Pilot and Feasibility Studies最新文献

{"title":"SENSE-Cog Residential Care: hearing and vision support for residents with dementia in long-term care in Ireland-protocol for a pilot cluster-randomised controlled trial.","authors":"J P Connelly, Erin Boland, Brenda Buckley, Niall Curley, Amr El Refaie, Miriam Galvin, Matthew Gibb, Liz Graham, Brendan Lennon, Alejandro Lopez Valdes, Ann-Michelle Mullally, Nicole Müller, Janice Nolan-Palmer, Gerald O' Nolan, Cíara O'Reilly, Valeria Raaft Rezk, Helen Rochford-Brennan, Katy Tobin, Helen Tormey, Dominic Trépel, Iracema Leroi","doi":"10.1186/s40814-024-01582-5","DOIUrl":"10.1186/s40814-024-01582-5","url":null,"abstract":"<p><strong>Background: </strong>Hearing and vision loss is highly prevalent in residents with dementia (RwD) living in long-term care (LTC) facilities. Sensory loss often has a negative impact on quality of life and other dementia-related outcomes. Optimising sensory function may improve dementia-related outcomes in LTC facilities. The SENSE-Cog Residential Care pilot trial will evaluate whether a multi-faceted hearing and vision intervention for RwD and concurrent sensory loss is suitable for definitive testing in a large-scale cluster-randomised control trial (RCT) in Ireland and how this can best be achieved.</p><p><strong>Methods: </strong>This is a 6-month feasibility-pilot, multicentre, cluster RCT. Between eight and 15 LTC facilities (with an average of 5 RwD recruited per home) will be randomly assigned to receive either 'care as usual' (CAU) or a multi-component sensory intervention comprising (1) personalised resident hearing and vision support, (2) staff training in sensory health, (3) fostering a 'sensory friendly' environment, and (4) mapping sensory care provision with community-based audiologists and opticians. The intervention's feasibility, acceptability, and tolerability for residents and staff will be examined. In addition, a battery of exploratory outcome measures will be evaluated for suitability for the definitive trial and to inform the choice of primary and secondary outcome measures.</p><p><strong>Discussion: </strong>If the SENSE-Cog Residential Care pilot trial demonstrates that the sensory support intervention for residential care is feasible and tolerated in LTC facilities in Ireland, a larger definitive trial to evaluate its effectiveness in improving dementia-related outcomes will be conducted. Training materials, resources, and information will be made available to health and social care providers to enable the implementation of sensory support for RwD in routine LTC, potentially improving the quality of such care in Ireland.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN14462472. Registered 24 February 2022, https://doi.org/10.1186/ISRCTN14462472.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"17"},"PeriodicalIF":1.5,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11818014/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143409934","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":"Protocol for a single-arm feasibility trial of virtual family-centered rounds: increasing opportunities for family engagement among caregivers with language preference other than English.","authors":"Adrienne E Hoyt-Austin, Erika N Zerda, Daniel J Tancredi, James P Marcin, Audriana Ketchersid, Elva T Horath, Trevor R Bushong, Daniel S Merriott, Patrick S Romano, Kristin R Hoffman, Jennifer L Rosenthal","doi":"10.1186/s40814-025-01599-4","DOIUrl":"10.1186/s40814-025-01599-4","url":null,"abstract":"<p><strong>Background: </strong>Telehealth use during family-centered rounds in the neonatal intensive care unit has been shown to shorten length of hospitalization and improve breastfeeding outcomes. For families who speak languages other than English, access to and use of telehealth technologies can be impeded by lack of interpreter services. We aim to evaluate the feasibility of telehealth use during family-centered rounds in the neonatal intensive care unit for families who speak languages other than English.</p><p><strong>Methods: </strong>In this study proposal, we will conduct an intervention evaluation using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to assess the feasibility of telehealth use during family-centered rounds among families who speak languages other than English in a single-arm feasibility trial. We will provide language-appropriate materials to assist parents with accessing the telehealth technology and bring interpreters into the telehealth encounter directly with neonatal providers. All eligible infants whose families speak languages other than English in a single-site level 4 neonatal intensive care unit during the study period will be included. These families can participate in hospital rounds via telehealth, in-person, or not participate in hospital rounds. We will examine feasibility objectives that assess parental uptake of telehealth for rounds, parental participation in rounds, presence of a certified medical interpreter, telehealth technical issues, and parental survey response rates. We will conduct a mixed methods implementation evaluation using the RE-AIM framework. Exploratory outcomes include parent attendance, length of hospitalization of the infant, human milk feeding, frequency of medical error, parent-reported experience, parental comfort with their child's care, and parental quality of life will be collected.