Pilot and Feasibility Studies

IntroductionAssessing the fidelity of complex behavioural interventions and examining the contextual reasons why such interventions succeed, or fail are important activities but challenging and rarely reported. The Smoking Treatment Optimisation in Pharmacies (STOP) trial is a cluster randomised trial evaluating the effectiveness of a complex intervention to optimise the National Health Service (NHS) Stop Smoking Service delivered in community pharmacies. This complex intervention comprises a training package for pharmacy staff involving motivational interviewing and communication skills aimed at increasing smoking cessation knowledge and proactive client engagement. We report on a process evaluation which was planned alongside the trial to offer findings that will assist in the interpretation of the main trial results and help inform potential implementation in community pharmacy settings on a wider scale. Methods and analysisQuantitative data on recruitment and retention process of pharmacies, pharmacy staff and service users has been collected during the trial along with data on dose and fidelity of the intervention delivery from participating intervention arm pharmacies to identify potential implementation issues. Simulated client data on behaviour change skills and display of intervention materials from both control and intervention pharmacies is being assessed. These data will be combined with qualitative data; including adviser-smoker consultation recordings that provide a snapshot of behaviour skills delivery by stop smoking advisers and semi-structured interviews with pharmacy staff and services users from the intervention arm. DiscussionPublished protocols for process evaluations of complex health interventions are still rare despite increasing funding for this work to facilitate understanding of trial outcomes from an implementation perspective. This mixed methods protocol will contribute to the developing literature around the conduct of process evaluation and the value they add to health services research. Trial registration number ISRCTN16351033. Strengths and limitations of this studyO_LIA planned mixed methods process evaluation that draws together data from different sources to help explain the trial results and establish the feasibility of scaling this complex intervention up in community pharmacy settings. C_LIO_LIA strength is the use of a previously tested mystery shopping method to assess fidelity of skills performance at the pharmacy counter C_LIO_LIThe process evaluation relies on willing pharmacy staff and service users involved in the trial to collect some of the data, which may introduce bias. C_LIO_LIThis paper also provides a detailed example of how to use the MRC framework for process evaluation of complex interventions to design an extensive process evaluation within trial settings. C_LI

BackgroundOrthostatic hypotension (OH) is a common debilitating condition characterised by a significant drop in blood pressure (BP) on standing upright. Adults with OH are typically offered non-pharmacologic therapies, either alone or in combination with medication. The two most used agents are fludrocortisone and midodrine. There is a lack of good quality evidence for any of these treatments, all of which are in widespread clinical use. The aim of this internal pilot trial was to evaluate recruitment, attrition, treatment crossover and quality of outcomes. MethodsThe trial was designed as a pragmatic, open label, randomised, prospective, multicentre, superiority, multi-arm internal pilot. Within the 10-month pilot, a target of 64 adults with OH from 14 sites, was required to evaluate feasibility of recruitment, attrition, crossover and data collection. Participants were randomised to one of three treatments: non-drug therapies (control), fludrocortisone plus non-drug therapies or midodrine plus non-drug therapies. Outcomes measured included symptoms, quality of life, activities of daily living, postural BP, use of health and care services, falls and safety. Participants received treatment and were followed-up for 12 months. Pre-planned criteria to progress from internal pilot were defined for recruitment, retention, crossover and outcome completion. ResultsBetween the 3rd December 2021 and 31st August 2022, 13 participants were randomised from four of nine recruiting centres. Redeployment of clinical and research staff, due to COVID-19, limited the number of available sites. Participants already receiving fludrocortisone or midodrine accounted for 120 of 233 eligible participants being excluded. Due to the low sample size the rates of attrition and crossover are of limited value. Apart from the falls diaries, completion rates of the outcome measures were high. Due to low recruitment rates the pilot did not progress to the planned multi-arm multi-stage trial. ConclusionsIn its current design, this trial was not feasible. The main barriers to success were participants already receiving treatment and redeployment of clinical and academic staff during and after the COVID-19 pandemic. Trial registrationISRCTN 87213295, 23/07/2021, https://doi.org/10.1186/ISRCTN87213295 Key messages regarding feasibilityThe clinical and cost effectiveness of different treatment strategies for orthostatic hypotension is unknown. People with orthostatic hypotension tend to be older, have multiple long-term conditions and take multiple medications. There is uncertainty around recruitment of this population, attrition rates, potential crossover of treatments and completion of multiple outcome measures. Redeployment of clinical and research staff during COVID-19 and the post-COVID period meant that trial delivery was not feasible. Recent or current exposure to one of the trial interventions precluded a large proportion of participants being eligible. A flexible and pragmatic trial protocol was not sufficient to overcome these barriers. The number and timing of outcome measures appears to be appropriate and feasible.

