Dataset Information

Evaluation of a New Personalized Health Dashboard in Preventive Child Health Care: Protocol for a Mixed Methods Feasibility Randomized Controlled Trial.

ABSTRACT:

Background

A new dashboard, the 360ºCHILD-profile, was developed to adopt personalized health care within preventive child health care. On this profile, holistic health data are visualized in a single image to provide parents, adolescents, and caregivers direct access to a manageable résumé of a child's medical record. Theoretical ordering, conforming to "International Classification of Functioning, Disability and Health for Children and Youth", guides clinical reasoning toward the biopsychosocial concept of health. It is yet unknown if and how this promising tool functions in practice, and a variety of feasibility questions must be addressed.

Objective

This paper describes the design and methods of a feasibility randomized controlled trial (RCT), with the aim of evaluating the RCT's feasibility (recruitment, response, measure completion, and intervention allocation) and 360ºCHILD-profile's feasibility (usability and potential effectiveness).

Methods

A pragmatic mixed methods study design was chosen, starting with an RCT to measure feasibility and health literacy in 2 parallel groups (1:1). Qualitative research will then be used to understand and explain quantitative findings and to explore the stakeholders' perspectives on the potential of the 360ºCHILD-profile. Participants will include child health care professionals (n≥30), parents (n≥30), and caregivers (n≥10) of children who experience developmental problems (age 0-16 years). Children will only be able to participate if they are older than 11 years (adolescents, n≥10). The 2 groups included in the study will receive standard care. The experimental group will additionally receive personalized 360ºCHILD-profiles.

Results

After an intervention period of 6 months, quantitative outcomes will be measured, analyzed (descriptive feasibility statistics and preliminary between-group differences) and used to purposively sample for semistructured interviews.

Conclusions

Study results will provide knowledge for building theory on the 360ºCHILD-profile and designing future (effect) studies.

Trial registration

Netherlands Trial Register NTR6909; https://www.trialregister.nl/trial/6731.

International registered report identifier (irrid)

DERR1-10.2196/21942.

SUBMITTER: Weijers M

PROVIDER: S-EPMC8088845 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundWithin preventive Child Health Care (CHC), the 360°CHILD-profile has been developed. This digital tool visualises and theoretically orders holistic health data in line with the International Classification of Functioning, Disability and Health. It is anticipated that evaluating the effectiveness of the multifunctional 360°CHILD-profile within the preventive CHC-context is complex. Therefore, this study aimed at investigating the feasibility of RCT procedures and the applicability of potential outcome measures for assessing the accessibility and transfer of health information.MethodsDuring the first introduction of the 360°CHILD-profile in CHC practice, a feasibility RCT with an explanatory-sequential mixed methods design was executed. CHC professionals (n=38) recruited parents (n=30) who visited the CHC for their child (age 0-16). Parents were randomised to "care as usual" (n=15) or "care as usual with, in addition, the availability of a personalised 360°CHILD-profile during 6 months" (n=15). Quantitative data on RCT feasibility were collected on recruitment, retention, response, compliance rates and outcome data on accessibility and transfer of health information (n=26). Subsequently, thirteen semi-structured interviews (5 parents, 8 CHC professionals) and a member check focus group (6 CHC professionals) were performed to further explore and gain a deeper understanding of quantitative findings.ResultsIntegration of qualitative and quantitative data revealed that the recruitment of parents by CHC professionals was problematic and influenced by organisational factors. The used randomisation strategy, interventions and measurements were executable within the setting of this specific study. The outcome measures showed skewed outcome data in both groups and a low applicability to measure accessibility and transfer of health information. The study revealed points to reconsider regarding the randomisation and recruitment strategy and measures in the next steps.ConclusionsThis mixed methods feasibility study enabled us to gain a broad insight into the feasibility of executing an RCT within the CHC context. Trained research staff should recruit parents instead of CHC professionals. Measures, potentially for evaluating 360°CHILD-profile's effectiveness, need further exploration and thorough piloting before proceeding with the evaluation process. Overall findings revealed that executing an RCT within the context of evaluating 360°CHILD-profile's effectiveness in the CHC setting will be much more complex, time-consuming and costly than expected. Thereby, the CHC context requires a more complex randomisation strategy than executed during this feasibility study. Alternative designs including mixed methods research must be considered for the next phases of the downstream validation process.Trial registrationNTR6909; https://trialsearch.who.int/ .

