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Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol.

ABSTRACT: INTRODUCTION:Transition to adult care is a challenging and complex process for youth with special healthcare needs. We aim to compare effectiveness of a patient navigator service in reducing emergency room (ER) use among adolescents with chronic health conditions transitioning to adult care. METHODS AND ANALYSIS:Pragmatic randomised controlled trial parallel group design comparing ER visit rates between patients with access to a personalised navigator intervention compared with usual care. Unit of randomisation is the patient. Treatment assignment will not be blinded. Embedded qualitative study to understand navigator's role and cost analysis attributable to the intervention will be performed. Patients aged 16-21 years, followed within a chronic disease clinic, expected to be transferred to adult care within 12 months and residing in Alberta during study period will be recruited from three tertiary care paediatric hospitals. Sample size will be 300 in each arm. Navigator intervention over 24 months is designed to assist participants in four domains: transition preparation, health system brokering, socioeconomic determinants of health and self-management. Primary outcome is ER visit rate during observation period. Secondary outcomes are ambulatory and inpatient care utilisation measures, as well as Transition Readiness Assessment Questionnaire score, and Short-Form Health Survey 12 (SF-12) score at 6 and 18 months post-randomisation. Poisson regression will compare rates of ER/urgent care visits between navigator and control participants, using intention to treat principle. Cost analysis of the intervention will be conducted. Thematic analysis will be used to identify perceptions of stakeholders regarding the role of navigators. ETHICS AND DISSEMINATION:Ethics approval was obtained from the University of Calgary Conjoint Health Research Ethics Board (REB #162561) and the University of Alberta Health Research Ethics Board (Pro00077325). Our team is composed of diverse stakeholders who are committed to improving transition of care who will assist with dissemination of results. TRIAL REGISTRATION NUMBER:NCT03342495.

SUBMITTER: Samuel S

PROVIDER: S-EPMC6924868 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol.

Samuel Susan S Dimitropoulos Gina G Schraeder Kyleigh K Klarenbach Scott S Nettel-Aguirre Alberto A Guilcher Greg G Pacaud Daniele D Pinzon Jorge J Lang Eddy E Andrew Gail G Zwaigenbaum Lonnie L Scott Shannon S McBrien Kerry K Hamiwka Lorraine L Mackie Andrew A

BMJ open 20191210 12

<h4>Introduction</h4>Transition to adult care is a challenging and complex process for youth with special healthcare needs. We aim to compare effectiveness of a patient navigator service in reducing emergency room (ER) use among adolescents with chronic health conditions transitioning to adult care.<h4>Methods and analysis</h4>Pragmatic randomised controlled trial parallel group design comparing ER visit rates between patients with access to a personalised navigator intervention compared with us ...[more]

PMID: 31826899

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Project description:Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).

Project description:IntroductionPeople experiencing homelessness suffer from poor outcomes after hospitalisation due to systemic barriers to care, suboptimal transitions of care, and intersecting health and social burdens. Case management programmes have been shown to improve housing stability, but their effects on broad posthospital outcomes in this population have not been rigorously evaluated. The Navigator Programme is a Critical Time Intervention case management programme that was developed to help homeless patients with their postdischarge needs and to link them with community-based health and social services. This randomised controlled trial examines the impact of the Navigator Programme on posthospital outcomes among adults experiencing homelessness.Methods and analysisThis is a pragmatic randomised controlled trial testing the effectiveness of the Navigator Programme at an urban academic teaching hospital and an urban community teaching hospital in Toronto, Canada. Six hundred and forty adults experiencing homelessness who are admitted to the hospital will be randomised to receive support from a Homeless Outreach Counsellor for 90 days after hospital discharge or to usual care. The primary outcome is follow-up with a primary care provider (physician or nurse practitioner) within 14 days of hospital discharge. Secondary outcomes include postdischarge mortality or readmission, number of days in hospital, number of emergency department visits, self-reported care transition quality, and difficulties meeting subsistence needs. Quantitative outcomes are being collected over a 180-day period through linked patient-reported and administrative health data. A parallel mixed-methods process evaluation will be conducted to explore intervention context, implementation and mechanisms of impact.Ethics and disseminationEthics approval was obtained from the Unity Health Toronto Research Ethics Board. Participants will be required to provide written informed consent. Results of the main trial and process evaluation will be reported in peer-reviewed journals and shared with hospital leadership, community partners and policy makers.Trial registration numberNCT04961762.