</p><p><strong>Discussion: </strong>This study will aid in understanding gaps to telehealth care in languages other than English. We believe this approach will improve health outcomes for hospitalized premature infants, understanding of medical conditions, improve parental quality of life, and reduce inequities in access to healthcare via telehealth technologies.</p><p><strong>Trial registration: </strong>NCT05917899 Limited English Proficiency Virtual Family-Centered Rounds, first posted June 26, 2023, last update posted November 11, 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"16"},"PeriodicalIF":1.5,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11816777/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143409917","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 self-management intervention for newly diagnosed with inflammatory arthritis: a randomized controlled feasibility and fidelity study.","authors":"Luise Holberg Lindgren, Tanja Thomsen, Merete Lund Hetland, Mette Aadahl, Sara Danshøj Kristensen, Annette de Thurah, Bente Appel Esbensen","doi":"10.1186/s40814-025-01601-z","DOIUrl":"10.1186/s40814-025-01601-z","url":null,"abstract":"<p><strong>Background: </strong>Inflammatory arthritis affects approximately 2-3% of adults worldwide. For patients newly diagnosed with arthritis, effective self-management is crucial, as they often face several physiological, emotional, and social challenges. A self-management intervention called NISMA was thus developed to cater to this group. This study aimed to evaluate the feasibility and fidelity of this intervention before conducting a full-scale randomized controlled trial.</p><p><strong>Methods: </strong>This feasibility study was conducted as a single-center randomized controlled trial. Twenty participants were expected to be sufficient for assessing the feasibility outcomes. The control group received only the usual care, while the intervention group received the NISMA intervention in addition, which involved individual and group sessions in a multidisciplinary setting. Feasibility was evaluated based on the recruitment, data collection, retention, and randomization processes. The patient-reported outcome measures and clinical measures were collected to review their potential for inclusion in a future randomized controlled trial. Fidelity was assessed by using documentation sheets filled in by the health professionals and audio recordings of the sessions to examine whether the intervention's principles and components were adequately addressed.</p><p><strong>Results: </strong>Among 47 eligible patients, we recruited 23 participants during a period of 4 months. The recruitment rate was 47% and the retention rate 91%. Randomization, although accepted, led to some disappointment in the control group. Data collection was effective, with only minimal missing data (< 1%). The fidelity was considered as high, as results indicated that nurses effectively engaged in collaborative partnerships with patients, utilizing planned questioning techniques and self-management strategies for problem-solving and resource utilization. However, action planning was inconsistently applied.</p><p><strong>Conclusion: </strong>The study demonstrated the feasibility and the overall high fidelity of delivering the NISMA intervention to patients newly diagnosed with inflammatory arthritis. The insights from the study are useful for identifying the areas that require modifications before initiating a randomized controlled trial.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID: NCT06063252. Registered 02 October 2023 - retrospectively registered.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"15"},"PeriodicalIF":1.5,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11817759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143399667","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":"Shortening duration of untreated illness in young people with first episode eating disorders: protocol of a randomised controlled feasibility trial of a smartphone friendly multi-modal decision-making tool (FREED-M) to improve help-seeking.","authors":"Luiza Grycuk, Dina Monssen, Molly R Davies, Helen Sharpe, Karina L Allen, Vibhore Prasad, Rachel Potterton, Priya Popat, Victoria A Mountford, Sheryllin McNeil, Vanessa Lawrence, Nina Grant, Kimberley A Goldsmith, Danielle Glennon, Sarah Byford, Amy Brown, Ulrike Schmidt","doi":"10.1186/s40814-024-01585-2","DOIUrl":"10.1186/s40814-024-01585-2","url":null,"abstract":"<p><strong>Background: </strong>Early intervention gives young people the best chance to recover from eating disorders (EDs). An important focus of early intervention is shortening the time between a person first developing symptoms and starting treatment (duration of untreated eating disorder; DUED). Patient-related factors (e.g. poor mental health literacy and help-seeking difficulties) are strongly associated with DUED. The aims of our study are to co-design and test the feasibility of FREED-Mobile (FREED-M), an online intervention tool for young people with early-stage EDs. This tool aims to improve knowledge about EDs, increase motivation to seek treatment and teach early steps towards change or recovery, thus reducing DUED.