Correction:Complex care for kids Ontario: protocol for a mixed-methods randomised controlled trial of a population-level care coordination initiative for children with medical complexity

IntroductionTechnological and medical advances have led to a growing population of children with medical complexity (CMC) defined by substantial medical needs, healthcare utilisation and morbidity. These children are at a high risk of missed, fragmented and/or inappropriate care, and families bear extraordinary financial burden and stress. While small in number (<1% of children), this group uses ~1/3 of all child healthcare resources, and need coordinated care to optimise their health. Complex care for kids Ontario (CCKO) brings researchers, families and healthcare providers together to develop, implement and evaluate a population-level roll-out of care for CMC in Ontario, Canada through a randomised controlled trial (RCT) design. The intervention includes dedicated key workers and the utilisation of coordinated shared care plans.Methods and analysisOur primary objective is to evaluate the CCKO intervention using a randomised waitlist control design. The waitlist approach involves rolling out an intervention over time, whereby all participants are randomised into two groups (A and B) to receive the intervention at different time points determined at random. Baseline measurements are collected at month 0, and groups A and B are compared at months 6 and 12. The primary outcome is the family-prioritized Family Experiences with Coordination of Care (FECC) survey at 12 months. The FECC will be compared between groups using an analysis of covariance with the corresponding baseline score as the covariate. Secondary outcomes include reports of child and parent health outcomes, health system utilisation and process outcomes.Ethics and disseminationResearch ethics approval has been obtained for this multicentre RCT. This trial will assess the effect of a large population-level complex care intervention to determine whether dedicated key workers and coordinated care plans have an impact on improving service delivery and quality of life for CMC and their families.Trial registration numberNCT02928757.

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Habits-GDM mobile application in managing gestational diabetes in Singapore: A mixed-methods study (Preprint)

10.2196/preprints.23177 ◽

2020 ◽

Author(s):

Shilpa Surendran ◽

Chang Siang Lim ◽

Gerald Choon Huat Koh ◽

Tong Wei Yew ◽

E Shyong Tai ◽

...

Keyword(s):

Mixed Methods ◽

Randomised Controlled Trial ◽

Gestational Diabetes ◽

Healthcare Professionals ◽

Controlled Trial ◽

Perceived Usefulness ◽

Mixed Methods Study ◽

Automatic Data ◽

Glucose Testing ◽

Randomised Controlled

BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing in Singapore and the cost of providing traditional care for GDM is high. Mobile health (mHealth) applications may act as useful tools in the management of GDM. OBJECTIVE The objective of this mixed-methods study was to measure the usage behaviour and explore users’ perceived usefulness of the Habits-GDM application when managing GDM in a randomised controlled trial. METHODS We conducted a quantitative analysis of the application usage behaviour in 170 Habits-GDM application users and 14 semi-structured interviews with users from a randomised controlled trial. RESULTS The convenience of automatic data transfer of weight values to the Habits-GDM application helped users (116/170, 68%) log their weight at least once a week. However, when the application had usability challenges, users avoided using that feature, i.e. users logged only an average of less than one meal/week out of the recommended six meals/week. Of the usability challenges, many users (12/14, 85.7%) mentioned food items not worded in the commonly known way and limited ethnic food database as the primary barriers. Only half of the users (84/170, 49.4%) accessed the educational lessons, but many (9/14, 64%) identified the provision of always available, valuable health-related information as an advantage of the educational lessons. ‘Healthy eating’ and ‘Why exercise’ were the most (56/84, 66.67%) and least (38/84, 45.24%) frequently accessed educational lessons, respectively. Users (10/14, 71.4%) reported sending messages to the coach via the chat interface only when they faced logistic issues and 86.45% of all the coach messages were replies typed by the research coordinator in response to the logistics issues (i.e. a request for blood glucose testing strips and appointment confirmation) raised by the users. Healthcare professionals lack of access to the coach’s dashboard discouraged users from asking queries related to GDM via the e-coaching feature. CONCLUSIONS The findings suggest that mHealth application acts as a useful tool in managing GDM. Culturally sensitive mHealth applications with a provision for women to interact with healthcare professionals should be developed in cooperation with the users. CLINICALTRIAL Not applicable.

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Impact and acceptability of HIV self-testing for trans men and trans women: A mixed-methods subgroup analysis of the SELPHI randomised controlled trial and process evaluation in England and Wales

EClinicalMedicine ◽

10.1016/j.eclinm.2020.100700 ◽

2021 ◽

Vol 32 ◽

pp. 100700

Author(s):

T. Charles Witzel ◽

Talen Wright ◽

Leanne McCabe ◽

Michelle M. Gabriel ◽

Aedan Wolton ◽

...