ISO-101 is a novel wrist-worn device designed to deliver guided upper-limb isometric counter-manoeuvres via a retractable resistance tether with visual feedback. This proof-of-concept study evaluated feasibility, safety and preliminary efficacy in adults with orthostatic hypotension (OH). In a fixed-sequence, within-participant design, each participant completed three active-stand assessments: unassisted; device activation while supine immediately before standing; and device activation immediately after standing. The primary outcome was the proportion of responders, defined a priori as achieving, with device use versus the unassisted condition, [≥]10 mmHg improvement in any one of resting blood pressure, nadir standing blood pressure at 30- 60 s, or reduction in the orthostatic blood-pressure drop (systolic or diastolic). The study was powered to test the responder proportion against a 20% benchmark derived from standard non-pharmacological care. Seventeen participants were enrolled (mean age 72 years; 77% male) and fourteen completed all assessments. Six of fourteen (43%) met the responder definition, exceeding the benchmark (exact binomial p=0.012). When the device was used immediately after standing, responders showed mean (SD) increases of +22.13 (16.29) mmHg systolic and +19.52 (12.47) mmHg diastolic compared with the unassisted stand; pre-stand activation yielded smaller, non-significant changes. No adverse events occurred. Usability was high, with 88% rating the device easy to use and 69% indicating they would use it in daily life. ISO-101 produced clinically meaningful improvements in orthostatic blood pressure in a substantial subset of patients, supporting progression to larger, controlled evaluations. WHAT IS ALREADY KNOWNO_LIOrthostatic hypotension (OH) is common and clinically significant, yet counter-manoeuvres are often poorly implemented in practice. C_LIO_LIWearable assistance for standardised counter-manoeuvres has not previously been tested in OH. C_LI WHAT THIS STUDY ADDSO_LIIn this proof-of-concept study, ISO-101, a guided wrist-worn device, achieved a clinically meaningful and statistically significant responder rate, exceeding that typically observed with standard care. C_LIO_LIResponders demonstrated marked increases in postural blood pressure, the device was rated as highly usable, and no adverse events were reported. C_LI HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICYO_LIThese findings highlight the potential for wearable-assisted therapy in OH and support the need for further clinical evaluation. C_LI TRIAL REGISTRATION NUMBERClinicalTrials.gov: NCT06039410

IntroductionHealthcare systems must use treatments that are effective and safe. Regulators licensed many currently used older medications before introducing the stringent evidential requirements imposed on modern treatments. Also, there has been little encouragement to carry out within-class, head-to-head comparisons of licensed medicines. For commonly prescribed drugs, even small differences in effectiveness or safety could have significant public health implications. However, conventional clinical trials that randomise individual subjects are costly and unwieldy. Such trials are also often criticised as having low external validity. We describe an approach to rapidly generate externally valid evidence of comparative safety and effectiveness using the example of two widely used diuretics for the management of hypertension. Methods and AnalysisThe EVIDENCE (Evaluating Diuretics in Normal Care) study has a prospective, cluster-randomised, open-label, blinded end-point design. By randomising prescribing policy in primary care practices, the study compares the safety and effectiveness of commonly used diuretics in treating hypertension. Participating practices are randomised 1:1 to a policy of prescribing either indapamide or bendroflumethiazide when clinically indicated. Suitable patients who are not already taking the policy diuretic are switched accordingly. All patients taking the study medications are written to explaining the rationale for changing the prescribing policy and notifying them they can opt-out of any switch. The prescribing policies effectiveness and safety will be compared using rates of major adverse cardiovascular events (hospitalisation with myocardial infarction, heart failure or stroke or cardiovascular death), routinely collected in national healthcare administrative datasets. The study will seek to recruit 250 practices to provide a study population of approximately 50,000 individuals with a mean follow-up time of 2 years. The primary analysis will test for equivalence with a 30% margin in a per-protocol cohort. Ethics and DisseminationEVIDENCE has been approved by the East of Scotland Research Ethics Service (17/ES/0016, current approved protocol version 4, 28th September 2019). The results will be disseminated widely in peer review journals, guideline committees, National Health Service (NHS) organisations and patient groups. Trial registration numberISRCTN 46635087; registered pre-results, 11/08/2017. Strengths and limitations of this study designO_LIA cluster randomisation design maximises generalisability of results to UK NHS primary care. C_LIO_LIStudy interventions with minimal impact on existing NHS workflows should encourage recruitment. C_LIO_LIDevelopment of electronic study search tools and routinely collected data facilitates participation by remote and rural practices. C_LIO_LIOne-off policy interventions may have a limited long-term effect on prescribing behaviour. C_LI

The REdressing Long-tErm Antidepressant uSE in general practice (RELEASE) trial is a pragmatic cluster randomized controlled trial (cRCT) that seeks to determine whether a novel multi-strategy intervention that supports safe cessation of long-term antidepressants is superior to Usual Care.1 Pragmatic trials are designed to determine how well interventions work in clinical practice under everyday conditions.2 The multi-strategy intervention has two forms, known as RELEASE and RELEASE+. RELEASE for patients includes direct patient education and resources3 and an invitation to medication review; RELEASE for general practitioners (GPs) includes education, training in the brief intervention (Ask, Advise, Assist) and printable resources via practice management software. RELEASE+ additionally includes for patients links to freely available information online via an App, and for GPs clinical audit and feedback on practice prescribing of antidepressants. Patient directed education material has the potential to support safer prescribing, including in this case improved recognition and management of antidepressant withdrawal symptoms.4, 5 Brief interventions have the potential to change GP prescribing behaviour.6 The primary comparison of interest is whether any RELEASE intervention is superior to Usual Care. A secondary comparison will be between the two types of RELEASE interventions (RELEASE and RELEASE+). The purpose of this document is to minimise bias and ensure transparency and internal validity for the findings of the trial, by defining and making publicly available the analysis approach prior to reviewing or analysing trial data. The statistical analysis plan (SAP) will inform analysis and reporting of the main effectiveness findings of the trial. It provides a detailed description of the primary and secondary trial outcomes and the methods for statistical comparison.

