scholarly journals Development and implementation of a nurse-led allergy clinic model in primary care: feasibility trial protocol

2019 ◽  
Vol 29 (1) ◽  
Author(s):  
Margaret Kelman ◽  
Victoria Hammersley ◽  
Marilyn Kendall ◽  
Mome Mukherjee ◽  
Lynn Morrice ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Allergy Clinic ◽  
Randomised Controlled

AbstractIn the United Kingdom, there are acknowledged short comings in allergy care provision for patients seen in primary care. There is a lack of allergy training for healthcare professionals and this leads to inappropriate referrals to the limited number of allergy specialists. The primary aims of this study are to assess the feasibility of delivering and evaluating a new nurse-led allergy service in primary care, measured by recruitment, retention and quality of life. This is a single arm feasibility trial in which up to 250 participants referred to the nurse-led allergy clinic will receive the intervention and complete 6–12 weeks follow-up before being referred back to their usual care. Primary outcomes for this study will be establishment of clinics, recruitment and retention rates, and estimates of change in disease-specific quality of life measures. Secondary outcomes will be acceptability of the new service to participants/carers and healthcare professionals. A sample of participants and professional stakeholders will take part in more in-depth semi-structured qualitative interviews. Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.

scholarly journals PartnerCARE—a psycho-oncological online intervention for partners of patients with cancer: study protocol for a randomised controlled feasibility trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e035599
Author(s):  
Daniela Bodschwinna ◽  
Inga Lorenz ◽  
Natalie Bauereiss ◽  
Harald Gündel ◽  
Harald Baumeister ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Online Intervention ◽  
Feasibility Trial ◽  
Control Group ◽  
Negative Effects ◽  
Total N ◽  
Patients With Cancer ◽  
Randomised Controlled

IntroductionCancer burdens not only the patient but also the partner to a comparable extent. Partners of patients with cancer are highly involved in the caring process and therefore often experience distress and report a low quality of life. Interventions for supporting partners are scarce. Existing ones are rarely used by partners because they are often time-consuming per se and offer only limited flexibility with regard to schedule and location. The online intervention PartnerCARE has been developed on the basis of caregiver needs and consists of six consecutive sessions and four optional sessions, which are all guided by an e-coach. The study aims to evaluate feasibility and acceptance of the online intervention PartnerCARE and the related trial process. In addition, first insights of the putative efficacy of PartnerCARE should be gained.Methods and analysisA two-arm parallel-group randomised controlled trial will be conducted to compare the PartnerCARE online intervention with a waitlist control group. The study aims to recruit in total n=60 partners of patients with any type of cancer across different access paths (eg, university medical centres, support groups, social media). Congruent with feasibility study objectives, the primary outcome comprises recruitment process, study procedure, acceptance and satisfaction with the intervention (Client Satisfaction Questionnaire adapted to Internet-based interventions), possible negative effects (Inventory of Negative Effects in Psychotherapy) and dropout rates. Secondary outcomes include quality of life, distress, depression, anxiety, caregiver burden, fear of progression, social support, self-efficacy, coping and loneliness. Online measurements will be performed by self-assessment at three time points (baseline/pre-randomisation, 2 months and 4 months after randomisation). Data analyses will be based on intention-to-treat principle.Ethics and disseminationEthics approval has been granted by the Ethics Committee of the University of Ulm (No 390/18). Results from this study will be disseminated to relevant healthcare communities, in peer-reviewed journals and at scientific and clinical conferences.Trial registration numberDRKS00017019.

scholarly journals A feasibility, randomised controlled trial of a complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF): study protocol

2019 ◽  
Vol 5 (4) ◽  
pp. 00186-2019 ◽  
Author(s):  
Caroline Wright ◽  
Simon P. Hart ◽  
Victoria Allgar ◽  
Anne English ◽  
Flavia Swan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Usual Care ◽  
Study Protocol ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Randomised Controlled

IntroductionIdiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung disease that causes breathlessness and cough that worsen over time, limiting daily activities and negatively impacting quality of life. Although treatments are now available that slow the rate of lung function decline, trials of these treatments have failed to show improvement in symptoms or quality of life. There is an immediate unmet need for evidenced-based interventions that improve patients' symptom burden and make a difference to everyday living. This study aims to assess the feasibility of conducting a definitive randomised controlled trial of a holistic, complex breathlessness intervention in people with IPF.Methods and analysisThe trial is a two-centre, randomised controlled feasibility trial of a complex breathlessness intervention compared with usual care in patients with IPF. 50 participants will be recruited from secondary care IPF clinics and randomised 1:1 to either start the intervention within 1 week of randomisation (fast-track group) or to receive usual care for 8 weeks before receiving the intervention (wait-list group). Participants will remain in the study for a total of 16 weeks. Outcome measures will be feasibility outcomes, including recruitment, retention, acceptability and fidelity of the intervention. Clinical outcomes will be measured to inform outcome selection and sample size calculation for a definitive trial.Ethics and disseminationYorkshire and The Humber – Bradford Leeds Research Ethics Committee approved the study protocol (REC 18/YH/0147). Results of the main trial and all secondary end-points will be submitted for publication in a peer-reviewed journal.