Keyword(s):

Mixed Methods ◽

Randomised Controlled Trial ◽

Process Evaluation ◽

Subgroup Analysis ◽

Controlled Trial ◽

England And Wales ◽

Trans Men ◽

Self Testing ◽

Trans Women ◽

Randomised Controlled

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Developing and evaluating the implementation of a complex intervention: using mixed methods to inform the design of a randomised controlled trial of an oral healthcare intervention after stroke

Trials ◽

10.1186/1745-6215-12-168 ◽

2011 ◽

Vol 12 (1) ◽

Cited By ~ 33

Author(s):

Marian C Brady ◽

David J Stott ◽

John Norrie ◽

Campbell Chalmers ◽

Bridget St George ◽

...

Keyword(s):

Mixed Methods ◽

Randomised Controlled Trial ◽

Complex Intervention ◽

Controlled Trial ◽

Healthcare Intervention ◽

Randomised Controlled

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Lay Health Trainers Supporting Self-Management amongst Those with Low Heath Literacy and Diabetes: Lessons from a Mixed Methods Pilot, Feasibility Study

Journal of Diabetes Research ◽

10.1155/2016/4723636 ◽

2016 ◽

Vol 2016 ◽

pp. 1-10 ◽

Cited By ~ 1

Author(s):

Bernadette Bartlam ◽

Trishna Rathod ◽

Gillian Rowlands ◽

Joanne Protheroe

Keyword(s):

Mixed Methods ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Health Behaviours ◽

Structured Interview ◽

Health Care Practitioner ◽

Self Management ◽

Baseline Survey ◽

Ageing Population ◽

Randomised Controlled

This article reports a mixed methods process evaluation of a pilot feasibility randomised controlled trial comparing a Lay Health Trainer (LHT) intervention and usual care for those with poorly controlled Type 2 Diabetes Melitus (T2DM). Set in a deprived area in the UK, this research explores patient and health care practitioner (HCP) views on whether a structured interview between a patient and a Lay Health Trainer (LHT), for the purpose of developing a tailored self-management plan for patients, is acceptable and likely to change health behaviours. In doing so, it considers the implications for a future, randomised controlled trial (RCT). Participants were patients, LHTs delivering the intervention, service managers, and practice nurses recruiting patients to the study. Patients were purposively sampled on their responses to a baseline survey, and semistructured interviews were conducted within an exploratory thematic analysis framework. Findings indicate that the intervention is acceptable to patients and HCPs. However, LHTs found it challenging to work with older patients with long-term and/or complex conditions. In order to address this, given an ageing population and concomitant increases in those with such health needs, LHT training should develop skills working with these populations. The design of any future RCT intervention should take account of this.

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Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach

BMJ Open ◽

10.1136/bmjopen-2019-031819 ◽

2020 ◽

Vol 10 (5) ◽

pp. e031819

Author(s):

Marijn C Verwijs ◽

Stephen Agaba ◽

Marie Michele Umulisa ◽

Mireille Uwineza ◽

Adrien Nivoliez ◽

...

Keyword(s):

Mixed Methods ◽

Randomised Controlled Trial ◽

Sexual Risk ◽

Controlled Trial ◽

Vaginal Infections ◽

Pilot Randomised Controlled Trial ◽

Steady Partner ◽

Face To Face ◽

Male Clients ◽

Randomised Controlled

ObjectivesTo evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence.DesignRepeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial.SettingResearch clinic in Kigali, Rwanda.ParticipantsRwandan women with high sexual risk.InterventionsWomen diagnosed with BV and/or trichomoniasis were randomised to four groups (n=17 each) after completing metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi+ (EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet.Outcome measuresAdherence and acceptability were assessed by structured face-to-face interviews, semi-structured focus group discussions and in-depth interviews, daily diaries and counting of used/unused study products in randomised women (n=68). Vaginal infection knowledge was assessed by structured face-to-face interviews in randomised women and women attending recruitment sessions (n=131).ResultsMost women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics. All probiotic users (n=32) reported that insertion became easier over time. Triangulated adherence data showed that 17/17 EF+ users and 13/16 GynLP users used ≥80% of required doses (Fisher’s exact p=0.103). Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence. Women believed that the probiotics reduced BV recurrence, but reported that partners were sometimes unsupportive of study participation. Self-reported vaginal washing practices decreased during follow-up, but sexual risk behaviours did not. Most women (12/15) with an uncircumcised steady partner discussed penile hygiene with him, but many women found this difficult, especially with male clients.ConclusionsHigh-risk women require education about vaginal infections. Vaginal probiotic acceptability and adherence were high in this cohort. Our results can be used to inform future product development and to fine-tune counselling messages in prevention programmes.Trial registration numberNCT02459665.

