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

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.

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Barriers to recruitment, retention and intervention delivery in a randomized trial among patients with firearm injuries

Injury Epidemiology ◽

10.1186/s40621-021-00331-z ◽

2021 ◽

Vol 8 (1) ◽

Author(s):

Anthony S. Floyd ◽

Vivian H. Lyons ◽

Lauren K. Whiteside ◽

Kevin P. Haggerty ◽

Frederick P. Rivara ◽

...

Keyword(s):

Controlled Trial ◽

Critical Time ◽

Eligibility Criteria ◽

Intervention Delivery ◽

Firearm Injuries ◽

Link Type ◽

Stable Housing ◽

Study Staff ◽

Patient Resources ◽

Wide Variability

Abstract Background We discuss barriers to recruitment, retention, and intervention delivery in a randomized controlled trial (RCT) of patients presenting with firearm injuries to a Level 1 trauma center. The intervention was adapted from the Critical Time Intervention and included a six-month period of support in the community after hospital discharge to address recovery goals. This study was one of the first RCTs of a hospital- and community-based intervention provided solely among patients with firearm injuries. Main text Barriers to recruitment included limited staffing, coupled with wide variability in length of stay and admission times, which made it difficult to predict the best time to recruit. At the same time, more acutely affected patients needed more time to stabilize in order to determine whether eligibility criteria were met. Barriers to retention included insufficient patient resources for stable housing, communication and transportation, as well as limited time for patients to meet with study staff to respond to follow-up surveys. These barriers similarly affected intervention delivery as patients who were recruited, but had fewer resources to help with recovery, had lower intervention engagement. These barriers fall within the broader context of system avoidance (e.g., avoiding institutions that keep formal records). Since the patient sample was racially diverse with the majority of patients having prior criminal justice system involvement, this may have precluded active participation from some patients, especially those from communities that have been subject to long and sustained history of trauma and racism. We discuss approaches to overcoming these barriers and the importance of such efforts to further implement and evaluate hospital-based violence intervention programs in the future. Conclusion Developing strategies to overcome barriers to data collection and ongoing participant contact are essential to gathering robust information to understand how well violence prevention programs work and providing the best care possible for people recovering from injuries. Trial registration ClinicalTrials.govNCT02630225. Registered 12/15/2015.

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

10.21203/rs.3.rs-38632/v1 ◽

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)

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

10.21203/rs.3.rs-72353/v1 ◽

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)

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Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial

BMC Geriatrics ◽

10.1186/s12877-021-02070-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Kirsty Sprange ◽

Jules Beresford-Dent ◽

Gail Mountain ◽

Claire Craig ◽

Clare Mason ◽

...

Keyword(s):

Data Collection ◽

Complex Intervention ◽

Psychosocial Intervention ◽

Controlled Trial ◽

Complex Interventions ◽

Self Report ◽

Community Based ◽

Intervention Delivery ◽

Methodological Challenges ◽

Fidelity Assessment

Abstract Background Understanding intervention delivery as intended, particularly in complex interventions, should be underpinned by good quality fidelity assessment. We present the findings from a fidelity assessment embedded as part of a trial of a complex community-based psychosocial intervention, Journeying through Dementia (JtD). The intervention was designed to equip individuals with the knowledge and skills to successfully self-manage, maintain independence, and live well with dementia and involves both group and individual sessions. The methodological challenges of developing a conceptual framework for fidelity assessment and creating and applying purposely designed measures derived from this framework are discussed to inform future studies. Methods A conceptual fidelity framework was created out of core components of the intervention (including the intervention manual and training for delivery), associated trial protocols and pre-defined fidelity standards and criteria against which intervention delivery and receipt could be measured. Fidelity data collection tools were designed and piloted for reliability and usability. Data collection in four selected sites (fidelity sites) was via non-participatory observations of the group aspect of the intervention, attendance registers and interventionist (facilitator and supervisor) self-report. Results Interventionists from all four fidelity sites attended intervention training. The majority of group participants at the four sites (71%) received the therapeutic dose of 10 out of 16 sessions. Weekly group meeting attendance (including at ‘out of venue’ sessions) was excellent at 80%. Additionally, all but one individual session was attended by the participants who completed the intervention. It proved feasible to create tools derived from the fidelity framework to assess in-venue group aspects of this complex intervention. Results of fidelity assessment of the observed groups were good with substantial inter-rater reliability between researchers KAPPA 0.68 95% CI (0.58–0.78). Self-report by interventionists concurred with researcher assessments. Conclusions There was good fidelity to training and delivery of the group aspect of the intervention at four sites. However, the methodological challenges of assessing all aspects of this complex intervention could not be overcome due to practicalities, assessment methods and ethical considerations. Questions remain regarding how we can assess fidelity in community-based complex interventions without impacting upon intervention or trial delivery. Trial registration ISRCTN17993825.

