Implementation of an electronic patient-reported measure of barriers to antiretroviral therapy adherence with the Opal patient portal: Protocol for a mixed method type 3 hybrid pilot study at a large Montreal HIV clinic

Background Adherence to antiretroviral therapy (ART) remains problematic. Regular monitoring of its barriers is clinically recommended, however, patient-provider communication around adherence is often inadequate. Our team thus decided to develop a new electronically administered patient-reported outcome measure (PROM) of barriers to ART adherence (the I-Score) to systematically capture this data for physician consideration in routine HIV care. To prepare for a controlled definitive trial to test the I-Score intervention, a pilot study was designed. Its primary objectives are to evaluate patient and physician perceptions of the I-Score intervention and its implementation strategy. Methods This one-arm, 6-month study will adopt a mixed method type 3 implementation-effectiveness hybrid design and be conducted at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal, Canada). Four HIV physicians and 32 of their HIV patients with known or suspected adherence problems will participate. The intervention will involve having patients complete the I-Score through a smartphone application (Opal), before meeting with their physician. Both patients and physicians will have access to the I-Score results, for consideration during the clinic visits at Times 1, 2 (3 months), and 3 (6 months). The implementation strategy will focus on stakeholder involvement, education, and training; promoting the intervention’s adaptability; and hiring an Application Manager to facilitate implementation. Implementation, patient, and service outcomes will be collected (Times 1-2-3). The primary outcome is the intervention’s acceptability to patients and physicians. Qualitative data obtained, in part, through physician focus groups (Times 2–3) and patient interviews (Times 2–3) will help evaluate the implementation strategy and inform any methodological adaptations. Discussion This study will help plan a definitive trial to test the efficacy of the I-Score intervention. It will generate needed data on electronic PROM interventions in routine HIV care that will help improve understanding of conditions for their successful implementation. Clinical trial registration ClinicalTrials.gov identifier: NCT04702412; https://clinicaltrials.gov/.

Strengthening Mental Abilities with Relational Training (SMART) in Multiple Sclerosis (MS): Study Protocol for a Feasibility Randomised Controlled Trial

Background Multiple Sclerosis (MS) is a chronic condition of the central nervous system, affecting around 1 in every 600 people in the UK, with 130 new diagnoses every week. Cognitive difficulties are common amongst people with MS, with up to 70% experiencing deficits in higher-level brain functions – such as planning and problem-solving, attention, and memory. Cognitive deficits make it difficult for people with MS to complete everyday tasks and limit their abilities to work, socialise, and live independently. There is a clear need – and recognised research priority – for treatments that can improve cognitive functioning in people with MS. The absence of effective cognitive interventions exacerbates burdens on the services accessed by people with MS – requiring these services to manage sequelae of untreated cognitive deficits, including reduced quality of life, greater disability and dependence, and poorer adherence to disease-modifying treatments. Our planned research will fill the evidence gap through developing – and examining the feasibility of trialling – a novel online cognitive rehabilitation programme for people with MS (SMART). Methods The primary objective of this study aims to conduct a feasibility study to inform development of a definitive trial of SMART for improving cognitive functioning in people with MS. Secondary objectives include accessing the acceptability to participants of the intervention, delivery format, inclusion/exclusion criteria, baselines and outcome measures, randomisation protocol, and the study procedures. It will further assess the framework for a cost-effectiveness analysis alongside a definitive trial; participant recruitment and retention rates, sample-size needed for a fully powered trial, and signal of efficacy. Discussion As a feasibility trial, outcomes are unlikely to immediately effect changes to NHS practice. However, this is a necessary step towards developing a definitive trial – and will give us a signal of efficacy, a prerequisite for progression to a definitive trial. If found to be clinically- and cost-effective, the latter trial could create a step-change in MS cognitive rehabilitation – improving service-delivery and optimising support with limited additional resources. Trial Registration: Registration ID: ClnicalTrials.gov: NCT04975685 – registered on July 23rd, 2021 Protocol version: 2.0, 25 November 2021

Effects of immersive virtual reality for preventing and managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: A study protocol for an exploratory trial

