Pilot and Feasibility Studies最新文献

{"title":"Feasibility and acceptability of a two-phase survey for estimating the prevalence of mental disorders in adults with type 1 diabetes.","authors":"Jeni Baykoca, Madeleine Benton, Paul Moran, Beth Stuart, Ian Glass, Hermione Price, Khalida Ismail","doi":"10.1186/s40814-025-01669-7","DOIUrl":"10.1186/s40814-025-01669-7","url":null,"abstract":"<p><strong>Background: </strong>We assessed the feasibility and acceptability of conducting an epidemiological survey to estimate the distribution of mental disorders in a sample of adults with type 1 diabetes mellitus (T1D).</p><p><strong>Methods: </strong>Eligible participants were adults with T1D recruited from four general practices in southeast England. Phase 1 included screening measures for mental disorders in the DSM-5. Participants at phase 1 were invited to a structured clinical interview for DSM-5 at phase 2. Feasibility parameters included the proportions of those identified as eligible, consenting, and completing either or both phases, and acceptability.</p><p><strong>Results: </strong>The study population comprised 146 adults with T1D. 72% (n = 105) had correct contact details, were eligible and invited. 52% (n = 55) completed phase 1, of which 45% (n = 25) completed phase 2. Some measures had high rates of missing values and three mental disorders had concordant phase 1-2 pairs, namely schizophrenia spectrum and other psychotic disorders, depressive disorders, and substance-related and addictive disorders.</p><p><strong>Conclusions: </strong>Conducting a two-phase survey of mental disorders in people with T1D is feasible and acceptable and can be improved using methods to update current contact details; adding secondary care diabetes services (hospitals) as recruitment sites; reducing the screening measures; and omitting diagnostic interviews for those mental disorders already listed in routine medical records.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"115"},"PeriodicalIF":1.6,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12395789/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144965089","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility of an ultra-brief group cognitive behavioral skills workshops for organization, time management, and planning strategies in university students: study protocol.","authors":"Vickie Plourde, Hélène Corriveau, Shirko Ahmadi","doi":"10.1186/s40814-025-01696-4","DOIUrl":"10.1186/s40814-025-01696-4","url":null,"abstract":"<p><strong>Background: </strong>University students with ADHD and executive functioning challenges are at a higher risk of experiencing academic and functional challenges. Group cognitive-behavioral therapy (CBT) targeting organization, time management, and planning skills have shown promise in improving attention and academic functioning. However, attendance and logistic barriers may limit participation in traditional programs. This feasibility study aims to adapt and evaluate the feasibility of delivering ultra-brief, group CBT skills workshops (both in-person and online) to university students.</p><p><strong>Methods: </strong>A non-randomized pilot design with a convergent mixed-method approach will be used. From January 2024 to April 2025, 40-60 French-speaking students from Canadian postsecondary institutions that are experiencing attentional or executive challenges (with or without a formal ADHD diagnosis) will be recruited. The intervention consists of three weekly 90-min workshops, with strategies focusing on organization, time management, planning and prioritizing tasks, and managing procrastination. Data will be collected at pre- and post-workshop interventions including recruitment and retention rates, as well as standardized questionnaires assessing treatment perception, acceptability, and satisfaction (primary outcomes), along with ADHD symptoms, executive functioning, and functional impairment (secondary outcomes). Individual interviews (baseline evaluation) and focus groups (post-workshop evaluation) will further explore participants' functioning as well as expectations and experiences related to the intervention. Quantitative data will be analyzed using descriptive and inferential statistics, whereas qualitative data will undergo qualitative descriptive analysis using rapid assessment procedure (RAP) sheets.</p><p><strong>Discussion: </strong>This study will assess the \"feasibility of ultra-brief CBT skills workshops for university students with ADHD and executive functioning difficulties. If effective, it could inform scalable strategies to support academic success and daily functioning. Findings will also inform the feasibility and acceptability of this intervention for future large-scale studies.