scholarly journals Singing for people with aphasia (SPA): a protocol for a pilot randomised controlled trial of a group singing intervention to improve well-being

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e025167 ◽  
Author(s):  
Mark Tarrant ◽  
Mary Carter ◽  
Sarah Gerard Dean ◽  
Rod S Taylor ◽  
Fiona C Warren ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Public Involvement ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Well Being ◽  
Retention Rates ◽  
Short Version ◽  
Randomised Controlled

IntroductionThe singing for people with aphasia (SPA) intervention aims to improve quality of life and well-being for people with poststroke aphasia. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost effectiveness of SPA. The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design.Methods and analysisA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation. Forty-eight participants discharged from clinical speech and language therapy will be individually randomised 1:1 to SPA (10 group sessions plus a resource booklet) or control (resource booklet only). Outcome assessment at baseline, 3 and 6 months postrandomisation include: ICEpop CAPability measure for adults, Stroke and Aphasia Quality of Life, EQ-5D-5L, modified Reintegration into Normal Living Index, Communication Outcome After Stroke, Very Short Version of the Minnesota Aphasia Test, Service Receipt Inventory and Care Related Quality of Life. Feasibility, acceptability and process outcomes include recruitment and retention rates, with measurement burden and trial experiences being explored in qualitative interviews (15 participants, 2 music facilitators and 2 music champions). Analyses include: descriptive statistics, with 95% CIs where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis.Ethics and disseminationNHS National Research Ethics Service and the Health Research Authority confirmed approval in April 2017; recruitment commenced in June 2017. Outputs will include: pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised intervention manual for multicentre replication of SPA; presentations at conferences, public involvement events; internationally recognised peer reviewed journal publications, open access sources and media releases.Trial registration numberNCT03076736.

scholarly journals Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design—a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e035787
Author(s):  
Dumbor Ngaage ◽  
Natasha Mitchell ◽  
Alexandra Dean ◽  
Claire Hirst ◽  
Enoch Akowuah ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Cardiac Rehabilitation ◽  
Hospital Discharge ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Median Sternotomy ◽  
Retention Rates ◽  
Upper Body ◽  
Feasibility Trial ◽  
Randomised Controlled

IntroductionFollowing cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier.Methods and analysesThis is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18–80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial.Ethics and disseminationEthics approval was granted by East Midlands—Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders.Trial registration numberISRCTN80441309

scholarly journals Primary care treatment of insomnia: study protocol for a pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy to sleep hygiene (the HABIT trial)

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e036248
Author(s):  
Simon D Kyle ◽  
Claire Madigan ◽  
Nargis Begum ◽  
Lucy Abel ◽  
Stephanie Armstrong ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Sleep Hygiene ◽  
Sleep Restriction ◽  
Insomnia Disorder ◽  
Randomised Controlled ◽  
Insomnia Severity

IntroductionInsomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared with sleep hygiene advice.Methods and analysisIn the HABIT (Health-professional Administered Brief Insomnia Therapy) trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over 4 weekly sessions; total therapy time is approximately 1 hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the Insomnia Severity Index at 6 months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention-to-treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed.Ethics and disseminationEthical approval was granted by the Yorkshire and the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focussed on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder.Trial registration numberISRCTN42499563

scholarly journals TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial

2019 ◽  
Author(s):  
Jessica Frost ◽  
J Athene Lane ◽  
Nikki Cotterill ◽  
Mandy Fader ◽  
Lucy Hackshaw-McGeagh ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Patient Reported ◽  
Randomised Controlled

