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.

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:BackgroundNonadherence to medications by patients requiring hemodialysis (HD) leads to unfavorable clinical outcomes. Limited data exist to demonstrate the effect of incorporating patient-centered interventions using concepts of medication therapy management and motivational interview by pharmacists on pharmacoadherence in patients requiring HD. Therefore, we assessed the impact of patient-centered pharmacist care on pharmacoadherence and its outcomes in patients requiring HD.MethodsAdult patients who had received outpatient HD for at least 3 months were enrolled. The study was conducted from October 2016 to April 2017. Pharmacists interviewed the patients at month 1, 2, 4 and 6, and the intervention (comprehensive review) occurred at months 3 and 5. The primary outcome was the change in pharmacoadherence as assessed by pre-HD serum phosphate levels and the differences in the number of medications between patient' self-report and medications records at the electronic healthcare records (EHRs). The secondary outcomes included changes in systolic blood pressure (SBP), glycosylated hemoglobin levels, serum low-density lipoprotein (LDL) levels, and the prevalence and types of medication-related problems (MRPs).ResultsSeventy-two patients were enrolled. Their median age was 59 (interquartile range: 47-67.5) years, and 53% were men. Pre- and post-intervention pharmacoadherence, as indicated by serum phosphate levels and the differences in the number of medications between patient' self-report and the medication records at the EHRs, did not significantly differ (p = 0.682 and 0.348, respectively). Mean SBP and mean LDL did not significantly change post-intervention. The median number of MRPs declined between Months 3 and 5 (p = 0.002): the prevalence of MRPs at Month 3 was 44.9% (95 confidence interval [CI]: 40.4-49.3) and decreased to 29.8% (95 CI: 25.6-34.3) at Month 5. Drug use without indication was the most frequent MRP (23.9%).ConclusionsPatient-centered pharmacist care did not result in significant changes in pharmacoadherence. However, its clinical utility as a tool to identify and mitigate MRPs in patients requiring HD is indisputable.Trial registrationClinicalTrials.gov identifier: NCT03576404 (retrospectively registered on July 3rd, 2018).

Project description:BackgroundIndividuals with substance use disorders (SUD) have disproportionately high rates of unintended pregnancy. Reducing harm associated with this risk and its biopsychosocial consequences requires evidence-based, non-coercive interventions that ensure access to contraception for individuals who choose to prevent pregnancy. We examined feasibility and impact of SexHealth Mobile, a mobile unit-based intervention that aimed to increase access to patient-centered contraceptive care for individuals in SUD recovery programs.MethodsWe conducted a quasi-experimental study (enhanced usual care [EUC] followed by intervention) at three recovery centers with participants (n = 98) at risk for unintended pregnancy. EUC participants were offered printed information on community locations where they could access contraception care. SexHealth Mobile participants were offered same-day, onsite clinical consultation on a medical mobile unit and contraception if desired. The primary outcome was use of contraception (hormonal or intrauterine device) at one-month post-enrollment. Secondary outcomes were at two-weeks and three-months. Confidence in preventing unintended pregnancy, reasons for non-use of contraception at follow-up, and intervention feasibility were also assessed.ResultsParticipants (median age = 31, range 19-40) enrolled in the intervention period were almost 10 times more likely to be using contraception at one-month (51.5%) versus the those enrolled in the EUC period (5.4%) (unadjusted relative risk [URR] = 9.3 [95%CI: 2.3-37.1]; adjusted relative risk [ARR] = 9.8 [95%CI: 2.4-39.2]). Intervention participants were also more likely to be using contraception at 2-weeks (38.7% vs. 2.6%; URR = 14.3 [95%CI: 2.0-104.1]) and three-months (40.9% vs. 13.9%; URR = 2.9 [95% CI: 1.1-7.4]). EUC participants reported more barriers (cost, time) and less confidence in preventing unintended pregnancies. Mixed-methods feasibility data indicated high acceptability and feasible integration into recovery settings.ConclusionsMobile contraceptive care based on principles of reproductive justice and harm reduction reduces access barriers, is feasible to implement in SUD recovery settings, and increases contraception use. Expanding interventions like SexHealth Mobile may help reduce harm from unintended pregnancies among individuals in SUD recovery. Trial Registration NCT04227145.