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Protocol for an effectiveness- implementation hybrid trial to assess the effectiveness and cost-effectiveness of an m-health intervention to decrease the consumption of discretionary foods packed in school lunchboxes: the ‘SWAP IT’ trial

BMC Public Health ◽

10.1186/s12889-019-7725-x ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

Rachel Sutherland ◽

Alison Brown ◽

Nicole Nathan ◽

Lisa Janssen ◽

Renee Reynolds ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Energy Intake ◽

Primary Schools ◽

Controlled Trial ◽

Population Level ◽

Health Intervention ◽

Trial Registration ◽

School Based ◽

Randomised Controlled

Abstract Background At a population level, small reductions in energy intake have the potential to contribute to a reduction in the prevalence of childhood obesity. In many school systems, there is the potential to achieve a reduction in energy intake through modest improvements in foods packed in children’s school lunchboxes. This study will assess the effectiveness and cost-effectiveness of a multi-component intervention that uses an existing school-based communication application to reduce the kilojoule content from discretionary foods and drinks consumed by children from school lunchboxes whilst at school. Methods A Type I hybrid effectiveness-implementation cluster randomised controlled trial will be conducted in up to 36 primary schools in the Hunter New England, Central Coast and Mid North Coast regions of New South Wales, Australia. Designed using the Behaviour Change Wheel, schools will be randomly allocated to receive either a 5-month (1.5 school terms) multi-component intervention that includes: 1) school lunchbox nutrition guidelines; 2) curriculum lessons; 3) information pushed to parents via an existing school-based communication application and 4) additional parent resources to address common barriers to packing healthy lunchboxes or a control arm (standard school practices). The study will assess both child level dietary outcomes and school-level implementation outcomes. The primary trial outcome, mean energy (kJ) content of discretionary lunchbox foods packed in children’s lunchboxes, will be assessed at baseline and immediately post intervention (5 months or 1.5 school terms). Analyses will be performed using intention to treat principles, assessing differences between groups via hierarchical linear regression models. Discussion This study will be the first fully powered randomised controlled trial internationally to examine the impact of an m-health intervention to reduce the mean energy from discretionary food and drinks packed in the school lunchbox. The intervention has been designed with scalability in mind and will address an important evidence gap which, if shown to be effective, has the potential to be applied at a population level. Trial registration Australian Clinical Trials Registry ACTRN:12618001731280 registered on 17/10/2018. Protocol Version 1.

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Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): the protocol of a mixed-methods study including a cluster randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-028427 ◽

2019 ◽

Vol 9 (7) ◽

pp. e028427 ◽

Cited By ~ 1

Author(s):

Charilaos Lygidakis ◽

Jean Paul Uwizihiwe ◽

Per Kallestrup ◽

Michela Bia ◽

Jeanine Condo ◽

...

Keyword(s):

Mixed Methods ◽

Randomised Controlled Trial ◽

Integrated Management ◽

Controlled Trial ◽

Health Behaviours ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Chronic Patients ◽

Cluster Randomised ◽

Randomised Controlled

IntroductionIn Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the efficacy of an integrated programme for the management of diabetes in Rwanda, which will provide monthly patient assessments by HBCPs, and an educational and self-management mHealth patient tool, and; (b) exploring qualitatively the ways the interventions will have been enacted, their challenges and effects, and changes in the patients’ health behaviours and HBCPs’ work satisfaction.Methods and analysisThis is a mixed-methods sequential explanatory study. First, there will be a one-year cluster randomised controlled trial including two interventions ((1) HBCPs’ programme; (2) HBCPs’ programme + mobile health application) and usual care (control). Currently, nine hospitals run the HBCPs’ programme. Under each hospital, administrative areas implementing the HBCPs’ programme will be randomised to receive intervention 1 or 2. Eligible patients from each area will receive the same intervention. Areas without the HBCPs’ programme will be assigned to the control group. The primary outcome will be changes in glycated haemoglobin. Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy. Second, at the end of the trial, focus group discussions will be conducted with patients and HBCPs. Financial support was received from the Karen Elise Jensens Fond, and the Universities of Aarhus and Luxembourg.Ethics and disseminationEthics approval was obtained from the Rwanda National Ethics Committee and the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberNCT03376607; Pre-results.

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