Project description:IntroductionThe objective of this parallel group, randomised controlled trial is to evaluate a community health navigator (CHN) intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes. Unplanned hospital readmissions are costly for the health system and negatively impact patients.Methods and analysisPatients are randomised post hospital discharge to the CHN intervention or usual care. A comparison of outcomes between intervention and control groups will use multivariate regression techniques that adjust for age, sex and any independent variables that are significantly different between the two groups, using multiple imputation for missing values. Time-to-event analysis will examine the relationship between seeing a CHN following discharge from the index hospitalisation and reduced rehospitalisations in the subsequent 60 days and 6 months. Secondary outcomes include medication adherence, health literacy, quality of life, experience of healthcare and health service use (including the cost of care). We will also conduct a qualitative assessment of the implementation of the navigator role from the viewpoint of stakeholders including patients, health professionals and the navigators themselves.Ethics approvalEthics approval was obtained from the Research Ethics and Governance Office, Sydney Local Health District, on 21 January 2022 (Protocol no. X21-0438 and 2021/ETH12171). The findings of the trial will be disseminated through peer-reviewed journals and national and international conference presentations. Data will be deposited in an institutional data repository at the end of the trial. This is subject to Ethics Committee approval, and the metadata will be made available on request.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN 12622000659707).Article summaryThe objective of this trial is to evaluate a CHN intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes.

Project description:BackgroundYouth in the child welfare system (child welfare-involved [CWI] youth) have high documented rates of mental health symptoms and experience significant disparities in mental health care services access and engagement. Adolescence is a developmental stage that confers increased likelihood of experiencing mental health symptoms and the emergence of disorders that can persist into adulthood. Despite a high documented need for evidence-based mental health services for CWI youth, coordination between child welfare and mental health service systems to increase access to care remains inadequate, and engagement in mental health services is low. Navigator models developed in the health care field to address challenges of service access, fragmentation, and continuity that affect the quality of care provide a promising approach to increase linkage to, and engagement in, mental health services for CWI youth. However, at present, there is no empirically supported mental health navigator model to address the unique and complex mental health needs of CWI youth and their families.ObjectiveUsing a randomized controlled trial, this study aims to develop and test a foster care family navigator (FCFN) model to improve mental health service outcomes for CWI adolescents (aged 12-17 years).MethodsThe navigator model leverages an in-person navigator and use of adjunctive digital health technology to engage with, and improve, care coordination, tracking, and monitoring of mental health service needs for CWI youth and families. In total, 80 caregiver-youth dyads will be randomized to receive either the FCFN intervention or standard of care (clinical case management services): 40 (50%) to FCFN and 40 (50%) to control. Qualitative exit interviews will inform the feasibility and acceptability of the services received during the 6-month period. The primary trial outcomes are mental health treatment initiation and engagement. Other pre- and postservice outcomes, such as proportion screened and time to screening, will also be evaluated. We hypothesize that youth receiving the FCFN intervention will have higher rates of mental health treatment initiation and engagement than youth receiving standard of care.ResultsWe propose enrollment of 80 dyads by March 2024, final data collection by September 2024, and the publication of main findings in March 2025. After final data analysis and writing of the results, the resulting manuscripts will be submitted to journals for dissemination.ConclusionsThis study will be the first to produce empirically driven conclusions and recommendations for implementing a family mental health navigation model for CWI youth with long-standing and unaddressed disparities in behavioral health services access. The study findings have potential to have large-scale trial applicability and be feasible and acceptable for eventual system implementation and adoption.Trial registrationClinicalTrials.gov NCT04506437; https://www.clinicaltrials.gov/study/NCT04506437.International registered report identifier (irrid)DERR1-10.2196/49999.

Project description:BackgroundEmergency department (ED) visits contribute substantially to health care expenditures. Case management has been proposed as a strategy to address the medical and social needs of complex patients. However, strong research designs to evaluate the effectiveness of such interventions are limited.ObjectivesTo evaluate whether a community-based case management program was associated with reduced ED utilization among complex patients.DesignPatients whose risk exceeded a threshold were randomly assigned to a group offered case management or to the control group. Assignment occurred at five intervals between November 2017 and January 2019. Program effectiveness for all assigned patients was assessed using an intention-to-treat effect. Program effectiveness among those who received treatment was assessed using a local average treatment effect, estimated using instrumental variables. Both estimators were adjusted for baseline characteristics using linear models.ParticipantsAdults over age 18 with at least one health care encounter with Michigan Medicine or St. Joseph Mercy Health System between June 2, 2016, and November 27, 2018.InterventionsIntervention arm participants (n = 486) were offered coordinated case management across medical, mental health, and social service organizations. Control arm participants (n = 409) received usual care.Main measuresThe primary outcome was the number of ED visits in the 6 months following randomization into the study. Secondary outcomes were 6-month counts of inpatient and outpatient visits.Key resultsOf the 486 patients assigned to the intervention, 131 (27%) consented to receive case management. The intention-to-treat effect on ED visits was + 0.14 (95% CI: - 0.27 to + 0.55). The local average treatment effect among those who consented and received case management was + 0.53 (95% CI: - 1.00 to + 2.05). Intention-to-treat and local average treatment effects were not significant for secondary outcomes.ConclusionsThe community case management intervention targeting ED visits was not associated with reduced utilization. Future case management interventions may benefit from additional patient engagement strategies and longer evaluation time periods.Trial registrationClinicaltrials.gov Identifier: NCT03293160.

Dataset Information

Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol.

Publications

Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol.

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