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"114"},"PeriodicalIF":1.6,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12379549/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144965140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hoosier Sport Re-Social: a protocol for developing a biopsychosocial body satisfaction intervention in rural Indiana.","authors":"Janette M Watkins, Janelle M Goss, Vanessa M Martinez Kercher, Cassandra J Coble, Nicole E Werner, R Glenn Weaver, Kyle A Kercher","doi":"10.1186/s40814-025-01695-5","DOIUrl":"10.1186/s40814-025-01695-5","url":null,"abstract":"<p><strong>Background: </strong>Body dissatisfaction is a growing concern among adolescent females, particularly those living in rural communities where access to supportive mental and physical health resources is limited. High levels of social media use and low engagement in structured physical activity are linked to negative body image, elevated anxiety, and reduced overall well-being in this population. The Hoosier Sport Re-Social intervention was developed to address these challenges by integrating sport participation, social media literacy, and mental skills training in a community-based program designed for adolescent girls.</p><p><strong>Methods: </strong>This study follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines and is structured around three aims. First, we will conduct a cross-sectional study with adolescent girls in grades 6 through 9 to examine the relationship between body satisfaction, physical activity levels, and social media use. Second, we will develop the Hoosier Sport Re-Social intervention using a co-design process that actively involves adolescents, parents, and school staff to ensure relevance and feasibility. Finally, we will conduct a mixed-methods pilot study in two rural middle and high schools to assess feasibility and acceptability. The intervention will be implemented within physical education and health classes over a 6-week period. Primary outcomes will include feasibility indicators such as recruitment, retention, fidelity, and participant engagement. Secondary outcomes will include measures of body satisfaction and social media literacy, while exploratory outcomes will examine changes in psychosocial factors and physical literacy.</p><p><strong>Discussion: </strong>This study will provide important insights into the acceptability and practicality of delivering a biopsychosocial, school-based intervention targeting body dissatisfaction among rural adolescent girls. Findings will inform future efforts to scale the program and evaluate its effectiveness in improving mental, physical, and cognitive health outcomes.</p><p><strong>Trial registration: </strong>This trial was prospectively registered with ClinicalTrials.gov (NCT06556719).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"113"},"PeriodicalIF":1.6,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12376494/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144965097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A randomised controlled trial of a faith-based culturally adapted intervention for depression in young Muslim women (IM-Adapted): a multi-site feasibility trial protocol.","authors":"Megan Smith, Andy Jones, Pashtana Zormati, Louca-Mai Brady, Allan Clark, Atiya Kamal, Farzana Karawalli, Safiya Khan, Silvana E Mengoni, Ghazala Mir, David Turner, Salman Waqar, David Wellsted, Daksha Trivedi","doi":"10.1186/s40814-025-01691-9","DOIUrl":"10.1186/s40814-025-01691-9","url":null,"abstract":"<p><strong>Background: </strong>Growing evidence suggests that mental health issues heavily impact Muslims, the largest, fastest growing minority religious group in the UK. High prevalence of anxiety and depression has been reported in young women aged 18 to 30 largely from Bangladeshi and Pakistani Muslim communities in Britain. Evidence suggests that incorporating religious and culturally adapted interventions may improve their effectiveness for Muslim populations, but their feasibility for young women in UK contexts is uncertain. This study aims to test whether a randomised controlled trial (RCT) of a faith-based intervention for young Muslim women living with depression is feasible.</p><p><strong>Methods: </strong>This study is a two-arm cluster randomised controlled feasibility trial with embedded process evaluation. Participants will be young Muslim women aged 18 to 24 years experiencing mild to moderate low mood or depression in Birmingham and London. The intervention will be delivered by trained therapists, supported by mental health support workers, once a week for 6 weeks. The two arms will be the IM-Adapted faith-based intervention and the standard NHS psychoeducation support group control with a proposed sample size of 30 per arm. Outcomes are referral, recruitment and retention rates, session attendance, adherence and acceptability of intervention, data collection, and adverse events, measured at baseline, 3 and 6 months.