scholarly journals Can a Complex Vocational Rehabilitation Intervention Be Delivered With Fidelity? Fidelity Assessment in the Fresh Feasibility Trial

2020 ◽  
Author(s):  
Jain Anne Holmes ◽  
Joanna Clare Fletcher-Smith ◽  
Jose Antionio Merchán-Baeza ◽  
Julie Phillips ◽  
Kathryn Radford
Keyword(s):  
Mixed Methods ◽  
Vocational Rehabilitation ◽  
Qualitative Data ◽  
Controlled Trial ◽  
Implementation Fidelity ◽  
Feasibility Trial ◽  
Intervention Fidelity ◽  
Factors Affecting ◽  
Fidelity Assessment ◽  
Clinical Records

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)

scholarly journals Can a Complex Vocational Rehabilitation Intervention Be Delivered With Fidelity? Fidelity Assessment in the Fresh Feasibility Trial

2020 ◽  
Author(s):  
Jain Anne Holmes ◽  
Joanna Clare Fletcher-Smith ◽  
Jose Antionio Merchán-Baeza ◽  
Julie Phillips ◽  
Kathryn Radford
Keyword(s):  
Mixed Methods ◽  
Vocational Rehabilitation ◽  
Qualitative Data ◽  
Controlled Trial ◽  
Implementation Fidelity ◽  
Feasibility Trial ◽  
Intervention Fidelity ◽  
Factors Affecting ◽  
Fidelity Assessment ◽  
Clinical Records

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)

scholarly journals Can a complex vocational rehabilitation intervention be delivered with fidelity? Fidelity assessment in the FRESH feasibility trial

2021 ◽  
Author(s):  
Jain Anne Holmes ◽  
Joanna Clare Fletcher-Smith ◽  
Jose Antionio Merchán-Baeza ◽  
Julie Phillips ◽  
Kathryn Radford
Keyword(s):  
Mixed Methods ◽  
Vocational Rehabilitation ◽  
Qualitative Data ◽  
Implementation Fidelity ◽  
Feasibility Trial ◽  
Clinical Report ◽  
Intervention Fidelity ◽  
Factors Affecting ◽  
Fidelity Assessment ◽  
Clinical Records

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

scholarly journals A mixed methods process evaluation of a person-centred falls prevention program

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Rebecca L. Morris ◽  
Keith D. Hill ◽  
Ilana N. Ackerman ◽  
Darshini Ayton ◽  
Glenn Arendts ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Process Evaluation ◽  
Prevention Program ◽  
Social Issues ◽  
Controlled Trial ◽  
Intervention Group ◽  
Implementation Fidelity ◽  
Falls Prevention ◽  
Barriers And Facilitators ◽  
Trial Registration

Abstract Background RESPOND is a telephone-based falls prevention program for older people who present to a hospital emergency department (ED) with a fall. A randomised controlled trial (RCT) found RESPOND to be effective at reducing the rate of falls and fractures, compared with usual care, but not fall injuries or hospitalisations. This process evaluation aimed to determine whether RESPOND was implemented as planned, and identify implementation barriers and facilitators. Methods A mixed-methods evaluation was conducted alongside the RCT. Evaluation participants were the RESPOND intervention group (n = 263) and the clinicians delivering RESPOND (n = 7). Evaluation data were collected from participant recruitment and intervention records, hospital administrative records, audio-recordings of intervention sessions, and participant questionnaires. The Rochester Participatory Decision-Making Scale (RPAD) was used to evaluate person-centredness (score range 0 (worst) - 9 (best)). Process factors were compared with pre-specified criteria to determine implementation fidelity. Six focus groups were held with participants (n = 41), and interviews were conducted with RESPOND clinicians (n = 6). Quantitative data were analysed descriptively and qualitative data thematically. Barriers and facilitators to implementation were mapped to the ‘Capability, Opportunity, Motivation – Behaviour’ (COM-B) behaviour change framework. Results RESPOND was implemented at a lower dose than the planned 10 h over 6 months, with a median (IQR) of 2.9 h (2.1, 4). The majority (76%) of participants received their first intervention session within 1 month of hospital discharge with a median (IQR) of 18 (12, 30) days. Clinicians delivered the program in a person-centred manner with a median (IQR) RPAD score of 7 (6.5, 7.5) and 87% of questionnaire respondents were satisfied with the program. The reports from participants and clinicians suggested that implementation was facilitated by the use of positive and personally relevant health messages. Complex health and social issues were the main barriers to implementation. Conclusions RESPOND was person-centred and reduced falls and fractures at a substantially lower dose, using fewer resources, than anticipated. However, the low dose delivered may account for the lack of effect on falls injuries and hospitalisations. The results from this evaluation provide detailed information to guide future implementation of RESPOND or similar programs. Trial registration This study was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12614000336684 (27 March 2014).