</p><p><strong>Methods: </strong>We will carry out a randomised controlled feasibility trial comparing the FREED-M tool with a control intervention where individuals are sign-posted to an ED charity website. The objectives of the proposed trial are to establish/estimate: (a) attrition rates at follow-up (primary feasibility outcome); (b) participant recruitment; (c) intervention uptake, completion rates and acceptability; (d) intervention effect sizes and standard deviations for outcomes to inform the sample size calculation for a large-scale randomised controlled trial (RCT); (e) stakeholder views on the intervention. We aim to recruit 116 participants (young people, aged 16-25, with first episode ED) from primary care, schools and universities, ED services and social media. Online assessments will be carried out at baseline, end of intervention and follow-up (weeks 0, 4 and 12 post-randomisation, respectively). Outcomes will include motivation and readiness to change, attitudes and intentions towards help-seeking, ED symptoms, mood and social functioning, and health-related quality of life. Additionally, we will carry out a qualitative evaluation of participants' views of the intervention and study design.</p><p><strong>Discussion: </strong>The results of this feasibility trial will inform adaptations to the intervention as needed, as well as the study design (e.g. sample size, primary outcomes) of a future large-scale RCT to assess the effectiveness of the FREED-M intervention. If effective, this novel, online intervention has the potential for wide dissemination and for substantially reducing DUED to improve long-term patient outcomes.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN15662055. Registered 27 July 2022, https://www.isrctn.com/ISRCTN15662055 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"14"},"PeriodicalIF":1.5,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11804029/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143370933","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":"Evaluation of a transdiagnostic mental health intervention in German primary care: study protocol for a parallel-group, two-arm, cluster randomised controlled pilot study.","authors":"Christopher Ebert, Marie Vogel, Jochen Gensichen, Hanna Reif, Lena Grögor, Lukas Junker, Thomas Ehring, Alkomiet Hasan, Stefan Leucht, Kirsten Lochbühler","doi":"10.1186/s40814-025-01597-6","DOIUrl":"10.1186/s40814-025-01597-6","url":null,"abstract":"<p><strong>Background: </strong>General practitioners play an important role in the first-line care of individuals with mental health conditions. However, factors such as time constraints, limited experience in managing mental health conditions and high rates of comorbidity may hinder adequate treatment. To improve psychological care, adopting a transdiagnostic approach shows potential. Research on transdiagnostic interventions delivered by general practitioners is scarce. Thus, a transdiagnostic intervention adapted from the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was developed specifically for primary care. In a parallel-group, two-arm, cluster randomised controlled pilot study, the transdiagnostic intervention will be evaluated for feasibility, acceptability and potential effectiveness in German primary care.</p><p><strong>Methods: </strong>A total of 100 adult patients with a mental health condition will be recruited by general practitioners. In the intervention group, general practitioners will administer the transdiagnostic intervention, introducing patients to psychological concepts based on transdiagnostic factors (i.e., understanding emotions, cognitive flexibility, countering emotion-based avoidance). In the control group, general practitioners will provide improved treatment as usual oriented on official German treatment guidelines for depression, anxiety and somatoform disorders. In both study groups, treatment will be carried out in four 20-min sessions over 12-weeks. Self-report questionnaires will be completed before treatment initiation (only patients) and after treatment completion (patients and general practitioners) to assess feasibility and acceptability (i.e., treatment recruitment, delivery, response, effectiveness, unintended consequences and maintenance) as well as potential effectiveness (i.e., change in transdiagnostic factors).</p><p><strong>Discussion: </strong>The pilot study will address the research gap concerning general practitioner-led psychological interventions in primary care and will give insights into whether the adoption of a transdiagnostic approach is of benefit to general practitioners and patients. Findings may inform the design of a main trial by identifying barriers to the transdiagnostic intervention's feasibility and acceptability, whilst advancing treatment delivery protocols to support effectiveness.