</p><p><strong>Discussion: </strong>The findings will provide early indication as to whether tailored mental health interventions may increase accessibility and effectiveness of support in underserved communities, addressing barriers linked to social and cultural factors. This will guide health services on the incorporation of cultural and religious adaptations in their programmes to better engage minority groups and improve mental health outcomes.</p><p><strong>Trial registration: </strong>ISRCTN, https://www.isrctn.com/ISRCTN17842222 , registered 17th April 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"112"},"PeriodicalIF":1.6,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12372288/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144965065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Combining mindfulness intervention and open-label placebo treatment for chronic pain: a protocol for a feasibility study.","authors":"Chung Jung Mun, Estrella Contreras, Yushu Xiao, Ryan Eckert, Alexandra Harting, Sathvika Damera, Iosef Perez, Hemant K Pandey, Aram S Mardian, Frank LoVecchio, Luana Colloca, Kelly E Dunn, Michael Todd, Roger B Fillingim, Mary C Davis","doi":"10.1186/s40814-025-01692-8","DOIUrl":"10.1186/s40814-025-01692-8","url":null,"abstract":"<p><strong>Background: </strong>Mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR), are efficacious mind-body treatments for chronic pain, though their modest effect sizes suggest room for improvement. Notably, recent studies indicate that mindfulness meditation does not engage the endogenous opioid system, which plays an important role in analgesia. Therefore, exploring the combination of a mindfulness-based intervention with a non-opioid treatment that activates this system is warranted. Open-label placebo (OLP), a placebo that is given to a participant without deception, has shown significant promise as a safe and potentially effective analgesic, with studies indicating its effects are mediated by the release of endogenous opioids. This study aims to evaluate the feasibility and acceptability of combining MBSR and OLP treatment compared to each intervention alone for chronic pain in a three-arm randomized controlled trial (RCT).</p><p><strong>Methods: </strong>This study will include an 8-week exposure to one of three treatments for individuals with chronic pain: MBSR-only, OLP-only, or a combined MBSR + OLP intervention. Participants will attend four in-person sessions (baseline assessment, randomization session, mid-treatment assessment, and posttreatment assessment), followed by an online assessment at a 3-month follow-up. MBSR sessions will be conducted live via Zoom. Participants in OLP groups will take placebo pills twice daily, with adherence monitored using an electronic pill bottle cap and urine riboflavin tracer testing. Daily diary assessments will be completed over 7-day periods at baseline, mid-treatment, post-treatment, and 3-month follow-up.</p><p><strong>Discussion: </strong>Findings from this single-site feasibility RCT will help refine and optimize study protocols needed for a future, fully powered multi-site efficacy trial.</p><p><strong>Trial registration: </strong>NCT06720909 . Registered 12/06/2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"111"},"PeriodicalIF":1.6,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12366083/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144965086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring tolerance and side effects of an innovative yeast-bound iron supplement: a feasibility trial.","authors":"Keely A Shaw, Thomas A Tompkins, Brendan Abrahamson-Durant, Gillian MacNevin, Jill A Parnell, Martin J MacInnis, Raylene A Reimer, Jane Shearer","doi":"10.1186/s40814-025-01690-w","DOIUrl":"10.1186/s40814-025-01690-w","url":null,"abstract":"<p><strong>Background: </strong>Iron deficiency is prevalent among female athletes, often leading to fatigue, impaired recovery, and decreased performance. Conventional oral iron supplements are associated with poor absorption and negative gastrointestinal side effects, resulting in low adherence. This feasibility trial investigated the tolerability and gastrointestinal effects of an iron-yeast complex (FeSC) supplement in physically active females to assess its potential for further study.</p><p><strong>Methods: </strong>This single-arm, mixed-methods feasibility trial recruited 14 active females (18-25 years) who consumed FeSC-fortified cookies (40 mg elemental iron) every other day for 14 days. Gastrointestinal symptoms, stress, and recovery were assessed through daily and weekly questionnaires (daily questionnaires: Gastrointestinal Symptoms Questionnaire and Short Recovery and Stress Scale; weekly questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scale; RESTQ Basic-24). Qualitative data on supplement acceptability were collected post-intervention. Feasibility was evaluated based on recruitment, retention, adherence, and safety criteria.