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Comparison of family centered care with family integrated care and mobile technology (mFICare) on preterm infant and family outcomes: a multi-site quasi-experimental clinical trial protocol.

ABSTRACT: BACKGROUND:Family Centered Care (FCC) has been widely adopted as the framework for caring for infants in the Neonatal Intensive Care Unit (NICU) but it is not uniformly defined or practiced, making it difficult to determine impact. Previous studies have shown that implementing the Family Integrated Care (FICare) intervention program for preterm infants in the NICU setting leads to significant improvements in infant and family outcomes. Further research is warranted to determine feasibility, acceptability and differential impact of FICare in the US context. The addition of a mobile application (app) may be effective in providing supplemental support for parent participation in the FICare program and provide detailed data on program component uptake and outcomes. METHODS:This exploratory multi-site quasi-experimental study will compare usual FCC with mobile enhanced FICare (mFICare) on growth and clinical outcomes of preterm infants born at or before 33?weeks gestational age, as well as the stress, competence and self-efficacy of their parents. The feasibility and acceptability of using mobile technology to gather data about parent involvement in the care of preterm infants receiving FCC or mFICare as well as of the mFICare intervention will be evaluated (Aim 1). The effect sizes for infant growth (primary outcome) and for secondary infant and parent outcomes at NICU discharge and three months after discharge will be estimated (Aim 2). DISCUSSION:This study will provide new data about the implementation of FICare in the US context within various hospital settings and identify important barriers, facilitators and key processes that may contribute to the effectiveness of FICare. It will also offer insights to clinicians on the feasibility of a new mobile application to support parent-focused research and promote integration of parents into the NICU care team in US hospital settings. TRIAL REGISTRATION:ClinicalTrials.gov, ID NCT03418870. Retrospectively registered on December 18, 2017.

SUBMITTER: Franck LS

PROVIDER: S-EPMC6886221 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Comparison of family centered care with family integrated care and mobile technology (mFICare) on preterm infant and family outcomes: a multi-site quasi-experimental clinical trial protocol.

Franck Linda S LS Kriz Rebecca M RM Bisgaard Robin R Cormier Diana M DM Joe Priscilla P Miller Pamela S PS Kim Jae H JH Lin Carol C Sun Yao Y

BMC pediatrics 20191202 1

<h4>Background</h4>Family Centered Care (FCC) has been widely adopted as the framework for caring for infants in the Neonatal Intensive Care Unit (NICU) but it is not uniformly defined or practiced, making it difficult to determine impact. Previous studies have shown that implementing the Family Integrated Care (FICare) intervention program for preterm infants in the NICU setting leads to significant improvements in infant and family outcomes. Further research is warranted to determine feasibili ...[more]

PMID: 31791285

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Project description:Background Family Integrated Care (FICare) benefits preterm infants compared with Family-Centered Care (FCC), but research is lacking in United States (US) Neonatal Intensive Care Units (NICUs). The outcomes for infants of implementing FICare in the US are unknown given differences in parental leave benefits and health care delivery between the US and other countries where FICare is used. We compared preterm weight and discharge outcomes between FCC and mobile-enhanced FICare (mFICare) in the US. Methods In this quasi-experimental study, we enrolled preterm infant (≤ 33 weeks)/parent dyads from 3 NICUs into sequential cohorts: FCC or mFICare. Our primary outcome was 21-day change in weight z-scores. Our secondary outcomes were nosocomial infection, bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), and human milk feeding (HMF) at discharge. We used intention-to-treat analyses to examine the effect of the FCC and mFICare models overall and per protocol analyses to examine the effects of the mFICare intervention components. Findings 253 infant/parent dyads participated (141 FCC; 112 mFICare). There were no parent-related adverse events in either group. In intention-to-treat analyses, we found no group differences in weight, ROP, BPD or HMF. The FCC cohort had 2.6-times (95% CI: 1.0, 6.7) higher odds of nosocomial infection than the mFICare cohort. In per-protocol analyses, we found that infants whose parents did not receive parent mentoring or participate in rounds lost more weight relative to age-based norms (group-difference=-0.128, CI: -0.227, -0.030; group-difference=-0.084, CI: -0.154, -0.015, respectively). Infants whose parents did not participate in rounds or group education had 2.9-times (CI: 1.0, 9.1) and 3.8-times (CI: 1.2, 14.3) higher odds of nosocomial infection, respectively. Conclusion We found indications that mFICare may have direct benefits on infant outcomes such as weight gain and nosocomial infection. Future studies using implementation science designs are needed to optimize intervention delivery and determine acute and long-term infant and family outcomes. Clinical Trial Registration NCT03418870 01/02/2018.

