A physiotherapy-led transition to home intervention for older adults following emergency department discharge: protocol for a pilot feasibility randomised controlled trial

Background Older adults frequently attend the emergency department (ED) and experience high rates of adverse outcomes following ED presentation including functional decline, ED re-presentation and unplanned hospital admission. The development of effective interventions to prevent such outcomes is a key priority for research and service provision. This paper reports a protocol designed to evaluate the feasibility of conducting a three arm randomised controlled trial (RCT) within the ED setting and in the patient’s home. The interventions are comprehensive geriatric assessment (CGA), ED PLUS and usual care. Methods The ED PLUS pilot trial is designed as a feasibility RCT conducted in the ED and Acute Medical Assessment Unit of a university teaching hospital in the mid-west region of Ireland. We aim to recruit 30 patients, aged 65 years and over presenting to the ED with undifferentiated medical complaints and discharged within 72 h of index visit. Patients will be randomised by a computer in a ratio of 1:1:1 to deliver usual care, CGA or ED PLUS during a 6-month study period. A randomised algorithm is used to perform randomization. CGA will include a medical assessment, medication review, nursing assessment, falls assessment, assessment of mobility and stairs, transfers, personal care, activities of daily living (ADLs), social supports and baseline cognition. ED PLUS, a physiotherapist led, multidisciplinary intervention, aims to bridge the transition of care between the index visit to the ED and the community by initiating a CGA intervention in the ED and implementing a 6-week follow-up self-management programme in the patient’s own home following discharge from the ED. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively. Discussion Rising ED visits and an ageing population with chronic health issues render ED interventions to reduce adverse outcomes in older adults a research priority. This feasibility RCT will generate data and experience to inform the conduct and delivery of a definite RCT. Trial registration The trial was registered in Clinical Trials Protocols and Results System as of 21st July 2021, with registration number NCT049836020.

Tailored Music Listening to Improve Sleep in Older Adults With Dementia: A Randomized Clinical Trial

Sleep disturbances in persons living with dementia (PLWD) contribute to reduced well-being. Music has shown promise to improve sleep among older adults, but there is limited evidence of music interventions improving sleep specifically in PLWD. The purpose of this wait-list RCT was to examine the i) feasibility; ii) acceptability and iii) preliminary efficacy of tailored music listening intervention in community-dwelling PLWD and their caregivers (dyads). Thirty consented dyads out of 33 (91%) completed the RCT. Tailored music for sleep was feasible based on screening (26%), enrollment (89%), and recruitment (3 dyads/month) rates. The intervention was found acceptable, as evidenced by post-intervention interviews. Compared to controls, PLWD in the intervention group reported greater global sleep quality improvement post-intervention (PSQI mean change -0.08 vs -1.65; p=0.06). The results from this feasibility RCT have informed the development of a music mobile application that will be tested in a future clinical trial.

Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study

Background: Therapeutic footwear and insoles are preventative strategies to reduce elevated plantar pressures associated with diabetic foot ulcer risk. An insole intervention appropriate for chairside delivery optimizing plantar foot pressure reduction in people with diabetes has been developed. Aim: To explore the feasibility and acceptability of testing an optimized insole compared with an active control insole to reduce plantar pressures for people with diabetic peripheral neuropathy.Methods: A double-blinded multicentre feasibility RCT with an embedded qualitative study. In addition to usual care, participants were randomized to either an optimized insole group (Intervention) or a standard cushioned insole group (Active control). Participants were assessed at baseline, 3, 6 and 12 months with clinical outcome of mean peak plantar pressure (MPPP) reduction. An embedded qualitative study involved semi-structured interviews with 12 study participants and three podiatrists to explore their experiences of the intervention and trial procedures. Data were analyzed using descriptive statistics (quantitative data) and thematic analysis (qualitative data).Results: Screened were142 patients from which 61 were recruited; 30 participants were randomized to the Intervention group and 31 to the Active control group. Forty-two participants completed the study. At 12-months, 69% of the patient-reported questionnaires were returned and 68% of the clinical outcomes were collected. Mean difference in MPPP between the Intervention and Active control groups for all regions-of-interest combined favoured the Intervention, with increases from 87kPa at post-randomization to 255kPa at 12-months. Thematic analysis revealed three themes; accepting the study, behaviour and support during study procedures, and impact from study participation. Conclusion: The results of the feasibility RCT suggest that the optimized insole holds promise as an intervention, and that a full RCT to evaluate the clinical and cost-effectiveness of this intervention is feasible and warranted for people with diabetic peripheral neuropathy. Trial registration: International Standard Randomized Controlled Trial Number: ISRCTN16011830. Registered 9th October 2017, https://www.isrctn.com/ISRCTN16011830

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.

