Tailoring Post Discharge (The TPD Study)

NCT05692921 | Recruiting

• 1 other identifier: TPD Protocol
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Mortality - Composite outcome measure

  mortality - measured as yes/no (Alive at 30 days = no)

  30-days post hospital discharge

• Repeat MI - Composite outcome measure

  repeat myocardial infarction - measured as yes/no (repeat MI at 30 days = yes)

  30-days post hospital discharge

• Re-Admission - Composite outcome measure

  re-hospitalization and emergency room/urgent care visits measured as yes/no (rehospitalization at 30 days = yes)

  30-days post hospital discharge

• Congestive Heart Failure - Composite outcome measure

  congestive heart failure - measured as yes/no (Ejection fraction \< 40% is CHF)

  30-days post hospital discharge

• Congestive Heart Failure - Composite outcome measure

  serious arrhythmia (VT, VF) measured as yes/no (Arrhythmia at 30 days = yes)

  30-days post hospital discharge

Secondary Outcomes (4)

• EQ-5D-5L - Health related Quality of Life

  baseline (before discharge from hospital), 2-weeks post hospital discharge, and 30 Days post hospital Discharge

• EQ-VAS - 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

Study Arms (3)

Remote Home Monitoring (RHM)

EXPERIMENTAL

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.

Other: Remote Home Monitoring (RHM)

Rapid Response Nursing (RRN)

ACTIVE COMPARATOR

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.

Other: Rapid Response Nursing

Registry

NO INTERVENTION

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) OTHER

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

Remote Home Monitoring (RHM)

Rapid Response Nursing OTHER

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

Rapid Response Nursing (RRN)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients who presented with ACS to St. Boniface Hospital
• Considered low risk based on cardiac risk, comorbidities, community and patient resources

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Boniface Hospital: lead

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H2A6, Canada

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Shuangbo Liu, MD

CONTACT

2042581266; sliu@sbgh.mb.ca

David Kent, MSc

CONTACT

2042372985; dkent@sbgh.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Comparing 2 interventional groups: 1) Virtual Remote Home Monitoring and 2) Rapid Response Nursing care

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: February 15, 2023
• Primary Completion: March 30, 2025
• Study Completion: July 30, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

CA (1)