</p><p><strong>Results: </strong>Out of 52 participants who completed our screening questionnaire, 14 (age = 22 SD 2 years; weekly physical activity = 420 SD 140 min/week) met all criteria and completed the intervention. All feasibility criteria were met, including 100% retention, adherence, and questionnaire completion rates. Participants reported good supplement tolerability, with only a few cases of mild, transient gastrointestinal symptoms. A reduction in constipation symptoms compared to baseline and a reduction in diarrhea symptoms on days cookies were consumed compared to days they were not were observed. No serious adverse events occurred. While some participants noted a metallic aftertaste, 57% indicated that they would prefer the supplement in cookie form over traditional iron pills if given the choice.</p><p><strong>Conclusions: </strong>This study demonstrates the feasibility and tolerability of FeSC supplementation in active females, with potential gastrointestinal benefits. Findings support progression to a larger trial assessing FeSC's impact on iron status and long-term adherence.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06285851. Registered on January 30, 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"110"},"PeriodicalIF":1.6,"publicationDate":"2025-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12357401/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144859500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study protocol testing feasibility of the Comfort Measures Only Time out (CMOT) to reduce distress during palliative withdrawal of mechanical ventilation.","authors":"Abigail G Fischer, Margaret L Campbell, Margaret M Hayes, Richard M Schwartzstein, Douglas B White, Susan L Mitchell, Corey R Fehnel","doi":"10.1186/s40814-025-01688-4","DOIUrl":"10.1186/s40814-025-01688-4","url":null,"abstract":"<p><strong>Introduction: </strong>Distress is experienced by more than 30% of patients during palliative withdrawal of mechanical ventilation at the end of life in the intensive care unit. There is a lack of high-quality evidence for specific approaches to risk factor identification and management of distress during this process. Structured \"time-outs\" and checklist interventions improve surgical outcomes and have been widely adopted in procedural care, but they have not been tested for use at end-of-life in intensive care unit settings.</p><p><strong>Methods: </strong>We describe the development and planned testing of a novel time-out checklist intervention, the Comfort Measures Only Time Out (CMOT) in a non-randomized single arm pilot study. Intervention development was guided by published literature and a structured inter-professional advisory panel. The intervention will be tested by clinical teams caring for 46 patients undergoing palliative withdrawal of mechanical ventilation. Nurses, physicians, advanced practice providers, and respiratory therapists will convene within an hour before withdrawal of mechanical ventilation to complete the checklist. Implementation outcomes, including feasibility, will be measured by a 12-question survey and by clinician protocol adherence. Effect size calculations will determine power for future randomized controlled trials testing efficacy of the CMOT in reducing patient distress.</p><p><strong>Discussion: </strong>This protocol will pilot test the feasibility of the CMOT, a structured time-out and checklist intervention, for WMV in the ICU. The study will inform potential changes to the protocol and intervention for a future randomized control trial. The CMOT is grounded in a quality and safety framework already adopted in procedural and critical care settings. Given high rates of distress, the CMOT will fill an identified gap in evidence surrounding the process of WMV.</p><p><strong>Trial registration: </strong>Clinical trials.gov ( NCT05861323 ); 16 May 2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"109"},"PeriodicalIF":1.6,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12345127/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144848284","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"North of England Women's Diet and ActivitY - After Breast Cancer (NEWDAY-ABC) intervention in women diagnosed with early oestrogen-positive, HER2-negative breast cancer: a randomised controlled feasibility study.","authors":"C Wilson, K Pickering, S Wane, J Cohen, C Huang, M Northgraves, H Crank, A Anderson, H Cain, R Copeland, J Gray, J Hargreaves, R J Q McNally, J M Saxton","doi":"10.1186/s40814-025-01689-3","DOIUrl":"10.1186/s40814-025-01689-3","url":null,"abstract":"<p><strong>Background: </strong>Excess body weight is associated with higher breast cancer mortality rate. This study assessed the feasibility of a co-designed weight loss intervention (NEWDAY-ABC) versus standard care in early-stage oestrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients.