Enhancing Cardiac Rehabilitation Attendance After Secondary Myocardial Infarction Through Clinician Messaging and Motivational Calls

Официальное название

Activating Teams and Patients to Enhance Attendance at Cardiac Rehabilitation After Secondary Myocardial Infarction (ATTEND-CR) Trial

Обзор

The goal of this clinical trial is to determine if a behavioral intervention can increase attendance at cardiac rehabilitation (CR) after secondary/type 2 myocardial infarction in adult patients. The main question it aims to answer is: * Does the ATTEND-CR intervention increase attendance at ≥1 CR exercise session within 140 days of randomization? * Does the intervention increase completion of ≥12 CR exercise sessions within 140 days of randomization? Researchers will compare participants receiving the ATTEND-CR intervention (clinician notifications and a motivational interviewing participant phone call) to usual care to see if attendance and completion of CR improve. Participants: * Clinicians will receive informational messaging regarding CR and the referral process * Participate in a motivational interviewing phone call (intervention group only) * Have follow-up assessments via telephone and electronic health record (EHR) review to track CR attendance, clinical events, and health outcomes

Подробное описание

The ATTEND-CR trial ("Activating Teams and Patients to Enhance Attendance at Cardiac Rehabilitation After Secondary Myocardial Infarction") is a single-center pilot randomized clinical trial designed to evaluate strategies to increase participation in cardiac rehabilitation (CR) among patients hospitalized with secondary/type 2 (demand/supply mismatch) myocardial infarction (MI). Although CR has been demonstrated to improve functional capacity, quality of life, and cardiovascular outcomes after acute MI, participation rates remain low, particularly in patients with secondary/type 2 MI. This study tests whether a low-risk, behavioral intervention can improve attendance in CR programs.

Participants are randomized to either the ATTEND-CR intervention or usual care. The intervention consists of informational messaging to clinicians regarding CR and the referral process, combined with a follow-up phone call to the patient applying principles of motivational interviewing to support their attendance at CR. Usual care participants receive standard post-MI management without study-driven notifications or motivational support.

Participants are followed for 140 days post-randomization. Study procedures include remote follow-up calls and review of electronic health records to capture participation in CR, clinical events, medication use, and patient-reported health status. The study team monitors safety throughout the trial, focusing on adverse events occurring during or shortly after CR sessions and any serious adverse events that arise during the follow-up period.

Вмешательства

• Поведенческое Clinician-level intervention
  The inpatient clinical team receives an EPIC in-basket and email detailing the patient's study participation, benefits of cardiac rehabilitation, and guidance on how to place a cardiac referral if appropriate. If a cardiac rehabilitation referral is not placed within 3 days post-discharge, a follow-up message is sent to one of the patient's outpatient clinician within 4-28 days post-discharge and within 140 days of randomization.
• Поведенческое Patient-level intervention
  Participants receive a phone call applying motivational interviewing principles if a cardiac rehabilitation referral has been placed by their clinical team within 56 days post-discharge and within 140 days of randomization. The phone call aims to discuss cardiac rehabilitation, barriers to participation, and support engagement in cardiac rehabilitation.

Первичные конечные точки

• Number of Participants Who Attended one or more Cardiac Rehabilitation Exercise Session [Срок оценки: Within 140 days (inclusive) post-randomization]

Вторичные конечные точки (3)

• Number of Participants With a Cardiac Rehabilitation Referral [Срок оценки: Within 140 days (inclusive) post-randomization]
• Number of Participants who Completed Cardiac Rehabilitation [Срок оценки: Within 140 days (inclusive) post-randomization]
• Feasibility indicators [Срок оценки: Recruitment Time Frame: Through completion of enrollment, an average of 18 months. Retention Time Frame: Through completion of participant follow-up, an average of 20 weeks.]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Inpatient at MGH with an index secondary (type 2) MI
• Primary care provider (PCP) within the Mass General Brigham (MGB) network with at least one visit in the past 2 years
• Anticipated ability to ambulate independently without walking aids or supplemental ambulatory oxygen at discharge
• Ability to provide informed consent

Критерии исключения

• Known severe untreated valvular heart disease or severe prosthetic valve dysfunction
• Known hypertrophic obstructive cardiomyopathy
• End-stage heart failure (VAD, transplant patient, or undergoing evaluation for VAD or transplant)
• Hemodynamic instability at the time of pre-screening
• Terminal illness with life expectancy < 1 year
• Severe anemia (hemoglobin < 8 g/dL) at the time of pre-screening
• Active, unstable cancer (excluding non-metastatic skin cancer) or currently receiving intensive cancer therapy
• Advanced kidney disease requiring renal replacement therapy
• Receiving palliative or comfort care only
• Recurrent falls (≥2) or falls with injury in the past year
• Physical or cognitive impairment likely to prevent safe participation in exercise over the next 5 months (e.g., significant stroke deficits, dementia)
• High-risk for non-adherence to study requirements
• Incarcerated individuals
• Currently pregnant or within 3 months postpartum
• Previously referred to or participated in CR within the past year
• Alternative MI subtype (spontaneous \[type 1 MI\] or procedural MI \[type 4 or 5 MI\]) in the past 6 months
• Suspected or confirmed coronary mechanism of index MI (vasospasm, embolism, or spontaneous coronary artery dissection)
• Anticipated discharge or discharged before enrollment measures can be completed
• Anticipated discharge to a facility where independent participation in CR is not feasible
• Previously enrolled in or declined participation in this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07485491 · 2026P000632 · 5K23HL167659

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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