Male urinary incontinence (UI) is most prevalent in older men, with one in three men aged 65 and above having problems maintaining continence. Addressing health inequalities, male-female disparities in continence services, and low health-seeking behavior among men emphasizes the necessity for co-creating an intervention that empowers them to self-manage their UI. We aim to co-create a self-management intervention with an older men and Health care provider (HCP) group and assess its usability/acceptability among older men with UI. The intervention mapping (IM) framework, a co-creation strategy, will be used to co-create a self-management tool, followed by usability/acceptability testing. The study will be guided by the first four IM steps: the logic model of the problem, the logic model of change, program/intervention design, and program/intervention production, followed by preliminary testing. A participatory group of older men with UI recruited from an existing group of patient partners, and continence care experts will be involved in all steps of the IM process. Usability/acceptability testing will be conducted on a sample of 20 users recruited through seniors associations and retirement living facilities. After accessing the self-management tool for a week, participants will complete a product usability testing scale (aka System Usability Scale-SUS) and/or an acceptability test, depending on the preferred mode(s) of intervention delivery. Data will be analyzed using descriptive statistics. A benchmark overall mean usability score of 70 represents a good/usable product, based on the large database of SUS scores.

BackgroundSmoking rates in the UK have declined steadily over the past decades, masking considerable inequalities, as little change has been observed among people with a mental health condition. This trial sought to assess the feasibility and acceptability of supplying an electronic cigarette (e-cigarette) starter kit for smoking cessation as an adjunct to usual care for smoking cessation, to smokers with a mental health condition treated in the community, to inform a future effectiveness trial. MethodsThis randomised controlled feasibility trial, conducted March-December 2022, compared the intervention (e-cigarette starter kit with a corresponding information leaflet and demonstration with Very Brief Advice) with a usual care control at 1-month follow-up. Participants were [&ge;]18 years, receiving treatment for any mental health condition in primary or secondary care in three Mental Health Trusts in Yorkshire and one in London, UK. They were also willing to address their smoking through either cessation or reduction of cigarette consumption. The agreed primary outcome measure was feasibility (consent[~]15% of eligible participants; attrition rate<30%). Acceptability, validated sustained abstinence and [&ge;]50% cigarette consumption reduction at 1-month, were also evaluated and qualitative interviews conducted to further explore acceptability in this population. ResultsFeasibility targets were partially met; of 201 eligible participants, 43 (mean age = 45.2, SD = 12.7; 39.5% female) were recruited (21.4%) and randomised (intervention:48.8%, n=21; control:51.2%, n=22). Attrition rate was 37.2% at 1-month follow-up and was higher (45.5%) in the control group. At follow-up (n=27), 93.3% (n=14) in the intervention group and 25.0% (n=3) in the control group reported e-cigarette use. The intervention was well received with minimal negative effects. In intention-to-treat analysis, validated sustained abstinence at 1-month was 2/21 (9.5%) and 0/22 (0%) and at least 50% reduction in cigarette consumption 13/21 (61.9%) and 3/22 (13.6%), for the intervention and control group, respectively. Qualitative analysis of participant interviews (N=5) showed the intervention was broadly acceptable, but they also highlighted areas of improvements for the intervention and trial delivery. ConclusionsOffering an e-cigarette starter kit to smokers with a mental health condition treated in the community was acceptable and largely feasible, with harm reduction outcomes (i.e. switching from cigarette smoking to e-cigarette use and substantial reduction in cigarette consumption) favouring the intervention. The findings of the study will be used to help inform the design of a main trial. Trial RegistrationRegistry: ISRCTN Registration number: ISRCTN17691451 Date of registration: 30/09/2021

