Factors affecting the delivery of complex rehabilitation interventions in research with neurologically impaired adults: a systematic review

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

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

10.21203/rs.3.rs-470673/v1 ◽

2021 ◽

Author(s):

Kristelle Craven ◽

Jain Holmes ◽

Katie Powers ◽

Sara Clarke ◽

Rachel L Cripps ◽

...

Keyword(s):

Vocational Rehabilitation ◽

Qualitative Data ◽

Complex Interventions ◽

Real Life ◽

Implementation Fidelity ◽

Text Messages ◽

Successful Implementation ◽

Stroke Survivors ◽

Intervention Delivery ◽

Mentoring Support

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.

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Factors Affecting Delivery of the HPV Vaccination: A Focus Group Study With NHS School-Aged Vaccination Teams in London

The Journal of School Nursing ◽

10.1177/1059840518792078 ◽

2018 ◽

Vol 36 (2) ◽

pp. 135-143

Author(s):

Lauren Rockliffe ◽

Emily McBride ◽

Catherine Heffernan ◽

Alice S. Forster

Keyword(s):

Thematic Analysis ◽

School Engagement ◽

Hpv Vaccination ◽

Barriers And Facilitators ◽

Vaccination Program ◽

Focus Group Study ◽

Immunization Program ◽

Factors Affecting ◽

Staff Members ◽

Allocation Of Time

This study sought to identify barriers and facilitators to delivery of human papillomavirus (HPV) vaccination in schools. Four focus groups were conducted with 28 staff members, from four National Health Service school-aged vaccination (SAV) teams in London. Data were analyzed using thematic analysis. School engagement and support, and understanding and education about the vaccination (or conversely, a lack of) were identified as both barriers and facilitators. Limited school and team resources, fear of the vaccination, and poor consent form return were identified as barriers. Explanations for why some girls do not complete the vaccination series were provided. Individualizing approaches used to promote and encourage the vaccination was identified as a facilitating factor. Optimal delivery of the HPV vaccination program is dependent on school engagement and the allocation of time for SAV teams to promote vaccination uptake. Immunization program providers should work with schools to improve understanding and support of the HPV vaccination program.

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

BMC Medical Research Methodology ◽

10.1186/s12874-021-01382-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Kristelle Craven ◽

Jain Holmes ◽

Katie Powers ◽

Sara Clarke ◽

Rachel L. Cripps ◽

...

Keyword(s):

Vocational Rehabilitation ◽

Qualitative Data ◽

Complex Interventions ◽

Real Life ◽

Implementation Fidelity ◽

Text Messages ◽

Successful Implementation ◽

Stroke Survivors ◽

Intervention Delivery ◽

Mentoring Support

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.

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An engagement-facilitation intervention (EFI) for increasing uptake and engagement for self-guided online mental health interventions: Consumer-guided development (Preprint)

10.2196/preprints.16107 ◽

2019 ◽

Author(s):

Amelia Gulliver ◽

Alison L Calear ◽

Matthew Sunderland ◽

Frances Kay-Lambkin ◽

Louise M Farrer ◽

...

Keyword(s):

Mental Health ◽

Lived Experience ◽

Health Program ◽

Mental Health Program ◽

Health Interventions ◽

Barriers And Facilitators ◽

Health Programs ◽

Current Evidence ◽

Mental Health Interventions ◽

Mental Health Programs

BACKGROUND Self-guided online mental health programs are effective in treating and preventing mental health problems. However, both the uptake and engagement with these programs in the community is suboptimal, and there is limited current evidence indicating how to increase the use of existing evidence-based programs. OBJECTIVE The current study aims to investigate the views of people with lived experience of depression and anxiety on the barriers and facilitators to using e-mental health interventions and to use these perspectives to help develop an engagement-facilitation intervention (EFI) to increase uptake and engagement with self-guided online mental health programs. METHODS A total of 24 community members (female = 21; male = 3) with lived experience of depression and/or anxiety participated in four focus groups that discussed: 1) barriers and facilitators to self-guided e-mental health programs, 2) specific details needed to help them decide to use an online program, and 3) the appearance, delivery mode, and functionality of content for the proposed EFI. A total of 14 of the focus group attendees participated in a subsequent follow-up survey to evaluate the resultant draft EFI. Data were thematically analysed using both inductive and deductive methods. RESULTS Participants suggested that the critical component of an EFI was information that would challenge personal barriers to engagement with psychosocial interventions. These were providing personalised feedback about symptoms, information about the content and effectiveness of the e-mental health program, normalisation of participation in e-mental health programs including testimonials, and brief information on data security. Reminders, rewards, feedback about their progress, and coaching were all mentioned as being useful in assisting people to continue to engage with a program once they had started. Feedback on the developed EFI was positive; with participants reporting satisfaction with the content of the EFI and that it would likely positively affect their use of an e-mental health program. CONCLUSIONS EFIs have the potential to improve the uptake of e-mental health programs in the community and should focus on providing information on the content and effectiveness of e-mental health programs, as well as normalising their use. There is strong value in involving people with a lived experience in the design and development of EFIs to maximise their effectiveness.