scholarly journals Fidelity Assessment of a Social Work–Led Intervention Among Patients With Firearm Injuries

2020 ◽  
Vol 30 (6) ◽  
pp. 678-687
Author(s):  
Vivian H. Lyons ◽  
Lina R. Benson ◽  
Elizabeth Griffin ◽  
Anthony S. Floyd ◽  
Sharon W. Kiche ◽  
...  
Keyword(s):  
Social Work ◽  
Controlled Trial ◽  
Implementation Fidelity ◽  
Assessment Process ◽  
Ongoing Trial ◽  
Intervention Delivery ◽  
Firearm Injury ◽  
Firearm Injuries ◽  
Fidelity Assessment ◽  
Study Intervention

Purpose: To support future development and refinement of social work–led intervention programs among patients with firearm injuries and to demonstrate how a fidelity assessment can be used to adjust and refine intervention delivery in an ongoing trial. Method: We conducted a fidelity assessment of a randomized controlled trial of a social work–led intervention among patients with a firearm injury. Results: We found that our study intervention was well implemented, meeting 70% of the fidelity assessment score items, however, noted lower fidelity with client-based items. Discussion: As a result of fidelity assessment findings, we refined intervention delivery to improve implementation fidelity including beginning to review cases of all patients each month rather than focusing on patients in crisis. Our fidelity assessment process and findings offer insight into the challenges of implementing an intervention among patients with firearm injuries and highlight the value of monitoring intervention fidelity during an ongoing trial.

Working With Business: Counselor Expectations, Actions, and Challenges

2017 ◽  
Vol 31 (2) ◽  
pp. 135-145 ◽  
Author(s):  
Michele C. McDonnall
Keyword(s):  
Mixed Methods ◽  
Vocational Rehabilitation ◽  
Quantitative Data ◽  
Qualitative Data ◽  
Rehabilitation Counseling ◽  
Master's Programs ◽  
Mixed Methods Approach ◽  
Workforce Innovation ◽  
Almost All

Purpose:The purpose of this study was to (a) explore state-federal vocational rehabilitation (VR) agency expectations for counselor engagement with business, (b) determine what VR counselors are actually doing in terms of interacting with businesses, and © identify challenges VR counselors experience to working with business.Method:A mixed-methods approach, including both quantitative data from surveys and qualitative data from interviews, was used. Surveys were conducted with 47 VR agency administrators and 121 counselors, and interviews were conducted with 6 administrators and 19 counselors.Results:Almost all VR agencies had a clear expectation that counselors will engage with business, but the specific expectations varied by agency. Counselors spend approximately 20% of their time interacting with businesses, and most counselors reported providing one or more service to businesses on a regular basis. Challenges experienced by counselors were lack of time, lack of comfort, and lack of preparation to engage with business.Conclusion:Given the current expectations for business engagement and the increased importance of business engagement with the passage of the Workforce Innovation and Opportunity Act (2015), it is vital that rehabilitation counseling master’s programs increase their focus on working with business.

scholarly journals Beliefs about prescribed medication among older patients with polypharmacy: a mixed methods study in primary care

2017 ◽  
Vol 67 (660) ◽  
pp. e507-e518 ◽  
Author(s):  
Barbara Clyne ◽  
Janine A Cooper ◽  
Fiona Boland ◽  
Carmel M Hughes ◽  
Tom Fahey ◽  
...  
Keyword(s):  
Primary Care ◽  
Mixed Methods ◽  
Older Patients ◽  
Qualitative Data ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Inappropriate Prescribing ◽  
Adverse Outcomes ◽  
Mixed Methods Study ◽  
Negative Attitudes