Project description:There are wide variations in maternal-newborn care practices and outcomes across Ontario. To help institutions and care providers learn about their own performance, the Better Outcomes Registry & Network (BORN) Ontario has implemented an audit and feedback system, the Maternal-Newborn Dashboard (MND), for all hospitals providing maternal-newborn care. The dashboard provides (1) near real-time feedback, with site-specific and peer comparison data about six key performance indicators; (2) a visual display of evidence-practice gaps related to the indicators; and (3) benchmarks to provide direction for practice change. This study aims to evaluate the effects of the dashboard, dashboard attributes, contextual factors, and facilitation/support needs that influence the use of this audit and feedback system to improve performance. The objectives of this study are to (1) evaluate the effect of implementing the dashboard across Ontario; (2) explore factors that potentially explain differences in the use of the MND among hospitals; (3) measure factors potentially associated with differential effectiveness of the MND; and (4) identify factors that predict differences in hospital performance.A mixed methods design includes (1) an interrupted time series analysis to evaluate the effect of the intervention on six indicators, (2) key informant interviews with a purposeful sample of directors/managers from up to 20 maternal-newborn care hospitals to explore factors that influence the use of the dashboard, (3) a provincial survey of obstetrical directors/managers from all maternal-newborn hospitals in the province to measure factors that influence the use of the dashboard, and (4) a multivariable generalized linear mixed effects regression analysis of the indicators at each hospital to quantitatively evaluate the change in practice following implementation of the dashboard and to identify factors most predictive of use.Study results will provide essential data to develop knowledge translation strategies for facilitating practice change, which can be further evaluated through a future cluster randomized trial.

Project description:BackgroundAlabama is one of seven priority states for the National Ending the HIV Epidemic Initiative due to a disproportionate burden of rural infections. To reverse growing infection rates, the state must increase its focus on prevention efforts, including novel strategies. One such approach is to utilize dashboards that visualize real-time data on the pre-exposure prophylaxis (PrEP) care continuum to assist in prioritizing evidence-based preventative care for those most vulnerable for HIV infection.MethodsWe conducted a mixed methods evaluation to ascertain stakeholders' perceptions on the acceptability, feasibility, appropriateness, and usability of a PrEP care continuum dashboard, as well as gain insight on ways to improve the activities necessary to sustain it. Clinicians, administrators, and data personnel from participating sites in Alabama completed surveys (n = 9) and participated in key informant interviews (n = 10) to better understand their experiences with the prototype data dashboard and to share feedback on how it can be modified to best fit their needs.ResultsSurveys and interviews revealed that all participants find the pilot data dashboard to be an acceptable, feasible, and appropriate intervention for clinic use. Overall, stakeholders find the pilot dashboard to be usable and helpful in administrative efforts, such as report and grant writing; however, additional refining is needed in order to reduce burden and optimize usefulness. Participants voiced concerns about their site's abilities to sustain the dashboard, including the lack of systematized PrEP protocols and limited funds and staff time dedicated to PrEP data collection, cleaning, and upload.ConclusionStudy participants from clinics providing HIV prevention services, including PrEP, in Alabama voiced interest in sustaining and refining a data dashboard that tracks clients across the PrEP care continuum. Despite viewing the platform itself as an acceptable, feasible, and appropriate intervention, participants agreed that efforts need to be focused on standardizing PrEP data collection protocols in order to ensure consistent, accurate data capture and that limited funds and staff time are barriers to the sustained implementation of the dashboard in practice.

Project description:BackgroundGenetic testing for pathogenic variants associated with hereditary breast and ovarian cancer risk can improve cancer outcomes through enhanced preventive care in both people with known variants and their biologic relatives. Cascade screening-the process of case-finding in relatives by notifying and inviting them to consider testing-currently relies on the patient to notify their own at-risk relatives. However, many of these relatives never learn they might be at risk. We developed and implemented a new health system-led familial genetic risk notification process where the care team offers to contact at-risk relatives directly. This protocol describes a study to assess the feasibility, acceptability, and limited efficacy of this intervention.MethodsThis feasibility study will use a single-arm, nonrandomized, mixed-methods prospective design. We will enroll two groups of participants: probands and relatives of probands. Eligible probands are currently enrolled Kaiser Permanente Washington (KPWA) members with an upcoming appointment for pre-test genetic counseling for hereditary Lynch syndrome, breast, or ovarian cancer. Eligible relatives, who do not have to be KPWA members, are first-and second-degree relatives of probands. During the appointment with the proband, the genetic counselor will determine whether the proband is appropriate for genetic testing and if so, which relatives might benefit from cascade testing. The genetic counselor then will offer to contact any or all identified relatives directly to discuss genetic risk and testing. The primary outcome of this study is the feasibility of the implemented familial notification process, which we will measure using quantitative and qualitative data on intervention reach, intervention acceptability, and limited efficacy. Analyses will be primarily descriptive and exploratory, with the intent of preparing for a future, larger trial of direct contact interventions.DiscussionOur findings will provide new, foundational evidence for the creation of US-based familial notification systems that directly address logistical and ethical challenges while prioritizing the preferences of patients and families.