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What methods and challenges for taking account of context when transferring complex interventions?

European Journal of Public Health ◽

10.1093/eurpub/ckaa165.1071 ◽

2020 ◽

Vol 30 (Supplement_5) ◽

Author(s):

S Villadsen ◽

S Dias

Keyword(s):

Public Health ◽

Health Care ◽

Reproductive Health ◽

Health Care Providers ◽

Complex Interventions ◽

Health Interventions ◽

Care Providers ◽

Public Health Interventions ◽

Reproductive Health Care

Abstract For complex public health interventions to be effective their implementation needs to adapt to the situation of those implementing and those receiving the intervention. While context matter for intervention implementation and effect, we still insist on learning from cross-country comparison of implementation. Next methodological challenges include how to increase learning from implementation of complex public health interventions from various context. The interventions presented in this workshop all aims to improve quality of reproductive health care for immigrants, however with different focus: contraceptive care in Sweden, group based antenatal care in France, and management of pregnancy complications in Denmark. What does these interventions have in common and are there cross cutting themes that help us to identify the larger challenges of reproductive health care for immigrant women in Europe? Issues shared across the interventions relate to improved interactional dynamics between women and the health care system, and theory around a woman-centered approach and cultural competence of health care providers and systems might enlighten shared learnings across the different interventions and context. Could the mechanisms of change be understood using theoretical underpinnings that allow us to better generalize the finding across context? What adaption would for example be needed, if the Swedish contraceptive intervention should work in a different European setting? Should we distinguish between adaption of function and form, where the latter might be less important for intervention fidelity? These issues will shortly be introduced during this presentation using insights from the three intervention presentations and thereafter we will open up for discussion with the audience.

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Social Network Research contribution to evaluating process in a feasibility study of a peer-led and school-based sexual health intervention

Scientific Reports ◽

10.1038/s41598-021-90852-w ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Chiara Broccatelli ◽

Peng Wang ◽

Lisa McDaid ◽

Mark McCann ◽

Sharon Anne Simpson ◽

...

Keyword(s):

Social Network ◽

Sexual Health ◽

Health Knowledge ◽

Complex Interventions ◽

Individual Characteristics ◽

Feasibility Trial ◽

Friendship Networks ◽

Intervention Delivery ◽

School Based ◽

Network Research

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.

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Recurrence after Curative Resection for Intrahepatic Cholangiocarcinoma: How to Predict the Chance of Repeat Hepatectomy?

Journal of Clinical Medicine ◽

10.3390/jcm10132820 ◽

2021 ◽

Vol 10 (13) ◽

pp. 2820

Author(s):

Serena Langella ◽

Nadia Russolillo ◽

Paolo Ossola ◽

Andrea-Pierre Luzzi ◽

Michele Casella ◽

...

Keyword(s):

Liver Resection ◽

Intrahepatic Cholangiocarcinoma ◽

Major Hepatectomy ◽

Multivariable Analysis ◽

Study Data ◽

Good Survival ◽

Lower Probability ◽

Factors Affecting ◽

Time To Recurrence ◽

Second Resection

(1) Background: Tumor recurrence after liver resection (LR) for intrahepatic cholangiocarcinoma (ICC) is common. Repeat liver resection (RLR) for recurrent ICC results in good survival outcomes in selected patients. The aim of this study was to investigate factors affecting the chance of resectability of recurrent ICC. (2) Methods: LR for ICC performed between January 2001 and December 2020 were retrospectively reviewed. Patients who had undergone first LR were considered for the study. Data on recurrences were analyzed. A logistic regression model was used for multivariable analysis of factors related to RLR rate. (3) Results: In total, 140 patients underwent LR for ICC. Major/extended hepatectomies were required in 105 (75%) cases. The 90-day mortality was 5.7%, Clavien–Dindo grade 3, 4 complications were 9.3%, N+ disease was observed in 32.5%, and the median OS was 38.3 months. Recurrence occurred in 91 patients (65%). The site of relapse was the liver in 53 patients (58.2%). RLR was performed in 21 (39.6%) patients. Factors that negatively affected RLR were time to recurrence ≤12 months (OR 7.4, 95% CI 1.68–33.16, p = 0.008) and major hepatectomy (OR 16.7, 95% CI 3.8–73.78, p < 0.001) at first treatment. Survival after recurrence was better in patients who underwent RLR as compared with not resected patients (31 vs. 13.2 months, p = 0.02). (4) Conclusions: Patients with ICC treated at first resection with major hepatectomy and those who recurred in ≤12 months had significantly lower probability to receive a second resection for recurrence.