BackgroundPolypharmacy (≥5 medications) is common in older patients and is associated with adverse outcomes. Patients’ beliefs about medication can influence their expectations for medication, adherence, and willingness to deprescribe. Few studies have examined beliefs about prescribed medication among older patients with polypharmacy in primary care.AimTo explore medication-related beliefs in older patients with polypharmacy and factors that might influence beliefs.Design and settingA mixed methods study utilising data from a randomised controlled trial aiming to decrease potentially inappropriate prescribing in older patients (≥70 years) in Ireland.MethodBeliefs were assessed quantitatively and qualitatively. Participants completed the Beliefs about Medicines Questionnaire by indicating their degree of agreement with individual statements about medicines on a 5-point Likert scale. Semi-structured qualitative interviews were conducted with a purposive sample of participants. Interviews were transcribed verbatim and a thematic analysis conducted. Quantitative and qualitative data were analysed separately and triangulated during the interpretation stage.ResultsIn total, 196 patients were included (mean age 76.7 years, SD 4.9, 54% male), with a mean of 9.5 (SD 4.1) medications per patient. The majority (96.3%) believed strongly in the necessity of their medication, while 33.9% reported strong concerns. Qualitative data confirmed these coexisting positive and negative attitudes to medications and suggested the importance of patients’ trust in GPs in establishing positive beliefs and potential willingness to deprescribe.ConclusionParticipants reported strong beliefs in medications with coexisting positive and negative attitudes. The doctor–patient relationship may have influenced beliefs and attitudes towards medicines, highlighting the importance of strong doctor–patient relationships, which need to be considered in the context of deprescribing.

scholarly journals Home-based rehabilitation for heart failure with reduced ejection fraction: mixed methods process evaluation of the REACH-HF multicentre randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e026039 ◽  
Author(s):  
Julia Frost ◽  
Jennifer Wingham ◽  
Nicky Britten ◽  
Colin Greaves ◽  
Charles Abraham ◽  
...  
Keyword(s):  
Heart Failure ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Intervention Fidelity ◽  
Reduced Ejection Fraction ◽  
Randomised Controlled

ObjectiveTo identify and explore change processes explaining the effects of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention taking account of reach, amount of intervention received, delivery fidelity and patient and caregiver perspectives.DesignMixed methods process evaluation parallel to a randomised controlled trial using data from the intervention group (REACH-HF plus usual care).SettingFour centres in the UK (Birmingham, Cornwall, Gwent and York).ParticipantsPeople with heart failure with reduced ejection fraction (HFrEF) and their caregivers.MethodsThe REACH-HF intervention consisted of a self-help manual for patients with HFrEF and caregivers facilitated over 12 weeks by trained healthcare professionals. The process evaluation used multimodal mixed methods analysis. Data consisted of audio recorded intervention sessions; demographic data; intervention fidelity scores for intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers.Outcome measuresQuantitative data: intervention fidelity and number, frequency and duration of intervention sessions received. Qualitative data: experiences and perspectives of intervention participants and caregivers.ResultsIntervention session attendance with facilitators was high. Fidelity scores were indicative of adequate quality of REACH-HF intervention delivery, although indicating scope for improvement in several areas. Intervention effectiveness was contingent on matching the intervention implementation to the concerns, beliefs and goals of participants. Behaviour change was sustained when shared meaning was established. Respondents’ comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life.ConclusionsBy combining longitudinal mixed methods data, the essential ingredients of complex interventions can be better identified, interrogated and tested. This can maximise the clinical application of research findings and enhance the capacity of multidisciplinary and multisite teams to implement the intervention.Trial registration numberISRCTN25032672; Pre-results.

scholarly journals Yoga for Health-Related Quality of Life in Adult Cancer: A Randomized Controlled Feasibility Study

2015 ◽  
Vol 2015 ◽  
pp. 1-12 ◽  
Author(s):  
Marcy McCall ◽  
Melanie McDonald ◽  
Sally Thorne ◽  
Alison Ward ◽  
Carl Heneghan
Keyword(s):  
Mixed Methods ◽  
Large Scale ◽  
Online Survey ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Yoga Intervention ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Related Quality ◽  
Implementation Costs

An increase in patient-led uptake of complementary therapies in adult cancer has led to a need for more rigorous study of such interventions and their outcomes. This study therefore aimed to evaluate the feasibility and acceptability of a yoga intervention in men and women receiving conventional treatment for a cancer diagnosis. Prospective, mixed methods feasibility trial allocated participants to receive one of three yoga interventions over a four-week study period. Data collection was completed through online survey of QOL-CA/CS and customized surveys. Fifteen participants were included (11 female) undergoing treatment for breast, prostate, colorectal, brain, and blood and lung cancer. Two participants dropped out and complete qualitative and quantitative data sets were collected from 12 participants and four yoga instructors. Other outcome measures included implementation costs patient-reported preferences for yoga intervention and changes in QOL-CA/CS. Three types of yoga intervention were safely administered in adult cancer. Mixed methods, cost-efficiency, QOL-CA/CS, and evidence-based design of yoga intervention have been used to establish feasibility and patient-preferences for yoga delivery in adult caner. Results suggest that, with some methodological improvements, a large-scale randomized controlled trial is warranted to test the efficacy of yoga for male and female cancer patients. This trial is registered with Clinicaltrials.govNCT02309112.

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

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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