Project description:IntroductionTransition from child and adolescent mental health services (CAMHS) to community or adult mental health services (AMHS) is a highly problematic health systems hurdle, especially for transition-aged youth. A planned and purposeful transition process is often non-existent or experienced negatively by youth and their caregivers. Stakeholders, including youth and their caregivers, have demanded interventions to support more effective transitions, such a transition navigator. The transition navigator model uses a navigator to facilitate complex transitions from acute care CAMHS to community or AMHS. However, despite the widespread implementation of this model, there has been no evaluation of the programme, hindering its scalability. This paper describes the study protocol of the Navigator Evaluation Advancing Transitions study that aims to collaborate with patients, caregivers and clinicians in the evaluation of the navigator model.Methods and analysisA pre and post mixed-method study will be conducted, using the Triple Aim Framework, to evaluate the navigator model. We will recruit participants from one large tertiary and two community hospitals in Toronto, Canada. For the quantitative portion of the study, we will recruit a sample of 45 youth (15 at each site), aged 16-18, and their caregivers at baseline (referral to navigator) (T1) and 6 months (T2). Youth and caregiver participants will complete a set of standardised measures to assess mental health, service utilisation, and satisfaction outcomes. For the qualitative portion of the study, semistructured interviews will be conducted at 6 months (T2) with youth, their caregivers and clinicians to better understand their experience and satisfaction with the model.Ethics and disseminationResearch Ethics Board (REB) approval has been obtained from the lead research sites, the University of Toronto and the Hospital for Sick Children. The results of the study will be reported in peer-reviewed publications, webinars and conferences and to all relevant stakeholders.

Project description:BackgroundIndividuals with spinal cord injury (SCI) are at high risk of experiencing secondary conditions like pressure injuries. Self-management programs may reduce the risk of complications, but traditional programs have proven to be insufficiently tailored to the needs of people with SCI. To overcome barriers to self-management support, a web-based, self-management program was developed for Canadians with SCI called SCI & U.ObjectiveThis study aims to evaluate the feasibility and potential impact of the SCI & U program in the context of a mixed methods pilot study.MethodsThe study followed an explanatory, sequential mixed methods design. Participants (N=11) were Canadians with SCI who had been living in the community for more than 1 year. Each took part in a self-paced, six-session self-management program guided by a trained peer health coach. During sessions, participants could discuss a health topic with their coach from a predefined list (eg, skin or bowel management). Quantitative data were gathered before and after program participation to assess program feasibility and impact. Feasibility measures included attrition rates, frequency of topics selected, and recorded goals, whereas impact measures included measures of self-efficacy (University of Washington Self-Efficacy Scale [UW-SES]), mood (Personal Health Questionnaire Depression Scale [PHQ-8]), secondary conditions (Spinal Cord Injury Secondary Conditions Scale [SCI-SCS]), and resilience (Spinal Cord Injury Quality of Life Resilience Scale [SCI-QOL-R]). Qualitative measures were based on postintervention interviews; these were designed to confirm and expand on quantitative.ResultsOf the 11 participants, 10 completed pre- and postassessments, and 6 coaching sessions. Sessions lasted between 31 and 81 min (average 55, SD 13), and the duration of the program ranged from 35 to 88 days (average 56, SD 23). Diet and exercise were selected as topics 40% (20/50 sessions with topics) of the time, whereas topics such as mental health, bladder management, pain, and bowel management were chosen less frequently. Results gathered before and after the pilot study demonstrated improvements with moderate effect sizes on the UW-SES and the electronic health literacy scale (ie, Hedges g>0.5). Effect sizes for measures of resilience (SCI-QOL-R), depression (PHQ-8), and secondary conditions (SCI-SCS) were small (ie, Hedges g>0.3). Qualitative results confirmed a common focus on diet and exercise, and defined coaches as sources of accountability, information, reassurance and affirmation, and emotional and technical support.ConclusionsResults demonstrated that a web-based self-management program is feasible and acceptable by Canadians with SCI. Results also indicated a web-based, peer-led self-management program may impact resilience, self-efficacy, mood, and secondary complications. Finally, results illuminated the role of the coach in facilitating behavior change. Future work seeks to validate results in the context of a randomized controlled trial.