Procedures carried out in acute care settings, such as emergency departments (EDs), are among the most common sources of acute pain experienced by children. Such procedures may include intravenous insertions (IVs), venipuncture, and wound irrigation and repair. Inadequately managed procedural pain can cause negative short-term and long-term implications for children, ranging from anxiety to aversion to healthcare. Parents have repeatedly expressed that they do not have the necessary tools to comfort or distract their child during uncomfortable medical procedures. As such, the purpose of this study was to work with parents to develop and evaluate two digital tools for pediatric procedural pain. A whiteboard animation video and interactive infographic were developed following a systematic review and interview with parents. Prototypes were tested in five ED waiting rooms in two Canadian provinces. Sites included those in urban, rural, and remote settings. Overall, parents rated the tools highly, suggesting that engaging with parents to develop arts-based digital tools is a highly effective method in ensuring that parents can understand and utilize complex health information. Author ContributionsThis study was conducted under the supervision of Drs. Shannon D. Scott (SDS) and Lisa Hartling (LH), PIs for translation Evidence in Child Health to enhance Outcomes (ECHO) Research and the Alberta Research Centre for Health Evidence (ARCHE), respectively. Both PIs designed the research study and obtained research funding through Translating Emergency Knowledge for Kids (TREKK) Networks of Centres of Excellence of Canada (NCE). SDS designed and supervised all aspects of tool development and evaluation. LH co-designed and supervised the qualitative study involving interviews with parents and systematic review of parent experiences and information needs. Tony An developed the infographic. Kassi Shave conducted and analyzed qualitative interviews with parents. Anne Le (AL) conducted usability testing. AL analyzed usability data. All authors contributed to the writing of this technical report and provided substantial feedback. This work was funded by: Networks of Centres of ExcellenceO_LIKlassen, T., Hartling, L., Jabbour, M., Johnson, D., & Scott, S.D. (2015). Translating emergency knowledge for kids (TREKK). Networks of Centres of Excellence of Canada Knowledge Mobilization Renewal ($1,200,000). January 2016 - December 2019. C_LI Women and Childrens Health Research Institute (WCHRI)O_LIScott, S.D & Hartling L. (2016). Translating Emergency Knowledge for Kids renewal. Women and Childrens Health Research Institute (matched dollars, $150,000). April 2016 - December 2019. C_LI This report should be cited asLe, A., Hartling, L., Scott, S.D. (2021). The development and usability testing of two arts-based knowledge translation tools for pediatric procedural pain. Technical Report. ECHO Research, University of Alberta. Available at: http://www.echokt.ca/research/technical-reports/

IntroductionCompared with the general population, people with serious mental illness (SMI) are 2-3 times more likely to develop type 2 diabetes, have poorer outcomes, and die 15 to 20 years younger, often as a result of long-term physical health conditions. Standard diabetes care does not meet the needs of people with SMI and they are frequently excluded from research, missing out on innovation. As diabetes care increasingly uses technology like continuous glucose monitoring (CGM) it is important to consider the views of people with SMI when new interventions are developed. This is a study protocol to identify candidate components of a structured CGM intervention for people with SMI, including the co-design of a logic model and programme theory. MethodsDrawing on experience-based co-design (EBCD) methods, we propose to collaborate with service-users, carers, and healthcare professionals to undertake early-phase development work for a novel intervention that maximises the potential of CGM to facilitate behaviour change. Fifteen participants will be recruited through existing cohorts and networks in England. The co-design will be informed by existing evidence and based on links between mechanisms of action and behaviour change techniques. Through a series of events (discovery sessions, co-design workshop, celebration event), we will identify candidate components for a prototype intervention ready for further development and testing. A logic model and programme theory will be developed and refined iteratively. DiscussionThe main output of this study will be a logic model and programme theory for a novel prototype intervention, ready for further testing following best practice intervention development, such as the Medical Research Council guidance for the development and evaluation of complex interventions. An intervention that makes CGM accessible for people with SMI has the potential to make a considerable contribution to reducing the profound health inequalities experienced by this population.

Young people living with type 1 diabetes (T1D) navigate daily complex diabetes related tasks as they take on increasing (and eventually full) responsibility for managing their condition, in addition to developing their lives as independent adults. Alongside the need for careful day-to-day diabetes management, the psychosocial burden and mental health impact and stigma are well recognised. Despite advances in psychological care, many young people with diabetes still experience a greater mental health burden than those without diabetes. This study aims to develop a brief and simple intervention for young people with T1D that will support their wellbeing day to day, as required, and grow their ability to live confidently with their condition that requires lifelong meticulous management. This study will consist of qualitative research and collaboration with young people with T1D and their siblings, friends, and peers to co-create a testable intervention. In Part 1, research interviews will be conducted with young people (16-24 years old) with T1D and, where possible, their siblings/peers to understand the day-to-day challenges of type 1 and what a novel intervention should address. Thematic analysis of interviews will inform the generation of a prototype intervention to take into part two, focus group discussions. Focus groups with (i) young people with T1D and, separately (ii) carers (comprising parents, carers, teachers, specialist nurses). Collaborative principles will be used to review, redesign and evolve the intervention to meet user needs. A blend of narrative and thematic analysis will inform the findings and report. Insights from Parts 1 and 2 will shape a user-defined and formatively analysed brief and simple intervention and future study design ready for pilot testing. The aim of this part of the research is to maximise acceptability and usability of a testable intervention by the target population. To aim of the future intervention will be to demonstrate effectiveness in helping young adults to live well with T1D. METADATAThis research is funded by a studentship to the first author, provided by University of Brighton as part of its partnership activities with the National Institute for Health Research (NIHR) Applied Research Collaboration Kent, Surrey, Sussex. The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Ethical approval for this study was provided by Cornwall and Plymouth Research Ethics Committee on behalf of the Health Research Authority and Health and Care Research Wales on 22 Aug 2022 (22/SW/0097). The University of Brighton is the Sponsor (protocol number 2022-9871).