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Examining fidelity in the INFORM trial, a complex team-based behavioural intervention

10.21203/rs.3.rs-17994/v1 ◽

2020 ◽

Author(s):

Liane Ginsburg ◽

Matthias Hoben ◽

Adam Easterbrook ◽

Elizabeth Andersen ◽

Ruth Anderson ◽

...

Keyword(s):

Nursing Homes ◽

Primary Outcome ◽

Clinical Care ◽

Implementation Fidelity ◽

Behavioural Intervention ◽

Concurrent Process ◽

Intervention Delivery ◽

Resident Care ◽

Fidelity Assessment ◽

Study Participants

Abstract Background Fidelity in complex behavioural interventions is underexplored. This study examines fidelity of the INFORM trial and explores the relationship between fidelity, study arm and the trial’s primary outcome – care aide involvement in formal team communications about resident care. We examined fidelity of intervention delivery, receipt, and enactment. The primary outcome in the INFORM study (care aide involvement in formal team communications about resident care) was also included as an outcome in this fidelity study.Methods A concurrent process evaluation of implementation fidelity was conducted in 33 nursing homes in Western Canada (Alberta and British Columbia). Study participants are from 106 clinical care units clustered in 33 nursing homes randomized to the Basic and Enhanced Assisted Feedback arms of the INFORM trial.Results Fidelity of the INFORM intervention was moderate to high, with fidelity delivery and receipt higher than fidelity enactment for both study arms. Higher enactment teams experienced a significantly larger improvement in formal team communications between baseline and follow-up than lower enactment teams ( F (1, 70) = 4.27, p = .042).Conclusions Overall fidelity enactment was associated with improvements in formal team communications, but study arm was not. This suggests that the intensity with which an intervention is offered and delivered may be less important than the intensity with which intervention participants enact the core components of an intervention. Greater attention to fidelity assessment and publication of fidelity results through studies such as this one is critical to improving the utility of published trials.

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The Feasibility of the “Omega Kid” Study Protocol: A Double-Blind, Randomised, Placebo-Controlled Trial Investigating the Effect of Omega-3 Supplementation on Self-Regulation in Preschool-Aged Children

Nutrients ◽

10.3390/nu13010213 ◽

2021 ◽

Vol 13 (1) ◽

pp. 213

Author(s):

Lauren A. Roach ◽

Mitchell K. Byrne ◽

Steven J. Howard ◽

Stuart J. Johnstone ◽

Marijka Batterham ◽

...

Keyword(s):

Study Protocol ◽

Controlled Trial ◽

Self Regulation ◽

Dietary Supplementation ◽

Omega 3 ◽

Double Blind ◽

Manipulation Check ◽

Finger Prick ◽

Study Intervention ◽

Preschool Aged Children

Self-regulation, the regulation of behaviour in early childhood, impacts children’s success at school and is a predictor of health, wealth, and criminal outcomes in adulthood. Self-regulation may be optimised by dietary supplementation of omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFAs). The aim of the “Omega Kid” study is to investigate the feasibility of a protocol to investigate whether n-3 LCPUFA supplementation enhances self-regulation in preschool-aged children. The protocol assessed involved a double-blind, randomised, placebo-controlled trial of 12 weeks duration, with an intervention of 1.6 g of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day (0.3 g EPA and 1.3 g DHA) in a microencapsulated powder compared to placebo. Children (n = 78; 40 boys and 38 girls) aged 3–5 years old were recruited and randomly allocated to the treatment (n = 39) or placebo group (n = 39). The HS–Omega-3 Index® served as a manipulation check on the delivery of either active (n-3 LCPUFAs) or placebo powders. Fifty-eight children (76%) completed the intervention (28–30 per group). Compliance to the study protocol was high, with 92% of children providing a finger-prick blood sample at baseline and high reported-adherence to the study intervention (88%). Results indicate that the protocol is feasible and may be employed in an adequately powered clinical trial to test the hypothesis that n-3 LCPUFA supplementation will improve the self-regulation of preschool-aged children.