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The use of Qualitative Comparative Analysis (QCA) to address causality in complex systems: a systematic review of research on public health interventions

BMC Public Health ◽

10.1186/s12889-021-10926-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Benjamin Hanckel ◽

Mark Petticrew ◽

James Thomas ◽

Judith Green

Keyword(s):

Public Health ◽

Comparative Analysis ◽

Complex Systems ◽

Qualitative Comparative Analysis ◽

Complex Interventions ◽

Health Interventions ◽

Data Availability ◽

Future Research ◽

Public Health Interventions ◽

Minimum Criteria

Abstract Background Qualitative Comparative Analysis (QCA) is a method for identifying the configurations of conditions that lead to specific outcomes. Given its potential for providing evidence of causality in complex systems, QCA is increasingly used in evaluative research to examine the uptake or impacts of public health interventions. We map this emerging field, assessing the strengths and weaknesses of QCA approaches identified in published studies, and identify implications for future research and reporting. Methods PubMed, Scopus and Web of Science were systematically searched for peer-reviewed studies published in English up to December 2019 that had used QCA methods to identify the conditions associated with the uptake and/or effectiveness of interventions for public health. Data relating to the interventions studied (settings/level of intervention/populations), methods (type of QCA, case level, source of data, other methods used) and reported strengths and weaknesses of QCA were extracted and synthesised narratively. Results The search identified 1384 papers, of which 27 (describing 26 studies) met the inclusion criteria. Interventions evaluated ranged across: nutrition/obesity (n = 8); physical activity (n = 4); health inequalities (n = 3); mental health (n = 2); community engagement (n = 3); chronic condition management (n = 3); vaccine adoption or implementation (n = 2); programme implementation (n = 3); breastfeeding (n = 2), and general population health (n = 1). The majority of studies (n = 24) were of interventions solely or predominantly in high income countries. Key strengths reported were that QCA provides a method for addressing causal complexity; and that it provides a systematic approach for understanding the mechanisms at work in implementation across contexts. Weaknesses reported related to data availability limitations, especially on ineffective interventions. The majority of papers demonstrated good knowledge of cases, and justification of case selection, but other criteria of methodological quality were less comprehensively met. Conclusion QCA is a promising approach for addressing the role of context in complex interventions, and for identifying causal configurations of conditions that predict implementation and/or outcomes when there is sufficiently detailed understanding of a series of comparable cases. As the use of QCA in evaluative health research increases, there may be a need to develop advice for public health researchers and journals on minimum criteria for quality and reporting.

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A systematic approach to context-mapping to prepare for health interventions: development and validation of the SETTING-tool in four countries

BMJ Global Health ◽

10.1136/bmjgh-2020-003221 ◽

2021 ◽

Vol 6 (1) ◽

pp. e003221

Author(s):

Evelyn A Brakema ◽

Rianne MJJ van der Kleij ◽

Charlotte C Poot ◽

Niels H Chavannes ◽

Ioanna Tsiligianni ◽

...

Keyword(s):

Health Workers ◽

Rapid Assessment ◽

Implementation Strategies ◽

Implementation Fidelity ◽

Chronic Respiratory Disease ◽

Health Interventions ◽

Successful Implementation ◽

Mapping Tool ◽

Implementation Failure ◽

Development And Validation

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.

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Understanding Gap Acceptance Behavior at Unsignalized Intersections using Naturalistic Driving Study Data

Transportation Research Record Journal of the Transportation Research Board ◽

10.1177/03611981211007140 ◽

2021 ◽

pp. 036119812110071

Author(s):

Yingfeng (Eric) Li ◽

Haiyan Hao ◽

Ronald B. Gibbons ◽

Alejandra Medina

Keyword(s):

Road Traffic ◽

Wait Time ◽

Study Data ◽

Gap Acceptance ◽

Factors Affecting ◽

Unsignalized Intersections ◽

Research Activities ◽

Stop Sign ◽

Naturalistic Driving Study ◽

Naturalistic Driving

Even though drivers disregarding a stop sign is widely considered a major contributing factor for crashes at unsignalized intersections, an equally important problem that leads to severe crashes at such locations is misjudgment of gaps. This paper presents the results of an effort to fully understand gap acceptance behavior at unsignalized intersections using SHPR2 Naturalistic Driving Study data. The paper focuses on the findings of two research activities: the identification of critical gaps for common traffic/roadway scenarios at unsignalized intersections, and the investigation of significant factors affecting driver gap acceptance behaviors at such intersections. The study used multiple statistical and machine learning methods, allowing a comprehensive understanding of gap acceptance behavior while demonstrating the advantages of each method. Overall, the study showed an average critical gap of 5.25 s for right-turn and 6.19 s for left-turn movements. Although a variety of factors affected gap acceptance behaviors, gap size, wait time, major-road traffic volume, and how frequently the driver drives annually were examples of the most significant.

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