ObjectivesMost patients with health conditions necessitating time off work consult in primary care. Offering vocational advice (VA) early within this setting may help them to return-to-work (RTW) and reduce sickness absence. Previous research shows the benefits of VA interventions for musculoskeletal pain in primary care, but an intervention for a much broader primary care patient population has yet to be tested. The WAVE feasibility study tested patient identification and recruitment methods, explored participants experiences of being invited to the study and their experiences of receiving VA. DesignA mixed method, single arm feasibility study comprising both quantitative and qualitative analysis of recruitment and participation in the study. SettingPrimary care MethodsThe study included participant follow-up by fortnightly SMS text and 6-week questionnaire. Stop/go criteria focused on recruitment and intervention engagement. The semi-structured interviews explored participants experiences of recruitment and receipt and engagement with the intervention. ResultsNineteen participants were recruited (4.3% response rate). Identification of participants via retrospective fit-note searches was reasonably successful (13/19 (68%) identified), recruitment stop/go criteria were met with >50% of those eligible and expressing an interest recruited. The stop/go criterion for intervention engagement was met with 16/19 (86%) participants having at least one contact with a Vocational Support Worker (VSW). Five participants were interviewed; they reported positive experiences of recruitment and felt the VA intervention was acceptable. ConclusionThis study demonstrates that delivering VA in primary care is feasible and acceptable. To ensure a future trial is feasible, recruitment strategies and data collection methods require additional refinement. Trial registration: Clinical Trials: NCT04543097 Protocol number: Version 5.1 Article summary- This is the first study to test the feasibility of delivering a VA intervention to patients who present in primary care, regardless of their health condition. - The study used mixed methods to fully explore feasibility of the delivery of a full trial - The findings can usefully inform the development of the methods for a future trial to ensure that it meets the needs of participants in supporting them to return-to-work after a period of absence

ImportanceInappropriate prescribing and prescribing omissions are major drivers of healthcare-related harm. Medication review may help improve pharmacotherapy. ObjectiveTo study the effects of a primary care medication review intervention centered around an electronic clinical decision support system (eCDSS) on medication appropriateness and the number of prescribing omissions in older adults with multimorbidity and polypharmacy compared to usual care. Design and SettingThe "Optimising PharmacoTherapy In the multimorbid elderly in primary Care" (OPTICA) trial is a cluster randomized clinical trial conducted with general practitioners (GPs) and older multimorbid patients with polypharmacy in Swiss primary care settings, between January 2019 and February 2020. The 12-month follow-up was completed in February 2021. ParticipantsEligible patients had to be [&ge;]65 years of age with [&ge;]3 chronic conditions and [&ge;]5 long-term medications. InterventionThe intervention to optimize pharmacotherapy centered around an eCDSS compared to usual care. Main Outcomes and MeasuresThe two primary outcomes were the improvement in the Medication Appropriateness Index (MAI) and the Assessment of Underutilization (AOU) at 12 months. Secondary outcomes included the number of medications, number of falls and fractures and quality of life. ResultsIn 43 GP clusters, 323 patients were recruited (median age: 77 years (IQR: 73-83), 45% were female). 21 GPs with 160 patients were assigned to the intervention group and 22 GPs with 163 patients to the control group. On average, 1 recommendation to stop or start a medication were reported to be implemented per patient. At 12 months, there were no group differences in the improvement of medication appropriateness (Odds ratio (OR): 1.05; 95% confidence interval (CI): 0.59 to 1.87) nor the number of prescribing omissions (OR: 0.90; 95% CI: 0.41 to 1.96) in the intention-to-treat analysis. The per-protocol analysis showed no statistically significant group difference and there were no group differences in the secondary outcomes either. Conclusions and RelevanceIn this randomized trial of GPs and older adults, medication reviews based on the eCDSS reduced inappropriate prescriptions but did not lead to higher appropriateness of patients medications. The intervention could be safely delivered to patients without causing any detriment to their health. FundingSwiss National Science Foundation (407440_167465) Key points QuestionWhat is the effect of a GP administered medication review intervention supported by an electronic clinical decision support system on medication appropriateness in older patients with multimorbidity and polypharmacy? FindingsThis cluster randomized controlled trial included 43 general practitioners and 323 patients. At the end of the 12-month follow-up period, medication appropriateness and the number of prescribing omissions did not differ between patients who received the intervention and those who received usual care. MeaningThe intervention to optimize pharmacotherapy was feasible and safe to implement in primary care but did not improve overall medication appropriateness nor reduce the number of prescribing omissions.