Project description:BackgroundWorkplace cyberbullying harms the psychological and social functioning of professionals working in an organization and may decrease the productivity and efficiency of daily life tasks. A recent study on trainee doctors across 8 different United Kingdom National Health Service trusts found health issues and job dissatisfaction in people who have experienced workplace cyberbullying. This disabling effect is even more noticeable in low-socioeconomic communities within low-income countries. In Malaysia, there is a need to create a personalized mobile mental health intervention program for health care professionals. These programs should be directed to prevent and decrease psychosocial issues and enhance coordination among health care professionals to solve health issues in the community.ObjectiveOur main objective is to study the pre-effects and posteffects of the Personalized Mobile Mental Health Intervention (PMMH-I) for workplace cyberbullying in public and private hospitals in Malaysia.MethodsA hospital-based multimethod multi-analytic evidential approach is proposed, involving social and psychological health informatics. The project has been subdivided into 3 stages, starting with Phase 1, a prevalence study, followed by exploratory studies. Phase 2 consists of a quasi-experimental design, whereas the development of a prototype and their testing will be proposed in Phase 3. Each stage includes the use of quantitative and qualitative methods (mixed-method program), using SPSS (version 26.0; IBM Corp) and Stata (version 16.1; StataCorp) as tools for quantitative research, and NVivo (version 1.0; QSR International) and Atlas.ti (version 9.0.16; ATLAS.ti Scientific Software Development GmbH) for qualitative research.ResultsThe results of this study will determine the pre- and posteffectiveness of an integrated PMMH-I for health care professionals. The prototype system platform will be developed and implemented in a public and private hospital. Results from Phase 1 will be published in 2021, followed by the implementation of Phase 2 in subsequent years.ConclusionsThis study will provide evidence and guidance regarding the implementation of a personalized mobile mental health intervention for health care professionals into routine public and private hospitals to enhance communication and resolve conflicts.International registered report identifier (irrid)PRR1-10.2196/23112.

Project description:BackgroundSeveral systematic reviews have reviewed the evidence relating to nature on aspects of children and adolescent's health and wellbeing; however, none have looked at the associations or effectiveness of attending nature-based early childhood education (ECE). The main objective is to systematically review and synthesise the evidence to determine if nature-based ECE enhances children's health, wellbeing and development.MethodsWe will search the following electronic databases (from inception onwards): MEDLINE, Scopus, PsycINFO, ERIC, SportDiscus, Australian Education Index, British Education Index, Child Development and Adolescent studies, and Applied Social Sciences Index and Abstracts. Grey literature will be identified searching dissertations and reports (e.g. Open Grey, Dissertations Theses Database [ProQuest], and Google Scholar). All types of studies (quantitative and qualitative) conducted in children (aged 2-7 years old) attending ECE who had not started education at primary or elementary school will be included. The exposure of interest will be nature-based ECE settings that integrate nature into their philosophy and/or curriculum and environment. The outcomes of interest will be all aspects of the child's physical, cognitive, social and emotional health wellbeing and development. Two reviewers will independently screen full-text articles. The study methodological quality (or bias) will be appraised using appropriate tools. If feasible, a meta-analysis will be conducted using a random-effect model for studies similar in exposure and outcome. Where studies cannot be included in a meta-analysis, findings will be summarised based on the effect directions and a thematic analysis will be conducted for qualitative studies.DiscussionThis systematic review will capture the state of the current literature on nature-based ECE for child health, wellbeing and development. The results of this study will be of interest to multiple audiences (including researchers and policy makers). Results will be published in a peer-reviewed journal. Gaps for future research will be identified and discussed.Systematic review registrationPROSPERO CRD42019152582.