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Nurse-Led Self-Management Support After Coronary Artery Bypass Surgery (BRIDGE-SM)

5. listopadu 2026 aktualizováno: Jafar Alshraideh, University of Jordan

The Effect of BRIDGE-SM Model on Unplanned Healthcare Utilization and Patients' Outcomes Among Adults Undergoing CABG Surgery: Randomized Controlled Trial

The goal of this clinical trial is to learn if a nurse-led self-management support program, called BRIDGE-SM, reduces unplanned hospital readmissions and emergency department visits in adults having planned (elective) coronary artery bypass graft (CABG) surgery. It will also learn if the program improves heart self-care and lowers depression, anxiety, and stress after surgery.

The main questions it aims to answer are:

  • Does BRIDGE-SM lower the number of patients who are readmitted to hospital or visit the emergency department within 45 days after discharge?
  • Does BRIDGE-SM improve patients' heart self-care at 45 days after discharge?
  • Does BRIDGE-SM lower depression, anxiety, and stress at 45 days after discharge?

Researchers will compare patients who receive BRIDGE-SM plus usual hospital care with patients who receive usual hospital care alone. They will also compare deaths from any cause within 45 days after hospital discharge between the two groups to check safety.

Participants in the BRIDGE-SM group will:

  • Attend one face-to-face education session (20 to 40 minutes) with a specialist cardiac nurse at the preoperative assessment clinic, and receive an Arabic educational video and electronic leaflets by WhatsApp
  • Attend one face-to-face discharge session (20 to 45 minutes) on the day they leave hospital, and receive a printed Arabic self-management booklet
  • Receive four scheduled phone calls from the nurse on Days 3, 14, 21, and 30 after discharge
  • Be able to contact the nurse by WhatsApp or phone with questions at any time during the 30 days after discharge

All participants will complete questionnaires on heart self-care and on depression, anxiety, and stress at 45 days after discharge, two weeks after the nurse follow-up period ends. Participants in the usual care group will be offered a nurse consultation after their follow-up ends.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

Background and Rationale:

Coronary artery bypass graft (CABG) surgery is the most common major open-heart operation worldwide. Despite surgical advances, patients continue to face clinical, psychological, and self-management challenges during recovery. Anxiety is common during the preoperative waiting period, and depression and anxiety persist for many patients after surgery, which is associated with poorer adherence and recovery. The early period after discharge is a high-risk window in which patients must manage medications, wound care, symptom monitoring, and lifestyle changes at home, and inadequate preparation contributes to avoidable readmissions and emergency department visits.

Existing perioperative education studies are largely fragmented, delivering education either before surgery or at discharge only, without continuous nurse-led support across the full recovery pathway. Current care in this setting is mainly physician-directed and episodic, with limited proactive nursing follow-up after discharge. Telehealth follow-up offers a low-cost way to extend nursing support beyond the hospital stay, and WhatsApp is widely used across age groups in Jordan, making it a feasible delivery channel. No previous trial has combined preoperative, discharge, and post-discharge telehealth nurse-led support, including continuous nurse availability for patient-initiated questions, into a single continuous model for CABG patients.

Theoretical Framework:

BRIDGE-SM (Bridging Recovery through Integrated Digital Guidance and Education for Self-Management) is grounded in Orem's Self-Care Deficit Theory, operationalized as a supportive-educative nursing system, and the Transitional Care Model, which guides continuity across care transitions through a single consistent nurse. The Re-Engineered Discharge (RED) protocol from the Agency for Healthcare Research and Quality is used as the implementation framework for the discharge phase.

Intervention Development:

Before trial start, all BRIDGE-SM materials will undergo content validation by an 8-member expert panel: two consultant cardiologists, two advanced practice critical care nurse specialists with cardiac surgery experience, two patients who previously underwent CABG, and two academic nursing faculty with cardiac nursing and research expertise. All materials are in Arabic at a health literacy-appropriate level and reviewed for cultural appropriateness.

Intervention Delivery:

The intervention is delivered by a clinical nurse specialist with at least a Bachelor of Science in Nursing and at least three years of cardiac surgery perioperative experience, who completes a two-day structured orientation to the protocol before the trial begins.

Phase 1 (Preoperative Assessment Clinic): A face-to-face individualized session covering the surgical procedure and expected inpatient course; medication management; risk factor modification (diet, activity, smoking cessation, weight); wound care and sternal precautions; warning signs and an emergency action plan; psychological support including coping strategies and breathing exercises; and collaborative self-care goal setting with the patient and family caregiver. An Arabic educational video and electronic leaflets are sent via WhatsApp.