</p><p><strong>Methods: </strong>This was a two-arm, parallel group, randomised controlled feasibility study. Twenty-one ER + ve, HER2-ve stages I-III breast cancer patients, within 3 years of completing primary treatment (excluding endocrine therapy), were recruited from two UK National Health Service Breast Care Units and randomised (2:1) to intervention plus standard care or standard care alone. The intervention was co-designed with patients and comprised small group-based Support & Skills workshops delivered remotely via teleconference by trained lifestyle advisors and dieticians. Feasibility outcomes included recruitment rate, data quality, intervention acceptability and adherence. Exploratory clinical outcomes included weight loss, anthropometric measures, dietary change, physical activity and patient-reported outcomes.</p><p><strong>Results: </strong>Twenty-one women consented to the study, and 1 withdrew prior to randomisation, leaving 13 in the intervention group and 7 standard care controls, with 11 participants being followed up for 6 months. The overall attendance rate for intervention sessions was 79.6% (74/93 sessions completed). Body weight (candidate primary outcome for a fully powered randomised controlled trial) was reduced in the intervention group by 3.3 kg from baseline to 6 months, versus a 1.1 kg loss of body weight in the standard care control group. Furthermore, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ30) breast module symptom scale scores for breast and arm symptoms improved in the intervention arm only, accompanied by positive changes in physical activity and dietary behaviours.</p><p><strong>Conclusion: </strong>The NEWDAY-ABC intervention is feasible and showed preliminary evidence of efficacy in terms of weight loss and other important health outcomes in women with early-stage breast cancer. The clinical and cost-effectiveness of the intervention versus standard care now needs to be robustly evaluated via an adequately powered clinical trial.</p><p><strong>Trial registration number: </strong>ISRCTN15088551, registered 3 February 2020.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"108"},"PeriodicalIF":1.6,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12330054/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144799930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimal Implementation of Antimicrobial Stewardship in General Practice: protocol for a feasibility study and evaluation of a digital AMS Toolbox.","authors":"Colin H Cortie, Mary A Burns, Margaret Jordan, Judy Mullan, Grant M Russell, Nicholas Zwar, Danielle Mazza, Jan Radford, Gregory M Peterson, Indra Gajanayake, Simon Eckermann, Stephen Barnett, Caitlin Keighley, Katherine Michelmore, Christine Metusela, Fiona Williams, Marijka J Batterham, Andrew Bonney","doi":"10.1186/s40814-025-01686-6","DOIUrl":"10.1186/s40814-025-01686-6","url":null,"abstract":"<p><strong>Background: </strong>Antimicrobial resistance is a worldwide problem caused by the inappropriate use of antibiotics. In Australia, antibiotics are frequently prescribed in general practice (primary care) settings for acute respiratory infections (ARIs) despite these infections most commonly being caused by viruses. The Optimal Implementation of Antimicrobial Stewardship in General Practice (OptimasGP) study aims to provide implementation support for effective antimicrobial stewardship (AMS) interventions for ARIs. The current study will examine if a redesigned workflow, and an AMS Toolbox containing AMS resources, is an acceptable way to access AMS interventions and clinical data collected in general practice settings.</p><p><strong>Methods: </strong>A mixed-methods approach will be applied using a single-arm, pragmatic exploratory study. Data will be collected for a period of 3 months. Data collection from general practice settings in New South Wales, Australia, will involve the participation of 4 to 6 practices, 12 general practitioners (GPs), and 6 to 8 practice staff. We also aim to recruit 50-100 patients to complete surveys and 12 patients to participate in focus group discussions. Participating GPs and practice staff will be provided with an online AMS Toolbox to facilitate access to AMS resources. Two hours of online training and a reminder card will also be provided. The AMS Toolbox will contain AMS resources for shared decision-making, clinical decision support (including point-of-care testing), and delayed antibiotic prescribing in patients with ARIs. The primary outcome of the study will be the acceptability of the AMS Toolbox to GPs, practice staff, and patients. Secondary outcomes will include recruitment and completion rates, qualitative findings from the focus group discussions, resource use and antibiotic prescription rates, patient-reported outcome measures (PROMs), and patient-reported experience measures (PREMS).