Project description:BackgroundCare coordination is challenging but crucial for children with medical complexity (CMC). Technology-based solutions are increasingly prevalent but little is known about how to successfully deploy them in the care of CMC.ObjectiveThe aim of this study was to assess the feasibility and acceptability of GoalKeeper (GK), an internet-based system for eliciting and monitoring family-centered goals for CMC, and to identify barriers and facilitators to implementation.MethodsWe used the Consolidated Framework for Implementation Research (CFIR) to explore the barriers and facilitators to the implementation of GK as part of a clinical trial of GK in ambulatory clinics at a children's hospital (NCT03620071). The study was conducted in 3 phases: preimplementation, implementation (trial), and postimplementation. For the trial, we recruited providers at participating clinics and English-speaking parents of CMC<12 years of age with home internet access. All participants used GK during an initial clinic visit and for 3 months after. We conducted preimplementation focus groups and postimplementation semistructured exit interviews using the CFIR interview guide. Participant exit surveys assessed GK feasibility and acceptability on a 5-point Likert scale. For each interview, 3 independent coders used content analysis and serial coding reviews based on the CFIR qualitative analytic plan and assigned quantitative ratings to each CFIR construct (-2 strong barrier to +2 strong facilitator).ResultsPreimplementation focus groups included 2 parents (1 male participant and 1 female participant) and 3 providers (1 in complex care, 1 in clinical informatics, and 1 in neurology). From focus groups, we developed 3 implementation strategies: education (parents: 5-minute demo; providers: 30-minute tutorial and 5-minute video on use in a clinic visit; both: instructional manual), tech support (in-person, virtual), and automated email reminders for parents. For implementation (April 1, 2019, to December 21, 2020), we enrolled 11 providers (7 female participants, 5 in complex care) and 35 parents (mean age 38.3, SD 7.8 years; n=28, 80% female; n=17, 49% Caucasian; n=16, 46% Hispanic; and n=30, 86% at least some college). One parent-provider pair did not use GK in the clinic visit, and few used GK after the visit. In 18 parent and 9 provider exit interviews, the key facilitators were shared goal setting, GK's internet accessibility and email reminders (parents), and GK's ability to set long-term goals and use at the end of visits (providers). A key barrier was GK's lack of integration into the electronic health record or patient portal. Most parents (13/19) and providers (6/9) would recommend GK to their peers.ConclusionsFamily-centered technologies like GK are feasible and acceptable for the care of CMC, but sustained use depends on integration into electronic health records.Trial registrationClinicalTrials.gov NCT03620071; https://clinicaltrials.gov/ct2/show/NCT03620071.

Project description:Patient engagement in the process of developing a diabetes treatment plan is associated with person-centered care and improved treatment outcomes. The objective of the present study was to evaluate the self-reported patient and parent-centered satisfaction and well-being outcomes associated with the three treatment strategies utilized in a comparative effectiveness trial of technology-enhanced blood glucose monitoring and family-centered goal setting. We evaluated data from 97 adolescent-parent pairs at baseline and 6-months during the randomized intervention. Measures included: Problem Areas in Diabetes (PAID) child and parent scales, pediatric diabetes-related quality of life, sleep quality, and satisfaction with diabetes management. Inclusion criteria were 1) ages 12-18 years, 2) a T1D diagnosis for at least six months and 3) parent/caregiver participation. Longitudinal changes in survey responses were measured at 6 months from baseline. Differences between and within participant groups were evaluated using ANOVA. The average age of youth participants was 14.8 ± 1.6 years with half of the participants being female (49.5%). The predominant ethnicity/race was Non-Hispanic (89.9%) and white (85.9%). We found that youth perceived 1) greater of diabetes-related communication when using a meter capable of transmitting data electronically, 2) increased engagement with diabetes self-management when using family-centered goal setting, and 3) worse sleep quality when using both strategies together (technology-enhanced meter and family-centered goal setting). Throughout the study, scores for self-reported satisfaction with diabetes management were higher in youth than parents. This suggests that patients and parents have different goals and expectations regarding their diabetes care management and care delivery. Our data suggest that youth with diabetes value communication via technology and patient-centered goal setting. Strategies to align youth and parent expectations with the goal of improving satisfaction could be utilized as a strategy to improve partnerships in diabetes care management.

