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Using a Respectful Approach to Child-centred Healthcare (ReACH) in a paediatric clinical trial: A feasibility study.

ABSTRACT: BACKGROUND:There is a growing momentum in paediatric ethics to develop respectful research and healthcare protocols. We developed, tested and refined our 'Respectful Approach to Child-centred Healthcare' (ReACH), to underpin respectful participant interactions in a clinical trial. OBJECTIVE:To determine whether a ReACH-based approach is acceptable to children and parents, and effective in obtaining compliance with common healthcare assessments in a clinical trial of healthy 4-6-year-old children. METHODS:ReACH-based child assessments were evaluated at two baseline clinics and one post-intervention, using mixed methods. Children (n = 49; 46.9% female; mean age = 5.24±0.88 years at baseline) and their parents provided independent evaluation, via customised 5-point Likert scales and qualitative feedback. A dedicated child researcher evaluated adherence to the study ReACH principles. RESULTS:Children achieved compliance rates of 95% for body composition (BodPod) assessments; 89% for blood pressure measurements, and 92% (baseline) and 87% (post-intervention) for blood draws. Adherence to ReACH principles during clinic visits was positively associated with child compliance, significantly for baseline BodPod (p = 0.002) and blood test (p = 0.009) clinics. Satisfaction with BodPod protocols was positively associated with compliance, for children at baseline (p = 0.029) and for parents post-intervention (p <0.001). Parents rated the study itself very highly, with 91.7% satisfied at baseline and 100% post-intervention. Qualitative feedback reflected an enjoyable study experience for both parents and children. CONCLUSIONS:Adherence to our emerging ReACH approach was associated with high child compliance rates for common healthcare assessments, although no causality can be inferred at this preliminary stage of development. Participants expressed satisfaction with all aspects of the study. Our use of child-centred methods throughout a research intervention appears feasible and acceptable to children and their parents.

SUBMITTER: Nicholl A

PROVIDER: S-EPMC7652280 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Using a Respectful Approach to Child-centred Healthcare (ReACH) in a paediatric clinical trial: A feasibility study.

Nicholl Analise A Evelegh Kate K Deering Kane Evan KE Russell Kate K Lawrence David D Lyons-Wall Philippa P O'Sullivan Therese Anne TA

PloS one 20201109 11

<h4>Background</h4>There is a growing momentum in paediatric ethics to develop respectful research and healthcare protocols. We developed, tested and refined our 'Respectful Approach to Child-centred Healthcare' (ReACH), to underpin respectful participant interactions in a clinical trial.<h4>Objective</h4>To determine whether a ReACH-based approach is acceptable to children and parents, and effective in obtaining compliance with common healthcare assessments in a clinical trial of healthy 4-6-ye ...[more]

PMID: 33166989

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Project description:BackgroundBangladesh is one of the most vulnerable countries to climate change. People are getting educated at different levels on how to deal with potential impacts. One such educational mode was the preparation of a school manual, for high school students on climate change and health protection endorsed by the National Curriculum and Textbook Board, which is based on a 2008 World Health Organization manual. The objective of this study was to test the effectiveness of the manual in increasing the knowledge level of the school children about climate change and health adaptation.MethodsThis cluster randomized intervention trial involved 60 schools throughout Bangladesh, with 3293 secondary school students participating. School upazilas (sub-districts) were randomised into intervention and control groups, and two schools from each upazila were randomly selected. All year seven students from both groups of schools sat for a pre-test of 30 short questions of binary response. A total of 1515 students from 30 intervention schools received the intervention through classroom training based on the school manual and 1778 students of the 30 control schools did not get the manual but a leaflet on climate change and health issues. Six months later, a post-intervention test of the same questionnaire used in the pre-test was performed at both intervention and control schools. The pre and post test scores were analysed along with the demographic data by using random effects model.ResultsNone of the various school level and student level variables were significantly different between the control and intervention group. However, the intervention group had a 17.42% (95% CI: 14.45 to 20.38, P = <0.001) higher score in the post-test after adjusting for pre-test score and other covariates in a multi-level linear regression model.ConclusionsThese results suggest that school-based intervention for climate change and health adaptation is effective for increasing the knowledge level of school children on this topic.

