scholarly journals BreathEase: rationale, design and recruitment of a randomised trial and embedded mixed methods study of a multi-professional breathlessness service in early palliative care

2021 ◽  
pp. 00228-2020
Author(s):  
Michaela Schunk ◽  
Ursula Berger ◽  
Lien Le ◽  
Eva Rehfuess ◽  
Larissa Schwarzkopf ◽  
...  
Keyword(s):  
Palliative Care ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Randomised Trial ◽  
Underlying Disease ◽  
Postal Survey ◽  
Willingness To Participate ◽  
Early Palliative Care ◽  
Sample Characteristics ◽  
Randomised Controlled

BackgroundThe Munich Breathlessness Service (MBS) has adapted novel support services to the German context, to reduce burden in patients and carers from breathlessness in advanced disease. It has been evaluated in a pragmatic fast track randomised controlled trial (RCT) (BreathEase, NCT02622412) with embedded qualitative interviews and postal survey. The aim of this paper is to describe the intervention model and study design, analyse recruitment to the trial and compare sample characteristics with other studies in the field.MethodsAnalysis of recruitment pathways and enrolment, sociodemographic and clinical characteristics of participants and carers.ResultsOf 439 people screened, 253 (58%) were offered enrolment and 183 (42%) participated. n=97 (70%) carers participated. 186 people (42%) did not qualify for inclusion, mostly because breathlessness could not be attributed to an underlying disease. All participants were self-referring, 60% through media sources. Eligibility and willingness to participate were associated to social networks and illness-related activities as recruitment routes. Mean age of participants was 71 years (51% women), with COPD (63%), chronic heart failure (8%), interstitial lung disease (9%), pulmonary hypertension (6%) and cancer (7%) as underlying conditions. Postal survey response rate was 89%. Qualitative interviews were conducted with 16 patients and 9 carers.ConclusionThe BreathEase study has a larger and more heterogeneous sample compared to other trials. The self-referral-based and prolonged recruitment drawing on media sources approximates real-world conditions of early palliative care. Integrating qualitative and quantitative components will allow a better understanding and interpretation of the results of the main effectiveness study.

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.

scholarly journals Feasibility study of a randomised controlled trial of pre and postoperative nutritional supplementation in major lung surgery

2021 ◽  
Author(s):  
Amy Kerr ◽  
Sebastian T. Lugg ◽  
Salma Kadiri ◽  
Amelia Swift ◽  
Nikolaos Efstathiou ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Randomised Trial ◽  
Nutritional Intervention ◽  
Lung Surgery ◽  
List Type ◽  
Carbohydrate Loading ◽  
Randomised Controlled

AbstractObjectivesMalnutrition and weight loss are important risk factors for complications after lung surgery. However, it is uncertain whether modifying or optimising perioperative nutritional state with oral supplements results in a reduction in malnutrition, complications, and quality of life.DesignA randomised, open label, controlled feasibility study was conducted to assess the feasibility of carrying out a large multicentre randomised trial of nutritional intervention. The intervention consisted of preoperative carbohydrate-loading drinks (4x 200mls evening before surgery and 2x 200mls the morning of surgery), and early postoperative nutritional protein supplement drinks twice a day for 2 weeks following surgery compared to the control group receiving an equivalent volume of water. Qualitative interviews were conducted with participants to help determine the acceptance of the study.SettingSingle adult thoracic centre in the UK.ParticipantsAll patients admitted for major lung surgery. Participants were included if were able to take nutritional drinks prior to surgery and were able to give written informed consent. Patients were excluded if they were likely unable to comply with completion of the study questionnaires, they had a body mass index (BMI) < 18.5 kg/m2, were receiving parenteral nutrition or known pregnancy.ResultsAll patients presenting for major lung surgery were screened over a 6-month period, with 163 patients screened, 99 excluded and 64 (41%) patients randomised. Feasibility criteria were met and the study completed recruitment 5 months ahead of target. The 2 groups were well balanced, and tools used to measure outcomes were robust. 97% of patients were compliant with pre-surgery nutritional drinks and 89% of the questionnaires at 3 months were returned fully completed. The qualitative interviews demonstrated that the trial and the intervention were acceptable to patients. Patients felt the questionnaires used captured their experience of recovery from surgery well.ConclusionA large multicentre randomised controlled trial of nutritional intervention in major lung surgery is feasible. It is possible to randomise eligible patients and follow up with high fidelity. A pre-op carbohydrate-loading and post-surgery supplementation is highly acceptable to patients with good compliance to both intervention and trial measures. A large multi-centre clinical trial is required to test clinical efficacy in improving outcomes after surgery.Trial registration numberISRCTN16535341Strengths and limitation of this studyThis randomised, feasibility study had pre-planned feasibility to assess whether a larger randomised trial would be feasible.The study included a large regional thoracic surgical centre and cohort of patients undergoing major lung surgery predominantly for cancer, which would be representative of full trial national recruitment.The study was not designed and powered to be large enough to provide conclusive evidence to support the use of nutritional intervention in major lung surgery, but provided evidence that a larger, substantive randomised controlled trial is feasible.