</p><p><strong>Trial registration: </strong>The protocol for this study has been registered with the German Clinical Trials Register: DRKS00033386, Date of registration: 18^th of March 2024, https://drks.de/search/en/trial/DRKS00033386 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"13"},"PeriodicalIF":1.5,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784113/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143075074","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":"Telehealth group intervention for adolescents and young adults with cancer: a feasibility pilot study protocol.","authors":"Sherilynn F Chan, Joanna Patten, Nancy Lau","doi":"10.1186/s40814-024-01590-5","DOIUrl":"10.1186/s40814-024-01590-5","url":null,"abstract":"<p><strong>Background: </strong>Providing opportunities for social interaction and access to psychosocial interventions are 2 of the 15 Standards for Psychosocial Care for Children with Cancer and Their Families. Peer relationships are especially important among adolescents and young adults (AYAs), and cancer disrupts this aspect of social development. Many AYAs with cancer report a desire to engage in peer support groups; however, this remains a critical unmet need. Telehealth is a cost-effective and increasingly common modality for delivering health care that reduces access barriers and may be an especially good fit for AYAs with cancer. Little work has evaluated the feasibility and acceptability of peer support groups for AYAs with cancer. The purpose of this study is to evaluate the feasibility and acceptability of a telehealth peer support group intervention for AYAs with cancer.</p><p><strong>Methods: </strong>Telehealth group interventions are offered twice yearly as standard of care at Seattle Children's Hospital to AYAs on or off treatment for cancer or a brain tumor. Group members are assigned to a High School Group (grades 9-12) or an AYA Group (spring of grade 12 or older). Aim 1 is to determine the feasibility and acceptability of the intervention for all patients who participate in groups in their clinical care. Feasibility will be assessed based on a priori metrics (enrollment, attendance, attrition) for all group members. Group and telehealth acceptability will be assessed by a 16-item internally developed measure that was adapted from the Client Satisfaction Questionnaire. Aim 2 is to conduct patient stakeholder semi-structured interviews post-intervention with 20 AYAs to gather feedback and inform intervention refinement. Participants who opt-in for study procedures will also complete exploratory measures of social connectedness/isolation, depression, and benefit finding, pre- and post-intervention (Aim 3).</p><p><strong>Discussion: </strong>Findings from this pilot study will inform intervention refinement, intervention implementation, and sample sizes for future powered trials. This study will provide preliminary empirical evidence to support the development of effective group interventions for AYAs with cancer that increase opportunities for social interaction and access to peer support, with the potential to contribute to improved psychosocial care of AYAs with cancer.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"12"},"PeriodicalIF":1.5,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11783718/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143075078","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":"Protocol for a feasibility study evaluating a supported self-management intervention for stroke survivors with aphasia (StarStep study).","authors":"Faye Wray, Madeline Cruice, Ian Kellar, Anne Forster","doi":"10.1186/s40814-024-01589-y","DOIUrl":"10.1186/s40814-024-01589-y","url":null,"abstract":"<p><strong>Background: </strong>There is a growing evidence base to support the use of self-management interventions for improving quality of life after stroke. However, stroke survivors with aphasia have been underrepresented in research to date. It is therefore unclear if self-management is an appropriate or effective approach for this group. To address this gap in the evidence base, we have developed a supported self-management intervention (the 'Living with Aphasia' intervention) specifically for stroke survivors with aphasia in the first year after stroke. The StarStep study aims to assess the feasibility of implementing and evaluating the intervention (including the feasibility of participant recruitment, the feasibility of delivering facilitator training, the acceptability of the intervention, the fidelity of intervention delivery and outcome data completeness).