</p><p><strong>Discussion: </strong>AMS interventions are needed to help reduce inappropriate antibiotic prescribing for ARIs in general practice settings. The findings of this study will inform a hybrid type 3 implementation trial.</p><p><strong>Trial registration: </strong>Registered prospectively with the Australian and New Zealand Clinical Trial Registry (ACTRN12624001011572) on 20 August 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"106"},"PeriodicalIF":1.6,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12309048/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144753987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A protocol for a pilot randomised controlled trial of a Tailored Intervention for people with moderate-to-severe Chronic Obstructive Pulmonary Disease and Co-morbidities delivered by Pharmacists and Consultant respiratory Physicians (TICC-PCP) in Scotland.","authors":"Richard Lowrie, David Anderson, Aziz Sheikh, Jane Moir, Andrew McPherson, Bethany Stanley, Gillian Cameron, Lynda Attwood, Donald Noble, Elaine Rankine, Jennifer Anderson, Nicola Greenlaw, Fiona Hughes, Emma McIntosh, Samuel Owusu Achiaw, Caitlin Jones, Frances S Mair","doi":"10.1186/s40814-025-01681-x","DOIUrl":"10.1186/s40814-025-01681-x","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Symptomatic chronic obstructive pulmonary disease (COPD) is a global health problem associated with a number of co-morbidities, disproportionately affecting people who are poor. Sub-optimal management of symptomatic COPD and co-morbidities negatively impacts quality of life, ability to work and survival. Previous trials of healthcare professional-led complex interventions have targeted COPD management, but not also simultaneously targeted the treatment of co-morbidities. Recommendations for complex intervention testing include feasibility studies followed by pilot randomised controlled trials (RCTs), including economic and parallel process evaluations. Following a feasibility study, a Tailored, home-based Intervention for people with COPD and Co-morbidities by generalist prescribing Pharmacists collaborating with Consultant respiratory Physicians (TICC PCP) is undergoing pilot testing. The pilot study aims to recruit at least 70% of invited participants within 4 months; deliver TICC PCP to at least 70% of participants in the intervention arm; retain at least 80% of participants (excluding those who died or developed incapacity before the end of the study) until 21-month data collection; and collect at least 90% of in person data at each study time point. In addition, findings from the economic and process evaluations along with information obtained on the proposed quantitative efficacy outcomes inform on the sample size required for a subsequent definitive RCT will help inform on future research.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We describe methods for a multicentre pilot RCT, with parallel economic and qualitative process evaluations of TICC PCP. Set in Glasgow and Edinburgh (Scotland), we plan to recruit 100 people with symptomatic COPD and conduct home-based assessments at baseline and at subsequent three monthly follow up visits over a period of 21 months. Independent researchers will collect extensive health and social care data at recruitment (baseline) before participants are randomised (stratified by site and number of respiratory hospitalisations in the past 12 months), to TICC PCP in addition to usual care (UC), or UC alone. Collected data will include objective and subjective measures of health, healthcare utilisation (including prescribing), home circumstances, health related quality of life, healthcare resource use and intervention costs. Follow up data will be collected three monthly for 21 months. The intervention, delivered by NHS Pharmacists visiting participants at home monthly for 6 months, then every 2 months for the next 6 months, involves clinical assessment and intervention at home including prescribing for COPD and co-morbidities. Pharmacists will also assess and help participants to address wider health needs, e.g. appointment attendance and home equipment. Pharmacists will collaborate mainly with consultant respiratory physicians, and General Practitioners.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/stron","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"105"},"PeriodicalIF":1.6,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12308892/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144754049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}