Phase 2 (Discharge Day): A face-to-face session in the patient's room incorporating all 11 RED components, documented with a fidelity checklist. Content includes medication review and reconciliation, activity restrictions and sternal precautions, wound care and surgical site infection warning signs, post-CABG dietary guidance, an individualized After Hospital Care Plan, teach-back confirmation, and orientation to the telehealth follow-up schedule. Participants receive a printed Arabic discharge self-management booklet in addition to the standard institutional leaflets.

Phase 3 (Post-Discharge Telehealth, 30 days): Four scheduled telephone calls on Days 3, 14, 21, and 30 after discharge following a standardized assessment guide (symptom review, wound assessment, medication adherence, diet and activity, psychological well-being, and reinforcement of self-care goals). Throughout the 30-day post-discharge period, the nurse is available for participant-initiated WhatsApp messages or calls, with responses within four hours. The intervention ends at Day 30. All contacts are recorded in a Telehealth Contact Log. A predefined escalation protocol (new or worsening chest pain, acute shortness of breath, fever above 38.5 C, wound dehiscence or sternal instability, uncontrolled palpitations) triggers immediate referral to cardiac emergency services.

Standard Care (both groups): Routine preoperative assessment per the institutional clinical practice guideline, identical inpatient perioperative nursing care from admission to the day before discharge, standard verbal discharge instructions and written leaflets, and routine outpatient clinic appointments at 1 to 2 weeks after discharge without proactive nurse follow-up. Inpatient care is kept identical between groups to isolate the effect of the pre-admission, discharge, and post-discharge components.

Outcome Assessment Timing:

All outcomes are assessed in both groups at Day 45 after discharge, two weeks after completion of the 30-day post-discharge intervention.

Randomization and Blinding:

Participants are allocated 1:1 by computer-generated block randomization prepared before recruitment. Allocation is held by an independent person not involved in recruitment, intervention delivery, or outcome assessment, and is revealed only after consent and baseline assessment. Weekly operative lists serve only as a recruitment frame. Participants and the intervention nurse cannot be blinded; an independent record reviewer verifies readmission and emergency department events against medical records, and outcome assessors are blinded to allocation where feasible.

Sample Size:

Assuming a 15% composite event rate in the control group and a 40% relative reduction (9%) with BRIDGE-SM, two-sided alpha 0.05, and 80% power, 163 participants per group are required. Allowing for 10 to 15% attrition, 384 participants (192 per group) will be enrolled.

Statistical Analysis:

Analyses follow the intention-to-treat principle using IBM SPSS version 29. The primary outcome will be compared using the chi-square or Fisher's exact test, reported as relative risk, absolute risk reduction, and number needed to treat with 95% confidence intervals. Participants lost to follow-up will be classified as "no event" in the primary analysis, with a worst-case sensitivity analysis classifying them as "event." Continuous secondary outcomes will be compared using independent-samples t-tests or Mann-Whitney U tests. A per-protocol sensitivity analysis will include intervention participants who completed at least 3 of 4 scheduled calls. Intervention fidelity is monitored through session checklists, contact logs, and review of a 10% random sample of session notes; delivery of at least 80% of protocol elements defines adequate fidelity.

Ethics and Monitoring:

The study is approved by the Royal Medical Services Ethics Committee and the University of Jordan ethics committee. Given the single-centre design, short follow-up, and low-risk nursing intervention, trial conduct is monitored by the principal investigator and supervisor without a formal Data Monitoring Committee. Control group participants are offered a nurse consultation and After Hospital Care Plan review after their follow-up ends.

Typ studie

Intervenční

Zápis (Odhadovaný)

384

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Amman, Jordán
        • Royal Medical Services / Queen Alia Heart Institute

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Inclusion Criteria:
  • Age 18 years or older at the time of enrolment.
  • Registered on the Queen Alia Heart Institute elective surgery waiting list for isolated coronary artery bypass graft (CABG) surgery.
  • Scheduled for non-emergency, non-urgent elective CABG under general anaesthesia through open sternotomy.
  • EuroSCORE II predicted in-hospital mortality of 10% or less, calculated at the preoperative assessment clinic.
  • Owns a mobile telephone able to receive telephone calls and WhatsApp messages, or has a family caregiver with such a device who is willing to assist.
  • Able to communicate in Arabic verbally and in writing (literate).
  • Willing and able to provide written informed consent in Arabic.