</p><p><strong>Methods: </strong>StarStep is a mixed-methods, non-randomised feasibility study. The Living with Aphasia intervention will be facilitated by speech and language therapists and implemented in two community stroke teams in the north of England. We aim to recruit 30 stroke survivors who have aphasia (and/or their family members) and who are ≤ 12-month post-stroke to participate in data collection for the study. Following informed consent, participants will complete a baseline data collection questionnaire which will include measures of quality of life, symptoms of depression and perceived communicative effectiveness. Follow-up questionnaires will be completed at 3-month post-intervention. Qualitative data collection will include implementation groups and semi-structured interviews with speech and language therapists, semi-structured interviews with stroke survivors with aphasia (and/or their family members) and observations of the delivery of the intervention. A joint display table will be used to integrate findings from each element of data collection in order to consider overall feasibility.</p><p><strong>Discussion: </strong>This study will provide the information necessary to optimise data collection processes and to optimise the implementation and delivery of the self-management intervention. Feasibility data will inform decision-making regarding progression to a future definitive cluster randomised controlled trial to evaluate the effectiveness of the intervention.</p><p><strong>Trial registration: </strong>ISRCTN registry, trial registration number: ISRCTN10401966. Date of registration: 07/10/2023. URL of trial registry record: https://doi.org/10.1186/ISRCTN10401966 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"11"},"PeriodicalIF":1.5,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11780826/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067223","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":"Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trial.","authors":"Hassan Mir, Javad Heshmati, Kerri-Anne Mullen, Ashley Baldwin, Evyanne Quirouette, Andrew Pipe, Robert Reid","doi":"10.1186/s40814-024-01591-4","DOIUrl":"10.1186/s40814-024-01591-4","url":null,"abstract":"<p><strong>Background: </strong>Cigarette smoking is a leading cause of death and disease, including those related to the cardiovascular system. Cytisine is a plant-based medication, which works in a similar mechanism to varenicline. It is safe, efficacious, and cost-effective for smoking cessation. While there are effective therapies such as nicotine replacement therapy, bupropion, varenicline, and cytisine for smoking cessation, relapse remains common. It is unclear how best to support these individuals. This study aims to assess the feasibility of randomizing patients who relapse to combination NRT or cytisine after admission to a cardiac hospital.</p><p><strong>Study design: </strong>Randomized, two-group parallel feasibility trial.</p><p><strong>Methods: </strong>This trial will recruit relapsed smokers from the University of Ottawa Heart Institute. Participants will be randomized 1:1 to receive cytisine or combination NRT, alongside counseling and follow-up support. Feasibility outcomes include recruitment rates and treatment completion. Secondary outcomes include smoking cessation rates and adverse events. A total of 60 participants will be recruited using stratified randomization by sex to ensure gender balance. Data will be analyzed descriptively, focusing on feasibility and efficacy measures to inform future trials.</p><p><strong>Discussion: </strong>The primary aim of this study is to evaluate the feasibility of recruiting patients who were recently admitted to the hospital and have relapsed to smoking within 180 days post-discharge. This will inform future studies aimed at recruiting patients who have relapsed to understand how best to support them to quit smoking. This study will also compare the acceptability, efficacy, and safety of cytisine compared to combination NRT, as demonstrated in previous studies in other populations. Notably, cytisine's shorter regimen and natural composition broaden its appeal, potentially supporting a wider spectrum of people who smoke. The study's robust design, infrastructure, and expertise enhance its feasibility. Future research avenues, especially among cardiac patients and relapsed individuals, promise further insights, potentially transforming cessation strategies worldwide.</p><p><strong>Trial registration: </strong>Registered at Clinicaltrials.gov (CT04286295) on 14 March 2022. https://clinicaltrials.gov/study/NCT04286295?locStr=Canada&country=Canada&intr=Cytisine&rank=3 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"10"},"PeriodicalIF":1.5,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773697/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143060191","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":"The feasibility of assessing prognosis over 3 years in persons with a previous stroke/transient ischemic attack in general practice.","authors":"Eimear Ryan, Harmeet Gill, Róisín Doogue, David McCann, Andrew W Murphy, Peter Hayes","doi":"10.1186/s40814-025-01595-8","DOIUrl":"10.1186/s40814-025-01595-8","url":null,"abstract":"<p><strong>Background: </strong>Stroke has devastating consequences for survivors. Hypertension is the most important modifiable risk factor, and its management largely takes place in primary care. However, most stroke-based research does not occur in this setting. Ongoing hypertension and a risk of further stroke are a major concern for both patients and their general practitioners. We aim to assess whether it is feasible to assess prognosis in persons, with a previous stroke or transient ischemic attack (TIA), in general practice, and whether a well-powered observational study is possible.