Pilot and Feasibility Studies最新文献

Background: Hip fractures represent sentinel events in older adults' lives that can lead to a loss of function and permanent disability. Our team developed an evidence-based pathway intervention: PATH FOR timely transfer of geriatric HIP fracture patients from hospital to rehabilitation to home (PATH4HIP). The goal of the pathway is to facilitate early transfer of hip fracture patients to geriatric rehabilitation without having a negative impact on their rehabilitation outcomes. The purpose of this study was to pilot PATH4HIP with post-operative geriatric hip fracture patients during their transition from hospital to rehabilitation to home.

Methods: We conducted a mixed methods feasibility study using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to evaluate the feasibility, acceptability, and preliminary effects of PATH4HIP. Quantitative data were accessed through administrative databases, and qualitative data were collected from patients, caregivers, and clinicians to report on the five RE-AIM domains.

Results: A total of 317 hip fracture patients were screened between January and September 2022, and 152 met the study eligibility criteria. Reach was achieved, with 77.0% of eligible patients (n = 117) agreeing to participate (progression criteria of ≥ 75.0%). Effectiveness outcomes including rehabilitation length of stay, functional gains, discharge to the community, and 30-day emergency department return rates were comparable to previously reported data for this population. Adoption was also high, with 76.9% of enrolled patients (n = 90) completing the pathway. Implementation was carried out with minimal protocol variations; however, only 48.9% of patients (n = 44) were discharged from acute care by post-operative day 6 (progression criteria of ≥ 75.0%), falling short due to challenges associated with the COVID-19 pandemic. Finally, participants indicated that the PATH4HIP intervention was acceptable, supporting its Maintenance.

Conclusion: The study confirmed the feasibility and acceptability of the pathway, while key rehabilitation outcomes were not negatively affected. This pathway design prioritized best practices for hip fracture care and collaboration across health care sectors. This intervention was low cost as it used existing resources to improve use of surgical beds, while enhancing post-surgery hip fracture care. Further research is needed to examine the implementation of this intervention on a larger scale.

Background: Children with severe acute malnutrition (SAM) have a high risk of mortality and morbidity. After recovery from an initial episode of SAM, the risk of relapse can be high, although estimates vary across settings. Post-recovery surveillance for relapsed SAM in Burkina Faso consists of monthly clinic-based follow-up visits. However, adherence to the follow-up schedule can be variable, and children with missed surveillance visits may have delayed diagnoses of relapse. Here, we describe the protocol for a feasibility trial design to provide preliminary evidence to support the training of caregivers to screen for relapsed acute malnutrition using mid-upper arm circumference (MUAC) screening at home.

Methods: This feasibility trial will enroll 200 caregiver-child dyads in which the child has recovered in the past month from an episode of SAM in Boromo, Burkina Faso. Eligible children had an initial episode of SAM that they recovered from per Burkinabè guidelines (weight-for-height Z-score, WHZ ≥ -2 and/or MUAC ≥ 12.5 cm, depending on the admission criteria). Caregiver-child dyads are randomized to either weekly screening using a standard MUAC tape plus standard of care follow-up or standard of care alone, which consists of monthly clinic-based screening for relapse for 3 months. Caregiver-child dyads are followed for 6 months. Primary feasibility endpoints include acceptability, time for training, enrollment potential and refusals, adherence to the follow-up protocol, and adherence to the screening protocol. Clinical endpoints, measured to inform the design of a full-scale trial, include the proportion of children relapsing, anthropometric measurements at 6 months, hospitalization, and vital status.

Discussion: This feasibility trial will generate data to support the development and full-scale testing of an intervention to train caregivers to screen for relapsed acute malnutrition using MUAC.

Trial registration: This trial is registered at clinicaltrials.gov (NCT05932992), first posted 27 June 2023.

Background: Peer-provided services play a crucial role in healthcare delivery across health care issues. This study describes the process of implementing a peer navigation program called mentoring and peer support (MAPS) for individuals with serious mental illness (SMI) reentering the community after jail release.

Methods: In-depth interviews were conducted with four peer navigators, and the 12-item Working Alliance Inventory Scale was used to assess their perspectives on the program. Additionally, 25 administrative documents were reviewed to describe implementation processes. An applied thematic analysis was conducted using the Consolidated Framework for Implementation Research (CFIR).