scholarly journals Pain Squad+ smartphone app to support real-time pain treatment for adolescents with cancer: protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e037251
Author(s):  
Lindsay Jibb ◽  
Paul C Nathan ◽  
Vicky Breakey ◽  
Conrad Fernandez ◽  
Donna Johnston ◽  
...  
Keyword(s):  
Real Time ◽  
Pain Treatment ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Randomised Trial ◽  
Control Group ◽  
Management Support ◽  
Scientific Meetings ◽  
Randomised Controlled ◽  
The Impact

IntroductionPain negatively affects the health-related quality of life (HRQL) of adolescents with cancer. The Pain Squad+ smartphone-based application (app), has been developed to provide adolescents with real-time pain self-management support. The app uses a validated pain assessment and personalised pain treatment advice with centralised decision support via a registered nurse to enable real-time pain treatment in all settings. The algorithm informing pain treatment advice is evidence-based and expert-vetted. This trial will longitudinally evaluate the impact of Pain Squad+, with or without the addition of nurse support, on adolescent health and cost outcomes.Methods and analysisThis will be a pragmatic, multicentre, waitlist controlled, 3-arm parallel-group superiority randomised trial with 1:1:1 allocation enrolling 74 adolescents with cancer per arm from nine cancer centres. Participants will be 12 to 18 years, English-speaking and with ≥3/10 pain. Exclusion criteria are significant comorbidities, end-of-life status or enrolment in a concurrent pain study. The primary aim is to determine the effect of Pain Squad+, with and without nurse support, on pain intensity in adolescents with cancer, when compared with a waitlist control group. The secondary aims are to determine the immediate and sustained effect over time of using Pain Squad+, with and without nurse support, as per prospective outcome measurements of pain interference, HRQL, pain self-efficacy and cost. Linear mixed models with baseline scores as a covariate will be used. Qualitative interviews with adolescents from all trial arms will be conducted and analysed.Ethics and disseminationThis trial is approved by the Hospital for Sick Children Research Ethics Board. Results will provide data to guide adolescents with cancer and healthcare teams in treating pain. Dissemination will occur through partnerships with stakeholder groups, scientific meetings, publications, mass media releases and consumer detailing.Trial registration numberNCT03632343(ClinicalTrials.gov).

Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial

The Lancet ◽  
2014 ◽  
Vol 383 (9930) ◽  
pp. 1721-1730 ◽  
Author(s):  
Camilla Zimmermann ◽  
Nadia Swami ◽  
Monika Krzyzanowska ◽  
Breffni Hannon ◽  
Natasha Leighl ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Early Palliative Care ◽  
Cluster Randomised ◽  
Randomised Controlled

scholarly journals Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025692 ◽  
Author(s):  
Corita R Grudzen ◽  
Deborah J Shim ◽  
Abigail M Schmucker ◽  
Jeanne Cho ◽  
Keith S Goldfeld
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Case Management ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Randomised Controlled ◽  
End Stage

IntroductionEmergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysisThis is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.Ethics and disseminationInstitutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03325985; Pre-results.

scholarly journals Web-based early intervention for children with motor difficulties aged 3–8 years old using multimodal rehabilitation (WECARE): protocol of a patient-centred pragmatic randomised trial of paediatric telerehabilitation to support families

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e046561
Author(s):  
Chantal Camden ◽  
Jill G Zwicker ◽  
Melanie Morin ◽  
Tibor Schuster ◽  
Melanie Couture ◽  
...  
Keyword(s):  
Early Intervention ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Parental Knowledge ◽  
Performance Measure ◽  
Performance Goals ◽  
Web Based ◽  
Study Results ◽  
Motor Difficulties ◽  
Randomised Controlled

IntroductionMild motor difficulties in children are underdiagnosed despite being highly prevalent, leaving such children often underserved and at higher risk for secondary consequences such as cardiovascular disease and anxiety. Evidence suggests that early patient-oriented interventions, coaching parents and providing children with early stimulation should be provided, even in the absence of a diagnosis. Such interventions may be effectively delivered via telerehabilitation.Methods and analysisA family-centred, pragmatic randomised controlled trial will be carried out to evaluate the real-world effectiveness of a Web-based Early intervention for Children using multimodAl REhabilitation (WECARE). Families of children with motor difficulties, 3–8 years of age, living in Quebec, Canada, and receiving no public rehabilitation services (n=118) will be asked to determine up to 12 performance goals, evaluated using the Canadian Occupational Performance Measure (COPM, the primary outcome). Families will be randomised to receive either usual care or the WECARE intervention. The WECARE intervention will be delivered for 1 year via a web-based platform. Families will have access to videoconferences with an assigned rehabilitation therapist using a collaborative coaching approach, a private chat function, a forum open to all intervention arm participants and online resources pertaining to child development. Participants will be asked to re-evaluate the child’s COPM performance goals every 3 months up to 1 year post allocation. The COPM results will be analysed using a mixed Poisson regression model. Secondary outcomes include measures of the child’s functional ability, parental knowledge and skills and health-related quality of life, as well as qualitative outcomes pertaining to parental satisfaction and service delivery trajectories. Investigators and quantitative data analysts will be blinded to group allocation.Ethics and disseminationThe CIUSSS de l’Estrie—CHUS ethics committee approved this trial (2020-3429). Study results will be communicated via peer-reviewed journal publications, conference presentations and stakeholder-specific knowledge transfer activities.Trial registration numberNCT04254302.

Sign in / Sign up

Export Citation Format

Share Document