Background Anxiety, nausea and vomiting are common side effects suffered by paediatric patients receiving chemotherapy. Emerging evidence supports the efficacy of immersive virtual reality (IVR) on improving anxiety and distress symptoms including nausea and vomiting among this vulnerable group. This trial aims to assess the feasibility and acceptability of IVR for preventing and managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy. Method and analysis An exploratory trial supplemented by qualitative methods will be conducted. We will recruit 20 paediatric patients who are aged between 6 and 12 years, chemotherapy naïve, scheduled to receive their first intravenous chemotherapy and able to understand Chinese. Participants will be randomly allocated to intervention or control groups. The intervention group will receive the IVR intervention for three sessions as follows: 4 hours before chemotherapy, 5 minutes before and during their first course chemotherapy and 5 minutes before and during their second course chemotherapy. The control group will receive standard care only. Main outcome measures included (1) key parameters for the design of a definitive trial (i.e. screening, eligibility, consent and withdrawal rates); (2) anxiety, anticipatory and acute chemotherapy-induced nausea and vomiting for collection of preliminary data; (3) feasibility and acceptability of the intervention. Semi-structured interviews will be conducted with patients, parents and oncology nurses. Generalized estimating equations model will be used to compare each of the outcome measures across the time points between the two groups. Qualitative data will be analysed by conventional content analysis. Expected results The results of this exploratory trial will inform the design and conduct of future definitive trial. Trial registration number ChiCTR1900021694; Pre-results.

Feasibility and preliminary efficacy of web-based and mobile interventions for common mental health problems in working adults: a multi-arm randomised pilot trial (Preprint)

BACKGROUND There is growing interest in digital platforms as a means of implementing scalable, accessible, and cost-effective mental health interventions in the workplace. However, little is known about the efficacy of such interventions when delivered to employee groups. OBJECTIVE This study aimed to evaluate the feasibility and preliminary efficacy of a digital mental health platform for the workplace, that incorporates evidence-based practices such as cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT). Three brief, unguided interventions designed to address stress, anxiety, and resilience, respectively, were evaluated. The primary aim was to determine the feasibility of the study methods and interventions in preparation for a definitive randomised controlled trial (RCT). METHODS The study employed a fully remote, parallel, multi-arm, external pilot RCT, with three intervention arms and a no-intervention control group. Participants were working adults representative of the general UK population with respect to age, sex, and ethnicity, who were recruited from an online participant platform. Primary outcomes included objective and self-report measures of feasibility, acceptability, engagement, transferability, relevance, and negative effects. Secondary outcomes included four self-report measures of mental health and wellbeing, completed at baseline (t0), post-intervention (t1) and 1-month follow-up (t2). Secondary outcomes were analysed via linear mixed effects models using intention-to-treat principles. Preregistered criteria for progression to a definitive trial were evaluated. RESULTS Data were collected between January to March 2021. A total of 383 working adult participants meeting trial eligibility were randomised, of which 356 (93.0%) were retained at t2. Objective engagement data showed that 67.8% of all participants randomised to an intervention arm completed their intervention. 87.1% of participants reported being “satisfied” or “very satisfied” with their intervention, and 87.1% rated the quality of their intervention as “good” or “excellent”. All intervention groups reported significantly greater improvements than the control group on at least one secondary outcome at t1, with between-group Hedge’s g effect sizes for the pooled interventions ranging from 0.25 [95% CI 0.05-0.46] to 0.43 [95% CI 0.23-0.64]. All improvements were maintained at t2. CONCLUSIONS The study methods were feasible and all preregistered criteria for progression to a definitive trial were met. Several minor protocol amendments are noted. Preliminary efficacy findings suggest the study interventions may result in improved mental health outcomes when offered to working adults. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 80309011; http://www.isrctn.com/ISRCTN80309011.

Feasibility of a multifaceted implementation intervention to improve attendance at diabetic retinopathy screening in primary care in Ireland: a cluster randomised pilot trial

ObjectivesDiabetic retinopathy screening (DRS) uptake is suboptimal in many countries with limited evidence available on interventions to enhance DRS uptake in primary care. We investigated the feasibility and preliminary effects of an intervention to improve uptake of Ireland’s national DRS programme, Diabetic RetinaScreen, among patients with type 1 or type 2 diabetes.Design/settingWe conducted a cluster randomised pilot trial, embedded process evaluation and cost analysis in general practice, July 2019 to January 2020.ParticipantsEight practices participated in the trial. For the process evaluation, surveys were conducted with 25 staff at intervention practices. Interviews were conducted with nine staff at intervention practices, and 10 patients who received the intervention.InterventionsThe intervention comprised practice reimbursement, an audit of attendance, electronic prompts targeting professionals, General Practice-endorsed patient reminders and a patient information leaflet. Practices were randomly allocated to intervention (n=4) or wait-list control (n=4) (usual care).OutcomesStaff and patient interviews explored their perspectives on the intervention. Patient registration and attendance, including intention to attend, were measured at baseline and 6 months. Microcosting was used to estimate intervention delivery cost.ResultsThe process evaluation identified that enablers of feasibility included practice culture and capacity to protect time, systems to organise care, and staff skills, and workarounds to improve intervention ‘fit’. At 6 months, 22/71 (31%) of baseline non-attenders in intervention practices subsequently attended screening compared with 15/87 (17%) in control practices. The total delivery cost across intervention practices (patients=363) was €2509, averaging €627 per practice and €6.91 per audited patient. Continuation criteria supported proceeding to a definitive trial.ConclusionsThe Improving Diabetes Eye screening Attendance intervention is feasible in primary care; however, consideration should be given to how best to facilitate local tailoring. A definitive trial of clinical and cost-effectiveness is required with preliminary results suggesting a positive effect on uptake.Trial registration numberNCT03901898.