IntroductionNumbers of People Experiencing Homelessness (PEH) are increasing worldwide. Systematic reviews show high levels of multimorbidity and mortality due to treatable diseases including drug overdose. Integrated health and social care outreach interventions may improve outcomes. No previous studies have targeted PEH with recent drug overdose despite their high recorded levels of drug related deaths. There are few data on health and social care problems. Feasibility work suggests a collaborative health and social care intervention (Pharmacist and Homeless Outreach Engagement Non-medical Independent prescriber Rx-PHOENIx) is potentially beneficial. We describe the methods of a pilot randomised controlled trial(RCT) with parallel process and economic evaluation in PEH with at least one drug-related overdose in the preceding 6 months. MethodsDetailed health and social care information will be collected at baseline before 1:1 randomisation to: care-as-usual plus visits from a pharmacist and homeless outreach worker (PHOENIx) for 6-9 months; or care-as-usual. The main outcomes are rate of presentations to emergency department(ED) for overdose or other causes and whether to progress to a definitive RCT based on: recruitment of [&ge;] 100 participants within 4 months;[&ge;] 60% patients remaining in the study at 6 and 9 months follow up;[&ge;] 60% of patients in the PHOENIx group receiving the intervention; and[&ge;] 80% of patients with data collected. Secondary outcomes include: hospitalisations; treatment uptake and patient reported measures. Semi-structured interviews will explore future implementation of PHOENIx, and reasons for overdose and protective factors. An economic evaluation will assess the feasibility of conducting a cost effectiveness analysis in a subsequent definitive trial. DiscussionThe study will determine whether to proceed to a definitive RCT for PEH aiming to fulfil unmet health and social care needs of those experiencing homelessness and at risk of drug related harms and deaths while providing useful insights into barriers and facilitators to PHOENIx and characterising the health and social care needs of PEH. Ethics and disseminationThe trial was approved by the South East Scotland National Health Service Research Ethics Committee 01. Results will be available in the last quarter of 2022. Registration detailsThe trial is registered with the UK Clinical Trials Registry (ISRCTN 10585019). Strengths and limitations of the study- We plan to recruit patients normally excluded from intervention trials and collect a diverse health and social care dataset at baseline - The 6-9 month individualised, complex intervention offers longer consultations, integrated continuous, health and social care support on outreach - Mixed methods will enable determination of whether a subsequent trial is merited from an efficacy, economic and patient perspective. - By design, the pilot randomised controlled trial lacks the power to detect a clinically significant effect and recruitment was limited to 20 locations in Scotlands largest city

Background.Only one in five people with hypertension have their blood pressure (BP) controlled (<140/90 mmHg). Patient education improves BP control, yet there is limited guidance to adapt to individuals evolving needs across the hypertension management journey. This study aimed to identify key behavioural barriers and enablers to patient education throughout the hypertension management journey, which were synthesised into patient personas to support translation and practical application. Methods.Qualitative interviews with adults ([&ge;]18) who self-monitor BP, and primary care providers involved in hypertension care. Interviews explored the experience of accessing and delivering patient education for BP measurement and management. Using framework analysis, patient personas were developed in three steps: 1) thematic analysis of patient interviews to identify key barriers and enablers to hypertension patient education and mapping the identified barriers and enablers to key time-points in the hypertension journey (diagnosis, treatment initiation, long-term management), 2) clustering behavioural factors via the capability, opportunity, motivation-behaviour model, which were then synthesised as preliminary patient personas and refined using practitioner interviews and, 3) validation by consumer consultation feedback sessions. Results.Patients (n=27) and practitioners (n=12; n=4 general practitioners, n=4 nurses, and n=4 pharmacists) were aged 18-60 years (52% of patients and 100% of practitioners fell within this age range). Several behavioural barriers to patient education for hypertension management included patient overwhelm, inconsistent guidance provided by health professionals, and perceived patient disengagement, while a strong desire to self-manage was a consistent enabler. Six clusters of behavioural barriers and enablers were synthesised as patient personas, capturing the factors that shape education needs and experiences across the hypertension management journey. Conclusions.The patient personas highlight opportunities for tailored patient education strategies through the development of patient personas. Practice implications.The patient personas provide a practical tool for designing person-centred interventions in primary care.

Childhood obesity levels continue to rise, with significant impact on individuals and the NHS. The Complications of Excess Weight (CEW) clinics provide support to young people with complications of their weight. Our objective was to co-develop, with young people, a new intervention; AIM2Change, to enable young people to develop their intrinsic motivation to manage weight, using Acceptance and Commitment Therapy (ACT), with a person-centred approach. Young people from the Care of Childhood Obesity (CoCO) clinic in Bristol, UK, were recruited to co-develop this intervention. The study was registered on ISRCTN (ISRCTN16607863). The seven-session, ACT-based intervention was delivered one-to-one, securely online. Qualitative interviews were conducted after each intervention session was delivered. Qualitative data were coded and reviewed regularly to make iterative changes to individual sessions and the overall programme. Fourteen co-developers were recruited, of whom nine completed the co-development process (female=4; median age (IQR)=15(1.5); 4 with a parent; Indices of Multiple Deprivation (IMD) median = 3.5, range=1-10). Iterative changes made during co-development included introducing an earlier focus on eating behaviour and body image, with more practical activities to increase engagement. Thematic analysis of co-developer feedback identified four themes: theoretical understanding; delivery and receipt of therapy; view of strategies and engagement; real world benefits of co-development process. Framework analysis was conducted to map data pertaining to these themes into matrices according to each participant and session. Insights from the co-development process have shaped AIM2Change to optimise the interventions value, relevance and acceptability. Findings suggest that AIM2Change meets an unmet need in delivery of current childhood weight management services.

