Recruiting

Observational Study

Sponsor:

St. Boniface Hospital

Code:

NCT05692921

Conditions

Acute Coronary Syndrome

Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Remote Home Monitoring (RHM)

Rapid Response Nursing

Study Details

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

Conditions

Acute Coronary Syndrome

Myocardial Infarction

Study ID

NCT05692921

Start date

Feb 15, 2023

Status verified date

Apr, 2024

Completion date

Jul 30, 2025

Anticipated

Primary completion date

Mar 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

no intervention: 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.

Interventions

Remote Home Monitoring (RHM)

A Virtual platform will be used to provide education and support for ACS patients within the community after a patient is discharged home

Rapid Response Nursing

A Rapid Response Nurse will be used to provide education and support for ACS patients within the community after a patient is discharged home.

Primary outcome measure

  • Mortality - Composite outcome measure [ Time Frame: 30-days post hospital discharge ]
  • Repeat MI - Composite outcome measure [ Time Frame: 30-days post hospital discharge ]
  • Re-Admission - Composite outcome measure [ Time Frame: 30-days post hospital discharge ]
  • Congestive Heart Failure - Composite outcome measure [ Time Frame: 30-days post hospital discharge ]
  • Congestive Heart Failure - Composite outcome measure [ Time Frame: 30-days post hospital discharge ]

Central Contacts and Locations

Central contacts

Shuangbo Liu, MD

2042581266sliu@sbgh.mb.ca

David Kent, MSc

2042372985dkent@sbgh.mb.ca

Locations

St. Boniface Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H2A6

Contacts

Shuangbo Liu

2042581266sliu@sbgh.mb.ca

Principal Investigator:

Shuangbo Liu, MD

More Information

Sponsor

St. Boniface Hospital

Last update posted

Apr 18, 2024

Last verified

Apr, 2024

Keywords

  • Percutaneous Coronary Intervention
  • Education
  • Community Support
  • Remote Home Monitoring
  • Rapid Response Nurses
  • Low-risk assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Boniface Hospital on 2024-04-18.