Results: Results from qualitative exit interviews, the Working Alliance Inventory survey, and administrative reviews indicate that the MAPS program was feasible, acceptable, and culturally appropriate. However, opinions on its effectiveness were mixed. Peer navigators faced challenges accessing clients in jail due to facility lockdowns and short staffing. They also encountered client skepticism, as some initially mistook them for law enforcement or probation officers. Maintaining post-release contact was difficult due to unreliable phone numbers and unstable housing. Recommendations include aligning jail release times with community service hours, diversifying participant incentives, and employing full-time peer navigators for greater flexibility.

Conclusion: Peer navigation programs like MAPS hold promise for enhancing mental health service linkage among reentering individuals. Stronger post-release support systems and clearer role definitions to mitigate client distrust would advance implementation. Findings from this study will inform implementation of an adequately powered randomized trial evaluating effectiveness and cost-effectiveness of the MAPS intervention.

Background: This study protocol describes the use of two brain-directed treatments, i.e. mindfulness training (MT) and transcranial direct current stimulation (tDCS), as interventions for obesity-related behaviours (e.g. food craving, over-eating). Individually, mindfulness and tDCS are promising interventions for addressing maladaptive eating behaviours. We hypothesise that clinical outcomes from MT and tDCS will be improved when the two interventions are combined.

Methods: This protocol is described in accordance with SPIRIT guidelines for clinical trials. The study is a feasibility double-blind randomised sham-controlled (RCT) trial of MT concurrent with or without self-administered tDCS in adults with obesity/overweight (BMI ≥ 25 kg/m²) (the MINDED trial). Sixty-six adults will be randomly allocated to one of three groups: MT with active tDCS, MT with sham tDCS or waiting list control. Participants in both intervention arms will be asked to complete daily app-based MT for 8 weeks post-randomisation. They will also receive 10 sessions of active or sham tDCS over the first 3 weeks post-randomisation. On tDCS-days, MT will be delivered concurrently. Feasibility will be evaluated by recruitment, retention, and follow-up rates. Acceptability will be determined by monitoring side effects and by participant ratings. Clinical and cognitive outcomes (e.g. body fat percentage and working memory) will be assessed at baseline (T0), 3 weeks post-randomisation (T1) and 8 weeks post-randomisation (T2).

Discussion: The study will establish the feasibility of conducting a large-scale RCT of (MT + real tDCS) in adults with BMI ≥ 25 kg/m² classified as overweight or obese. This will involve assessing recruitment, retention and follow-up rates together with measures of acceptability and credibility. It will provide preliminary evidence on the clinical efficacy of the concurrent administration of tDCS and MT for people with obesity/overweight and preliminary information on possible underlying mechanisms (e.g. change in neurocognitive outcomes).

Trial registration: ClinicalTrials.gov Identifier (NCT number): NCT05865912. Registered on 19 May 2023.

Background: Chronic obstructive pulmonary disease (COPD) causes significant morbidity and mortality and is a substantial burden on healthcare systems. Disease self-management programs can reduce symptoms, lower hospitalizations, and improve patient quality of life. We adapted and piloted a COPD self-management program delivered by community health workers (CHWs) to Veterans. This study aimed to assess participants' perceived acceptability, appropriateness, and feasibility of the intervention. We investigated barriers and facilitators to achieving disease self-management practices. We explored participants' COPD health outcomes. Finally, we gathered insights from participants and CHWs to inform potential improvements.

Methods: Nine Veterans enrolled in the 12-week intervention and received a series of 9 CHW home, phone, or video visits. We assessed perceived intervention acceptability, appropriateness, and feasibility qualitatively and quantitatively. We conducted a qualitative content analysis of semi-structured interviews with intervention participants and their CHWs on overall perceptions of the intervention. An additional analysis phase included translation of the results into suggestions for future adaptations by the multi-disciplinary investigator team. We administered surveys on self-reported acceptability, appropriateness, and feasibility of the intervention, as well as COPD health outcomes.