Project description:ContextThe person-centred approach (PCA) is a promising avenue for care improvement. However, health professionals in Burkina Faso (hereafter referred to as caregivers) seem unprepared for taking into consideration patients' preferences and values in the context of healthcare provision.ObjectiveTo understand the meaning attributed to PCA in the Burkina Faso context of care and to identify the challenges related to its adoption from the perspective of caregivers and women service users (hereafter referred to as patients).MethodsAn ethnographic qualitative research design was used in this study. We conducted 31 semi-directed interviews with caregivers and patients from Koudougou (Burkina Faso) healthcare facilities. We also carried out direct observation of consultations. Data thematic analyses are based on the person-centred approach analysis framework.ResultsAccording to the caregivers and patients interviewed, the PCA in maternal and child healthcare in Burkina Faso includes the following five components used in our analytical framework: i) pregnancy follow-up consultations extend beyond examining physical health issues (biopsychosocial component), ii) healthcare professionals' mood affects the caregiver-patient relationship as well as care delivery (the healthcare professional as a person), iii) patients expect to be well received, listened to, and respected (the patient as a person), iv) healthcare professionals first acknowledge that both themselves and patients have power, rights but also responsibilities (sharing power, rights and responsibilities of professionals and patients), and v) healthcare professionals who are open to involving patients in decision-making about their care and patients asking to have a say in the organization of services (therapeutic alliance). Implementing each of these themes comes with challenges, such as i) talking about health problems in the presence of other women, especially those related to sexuality, even though they are common to parturient women (biopsychosocial component); ii) offering psychotherapy to healthcare professionals (healthcare professional as a person); iii) taking into consideration patients' cultural and linguistic differences (the patient as a person); iv) raising awareness among patients about their right to ask questions and healthcare professionals' duty to answer them (sharing power, and rights and responsibilities of professionals and patients); v) accepting the presence of birth attendants while avoiding traditional practices that are contrary to scientific recommendations (therapeutic alliance).ConclusionDespite some context-specific particularities, the PCA is not new in the context of health care in Burkina Faso. However, its implementation can pose a number of challenges. There is a need to train healthcare professionals with a view to being sensitive to these particularities. This may also require organizational adjustments so as to create the physical and sociocultural environments that are conducive to taking into account the patient's perspective.

Project description:IntroductionElectronic patient-reported outcomes (ePROs) have tremendous potential to optimise palliative and supportive care for children with cancer, their families and healthcare providers. Particularly, these children and their families are subjected to multiple strains caused by the disease and its treatment. The MyPal digital health platform is designed to address these complex demands by offering pursuant ePRO-based functionalities via two mobile applications, one developed for children and the other for their parents.Methods and analysisIn this observational prospective feasibility study, 100 paediatric oncology patients aged between 6 and 17 years and at least one of their parents/legal guardians will be recruited at three clinical sites in two European countries (Germany and Czech Republic). They will use the mobile applications which are part of the novel digital health platform. During a 6-month study period, participants will complete various ePROs via the applications addressing quality of life, satisfaction with care and impact of the disease on the family at monthly intervals. Additionally, priority-based symptom reporting is integrated into a serious game for children. Outcomes that will be assessed concern the feasibility and the evaluation of the newly designed digital health platform to contribute to the evidence base of clinical ePRO use in paediatric oncology and palliative care process.Ethics and disseminationThe MyPal-Child study obtained ethical approval from the Ethics Committee responsible for the University of Saarland, that is, the Ärztekammer des Saarlandes, the Ethics Committee of the Medical School Hannover and the Ethics Committee of the University of Brno. Study results will be disseminated through scientific publications, presentations at international conferences, congresses and a final report to the European Commission. General publicly accessible information can be found on the project website (www.mypal-project.eu) and social media.Trial registration numbersU1111-1251-0043, DRKS00021458, NCT04381221.

Dataset Information

Using a Respectful Approach to Child-centred Healthcare (ReACH) in a paediatric clinical trial: A feasibility study.

Publications

Using a Respectful Approach to Child-centred Healthcare (ReACH) in a paediatric clinical trial: A feasibility study.

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