Tailoring Post Discharge (TPD) - Bridging the Gap Through Education and Community Support
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- St. Boniface Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Congestive Heart Failure - Composite outcome measure
Study Overview
Brief Summary
This randomized control trial seeks to better understand the educational needs of Acute Coronary Symptom (ACS) patients including the optimal timing and method of delivery as well as linkages with appropriate community resources and supports are important for cardiac patients to self-manage post hospital discharge to improve outcomes. While there is some literature of the learning needs of ACS patients, there is a paucity of research related to the timing and preferred methods of delivery. This study aims to better understand how best to tailor care for ACS patients from hospital to community. Specifically, the investigators propose a 2 phased approach to understand the needs of patients, and then to develop and deliver a tailored approach to assess, educate and support patients both in-hospital and within the community. The intervention compares 1) a virtual remote home monitoring (RHM) platform and 2) Rapid Response Nursing (RRN) staff to follow, educate and support ACS patients post hospital discharge for a period of no more than 30 days.
The Primary Objective of this study is to safely transition low risk ACS patients, from hospital to home, with appropriate supports to safely self-manage in the community and to provide educational and community supports to improve post discharge outcomes of low risk ACS patients
Detailed Description
Study design: 2 phase single center randomized, prospective pilot study
Phase 1) Evaluation of quality indicator results from discharge questionnaires from patients post ACS and a further investigation through patient engagement techniques about education, community support and quality of care. This process, comprising of patient collaborators/partners, will contribute to the study design, tool and resource development.
Phase 2) Randomized trial - Intervention (low risk 24-hour discharge support using Rapid Response nursing (RRN) vs low risk 24-hour discharge support using Remote Home Monitoring (RHM). Patients will be assessed using a trialed multipoint tool developed for this research study utilizing the cardiac, medical, community and patient risks. After assessment, low-risk patients will be randomized into the study. The study interventions will utilize either the RRN or the RHM to deliver education and support to patients post discharge.
Phase 1 - Patient Engagement Panel:
Patient engagement in research involves meaningful and active collaboration between patients and researchers throughout the different phases of a research project, including planning, data collection, data analysis, and knowledge translation. These collaborative meetings inform and guide study development. The central tenet of patient engagement in research is that, while clinicians and investigators have disease and research specific expertise, patients have expertise that stems from lived experience of their health issues. By sharing their experiences of the daily impact of disease and their perspectives regarding unmet needs, therapeutic burdens, balance of benefits and risks, and types of research questions most important to them, patients can transform the research process from one directed by investigators to one driven and informed by the needs of patients and their caregivers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All adult patients who presented with ACS to St. Boniface Hospital
- •Considered low risk based on cardiac risk, comorbidities, community and patient resources
Exclusion Criteria
- •Age less than 18 years.
- •Unable or unwilling to provide consent
- •Considered high risk for early discharge
- •Lives outside of Winnipeg (for Phase 2 of the study, we will only be focusing on patients that live within Winnipeg)
- •No internet or mobile data access
Arms & Interventions
Remote Home Monitoring (RHM)
Remote Home Monitoring Platform (RHM): will be utilized to help tailor education and support for the patient after they have been discharged from the hospital. The platform will provide access to and delivery of health related education and information for continued self-care within the community. The platform will be used to evaluate post discharge symptoms and for health care providers to access the need for continued direct patient care and education through virtual processes.
Intervention: Remote Home Monitoring (RHM) (Other)
Rapid Response Nursing (RRN)
Rapid Response Nursing Team (RRN): The RRN will help clients/patients to:
- Understand their current health conditions, treatments, how to manage symptoms and when/who to ask for help; Specifically; they will
- Help clients to understand their hospital discharge plan;
- Support patients during their recovery at home;
- Reinforce and contribute to in-hospital education about heath health and recovering safely at home;
- Review medications to help clients understand the purpose, side effects and how to take prescribed medications correctly, including assisting clients with getting prescriptions filled;
- Connect with their Home Clinic, ensuring everyone has the necessary information for follow-up care;
- Connect clients with a Home Clinic if they do not have one; and
- Access appropriate home supports to help clients remain at home safely for as long as possible.
Intervention: Rapid Response Nursing (Other)
Registry
Registry Arm:
Patients who fit the criteria for study inclusion and choose not to participate in the main study will be provided with an opportunity to consent to the registry arm of the study. The registry arm of the study is an opportunity to establish a standard of care group free from research bias. Patients who enroll in the registry will only need to complete a short questionnaire before they are discharged home which will take approximately 5 minutes. Additionally, research staff will also complete a medical chart review to identify specific medical information related to their demographics, cardiac procedure, hospital stay, recovery, and to identify any re-admissions to hospital that may have occurred after the patient has been discharged home.
Outcomes
Primary Outcomes
Congestive Heart Failure - Composite outcome measure
Time Frame: 30-days post hospital discharge
congestive heart failure - measured as yes/no (Ejection fraction \< 40% is CHF)
Repeat MI - Composite outcome measure
Time Frame: 30-days post hospital discharge
repeat myocardial infarction - measured as yes/no (repeat MI at 30 days = yes)
Mortality - Composite outcome measure
Time Frame: 30-days post hospital discharge
mortality - measured as yes/no (Alive at 30 days = no)
Re-Admission - Composite outcome measure
Time Frame: 30-days post hospital discharge
re-hospitalization and emergency room/urgent care visits measured as yes/no (rehospitalization at 30 days = yes)
Secondary Outcomes
- EQ-VAS - Health related Quality of Life(baseline (before discharge from hospital), 2-weeks post hospital discharge, and 30 Days post hospital Discharge)
- EQ-5D-5L - Health related Quality of Life(baseline (before discharge from hospital), 2-weeks post hospital discharge, and 30 Days post hospital Discharge)
- General Anxiety Disorder (GAD) - 7(baseline (before discharge from hospital), 2-weeks post hospital discharge, and 30 Days post hospital Discharge)
- Patient Health Questionnaire (PHQ) - 9(baseline (before discharge from hospital), 2-weeks post hospital discharge, and 30 Days post hospital Discharge)
Investigators
Shuangbo Liu
Principal Investigator
St. Boniface Hospital