Results: The intervention had high participant-perceived acceptability (4.2 ± 0.8), appropriateness (4.3 ± 0.5), and feasibility (4.2 ± 0.6), on a scale from 1 to 5. Interviewed participants highlighted the benefits of CHW-led education on COPD understanding, breathing techniques, and proper inhaler use. Participants further emphasized the social support and connection to resources provided by the program. Overall, the participants and their CHW providers shared feedback that demonstrate the acceptability, appropriateness, and feasibility of this intervention. Exploratory results also showed improved health-related outcomes. Some suggested adaptations emerged, such as including optional caregiver involvement and addressing potential stigma related to COPD.

Conclusions: The pilot presents a promising CHW-led intervention to improve COPD self-management. These initial results suggest the intervention is acceptable, feasible, and appropriate and could improve health outcomes, including quality of life. Future programs or randomized controlled trial design could benefit from the study's recommended adaptations.

Background: Teaching Recovery Techniques (TRT) is a brief psychosocial intervention designed to reduce symptoms of post-traumatic stress among children. To strengthen the evidence base for TRT, a nationwide multisite cluster RCT of TRT with accompanied refugee children was planned in Sweden, including an internal pilot with the primary objectives of assessing screening, recruitment, attendance, and retention. Secondary objectives were to consider the feasibility of randomisation, the suitability of the questionnaires employed in the main RCT, and intervention acceptability.

Methods: Accompanied refugee children aged 8 to 17 years, who arrived in Sweden within the last 5 years and screened positive for symptoms of post-traumatic stress, were allocated to the intervention or waitlist arm using non-blinded cluster randomisation. Pre- and post-measurements were conducted at baseline (T1) and after 8 weeks (T2). Success criteria for the pilot were (i) at least 50% of those referred for participation meet the screening cut-off for post-traumatic stress; (ii) 28 eligible children recruited in the first three months; (iii) at least 50% of those randomised to intervention attending one of the five core sessions; and (iv) at least 50% of those screened at T1 complete the T2 data collection. To get a deeper understanding of the acceptability of the intervention, 11 semi-structured interviews were conducted with refugee children. The interviews were transcribed and analysed using thematic analysis.

Results: A change in recruitment strategy from referral to broader screening resulted in 44% meeting the cut-off for post-traumatic stress and, partly due to the COVID-19 pandemic, only five clusters (3 intervention, n = 11; 2 waitlist control, n = 11) were recruited over 12 months. However, 64% of those randomised to the intervention arm attended at least one of the five core intervention sessions, and 91% were retained at T2 data collection. The qualitative inquiry confirmed the acceptability of the intervention and the need for tools to address trauma symptoms but raised concerns about stigma related to both screening and participation.

Conclusions: Although the planned RCT was deemed not feasible due to low recruitment rates, this pilot study gave insight into important practical and ethical considerations. Adjustments to information, screening, and recruitment may improve the likelihood of a successful RCT. Adopting a strength-based approach when introducing a mental health intervention to refugee children is recommended; not only may this reduce stigma, but it may actively shift from a deficit-focused discourse.

Trial registration: ISRCTN17754931. Prospectively registered on 4th June 2019. https://doi.org/10.1186/ISRCTN17754931.

Background: There is an urgent need for feasible and effective mental health promoting interventions from early childhood. High-quality music education carries the potential to promote school thriving, positive class community, and social relations, which are key prerequisites for children's mental health. However, the implementation and potential benefits of this type of intervention have not yet been evaluated in the Nordic countries. The Everyone Can Sing intervention is a class-based singing intervention that integrates class choir into the regular school schedule, two lessons a week for primary school children in grades 0 to 3 (age 5-10 years). The lessons follow a manualised pedagogy, which combines co-teaching between the class teacher and an educated choir leader with enactive learning in a safe atmosphere, changing choir partners, musical arousal regulation, a song repertoire including movement and gestures, and choir performances in and outside school. The aim of this feasibility study is twofold: 1) To examine feasibility of the implementation of Everyone Can Sing in three Danish primary schools, and 2) to examine feasibility of the evaluation design.