Exclusion Criteria:

  • Emergency or urgent CABG (EuroSCORE II urgency: emergent or salvage).
  • Valvular heart surgery, combined CABG-valve procedures, redo cardiac surgery, or hybrid procedures.
  • Minimally invasive procedures in which open sternotomy is not performed.
  • Severe cognitive impairment, active psychosis, or intellectual disability precluding meaningful participation.

Exclusion Criteria:

-

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: BRIDGE-SM plus standard care

Participants receive the BRIDGE-SM model in addition to usual care. BRIDGE-SM is a structured, nurse-led self-management support program delivered from the preoperative period until one month after hospital discharge. It combines in-hospital education with telehealth follow-up after discharge to help patients manage recovery after coronary artery bypass graft (CABG) surgery.

BRIDGE-SM is a structured, individualized, nurse-led self-management support model for adults undergoing coronary artery bypass graft (CABG) surgery. It is delivered in three phases, from the preoperative period until one month after hospital discharge. Phase 1 (preoperative): an individual session to assess the patient's needs and prepare the patient for surgery and recovery. Phase 2 (in-hospital, before discharge): tailored education and skills training on medication management, wound care, symptom recognition, physical activity, diet, and when to seek help, supported by printed materials. Phase 3 (after discharge): telehealth follow-up by the research nurse for four weeks to reinforce self-management, monitor symptoms, support problem-solving, and arrange timely referral when needed. The intervention is provided in addition to usual care.

Žádný zásah: standard care

Participants receive the standard hospital care and routine discharge instructions provided to patients undergoing CABG surgery, without the BRIDGE-SM program.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Unplanned Healthcare Utilization (Unplanned Hospital Readmission or Emergency Department Visit)
Časové okno: From hospital discharge through Day 45 after discharge

Composite binary outcome (yes/no). A participant is classified as having the outcome if at least one unplanned hospital readmission or emergency department visit occurs within 45 days after hospital discharge following elective CABG surgery. Events are ascertained through participant self-report during telehealth follow-up and verified by medical record review conducted by an independent reviewer masked to group allocation. Results are reported as the proportion of participants with the outcome in each arm, with relative risk, absolute risk reduction, and number needed to treat.

From hospital discharge through Day 45 after discharge

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cardiac Self-Management
Časové okno: Day 45 after hospital discharge

Cardiac self-management behavior measured using the Arabic version of the Self-Care of Coronary Heart Disease Inventory (SC-CHDI v3.0), a 23-item self-report instrument rated on a 5-point Likert scale with three subscales: Self-Care Maintenance (9 items), Self-Care Monitoring (7 items), and Self-Care Management (7 items). Each subscale is transformed to a standardized score from 0 to 100; higher scores indicate better self-care, and a score of 70 or above indicates adequate self-care.

Day 45 after hospital discharge
Depression, Anxiety, and Stress Severity
Časové okno: Day 45 after hospital discharge

Psychological distress measured using the Arabic-validated DASS-21, a 21-item self-report instrument with three 7-item subscales: depression, anxiety, and stress. Items are rated from 0 to 3; each subscale score is calculated by summing its items and multiplying by two (range 0-42), and the total score ranges from 0 to 126. Higher scores indicate greater symptom severity. Each subscale is analyzed and reported separately.

Day 45 after hospital discharge
All-Cause Mortality (Safety Outcome)
Časové okno: From hospital discharge through Day 45 after discharge

Binary outcome (yes/no): death from any cause within 45 days after hospital discharge. Confirmed through medical record review and death registry verification, supplemented by telephone contact with next of kin when registry data are unavailable.

From hospital discharge through Day 45 after discharge

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Vrchní vyšetřovatel: Saja Ahmad Alwekhyan, PhD.C, Royal Medical Services

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. listopadu 2026

Primární dokončení (Odhadovaný)

1. prosince 2026

Dokončení studie (Odhadovaný)

1. června 2027

Termíny zápisu do studia

První předloženo

5. listopadu 2026

První předloženo, které splnilo kritéria kontroly kvality

5. listopadu 2026

První zveřejněno (Aktuální)

12. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 14/2026

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared. Participants consent to their data being accessed only by the research team and used solely for the study aims, in accordance with the approved ethics protocol and confidentiality commitments. Aggregate results will be published in peer-reviewed journals and summarized for participants in plain language.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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