Project description:IntroductionTechnology to enhance hypertension management is increasingly used in primary care; however, it has not been evaluated in an Asian primary care setting. We aimed to understand the clinical impact and cost-effectiveness of a technology-enabled home blood pressure monitor when deployed in primary care, and patients' perspectives about the technology.MethodsA quasi-experimental cohort study was conducted in a polyclinic in Singapore. In total, 120 patients with hypertension were assigned to the telemonitoring intervention group. Patients received a home blood pressure device connected to the clinical care team's dashboard through a mobile gateway. Tele-consultations and nurse-led tele-support were carried out using established clinical protocols. In total, 120 patients assigned to the control group continued to receive usual care in the polyclinic. Clinical outcomes, cost-effectiveness, and patient satisfaction were measured 6 months after recruitment.ResultsIn total, 217 patients completed 6 months of follow-up. Telemonitoring intervention patients had significantly increased odds of having controlled blood pressure by a factor of 2.69 (p = 0.01), with the greatest improvement in those whose blood pressure was uncontrolled at baseline (p < 0.05). The incremental cost-effectiveness ratios for all patients was S$23,935.14/quality-adjusted life year (<1 gross domestic product per capita), which was very cost-effective based on World Health Organization cost-effectiveness thresholds. There was greater satisfaction in telemonitoring intervention group relating to the convenience of recording and sharing blood pressure measurements with the health care team, consultation advice received, understanding by the health care team of their condition, and were more motivated to monitor their blood pressure.DiscussionTelemonitoring with tele-consultation improved blood pressure control and was more cost-effective than usual care. Patients receiving telemonitoring intervention were also more motivated and satisfied with their care.

Project description:BackgroundThe use of mobile health (mHealth) technology to improve quality of care (QoC) has increased over the last decade; limited evidence exists to espouse mHealth as a decision support tool, especially at the community level. This study presents evaluation findings of using a mobile application for integrated community case management (iCCM) by Malawi's health surveillance assistants (HSAs) in four pilot districts to deliver lifesaving services for children.MethodsA quasi-experimental study design compared adherence to iCCM guidelines between HSAs using mobile application (n = 137) and paper-based tools (n = 113), supplemented with 47 key informant interviews on perceptions about QoC and sustainability of iCCM mobile application. The first four sick children presenting to each HSA for an initial consultation of an illness episode were observed by a Ministry of Health iCCM trainer for assessment, classification, and treatment. Results were compared using logistic regression, controlling for child-, HSA-, and district-level characteristics, with Holm-Bonferroni-adjusted significance levels for multiple comparison.ResultsHSAs using the application tended to assess sick children according to iCCM guidelines more often than HSAs using paper-based tools for cough (adjusted proportion, 98% vs 91%; P < 0.01) and five physical danger signs - chest in-drawing; alertness; palmar pallor; malnourishment; oedema (80% vs 62%; P < 0.01), but not for fever (97% vs 93%; P = 0.06), diarrhoea (94% vs 87%; P = 0.03), and three danger signs - not able to eat or drink; vomits everything; has convulsions (88% vs 79%; P = 0.01). Across illnesses and danger signs, 81% of HSAs using the application correctly classified sick children, compared to 58% of HSAs using paper-based tools (P < 0.01). No differences existed for their treatment (P = 0.27). Interview respondents corroborated these findings that using iCCM mobile application ensures protocol adherence. Respondents noted barriers to its consistent and wide use including hardware problems and limited resources.ConclusionGenerally, the mobile application is a promising tool for improving adherence to the iCCM protocol for assessing sick children and classifying illness by HSAs. Limited effects on treatments and inconsistent use suggest the need for more studies on mHealth to improve QoC at community level.

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.

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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