Methods: A non-randomized single-group feasibility trial will be conducted from January 2024 to March 2025 among approximately 900 primary school children in grades 0 to 3 in three Danish public primary schools. Six domains relating to feasibility of the intervention (barriers and facilitators of implementation, adaptability, implementation capacity, responsiveness, acceptability, and signs of benefit and harms) and three domains relating to feasibility of the study design (validity of questionnaire, uncertainties in data collection, and outcome measures) will be assessed. The study primarily employs a convergent mixed methods design, collecting quantitative data (baseline and follow-up questionnaires from students, parents, and teachers) and qualitative data (observations of choir and interviews with students, parents, teachers, choir leaders, Everyone Can Sing school coordinators, Everyone Can Sing management, and school management) in parallel. The design also incorporates elements of explanatory and exploratory sequential approaches. In the convergent phase, the two strands will be analyzed separately and then integrated through triangulation to assess both the feasibility of implementation and the feasibility of the evaluation design.

Discussion: The results of this non-randomised feasibility study will inform whether the intervention should proceed to a future, full-size effectiveness trial, return to refinement of the intervention or the evaluation design, or stop. Trial registration ClinicalTrials.gov, ID: NCT06204029, registered January 2nd, 2024. https://clinicaltrials.gov/study/NCT06204029?cond=NCT06204029&rank=1 .

Background: Attentional bias to food when in a satiated state may promote dysfunctional food intake, thereby counteracting the wish to reduce weight in people with obesity. Reducing attentional bias when satiated via an attention bias modification (ABM) procedure may thus be a helpful intervention to reduce obesity.

Objective: As an important first step, this study examined the feasibility and acceptability of a relatively high-dose ABM using the Bouncing Image Training task (BITT) in individuals with obesity. The intervention required engagement in self-applied ABM sessions while in a satiated state (i.e., after a regular meal).

Methods: Participants were 25 women aged between 18 and 35 with obesity (body mass index > 30) and with an intention to diet. They were instructed to perform the food-based BITT as a daily ABM training for 3 weeks within their home context and following a regular meal. Feasibility and acceptability were assessed qualitatively and quantitatively.

Results: Findings indicated that for the targeted group of women with obesity, it was acceptable and feasible to self-apply the training-sessions within the required satiated state. There was no dropout, and completing > 80% of trials was achieved: 92% of the sessions, 97% of those on the intended day, and 94% in a satiated state. Adding further to the feasibility/acceptability of the current approach, the intervention received a rating between neutral and positive, and there was no evidence for an adverse effect (i.e., no increase) on craving.

Conclusions: The findings support the feasibility of setting the critical next step of testing the BITT's efficacy to facilitate a decrease in attentional bias to food cues and a decrease in food intake in women with obesity.

Teaser text: Attention bias modification (ABM) in obesity should be applied when satiated. Feasibility and acceptability of a daily 3-week ABM program were assessed. The program was acceptable and feasible.

Background: Individuals living with stage 4 chronic kidney disease and their caregivers face multiple health-related decisions as the disease progresses. The ImPart (Improving the decision-making PARTnership of chronic kidney disease dyads), community-informed, factorial pilot trial intervention aims to train members of the dyad in skills to enhance decision support for patients.

Methods: This single-site pilot 2³ factorial trial aims to evaluate the feasibility, acceptability, and preliminary efficacy of the ImPart decision-support training intervention components for individuals with stage 4 chronic kidney disease and their caregivers. Caregivers (n = 64) and patients (n = 64) will be randomly assigned to one of 8 combinations of 3 components with two levels each: (1) caregiver coaching on effective decision support (1 session vs. 3 sessions); (2) caregiver decision support communication training (1 session vs. no session); and (3) patient social support effectiveness psychoeducation (2 sessions vs. no sessions). The primary outcomes of this pilot study are feasibility and acceptability. Secondary outcomes will also be evaluated, including patient decision conflict, quality of life, patient and caregiver distress, and dyadic coping. Results will be used to create a version of ImPart for use in a future fully powered randomized controlled trial.

Discussion: This protocol outlines a pilot factorial trial, guided by the multiphase optimization strategy, to evaluate a community-engaged, co-developed decision-support intervention for individuals with stage 4 chronic kidney disease and their caregivers.

Trial registration: NCT06173323.