Protocol For a Randomised Controlled Feasibility Study Examining the Efficacy of Brief Cognitive Therapy For the Treatment of Panic Disorder in Adolescents (PANDA)

Background: Panic disorder occurs in between 1-3% of adolescents, is associated with high levels of co-morbidity, and without treatment, appears to have a chronic course. To improve access to effective psychological interventions, briefer versions of CBT have been developed and evaluated for pre-adolescent children with anxiety disorders. However, there are currently no brief evidence-based CBT interventions for adolescents with anxiety disorders that can be delivered in less than eight sessions. Given that a brief version of cognitive therapy has been shown to be effective in adults with panic disorder, with a large effect size, it is possible that an adapted version could be effective for adolescents with panic disorder.Methods: The study will examine whether a definitive trial can be conducted, based on a feasibility RCT using several well-defined criteria. The feasibility RCT is a single centre, randomised control trial. Between 30-48 young people (age 11-18 years) who meet diagnostic criteria for panic disorder, attending a routine clinical service, will be randomly allocated to receive either (i) brief cognitive therapy, or (ii) a general form of CBT treatment that is more commonly used for adolescents with anxiety disorders. Both will be delivered 1:1 by a therapist and involve five treatment sessions and two booster sessions. Young people’s outcomes will be assessed at the end of treatment and at 3 month follow up, and qualitative interviews will be conducted to examine acceptability. We will also explore outcomes 1-year after the completion of treatment. Discussion: This study will test the feasibility of a randomised controlled trial to compare brief cognitive therapy to a general form of CBT for adolescents with panic disorder in the UK. The outputs from the study will provide a clear indication of the feasibility of a future definitive trial and, if indicated, the critical resources that will be required and key information to inform the design and maximise the successful completion of the trial. This has the potential to bring direct benefits to young people and their families, as well as services and society more broadly.Trial Registration: This trial is registered on the ISRCTN Registry, registration number ISRCTN14884288, registered retrospectively on 05/12/2019.

The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: A protocol for a cross-border pilot cluster randomised controlled trial

BackgroundWhile international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically-informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)).MethodsA pilot cluster randomised controlled trial will be conducted, using a mixed methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention. A total of 16 practices will be recruited (eight in ROI; eight in NI) and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of GPs in ROI, and a GP and Practice Based Pharmacist (PBP) in NI. The GPs/GP and PBP will schedule time to review medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment, and 4- and 8-months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention, and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed.DiscussionThe findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies.Trial registrationRegistry: ISRCTN, ISRCTN80017020; Date of confirmation 4/11/2019; Retrospectively registered; http://www.isrctn.com/ISRCTN80017020.

PP32 Pathway to portfolio: from idea to full trial funding

BackgroundNIHR funding is provided to studies which will produce evidence to inform policy and practice in healthcare. Exploratory or feasibility work can be difficult to find funding for. We present the timeline and steps in the process from first having an idea for research through to gaining funding for a definitive trial.ObjectiveTo determine costs and effects of Fascia Iliaca Compartment Block delivered by paramedics at the scene of injury for suspected hip fracture.MethodsLiterature reviewDevelopment and testing of tool to support identification of hip fracture by paramedicsFeasibility trial (RAPID 1)Proposal for definitive trial (RAPID 2)ResultsFunding was gained from local NHS ‘Pathway to Portfolio’ resources to carry out the first stages of the programme; then a grant was won through the Welsh ‘Research for Patient and Public Benefit’ scheme to undertake a feasibility study. Finally, NIHR HTA funding was awarded to carry out a definitive trial, in five ambulance services.2015 – 16: A systematic review of the literature found that the effectiveness of FICB carried out by paramedics at the scene of injury is unknown, although nurse practitioners have been found to deliver this intervention safely in the Emergency Department.2015 – 16: A tool for identifying hip fracture at the scene of injury was developed by orthopaedic clinicians and tested by ambulance service staff. Sensitivity and positive predictive value were high.2015 – 18: Feasibility trial progression criteria related to methods and intervention safety and acceptability were met.2019 – 20: A full trial proposal was submitted, shortlisted, rejected, amended, resubmitted and funded.2020 – 2025: The RAPID 2 trial is now underway, with paramedic training and patient recruitment due to start in June 2021.ConclusionsResearch funding systems can work to help to progress from idea to full trial, although timescales can be lengthy.