BackgroundRecruiting and retaining participants in sarcopenia trials is challenging due to barriers in diagnosis, case-finding, exclusion criteria, frailty and drop-out. We describe and evaluate processes used by the MET-PREVENT randomised controlled trial to improve recruitment and retention. MethodsMET-PREVENT was a two-centre, double-blinded, placebo-controlled trial examining the efficacy of metformin in patients with probable sarcopenia and either pre frailty or frailty. A telephone pre-screening step used the SARC-F questionnaire to identify those at risk of sarcopenia. The study was designed to maximise inclusion; and all study assessments could be conducted in participants homes or at a clinical research facility according to participant preference. Outcome measures were chosen to be simple and quick to collect with low burden to participants. Data on absolute numbers approached and randomised from a range of recruitment channels were analysed along with percentage conversion from approach to randomisation. The relationship between baseline factors at prescreening and conversion to randomisation (age, sex, use of walking aids, SARC-F score) was analysed to evaluated. Results1630 people were approached and 268 people expressed interest in participation - of whom 214/268 (80%) underwent telephone pre-screening and 112/214 (42%) progressed to face-to-face screening.72/112 (64%) were randomised and 70/72 (97%) completed the trial. Recruitment took place from secondary care geriatric medicine clinics and via primary care mailshots; routes where patients had already had muscle strength recorded showed greater recruitment efficiency than those that did not. At face-to-face screening, SARC-F scores of 1 to 4 showed lower efficiency of recruitment compared to 5+ (49/82 [60%] vs 23/30 [77%] respectively) but accounted for most recruits (49/72 [68%]); age and sex were not associated with differences in recruitment. The majority (148/214 [69%]) of potential participants at prescreening expressed a preference for home visits; 101/112 (90%) undertook the screening visit at home and 45/72 (63%) of those randomised undertook either or both outcome visits at home. ConclusionA package of innovations in participant identification, recruitment processes and study visits enabled recruitment to target and the achievement of very high retention rates for a condition where it has traditionally been challenging to conduct clinical trials. Trial registrationISRCTN29932357

BackgroundFalls are the leading cause of injury-related mortality and hospitalization among adults aged [&ge;] 65 years. An important modifiable fall-risk factor is use of fall-risk increasing drugs (FRIDs). However, deprescribing is not always attempted or performed successfully. The ADFICE_IT trial evaluates the combined use of a clinical decision support system (CDSS) and a patient portal for optimizing the deprescribing of FRIDs in older fallers. The intervention aims to optimize and enhance shared decision making (SDM) and consequently prevent injurious falls and reduce healthcare-related costs. MethodsA multicenter, cluster-randomized controlled trial with process evaluation will be conducted among hospitals in the Netherlands. We aim to include 856 individuals aged [&ge;] 65 years that visit the falls clinic due to a fall. The intervention comprises the combined use of a CDSS and a patient portal. The CDSS provides guideline-based advice with regard to deprescribing and an individual fall-risk estimation, as calculated by an embedded prediction model. The patient portal provides educational information and a summary of the patients consultation. Hospitals in the control arm will provide care-as-usual. Fall-calendars will be used for measuring the time to first injurious fall (primary outcome) and secondary fall outcomes during one year. Other measurements will be conducted at baseline, 3, 6, and 12 months and include quality of life, cost-effectiveness, feasibility, and shared decision-making measures. Data will be analyzed according to the intention-to-treat principle. Difference in time to injurious fall between the intervention and control group will be analyzed using multilevel Cox regression. DiscussionThe findings of this study will add valuable insights about how digital health informatics tools that target physicians and older adults can optimize deprescribing and support SDM. We expect the CDSS and patient portal to aid in deprescribing of FRIDs, resulting in a reduction in falls and related injuries. Trial registrationClinicalTrials.gov NCT05449470 (7-7-2022) Participant recruitment7 July 2022-ongoing * * Results of this study have not yet been published or submitted to any journal. Protocol version1 Trial sponsorAmsterdam UMC, Meibergdreef 9, 1105 AZ Amsterdam

BackgroundThe focus of clinical trials is typically interventions efficacy, or whether they attain their desired outcomes. Comparatively less attention is focused on understanding how or why interventions succeed, or fail to attain, those outcomes. This may be particularly important in trials of complex interventions such as surgery or physiotherapy, which are multifaceted and often tailored to individual participants, providers, or settings, increasing the potential for variations in intervention delivery and effects. The correspondence between the intervention that was planned and what was actually delivered in a trial is the interventions fidelity. Several benefits for high levels of intervention fidelity have been proposed. However, a lack of a uniform definition for fidelity and its key components may hinder intervention delivery in clinical trials and the translation of evidence-based interventions to clinical practice. MethodsIn this study, we undertook systematic review, and "Best-fit" framework synthesis to develop an empirically-based intervention fidelity framework for complex interventions in rehabilitation. ResultsThe resulting CONSIDER (Complex iNterventionS Design dElivery Recepit) framework is first integrated fidelity framework developed specifically for clinical trials of for complex interventions rehabiliation. CONSIDER consists of three main components, Design, Delivery and Receipt and the factors moderating them. Design encompasses the core elements of the intervention and the protocol for the clinical trial to evaluate its effectiveness. Delivery encompasses the actual implementation of the protocol and treatment integrity. It is focused primarily on the actions of the intervention providers. Receipt addresses the exposure of the trial participants to the intervention and their response to it. ConclusionsThis fidelity framework is the first designed suit the unique complexities and challenges presented by physical complex interventions. It can help promote transparency and reproducibility and helps researchers design clinical trials that reduce waste, enable uptake into clinical practice, and benefit the practice and evidencing of physiotherapy, surgery and other physical complex interventions.