Abstract Background Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men presenting with LUTS are managed by their General Practitioner (GP) in the first instance, with conservative therapies recommended as initial treatment. However, the provision of conservative therapies in primary care is variable and can be time and resource limited. GPs require practical resources to enhance patient engagement with such interventions. TRIUMPH aims to determine whether a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for LUTS versus usual care. Methods TRIUMPH is a 2-arm cluster randomised controlled trial (RCT) being conducted in 30 National Health Service (NHS) General Practices in England. The TRIUMPH intervention comprises a standardised LUTS advice booklet developed for the trial with patient and health care professional (HCP) consultation. The booklet is delivered to patients by nurses/healthcare assistants following assessment of their urinary symptoms. Patients are directed to relevant sections of the booklet, providing the manualised element of the intervention. To encourage adherence, HCPs provide follow-up contacts over 12 weeks. Practices are randomised 1:1 to either deliver the TRIUMPH intervention or a usual care pathway. The patient-reported International Prostate Symptom Score (IPSS) at 12 months post-consent is the primary outcome. Secondary outcomes include cost-effectiveness, patient reported outcomes on LUTS, quality of life, and patient and HCP acceptability and experience of the intervention. Primary analyses will be conducted on an intention-to-treat basis. Discussion It is unclear whether conservative therapies for male LUTS are effectively delivered in primary care using current approaches. This can lead to men being inappropriately referred to secondary care or experiencing persistent symptoms. Primary care therefore holds the key to effective treatment for these men. The TRIUMPH intervention, through its standardised and manualised approach, has been developed to support GP practices in delivering effective conservative care. This pragmatic cluster RCT will provide robust evidence in a primary care setting to inform future guidelines.

scholarly journals Effectiveness of routine measurement of health-related quality of life in improving the outcomes of patients with musculoskeletal problems—a cluster randomised controlled trial: protocol paper

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040373
Author(s):  
Cindy Lam ◽  
Weng Yee Chin ◽  
Carlos King Ho Wong ◽  
Kalun Or ◽  
Daniel Yee Tak Fong ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Hong Kong ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Musculoskeletal Problems ◽  
Related Quality ◽  
Health Related ◽  
Randomised Controlled

IntroductionManaging chronic musculoskeletal problems usually focuses on pain control using medications, but outcomes are often unsatisfactory and sometimes harmful. Information on a patient’s health-related quality of life (HRQOL) may trigger a doctor to tailor management improving quality of life. The aim of this trial is to find out whether routine measurement and reporting of a patient’s EuroQoL 5-Dimension 5-Level (EQ-5D-5L) HRQOL data using an electronic platform can improve HRQOL and pain in patients with chronic knee or back problems in primary care. We will also assess the acceptability of routine electronic measurements and reporting of the EQ-5D-5L in primary care settings.MethodsThis is a multicentre, prospective, cluster randomised controlled trial set in six public primary care clinics in Hong Kong. At the intervention clinics, subjects will complete an electronic EQ-5D-5L form at recruitment and at each clinic follow-up over 12 months. A report of the patient’s longitudinal EQ-5D-5L data will be provided to the doctor. Subjects in the control clinics will receive care as usual. All subjects will complete the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a 10-point Pain Rating Scale and a structured questionnaire to collect sociodemographic information and data on morbidity and service utilisation at recruitment at baseline, 3, 6 and 12 months. Primary outcome is the change in WOMAC total score. Secondary outcomes are change in pain, other patient-reported outcome scores and doctor-rated severity of disease. Group differences in the changes in WOMAC and other outcome scores over time will be analysed using generalised estimating equation model with an intention-to-treat principle.Ethics and disseminationEthics approval has been obtained from The University of Hong Kong/Hospital Authority Hong Kong West Cluster (IRB reference number: UW 18-270). The results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03609762.

Experiences of patients and caregivers with early palliative care: A qualitative study

2016 ◽  
Vol 31 (1) ◽  
pp. 72-81 ◽  
Author(s):  
Breffni Hannon ◽  
Nadia Swami ◽  
Gary Rodin ◽  
Ashley Pope ◽  
Camilla Zimmermann
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Qualitative Study ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Cluster Randomised Controlled Trial ◽  
Early Palliative Care ◽  
Individual Interviews ◽  
Randomised Controlled

Background: Early palliative care improves quality of life and satisfaction with care and is increasingly endorsed for patients with advanced cancer. However, little is known about the experience of receiving early palliative care from a patient and caregiver perspective. Aim: The aim of this qualitative study was to determine, from a participant perspective, the experience of receiving early palliative care and elements of that care. Design: Qualitative grounded theory study using individual interviews. Setting/participants: The study took place at a comprehensive cancer centre. Patients ( n = 26) and caregivers ( n = 14) from the intervention arm of a cluster-randomised controlled trial of early palliative care versus standard oncology care participated in qualitative interviews. Participants were asked to comment on their quality of life, the quality of care provided over the intervention period and their experiences with the palliative care team. Results: Participants described feeling supported and guided in their illness experience and in their navigation of the healthcare system. Specific elements of early palliative care included prompt, personalised symptom management; holistic support for patients and caregivers; guidance in decision-making; and preparation for the future. Patients with symptoms particularly valued prompt attention to their physical concerns, while those without symptoms valued other elements of care. Although three patients were ambivalent about their current need for palliative care, no distress was reported as a consequence of the intervention. Conclusion: The elements of care described by participants may be used to develop, support and refine models of early palliative care for patients with cancer.

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