://doi.org/10.1186/ISRCTN38581822)


2020 ◽  
Author(s):  
Jain Anne Holmes ◽  
Joanna Clare Fletcher-Smith ◽  
Jose Antionio Merchán-Baeza ◽  
Julie Phillips ◽  
Kathryn Radford

Abstract Background:Determining whether complex rehabilitation interventions are delivered with fidelity is important as differences can occur between sites, therapists delivering the intervention and over time; threatening trial outcomes and increasing the risk of Type II and Type III errors. Aims: to (1) evaluate implementation fidelity of vocational rehabilitation delivered in FRESH, a multi-centre feasibility randomised controlled trial; and (2) understand factors affecting delivery. Methods:Mixed methods evaluation. Fidelity was measured quantitatively using intervention case report forms, fidelity checklists and clinical records. Qualitative data from mentoring records, interviews with the intervention therapists, participants and their employers and NHS staff at each site explored moderators of implementation fidelity. The quantitative and qualitative data informed data collection tools and analysis. Data were examined against a logic model and benchmarked against an earlier cohort study. Results:Analysis of 38 clinical records (one per participant), 699 content CRFs (42-248 per therapist) and 12 fidelity checklists suggest intervention was delivered as intended. The core intervention process was followed in each case despite therapist variation. Qualitative data from clinical records, fidelity checklists, 183 mentoring records and 38 interviews (4 therapists, 15 trial participants, 6 employers and 13 NHS staff) explained factors affecting intervention fidelity. Fidelity moderators were similar across sites. Facilitators included therapists’ community rehabilitation experience, expert mentoring, and ability to individually tailor intervention. Barriers involved a lack of access to NHS systems no backfill and limited line-manager support. Factors that both helped or hindered intervention delivery were effective communication with participants, intervention acceptability, participants’ changing needs and interagency working. Different fidelity measures answered different questions. Fidelity checklists determined whether intervention processes were followed and explained moderators. Interviews provided insights into acceptability. Adherence was determined by content forms. Mentoring records described implementation barriers and how they were overcome.Conclusions:Mixed methods fidelity assessments enable trialists to identify factors likely to affect intervention fidelity in a definitive trial and longer-term clinical implementation. Mentoring provided insight into engagement and fidelity deviations that could be addressed in real-time, facilitating fidelity and offering a window on trial processesTrial registration: ISRCTN Registry, ISRCTN38581822 (Registered: 02/01/2014) (https://doi.org/10.1186/ISRCTN38581822)


2021 ◽  
Author(s):  
Jain Anne Holmes ◽  
Joanna Clare Fletcher-Smith ◽  
Jose Antionio Merchán-Baeza ◽  
Julie Phillips ◽  
Kathryn Radford

Abstract Background:Determining whether complex rehabilitation interventions are delivered with fidelity is important as differences can occur between sites, therapists delivering the intervention and over time; threatening trial outcomes and increasing the risk of Type II and Type III errors. Aims: to (1) evaluate implementation fidelity of vocational rehabilitation delivered in Facilitating Return to work through Early Specialist Health-based interventions (FRESH), a multi-centre feasibility randomised controlled trial; and (2) understand factors affecting delivery. Methods:Mixed methods evaluation. Fidelity was measured quantitatively using intervention case report forms, fidelity checklists and clinical records. Qualitative data from mentoring records, interviews with the intervention therapists, participants and their employers and National Health Service (NHS) staff at each site explored moderators of implementation fidelity. The quantitative and qualitative data informed data collection tools and analysis. Data were examined against a logic model and benchmarked against an earlier cohort study. Results:Analysis of 38 clinical records (one per participant), 699 content clinical report form (CRF) (42-248 per therapist) and 12 fidelity checklists suggest intervention was delivered as intended. The core intervention process was followed in each case despite therapist variation. Qualitative data from clinical records, fidelity checklists, 183 mentoring records and 38 interviews (4 therapists, 15 trial participants, 6 employers and 13 NHS staff) explained factors affecting intervention fidelity. Fidelity moderators were similar across sites. Facilitators included therapists’ community rehabilitation experience, expert mentoring, and ability to individually tailor intervention. Barriers involved a lack of access to NHS systems no backfill and limited line-manager support. Factors that both helped or hindered intervention delivery were effective communication with participants, intervention acceptability, participants’ changing needs and interagency working. Different fidelity measures answered different questions. Fidelity checklists determined whether intervention processes were followed and explained moderators. Interviews provided insights into acceptability. Adherence was determined by content forms. Mentoring records described implementation barriers and how they were overcome.Conclusions:Mixed methods fidelity assessments enable trialists to identify factors likely to affect intervention fidelity in a definitive trial and longer-term clinical implementation. Mentoring provided insight into engagement and fidelity deviations that could be addressed in real-time, facilitating fidelity and offering a window on trial processes


Author(s):  
Aivis Dombrovskis

This research has emerged from a real-life situation where there was a need to find out for what are the life values and which values are followed by a participant.The study was commissioned in connection with legal proceedings. In this research there is only one participant. The purpose of the study is to explore the categories of personal values and the inherent characteristics of the person revealed in the documents submitted to the study. The study was conducted using a qualitative data-processing method: contentanalysis.The documents analysed in this study consist of three sets of data: telephone text messages, letters and notes and conclusions of psychological studies. A total of eight letters and notes on ten pages have been analysed four hundred and forty-two telephone text messages have been analysed and six psychological investigations conclusions have been analysed on fifteen pages. The conclusions of the psychological investigations where that they were also used as instruments for confirmation of external credibility. The study resulted in individual-specific value categories and external validation of the research has been confirmed. 