Project description:BackgroundThere is worldwide recognition that the future provision of health care requires a reorganization of provision of care, with increased empowerment and engagement of patients, along with skilled health professionals delivering services that are coordinated across sectors and organizations that provide health care. Technology may be a way to enable the creation of a coherent, cocreative, person-centered method to provide health care for individuals with one or more long-term conditions (LTCs). It remains to be determined how a new care model can be introduced that supports the intentions of the World Health Organization (WHO) to have integrated people-centered care.ObjectiveTo design, pilot, and test feasibility of a model of health care for people with LTCs based on a cocreative, iterative, and stepwise process in a way that recognizes the need for person-centered care, and embraces the use of digital technology.MethodsThe overall research method was inspired by action research and used an agile, iterative approach. In 2012, a living lab was established in a Danish municipality which allowed for the freedom of redesigning health care processes. As the first step, a wide group of stakeholders was gathered to create a layout for the reorganization of services and development of technology, based on established principles for innovative management of people with chronic conditions. The next three steps were (1) a proof of concept in 2012, (2) a pilot study, and (3) a feasibility study from 2013 to 2015, in which a total of 93 chronic obstructive pulmonary disease (COPD) patients were enrolled. Citizens were provided a tablet-based solution for remote follow-up and communication purposes, and access to a 24/7 response and coordination center that coordinated both virtual and face-to-face support for COPD management. In step five the initial model was extended with elements that support continuity of care. Beginning in the autumn of 2013, 1102 frail elderly individuals were included and offered two additional services: an outgoing acute medical team and a local subacute bed function.ResultsBased on the findings from the iterative process, and evolving technology and workflow solutions, we propose a robust and feasible model that can provide a framework for developing solutions to support an active life with one or more LTCs. The resulting Epital Care Model (ECM) consists of six stages, and serves as a template for how a digitally-enhanced health service can be provided based on patients' medical needs. The model is designed to be a proactive, preventive, and monitoring health care system that involves individuals in the management of their own health conditions.ConclusionsThe ECM is in accordance with WHO's framework for integrated people-centered health services, and may serve as a framework for the development of new technologies and provide a template for future reorganization.

Project description:BackgroundVariation exists in family-centered rounds (FCR).ObjectiveWe sought to understand patient/family and clinician FCR beliefs/attitudes and practices to support implementation efforts.Designs, settings and participantsPatients/families and clinicians at 21 geographically diverse US community/academic pediatric teaching hospitals participated in a prospective cohort dissemination and implementation study.InterventionWe inquired about rounding beliefs/attitudes, practices, and demographics using a 26-question survey coproduced with family/nurse/attending-physician collaborators, informed by prior research and the Consolidated Framework for Implementation Research.Main outcome and measuresOut of 2578 individuals, 1647 (64%) responded to the survey; of these, 1313 respondents participated in FCR and were included in analyses (616 patients/families, 243 nurses, 285 resident physicians, and 169 attending physicians). Beliefs/attitudes regarding the importance of FCR elements varied by role, with resident physicians rating the importance of several FCR elements lower than others. For example, on adjusted multivariable analysis, attending physicians (odds ratio [OR] 3.0, 95% confidence interval [95% CI] 1.2-7.8) and nurses (OR 3.1, 95% CI 1.3-7.4) were much more likely than resident physicians to report family participation on rounds as very/extremely important. Clinician support for key FCR elements was higher than self-reported practice (e.g., 88% believed family participation was important on rounds; 68% reported it often/always occurred). In practice, key elements of FCR were reported to often/always occur only 23%-70% of the time.ResultSupport for nurse and family participation in FCR is high among clinicians but varies by role. Physicians, particularly resident physicians, endorse several FCR elements as less important than nurses and patients/families. The gap between attitudes and practice and between clinician types suggests that attitudinal, structural, and cultural barriers impede FCR.

Dataset Information

Comparison of family centered care with family integrated care and mobile technology (mFICare) on preterm infant and family outcomes: a multi-site quasi-experimental clinical trial protocol.

Publications

Comparison of family centered care with family integrated care and mobile technology (mFICare) on preterm infant and family outcomes: a multi-site quasi-experimental clinical trial protocol.

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