Yoga Program for Type 2 Diabetes Prevention (YOGA-DP) Among High-Risk People: Qualitative Study to Explore Reasons for Non-participation in a Feasibility Randomized Controlled Trial in India

Background: Yoga-based interventions can be effective in preventing type 2 diabetes mellitus (T2DM). We developed a Yoga program for T2DM prevention (YOGA-DP) among high-risk people and conducted a feasibility randomized controlled trial (RCT) in India. The objective of this study was to identify and explore why potential participants declined to participate in the feasibility RCT.Methods: An exploratory qualitative study, using semi-structured interviews, was conducted at a Yoga center in New Delhi, India. Fourteen people (10 women and four men) who declined to participate in the feasibility RCT were interviewed, and 13 of them completed the non-participant questionnaire, which captured their socio-demographics, diets, physical activities, and reasons for declining.Results: Three types of barriers were identified and explored which prevented participation in the feasibility RCT: (1) personal barriers, such as lack of time, perceived sufficiency of knowledge, preferences about self-management of health, and trust in other traditional and alternative therapies; (2) contextual barriers, such as social influences and lack of awareness about preventive care; and (3) study-related barriers, such as lack of study information, poor accessibility to the Yoga site, and lack of trust in the study methods and intervention.Conclusions: We identified and explored personal, contextual, and study-related barriers to participation in a feasibility RCT in India. The findings will help to address recruitment challenges in future Yoga and other RCTs.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: CTRI/2019/05/018893.

A Live Video Program to Prevent Chronic Pain and Disability in At-Risk Adults With Acute Orthopedic Injuries (Toolkit for Optimal Recovery): Protocol for a Multisite Feasibility Study

Background Despite the pivotal role of psychosocial factors in pain and disability after orthopedic injury, there are no evidence-based preventive interventions targeting psychosocial factors in patients with acute orthopedic injuries. We developed the first mind-body intervention focused on optimizing recovery and improving pain and disability in patients with acute orthopedic injuries who exhibit high levels of catastrophic thinking about pain and/or pain anxiety (Toolkit for Optimal Recovery [TOR] after orthopedic injury). In a pilot single-site randomized controlled trial (RCT), the TOR met a priori set benchmarks for feasibility, acceptability, and satisfaction. The next step in developing TOR is to conduct a multisite feasibility RCT to set the stage for a scientifically rigorous hybrid efficacy-effectiveness trial. Objective The objective of this study is to conduct a rigorous multisite feasibility RCT of TOR to determine whether the intervention and study methodology meet a priori set benchmarks necessary for the successful implementation of a future multisite hybrid efficacy-effectiveness trial. In this paper, we describe the study design, manualized treatments, and specific strategies used to conduct this multisite feasibility RCT investigation. Methods This study will be conducted at 3 geographically diverse level 1 trauma centers, anonymized as sites A, B, and C. We will conduct a multisite feasibility RCT of TOR versus the minimally enhanced usual care (MEUC) control (60 patients per site; 30 per arm) targeting a priori set feasibility benchmarks. Adult patients with acute orthopedic injuries who endorse high pain catastrophizing or pain anxiety will be recruited approximately 1-2 months after injury or surgery (baseline). Participants randomized to the TOR will receive a 4-session mind-body treatment delivered via a secure live video by trained clinical psychologists. Participants randomized to the MEUC will receive an educational booklet. Primary outcomes include feasibility of recruitment, appropriateness, feasibility of data collection, acceptability of TOR (adherence to sessions), and treatment satisfaction across all sites. We will also collect data on secondary implementation outcomes, as well as pain severity, physical and emotional function, coping skills, and adverse events. Outcomes will be assessed at baseline, posttreatment, and at the 3-month follow-up. Results Enrollment for the RCT is estimated to begin in June 2021. The target date of completion of the feasibility RCT is April 2024. The institutional review board approval has been obtained (January 2020). Conclusions This investigation examines the multisite feasibility of TOR administered via live videoconferencing in adult patients with acute orthopedic injuries. If feasible, the next step is a multisite, hybrid efficacy-effectiveness trial of TOR versus MEUC. Preventive psychosocial interventions can provide a new way to improve patient and provider satisfaction and decrease suffering and health care costs among patients with orthopedic injuries who are at risk for chronic pain and disability. International Registered Report Identifier (IRRID) PRR1-10.2196/28155

Protocol for a feasibility randomised controlled trial comparing cognitive functional therapy with usual physiotherapy care in people with persistent low back pain

BACKGROUND: Combined physical and psychological programmes (CPPP) are recommended for people with disabling low back pain (LBP). Cognitive Functional Therapy (CFT) is a physiotherapist-led low intensity CPPP with positive effects in previous studies. The clinical and cost effectiveness of CFT has not previously been evaluated in a randomised controlled trial (RCT) in the United Kingdom (UK) National Health Service (NHS). Before a definitive RCT can be completed it is necessary to determine if completing such a study is possible. PURPOSE: To determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care for people with persistent LBP in the UK NHS. METHODS: A pragmatic two-arm parallel feasibility RCT comparing CFT with usual physiotherapy care for people with persistent LBP will be completed. Sixty participants will be randomly allocated to receive CFT or usual physiotherapy care. The primary outcome will be feasibility of completing a definitive RCT. Participant reported outcome measures will be recorded at baseline, three, six and twelve-month follow-up, including disability, pain intensity, quality of life and psychosocial function. Data will be analysed descriptively. A qualitative process evaluation will explore the acceptability of the research processes and interventions. DISCUSSION: The rationale and methodological design of a mixed methods feasibility RCT is presented. This study aims to inform the planning, design and completion of a future definitive RCT in the UK NHS. The results will be disseminated through peer reviewed open access journal publication.