ObjectiveLimited evidence suggests integration of pharmacists into the general practice team could improve medicines management for patients, particularly those with multimorbidity and polypharmacy. This study aimed to develop and assess the feasibility of an intervention involving pharmacists, working within general practices, to optimise prescribing in Ireland. DesignNon-randomised pilot study SettingPrimary care in Ireland ParticipantsFour general practices, purposively sampled and recruited to reflect a range of practice sizes and demographic profiles. InterventionA pharmacist joined the practice team for six months (10 hours/week) and undertook medication reviews (face-to-face or chart-based) for adult patients, provided prescribing advice, supported clinical audits, and facilitated practice-based education. Outcome measuresAnonymised practice-level medication (e.g. medication changes) and cost data were collected. Patient-Reported Outcome Measure (PROM) data were collected on a subset of older adults (aged [&ge;]65 years) with polypharmacy using patient questionnaires, before and six weeks after medication review by the pharmacist. ResultsAcross four practices, 787 patients were identified as having 1,521 prescribing issues by the pharmacists. Issues relating to potentially inappropriate or high-risk prescribing were addressed most often by the prescriber (51.8%), compared to cost-related issues (7.5%). Medication changes made during the study equated to approximately {euro}57,000 in cost savings assuming they persisted for 12 months. Ninety-six patients aged [&ge;]65 years with polypharmacy were recruited from the four practices for PROM data collection and 64 (66.7%) were followed up. There were no changes in patients treatment burden or attitudes to deprescribing following medication review, and there were conflicting changes in patients self-reported quality of life. ConclusionsThis non-randomised pilot study demonstrated that an intervention involving pharmacists, working within general practices is feasible to implement and has potential to improve prescribing quality. This study provides rationale to conduct a randomised controlled trial to evaluate the clinical and cost-effectiveness of this intervention. Article summary Strengths and limitations of this studyO_LIThis is the first study examining the role of general practice-based pharmacists in Ireland and the feasibility of evaluating this role. C_LIO_LIIntegration of pharmacists was limited to four general practices, although these were diverse in terms of practice characteristics. C_LIO_LIA range of medication and patient-reported outcome measures data were collected, although because this was a pilot study there was no control group to compare these to. C_LI

BackgroundThe World Health Organisations Medication Without Harm campaign aims to reduce severe avoidable medication related harm by 50%. This systematic review explored the characteristics of interventions that provide visual and longitudinal feedback on prescribing, or interactive dashboards, in general practice and the effect of these interventions on prescribing-related outcome measures. MethodsThis systematic review was registered prospectively and reported in line with PRISMA guidelines. Multiple databases and grey literature were searched in November 2023 to identify interventional studies that explored the effect of interactive dashboards on prescribing-related outcomes in general practice. Two independent researchers conducted screening, data extraction, and risk of bias assessment. Interventions were described narratively, and a random-effects meta-analysis was performed for comparable studies. ResultsEight randomised controlled trials, one controlled before-and-after study and three interrupted time series were included. Six studies reported a significant positive effect on prescribing-related outcomes, with an effect seen more often for studies focusing on potentially inappropriate prescribing (PIP) (four out of six). Two of the six studies that focused on antibiotic prescribing demonstrated a significant effect. A meta-analysis of three RCTs involving 160 general practices and 198,135 patients demonstrated the overall odds of PIP was 0.91 (95%CI: 0.77-1.06 I2=71.8%) in the intervention compared to control group. ConclusionInteractive dashboards show promise for supporting safe and effective prescribing in general practice. Future research should focus on developing core outcome sets to facilitate future meta-analyses of effectiveness as well as optimising their implementation and understanding how to sustain user engagement. Lay summaryThe World Health Organizations "Medication Without Harm" campaign aims to reduce preventable medication-related harm by 50%. One way to support safe prescribing is by giving prescribers ongoing feedback on their prescribing habits using interactive dashboards. These dashboards provide visual and long-term data to help guide safer and more effective prescribing. This research looked at how interactive dashboards have been used in general practice and whether their use improves prescribing. Researchers systematically searched the published literature and identified 12 relevant studies. Some studies involved randomly assigning doctors or practices to either use the dashboards or continue usual care. Others compared prescribing practices before and after introducing dashboards or looked at practices that used dashboards compared to those that did not. Six of the studies showed improvements in prescribing, especially when focused on reducing high-risk prescriptions. The data for three studies that looked at high-risk prescribing involving 160 general practices and 198,135 patients showed that interactive dashboards may reduce the chance of unsafe prescribing by 8.8%. However, this result was not statistically significant, and the difference in results between studies means the true effect remains uncertain. The findings highlight the potential of interactive dashboards to support safer prescribing in general practice, though further research is needed.