Healthy Parent Carers: feasibility randomised controlled trial of a peer-led group-based health promotion intervention for parent carers of disabled children

Background Parent carers of children with special educational needs or disability are at higher risk of poor mental and physical health. The need for a tailored, peer-led group programme was raised by parent carers, who co-developed the Healthy Parent Carers programme with researchers. This study aimed to test the feasibility of programme delivery in community settings, and the feasibility and acceptability of a randomised controlled trial design. Methods Participants were individually randomised with concealed allocation to a structured group programme and access to online resources (intervention), or access to the online resources only (control). Measures of wellbeing and secondary and economic outcomes were collected before randomisation, immediately post-intervention, and 6 months post-intervention. Descriptive statistics on recruitment and attrition, demographics, attendance, and fidelity of intervention delivery were analysed with feedback on the acceptability of the trial design. Results One hundred and ninety-three parent carers expressed an interest in taking part. Ninety-two participants recruited from across six sites were randomised (47 intervention, 45 control). Lead and assistant facilitators were trained and delivered the group sessions. Sixteen (34%) participants in the intervention arm did not attend any sessions, and attendance varied across sites and sessions. One participant withdrew post-randomisation, and 83 (90%) participants completed outcome measures at the six-month follow-up. Conclusions The study demonstrated that it was feasible to deliver the programme in community settings. The number of parent carers who expressed interest signifies the need for such a programme and the feasibility of recruiting to a definitive trial. Loss to follow-up was low. Further research is needed to explore ways to reduce barriers to participation in person and assess the feasibility and acceptability of programme content and delivery for more ethnically diverse groups, and potentially using interpreters. Given the Covid-19 pandemic and delivery format feedback, there is also a need to investigate remote or blended delivery strategies. Although the results indicate that a definitive trial is feasible, programme impact would be strengthened through exploration of these uncertainties. Trial registration ISRCTN, ISRCTN15144652, registered on 25 October 2018, ClinicalTrials.gov, NCT03705221, registered on 15 October 2018.

A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study

Background Water, sanitation and hygiene (WASH) interventions should support infant growth but trial results are inconsistent. Frequently, interventions do not consider behaviours or transmission pathways specific to age. A household playspace (HPS) is one intervention component which may block faecal-oral transmission. This study was a two-armed, parallel-group, randomised, controlled feasibility trial of a HPS in rural Ethiopia. It aimed to recommend proceeding to a definitive trial. Secondary outcomes included effects on infant health, injury prevention and women’s time. Methods November 2019−January 2020 106 households were identified and assessed for eligibility. Recruited households (N = 100) were randomised (blinded prior to the trial start) to intervention or control (both n = 50). Outcomes included recruitment, attrition, adherence, and acceptability. Data were collected at baseline, two and four weeks. Findings Recruitment met a priori criteria (≥80%). There was no loss to follow-up, and no non-use, meeting adherence criteria (both ≤10%). Further, 48.0% (95% CI 33.7−62.6; n = 24) of households appropriately used and 56.0% (41.3−70.0; n = 28) cleaned the HPS over four weeks, partly meeting adherence criteria (≥50%). For acceptability, 41.0% (31.3−51.3; n = 41) of infants were in the HPS during random visits, failing criteria (≥50%). Further, the proportion of HPS use decreased during some activities, failing criteria (no decrease in use). A modified Barrier Analysis described good acceptability and multiple secondary benefits, including on women’s time burden and infant injury prevention. Interpretation Despite failing some a priori criteria, the trial demonstrated mixed adherence and good acceptability among intervention households. A definitive trial to determine efficacy is warranted if recommended adjustments are made. Funding People In Need; Czech Development Agency. Trial registration RIDIE-ID-5de0b6938afb8.