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Chiara Broccatelli ◽  
Peng Wang ◽  
Lisa McDaid ◽  
Mark McCann ◽  
Sharon Anne Simpson ◽  
...  

AbstractThere is growing interest in social network-based programmes to improve health, but rigorous methods using Social Network research to evaluate the process of these interventions is less well developed. Using data from the “STis And Sexual Health” (STASH) feasibility trial of a school-based, peer-led intervention on sexual health prevention, we illustrate how network data analysis results can address key components of process evaluations for complex interventions—implementation, mechanisms of impacts, and context. STASH trained students as Peer Supporters (PS) to diffuse sexual health messages though face-to-face interactions and online Facebook (FB) groups. We applied a Multilevel Exponential Random Graph modelling approach to analyse the interdependence between offline friendship relationships and online FB ties and how these different relationships align. Our results suggest that the creation of online FB communities mirrored offline adolescent groups, demonstrating fidelity of intervention delivery. Data on informal friendship networks related to student’s individual characteristics (i.e., demographics, sexual health knowledge and adherence to norms, which were included for STASH), contributed to an understanding of the social relational ‘building’ mechanisms that sustain tie-formation. This knowledge could assist the selection of opinion leaders, improving identification of influential peers situated in optimal network positions. This work provides a novel contribution to understanding how to integrate network research with the process evaluation of a network intervention.


2021 ◽  
Vol 6 (1) ◽  
pp. e003221
Author(s):  
Evelyn A Brakema ◽  
Rianne MJJ van der Kleij ◽  
Charlotte C Poot ◽  
Niels H Chavannes ◽  
Ioanna Tsiligianni ◽  
...  

Effectiveness of health interventions can be substantially impaired by implementation failure. Context-driven implementation strategies are critical for successful implementation. However, there is no practical, evidence-based guidance on how to map the context in order to design context-driven strategies. Therefore, this practice paper describes the development and validation of a systematic context-mapping tool. The tool was cocreated with local end-users through a multistage approach. As proof of concept, the tool was used to map beliefs and behaviour related to chronic respiratory disease within the FRESH AIR project in Uganda, Kyrgyzstan, Vietnam and Greece. Feasibility and acceptability were evaluated using the modified Conceptual Framework for Implementation Fidelity. Effectiveness was assessed by the degree to which context-driven adjustments were made to implementation strategies of FRESH AIR health interventions. The resulting Setting-Exploration-Treasure-Trail-to-Inform-implementatioN-strateGies (SETTING-tool) consisted of six steps: (1) Coset study priorities with local stakeholders, (2) Combine a qualitative rapid assessment with a quantitative survey (a mixed-method design), (3) Use context-sensitive materials, (4) Collect data involving community researchers, (5) Analyse pragmatically and/or in-depth to ensure timely communication of findings and (6) Continuously disseminate findings to relevant stakeholders. Use of the tool proved highly feasible, acceptable and effective in each setting. To conclude, the SETTING-tool is validated to systematically map local contexts for (lung) health interventions in diverse low-resource settings. It can support policy-makers, non-governmental organisations and health workers in the design of context-driven implementation strategies. This can reduce the risk of implementation failure and the waste of resource potential. Ultimately, this could improve health outcomes.


2018 ◽  
Vol 26 (3) ◽  
pp. 198-210 ◽  
Author(s):  
Suat Gonul ◽  
Tuncay Namli ◽  
Sasja Huisman ◽  
Gokce Banu Laleci Erturkmen ◽  
Ismail Hakki Toroslu ◽  
...  

AbstractObjectiveWe aim to deliver a framework with 2 main objectives: 1) facilitating the design of theory-driven, adaptive, digital interventions addressing chronic illnesses or health problems and 2) producing personalized intervention delivery strategies to support self-management by optimizing various intervention components tailored to people’s individual needs, momentary contexts, and psychosocial variables.Materials and MethodsWe propose a template-based digital intervention design mechanism enabling the configuration of evidence-based, just-in-time, adaptive intervention components. The design mechanism incorporates a rule definition language enabling experts to specify triggering conditions for interventions based on momentary and historical contextual/personal data. The framework continuously monitors and processes personal data space and evaluates intervention-triggering conditions. We benefit from reinforcement learning methods to develop personalized intervention delivery strategies with respect to timing, frequency, and type (content) of interventions. To validate the personalization algorithm, we lay out a simulation testbed with 2 personas, differing in their various simulated real-life conditions.ResultsWe evaluate the design mechanism by presenting example intervention definitions based on behavior change taxonomies and clinical guidelines. Furthermore, we provide intervention definitions for a real-world care program targeting diabetes patients. Finally, we validate the personalized delivery mechanism through a set of hypotheses, asserting certain ways of adaptation in the delivery strategy, according to the differences in simulation related to personal preferences, traits, and lifestyle patterns.ConclusionWhile the design mechanism is sufficiently expandable to meet the theoretical and clinical intervention design requirements, the personalization algorithm is capable of adapting intervention delivery strategies for simulated real-life conditions.


2018 ◽  
Vol 82 (1) ◽  
pp. 51-74 ◽  
Author(s):  
Alice Goffman

Reviving classical attention to gathering times as sites of transformation and building on more recent microsociological work, this paper uses qualitative data to show how social occasions open up unexpected bursts of change in the lives of those attending. They do this by pulling people into a special realm apart from normal life, generating collective effervescence and emotional energy, bringing usually disparate people together, forcing public rankings, and requiring complex choreography, all of which combine to make occasions sites of inspiration and connection as well as sites of offense and violation. Rather than a time out from “real” life, social occasions hold an outsized potential to unexpectedly shift the course that real life takes. Implications for microsociology, social inequality, and the life course are considered.


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