Post-Discharge Care for Heart Attack

Overseen By David Kent, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Boniface Hospital

Disqualifiers: Age under 18, High risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

Is Rapid Response Nursing safe for patients?

Research shows that Rapid Response Nursing, which includes rapid response teams, is generally safe and can lead to positive outcomes like reduced rates of heart and breathing emergencies and lower death rates in hospitals. ^{1 2 3 4 5}

How does the post-discharge care treatment for heart attack differ from other treatments?

This treatment is unique because it involves a home-visiting service by district nursing staff, supported by a cardiac rehabilitation nurse specialist, which provides personalized care and support at home after discharge, unlike traditional outpatient services. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Rapid Response Nursing, Remote Home Monitoring, and Telehealth Monitoring for post-discharge care after a heart attack?

Research on remote monitoring for heart failure patients shows it can reduce hospital readmissions and improve patient care by allowing nurses to track vital signs and coordinate with doctors. This suggests that similar remote monitoring and nursing support could be beneficial for heart attack patients after they leave the hospital. ^{7 11 12 13 14}

Are You a Good Fit for This Trial?

This trial is for adults who had a heart attack or acute coronary syndrome, are low risk based on cardiac risk and other health conditions, and have internet access. They must live in Winnipeg and be able to consent. High-risk patients, those under 18, or without web access can't join.

Inclusion Criteria

I am considered low risk for heart problems and have support.

I was treated for acute coronary syndrome at St. Boniface Hospital.

Exclusion Criteria

No internet or mobile data access

I am under 18 years old.

Unable or unwilling to provide consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Patient Engagement Panel

Patient engagement sessions to gather insights and refine study design

2 weeks

3 sessions (in-person or virtual)

Prospective Research

Randomized trial with interventions using Rapid Response Nursing or Remote Home Monitoring

4 weeks

3 visits (1 in-person, 2 virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rapid Response Nursing
• Remote Home Monitoring (RHM)

Trial Overview The study tests two post-hospital discharge methods for heart attack patients: a virtual remote home monitoring platform versus rapid response nursing support for up to 30 days. It aims to determine the best way to educate and support these patients at home.

How Is the Trial Designed?

Group I: Remote Home Monitoring (RHM) Experimental Treatment 1 Intervention

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.

Group II: Rapid Response Nursing (RRN) Active Control 1 Intervention

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.

Group III: Registry Active Control 1 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.

Who Is Running the Clinical Trial?

St. Boniface Hospital

Lead Sponsor

Trials

55

Recruited

15,000+

Published Research Related to This Trial

Telemonitoring can help prevent rehospitalization risks for patients with heart failure, highlighting its importance in managing this health issue.

The article emphasizes the value of conducting a nursing interview shortly after hospital discharge, which is not typically included in standard telemonitoring protocols, based on experiences from a remote monitoring unit in Nantes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Telemonitoring of heart failure, the challenge of the first exchanges]. Mary, S.[2022]

Remote monitoring (RM) strategies, particularly structured telephone support (STS) delivered through human contact and home telemonitoring (TM), show promising trends in reducing all-cause mortality for patients recently discharged from heart failure hospitalization, based on a systematic review of 21 trials involving 6317 patients.

RM interventions also led to reductions in all-cause hospitalizations and improvements in health-related quality of life, indicating that these strategies can enhance patient care and outcomes after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote monitoring after recent hospital discharge in patients with heart failure: a systematic review and network meta-analysis. Pandor, A., Gomersall, T., Stevens, JW., et al.[2018]

The continuous remote patient monitoring (CRPM) system, utilizing wearable biosensors and machine learning algorithms, shows promise in managing heart failure patients post-discharge by potentially reducing readmissions through early intervention protocols.

During a soft launch involving five patients, the study identified areas for improvement in communication and protocol adherence, highlighting the need for further education and engagement of healthcare workers to effectively implement this technology in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Remote Patient Monitoring: Evaluation of the Heart Failure Cascade Soft Launch. Chi, WN., Reamer, C., Gordon, R., et al.[2022]

Remote monitoring (RM) of heart failure patients who are not homebound can be effectively implemented, as shown in a pilot study involving 150 participants from Massachusetts General Hospital over 6 months.

While the RM group showed a lower readmission rate compared to the usual care group, the difference was not statistically significant, suggesting that RM may help reduce hospital readmissions for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of remote monitoring to improve outcomes in patients with heart failure: a pilot trial. Kulshreshtha, A., Kvedar, JC., Goyal, A., et al.[2021]

A remote wireless monitoring system installed in five hospitals across three European countries effectively recorded vital signs every 2 minutes, allowing for continuous and accurate patient surveillance.

The system detected early signs of patient deterioration, such as in cases of atrial fibrillation and sepsis, before manual measurements could identify changes, potentially improving response times for critical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote wireless vital signs monitoring on the ward for early detection of deteriorating patients: A case series. Posthuma, LM., Downey, C., Visscher, MJ., et al.[2021]

The implementation of a nurse-led Rapid Response Team (RRT) at a large safety-net hospital in California significantly improved patient safety by enhancing the early detection of clinical deterioration, which is crucial in preventing code arrests and deaths.

Data from 2005 to 2010 indicated that the RRT approach, which included collaboration with nursing assistants and house staff, effectively reduced the frequency of non-ICU code arrests and improved post-arrest survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety to reduce preventable deaths: the case of a California safety net hospital. Leach, LS., Kagawa, F., Mayo, A., et al.[2013]

Rapid response teams (RRTs) can significantly improve patient outcomes by allowing for early intervention in cases of clinical decline, potentially reducing the incidence of cardiopulmonary arrests and mortality rates.

