Clinical trial NCT05628337: The TEACH (Texting After ACS Discharge) Pilot Randomized Trial
Official title: Effects of Mobile Text Intervention on Transitions of Care and Outcomes After Hospitalization With Acute Coronary Syndrome - The TEACH (Texting After ACS Discharge) Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Mobile health
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized trial, prospective, single centre, study intervention (texting motivation messages vs. placebo control), follow-up with administrative database linkage
Primary purpose: TREATMENT

Brief summary: Although there have been substantial advances in the treatment of heart disease, heart attacks remain one of the leading causes of death and suffering around the world. Each year, more than 80,000 patients are hospitalized with heart attacks or related conditions in Canada. Even after discharge, patients are at high risk of having complications such that almost one in two patients after a heart attack will be readmitted to hospitals within the first year. Given the shortage of doctors and allied health care professionals, there is an emerging focus of digital health as a way to improve the care and outcomes after heart attacks. With more than 30 million cell phone users across Canada and almost all are already using text message services, the goal of this study is to conduct a pilot test using an innovative clinical trial design to see if the care and outlook of heart attack patients using mobile text messages can be improved.

Detailed description: The healthcare system is in desperate need of novel strategies to better engage with cardiac patients to improve care and how patients interact with the healthcare system. Although almost everyone has a mobile phone in Canada, healthcare systems have not sufficiently explored mobile health strategies that can improve health. Yet, a recent survey suggests that alternative access to healthcare is highly desirable by Canadians. Adoption of mobile health technologies has the potential to add an additional avenue for how the healthcare system can interact with patients. Most importantly, these strategies are already used by many other industries and thus can be easily implementable and expandable in healthcare institutions across the country.

Due to the COVID-19 pandemic, it has become evident that the way healthcare is delivered in the future will be different than it has been for many decades. With the conversion of many forms of care to virtual and online platforms, mobile-based care could become an important component of cardiac care. Thus, this project will help to explore the use of mobile-based virtual care platforms in cardiac follow-up in the ACS populations.

The main goal of the study is to test the feasibility and potential effects of mobile text message-based intervention on transitions of care after hospitalization with heart attack.

The hypotheses are that i) the majority of patients will be willing to participate in the pilot study and continue to receive text messages during the study, ii) the group that receives texting will have more frequent physician visits and take medication more consistently at 1 year after discharge, iii) the group that receives texting will have lower rates of readmission at 1 year after discharge.

One of the most innovative aspects of this study is the ability to conduct an intervention of mobile technology and follow-up outcomes of patients using existing registries and data that are routinely collected in day-to-day care. Accordingly, this study will be conducted at a fraction of the cost compared to a traditional randomized design. It also means that the study concept could be easily replicated in many different areas of medicine.

The main goal of the study is to test the feasibility of mobile text message-based interventions on transitions of care after hospitalization with a heart attack.

Medication compliance, re-hospitalization, and Emergency Department presentation will be tracked. These outcomes will be measured using ICES database linking patient health care number, to determine hospital admissions, ER presentations, and prescription filling.

Eligibility criteria: Inclusion Criteria:

1. Patients \> 18 years old
2. Presentation or admission to Sunnybrook Hospital with diagnosis of Acute Coronary Syndrome (ACS)
3. Access to a cellphone that can receive text messages

Exclusion Criteria:

1. Inability to consent for study in English
2. Inability to read or answer English texts
3. Lack of cellphone with SMS capability

Primary outcomes:
measure: Physician visit
timeFrame: Within one month, 3 months, and 12 months of randomization
Secondary outcomes:
measure: Emergency Department presentation
timeFrame: Within one month, 3 months, and 12 months of randomization
measure: Re-hospitalization
timeFrame: Within one month, 3 months, and 12 months of hospital discharge
measure: Medication compliance
timeFrame: Within one month, 3 months, and 12 months of hospital discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Research Director
name: Dennis Ko, MD
role: PRINCIPAL_INVESTIGATOR
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