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Feasibility Aspects of Exploring Exercise-Induced Neuroplasticity in Parkinson’s Disease: A Pilot Randomized Controlled Trial

Parkinson s Disease ◽

10.1155/2020/2410863 ◽

2020 ◽

Vol 2020 ◽

pp. 1-12 ◽

Cited By ~ 1

Author(s):

Hanna Johansson ◽

Malin Freidle ◽

Urban Ekman ◽

Ellika Schalling ◽

Breiffni Leavy ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Dual Task ◽

Trial Design ◽

Controlled Trial ◽

Recruitment Rate ◽

Blood Sampling ◽

Assessment Process ◽

Control Group ◽

Exercise Induced

Background. Recent studies indicate that exercise can induce neuroplastic changes in people with Parkinson’s disease (PwPD). Reports of feasibility outcomes from existing pilot trials however are, of date, insufficient to enable replication by others in larger definitive trials. Objective. To evaluate trial design for a definitive trial by exploring process and scientific feasibility. Methods. The trial design was a parallel-group RCT pilot with a 1 : 1 allocation ratio to either HiBalance or an active control group (HiCommunication). Both groups received one-hour sessions twice weekly, plus home exercises weekly, for 10 weeks. Participants with mild-to-moderate Parkinson’s disease (PD) were recruited via advertisement. Assessment included physical performance, structural and functional MRI, blood sampling, neuropsychological assessment, and speech/voice assessment. Process and scientific feasibility were monitored throughout the study. Process feasibility involved recruitment, participant acceptability of assessments and interventions, assessment procedures (focus on imaging, blood sampling, and dual-task gait analysis), and blinding procedures. Scientific feasibility involved trends in outcome response and safety during group training and home exercises. Data are presented in median, minimum, and maximum values. Changes from pre- to postintervention are reported descriptively. Results. Thirteen participants were included (4 women, mean age 69.7 years), with a recruitment rate of 31%. Attendance rates and follow-up questionnaires indicated that both groups were acceptable to participate. Image quality was acceptable; however, diplopia and/or sleepiness were observed in several participants during MRI. With regard to dual-task gait performance, there appeared to be a ceiling effect of the cognitive tasks with seven participants scoring all correct answers at pretest. Blinding of group allocation was successful for one assessor but was broken for half of participants for the other. Conclusions. The overall trial design proved feasible to perform, but further strengthening ahead of the definitive RCT is recommended, specifically with respect to MRI setup, cognitive dual-tasks during gait, and blinding procedures. This trial is registered with NCT03213873.

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Effectiveness of a Weight-Loss Intervention in Preventing Frailty and Functional Decline in Community-Dwelling Obese Older People. A Randomized Controlled Trial

Journal of Frailty & Aging ◽

10.14283/jfa.2021.38 ◽

2021 ◽

pp. 1-9

Author(s):

M. Serra-Prat ◽

M. Terradellas ◽

I. Lorenzo ◽

M. Arús ◽

E. Burdoy ◽

...

Keyword(s):

Insulin Resistance ◽

Weight Loss ◽

Functional Performance ◽

Controlled Trial ◽

Functional Decline ◽

Community Dwelling ◽

Weight Loss Intervention ◽

Randomized Controlled ◽

Study Intervention

Background: Obesity is a risk factor for frailty and muscle weakness, so weight loss in obese older adults may prevent frailty and functional decline. Objective: To assess the safety and efficacy of a multimodal weight-loss intervention in improving functional performance and reducing frailty risk in obese older adults. Design: Randomized controlled trial with 2 parallel arms. Setting and participants: Community-dwelling obese adults aged 65-75 years with body mass index (BMI) 30-39 kg/m2. Intervention: 6-month multimodal intervention based on diet and a physical activity program. Control group: Usual care. Main and secondary outcome measures: Frailty (Fried criteria) rate and functional performance at 6, 12, and 24 months of follow-up, respectively. Intermediate outcome measures: Weight loss, body composition changes, and metabolic and inflammatory biomarker changes. Results: N=305. The study intervention increased gait speed at 12 and 24 months of follow-up, but had no significant effect on frailty prevention. It was effective in reducing weight, BMI, fat mass, interleukin 6, and insulin resistance and improving self-reported quality of life. Conclusions: The study intervention was not demonstrated to be effective in preventing frailty in obese people aged 65-75 years at 24 months of follow-up. However, it allowed weight loss and a reduction in inflammatory and insulin resistance markers, which could have a long-term effect on frailty that requires further research.