Clinical nurse specialists play a crucial role in leading and implementing RRTs, highlighting the need for further research to optimize these teams and their effectiveness in managing high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical nurse specialists as leaders in rapid response. Jenkins, SD., Lindsey, PL.[2018]

Registered nurses (RNs) find Rapid Response Teams (RRTs) to be an effective safety intervention that enhances their ability to rescue patients at risk of adverse events, as shown through interviews with 50 participants across six California hospitals.

The collaboration between RRT RNs and bedside RNs is crucial in preventing negative patient outcomes, although traditional hierarchies can sometimes hinder RN decision-making during critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How RNs rescue patients: a qualitative study of RNs' perceived involvement in rapid response teams. Leach, LS., Mayo, A., O'Rourke, M.[2022]

The effectiveness of rapid response systems in reducing major adverse events for deteriorating ward patients is still unclear, with some studies showing positive impacts on patient outcomes while others do not.

Nursing staff are often reluctant to activate rapid response systems, which may contribute to the inconclusive research findings, highlighting the need for further investigation into the barriers to their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Literature review: do rapid response systems reduce the incidence of major adverse events in the deteriorating ward patient? Massey, D., Aitken, LM., Chaboyer, W.[2010]

Rapid-response systems (RRSs) in hospitals have been shown to significantly reduce rates of cardiorespiratory arrest and mortality, based on moderate-strength evidence from a meta-analysis of 18 studies and additional lower-quality studies.

Despite their effectiveness, research indicates that there are barriers to the implementation of RRSs, suggesting that hospitals could improve their usage rates to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid-response systems as a patient safety strategy: a systematic review. Winters, BD., Weaver, SJ., Pfoh, ER., et al.[2022]

A home-visiting service for patients recovering from cardiac surgery or myocardial infarction was introduced to bridge the gap between hospital discharge and outpatient rehabilitation, addressing patients' difficulties during this transition.

The service, which involved district nursing staff and a cardiac rehabilitation nurse specialist, proved to be beneficial for clients and was established with a relatively low investment of time and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based cardiac rehabilitation. Imich, J.[2004]

The implementation of cardiac liaison nurses improved communication and follow-up care for patients with angina and myocardial infarction after hospital discharge, highlighting the importance of timely notifications and ongoing support.

The support from doctors was crucial for practice nurses to effectively provide post-hospital follow-up care, and the withdrawal of liaison nurses led to a significant decline in follow-up due to lack of discharge notifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The success of an integrated care programme for patients with ischaemic heart disease: the practice nurses' perspective of SHIP. Wright, L., Jolly, K., Speller, V., et al.[2019]

Patients recovering from acute myocardial infarction (AMI) have significant unmet information needs both during their hospital stay and after discharge, indicating a gap in current healthcare support.

Most AMI patients prefer follow-up communication via open telephone lines, suggesting that implementing a telephone follow-up system could enhance post-discharge support and information delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study of the information needs of acute myocardial infarction patients, and their preferences for follow-up contact after discharge. Hanssen, TA., Nordrehaug, JE., Hanestad, BR.[2015]

A systematic review of 10 randomized controlled trials found that telephone-based post-discharge nursing care significantly reduces hospital readmission rates for heart failure patients, indicating its effectiveness in promoting continuity of care.

The study highlights the need for further research on various aspects of telephone interventions, such as cost-effectiveness and feasibility, to enhance post-discharge support for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of telephone-based post-discharge nursing care in decreasing readmission rate in patients with heart failure: A systematic review. Lee, J., Park, S.[2020]

Citations

1. France pubmed.ncbi.nlm.nih.gov

[Telemonitoring of heart failure, the challenge of the first exchanges]. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Remote monitoring after recent hospital discharge in patients with heart failure: a systematic review and network meta-analysis. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Continuous Remote Patient Monitoring: Evaluation of the Heart Failure Cascade Soft Launch. [2022]

4. Egypt pubmed.ncbi.nlm.nih.gov

Use of remote monitoring to improve outcomes in patients with heart failure: a pilot trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Remote wireless vital signs monitoring on the ward for early detection of deteriorating patients: A case series. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Improving patient safety to reduce preventable deaths: the case of a California safety net hospital. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical nurse specialists as leaders in rapid response. [2018]

8. England pubmed.ncbi.nlm.nih.gov

How RNs rescue patients: a qualitative study of RNs' perceived involvement in rapid response teams. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Literature review: do rapid response systems reduce the incidence of major adverse events in the deteriorating ward patient? [2010]

10. United States pubmed.ncbi.nlm.nih.gov

Rapid-response systems as a patient safety strategy: a systematic review. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Home-based cardiac rehabilitation. [2004]

12. England pubmed.ncbi.nlm.nih.gov

The success of an integrated care programme for patients with ischaemic heart disease: the practice nurses' perspective of SHIP. [2019]

13. England pubmed.ncbi.nlm.nih.gov

A qualitative study of the information needs of acute myocardial infarction patients, and their preferences for follow-up contact after discharge. [2015]

14. Australia pubmed.ncbi.nlm.nih.gov

The effectiveness of telephone-based post-discharge nursing care in decreasing readmission rate in patients with heart failure: A systematic review. [2020]