</p><p><strong>Methods: </strong>We performed a search of the electronic health record of individuals previously identified as having had a stroke or TIA, to assess prognosis over 3 years. Feasibility was assessed by meeting five criteria: (1) all general practices approached participated, (2) greater than 90% of patient records were accessible, (3) all study outcomes were available to review, (4) that collection data was less than 15 min per patient, and (5) a power calculation for a planned observational study could take place.</p><p><strong>Results: </strong>All six general practices approached participated freely, and 193/196 patients' files were reidentified (98.5%). Twenty-eight cardiovascular events were recorded-most commonly a repeat TIA or ischemic stroke. Data collection took on average 5.5 min per file, and a power calculation for a planned observational study was completed.</p><p><strong>Conclusion: </strong>This study demonstrates that the proposed methodology for a full cohort study within general practice of patients post-stroke/TIA is both acceptable to practices and feasible. An adequately powered, \"time-to-event\" study is possible.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"9"},"PeriodicalIF":1.5,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11762887/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143041004","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":"Rapid Adaptation to Prevent Drug Use (RAPD): protocol of a pilot randomized trial to enhance the impact of an evidence-based intervention for youth.","authors":"Andria B Eisman, Christine Koffkey, Robert T Partridge, Suzanne Brown, Bo Kim","doi":"10.1186/s40814-024-01581-6","DOIUrl":"10.1186/s40814-024-01581-6","url":null,"abstract":"<p><strong>Background: </strong>Drug use trends change rapidly among youth, leaving intervention experts struggling to respond promptly. Delays in responses can lead to preventable morbidity and mortality. The COVID-19 pandemic underscored the need for implementation science to facilitate rapid, equitable responses using existing treatment and prevention efforts. Existing, widely adopted evidence-based interventions (EBIs; e.g., the Michigan Model for Health™: MMH) are well suited to address emerging drug trends. We have a critical need to advance implementation strategies to optimize system responsiveness to these emerging drug issues. This research aims to design and test implementation strategies to (1) improve the responsiveness of school-based EBIs in addressing urgent issues and (2) find ways to support teachers in implementing updated EBIs, attending to unique considerations of schools serving economically disadvantaged students.</p><p><strong>Methods: </strong>The research aims are as follows: aim 1: identify implementation gaps and best practices using After Action Review (a reflective process used by health organizations in responding to emergent public health events) using qualitative methods. Aim 2: design and pilot test RAPD (Rapid Adaptation to Prevent Drug use) based on aim 1 findings. RAPD refers to a novel set of implementation strategies designed to enhance the capacity of an existing, widely adopted evidence-based universal prevention curriculum (MMH) to respond to emerging drug issues among youth. We will pilot test RAPD in ten middle schools serving diverse student populations using a two-group, mixed method, cluster randomized controlled trial design. Aim 3: assess the costs and benefits of RAPD from multiple partner perspectives using a mixed methods approach.</p><p><strong>Discussion: </strong>This study focuses on designing and deploying implementation strategies to reduce the detrimental impact of emerging drugs and provide an infrastructure to make future adaptations that can be applied in other contexts. After Action Review (AAR) provides a valuable opportunity to review the statewide response to past drug use events, specifically the vaping crisis, using the MMH curriculum, which can systematically guide implementation strategy selection and deployment to meet identified gaps. The rationale for the proposed research is that designing and testing RAPD will advance implementation science in responding to urgent public health events and ensure equitable responses across youth populations.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05806840 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"8"},"PeriodicalIF":1.5,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11748840/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143009804","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}