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Effect of hydration with oral water on nonstress test in a hospital, Turkey: a randomized controlled trial

Journal of Health Research ◽

10.1108/jhr-12-2020-0647 ◽

2021 ◽

Vol ahead-of-print (ahead-of-print) ◽

Author(s):

Yeter Şener ◽

Hüseyin Aksoy ◽

Mürüvvet Başer

Keyword(s):

Pregnant Women ◽

Controlled Trial ◽

Stress Test ◽

Intervention Group ◽

Median Number ◽

Control Group ◽

Normal Range ◽

Content Type ◽

Randomized Controlled ◽

Study Intervention

PurposeThe aim of this study was to assess the effect of hydration with oral water on non-stress test (NST).Design/methodology/approachThe study was conducted as single-blinded and randomized controlled. Healthy and outpatient 32- to 40-week pregnant women who were aged 19 and older were included in the study. Intervention group pregnant women (n = 66) drank 500 ccs of water before the NST, and no attempt was made to the control group (n = 66). The NST parameters of the groups with fetal heart rate (FHR), variability, acceleration, deceleration, reactivity and nonreactivity were evaluated.FindingsBoth groups were found to be similar in terms of their descriptive characteristics and variables related to pregnancy (p > 0.05). The median FHR was 130.0 in the intervention group, 140.0 in the control group (p < 0.001), and the median number of the acceleration was 6.0 in the intervention group and 4.0 in the control group (p < 0.001). In terms of the median number of decelerations, the groups were similar (p > 0.05).Originality/valueIt was found that hydration with oral water had an effect on NST parameters of FHR and the number of accelerations. However, it was observed that the FHR was within the normal range in both groups. It was thought that it tended to increase the number of accelerations.

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Pediatric Firearm Injuries, Kansas City, 1992: A Population-Based Study

PEDIATRICS ◽

10.1542/peds.94.6.867 ◽

1994 ◽

Vol 94 (6) ◽

pp. 867-873 ◽

Cited By ~ 1

Author(s):

M. Denise Dowd ◽

Jane F. Knapp ◽

Laura S. Fitzmaurice

Keyword(s):

Kansas City ◽

Population Based ◽

Case Definition ◽

Medical Examiner ◽

Care Providers ◽

Unintentional Injuries ◽

Permanent Disability ◽

Census Tracts ◽

Firearm Injury ◽

Firearm Injuries

Objective. To determine the morbidity, mortality, and epidemiologic features of pediatric powder-firearm injuries in a defined urban population. Design and setting. A population-based, descriptive epidemiologic study was conducted of firearm injuries to children in a mid-size urban community (total population: 435 178) in 1992. The population was 56% white and 39% black. Data from prehospital care providers, all city and adjacent community hospitals, and medical examiner and police records were searched for cases of firearm injury. The 1990 United States census provided denominator data. Case definition. Subjects were all 0- to 16-year-old residents of Kansas City, Missouri who sought medical treatment at a hospital for a powder-firearm injury or who presented to the medical examiner with a fatal firearm injury in calendar year 1992. Results. Seventy-two children met the case definition, for an incidence of 70 per 100 000 persons per year. There were 12 (16.7%) fatalities, for a mortality rate of 11.7 per 100 000 persons per year. Almost 10% of the patients sustained permanent disability. Mean and median ages of the patients were 14.9 years and 15.8 years, respectively; 79% were male and 82% were black. The majority of the children (63%) lived in census tracts with a high proportion of families in poverty. Black males had the highest rates of firearm injury, with a 1-year incidence of 233 per 100 000 persons per year. At younger than 12 years, the rates were equal among the races; however, for those 12 years and older, black adolescents had 13 times the risk of white adolescents (541 compared to 42 per 100 000 persons per year). The majority (71%) of injuries were due to assaults, with drive-by shootings the most frequent circumstance. The majority of unintentional injuries occurred to adolescents as the result of an unplanned discharge of a handgun as it was being placed in or removed from concealment. Among the patients, 39% were admitted to the hospital and 26% required surgery. Conclusions. 1) Black male adolescents had the highest risk of firearm injury or fatality. 2) The majority of victims lived in census tracts characterized by poverty. 3) Injuries were alarmingly severe. 4) Interpersonal violence was the leading contributor to fatal and nonfatal injuries. 5) Unintentional injuries characteristically occurred during the process of weapon concealment. 6) The leading contributor to injury and death was the interaction of adolescents and guns, particularly handguns. The main implication for firearm-injury prevention in this population is the limiting of access to guns by adolescents. In addition, measures aimed at preventing violent behavior, such as education in nonviolent methods of conflict resolution, should be explored.

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