Transition and Transfer of Congenital Heart Disease Care From Pediatrics to Adulthood

Transition and Transfer of Congenital Heart Disease Care From Pediatrics to Adulthood.

Adults with congenital heart disease (CHD) are a growing patient population in need of ongoing specialized care. Lapses in appropriate transition and transfer processes from childhood to adulthood in CHD care can lead to loss in follow up, late detection of new or evolving cardiac complications and negative patient outcomes. Therefore, it is vital that a robust transition and transfer process is established. Through a retrospective study completed recently at the University of Ottawa Heart Institute (UOHI) we have shown that the average wait time to be assessed by an adult congenital heart disease (ACHD) specialist is about 10 months and within this wait period 1 in 8 ACHD patients have a decline in their health.

The goal of this study is to specifically reduce negative patient outcomes during this wait period. We aim to achieve this by (i) establishing a program to ensure early detection of patients at risk of deterioration and (ii) providing additional support to these patients. The program is designed to have a multipronged approach including tools to disseminate concise patient specific information among care providers, maintain open line of communication with patients on the waitlist and promote patient education.

We plan to improve our transition care by creating a multi-pronged transfer program specifically for patients on the wait list composed of a nurse check in, creation of a diagnosis summary, education day and combined pediatric cardiology/ACHD handover videocall (described below). This program is planned as part of our care pathway and will be offered to all patients on the wait list. We intend to document the efficacy of this transition program to improve transition care by assessing patient reported outcomes and clinical outcomes of the patients who consent to complete additional questionnaires.

The multi-pronged program will include the following:

1. ACHD nurse check-in (patient check-in via phone call or zoom from the ACHD nurse within 1 month of receiving referral) - allows early establishment of clinical relationship with the patient, screen for risk factors for deterioration and provision of ACHD clinic contact information to enable open line of communication. Patients considered at risk for deterioration on the wait-list based on this check-in conversation will be triaged for a more urgent first consult at the ACHD clinic.
2. Quick glance diagnosis summary (Electronic on Epic MyChart) - will be created during nurse check in and will be used to disseminate concise patient specific information among health care workers and acts as a reference for the patients.
3. Organization of an ACHD patient education day (half day hybrid event every 6 months) - allows formal introduction to the ACHD team, provides information session on ACHD care and lowers patients' threshold to inform the ACHD team in case of clinical deterioration.
4. Combined pediatric cardiology and ACHD handover video call at time of transfer - allows effective and efficient handover of patient care from pediatric to adult care and facilitates the coordination of care during the transfer period.

These four components of the program work together to provide tools to disseminate concise patient specific information among care providers, maintain open line of communication with patients on the waitlist and promote patient education.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease (CHD)
• Intervention / Treatment: Other: Multi-pronged transfer program

Detailed Description

This is a prospective quality improvement study, investigating the effectiveness of a structured multi-pronged transfer program on clinical outcomes and patient-reported outcomes. This program is planned as part of our care pathway and will be offered to all patients on the wait list. Charts of all patients enrolled in this transfer program will be reviewed to assess clinical outcomes. Further voluntary study participation will include an additional survey to assess patient reported outcomes. The patients willing to complete the survey will be consented verbally by the ACHD nurse. The surveys then will be delivered by the nurse using phone or zoom platform to those consenting to participate. Data collection from chart review and surveys will be performed by a research coordinator (KM).

There are 4 components of the transfer program. Groups of patients will be staggered so that the first 50 patients receive 1+2, next 50 patients receive 1+2+3 and the rest of the patients receive 1+2+3+4 as listed below:

1. ACHD nurse check-in
2. Quick glance diagnosis summary
3. ACHD patient education day
4. Combined pediatric cardiology and ACHD handover video call at time of transfer

Individual component described below:

1) ACHD nurse check-in via phone or zoom will be completed within 1 month of receiving referral.

1. Patients referred from CHEO and community will be called by the ACHD nurse within 1 month of receiving the referral as part of the ACHD nurse check-in.
2. ACHD nurse check-in template will be uploaded to patient chart on Epic. It will include the following (details attached as a separate document):

i. Access to family physician. ii. Assess patient's knowledge on their cardiac condition. iii. Patient' social circumstance. iv. Patient's dental health. v. Patient's lifestyle habits. vi. Any active cardiac symptoms. vii. Need to expedite ACHD cardiologist appointment. If patient meets any of the following criteria, then patient will be flagged as needing expedited cardiologist appointment:

1. Worsening arrhythmias (i.e. new or more frequent/intense symptomatic palpitations or new sustained arrythmias) 2. Decreasing exercise intolerance 3. Change in NYHA class 4. Syncope 5. Exercise induced chest pain 6. Peripheral edema or unexplained weight gain viii. Gage interest in patient education day. c. The nurse will also complete the quick glance diagnosis summary for the patient during this check in which is outlined below.

d. Initial assessment of patient reported outcomes (PROs) will be completed in the form of an additional survey for the patients who consent to participate.

2) Quick glance diagnosis summary will be completed and provided to the patient.

• This will be completed by the ACHD nurse at the time of the ACHD nurse check in (within 1 month of receiving the referral).
• This will be created electronically on the patient's Epic chart under letter/ communications section, which can also be accessed by the patients via their MyChart.
• The content will be reviewed by ACHD specialist to ensure accuracy.
• The components of the quick glance diagnosis summary have been reviewed by our patient partner and deemed helpful.

• The quick glance diagnosis summary will include (details attached as a separate document):

  • Patient name
  • Date of birth
  • Name of ACHD cardiologist
  • Congenital heart disease diagnosis
  • Main surgical/ percutaneous intervention
  • Cardiac device
  • Previous infective endocarditis/ need for endocarditis prophylaxis.
  • Exercise restriction
  • Need for bubble filters on intravenous lines
  • Anti-coagulation
  • Contraception
  • Alarm symptoms to monitor
  • Recommended vaccines

  • Contact information for ACHD clinic

    3) Organization of patient education day for all patients on the waitlist. This is a half day event. Ideally this event will occur every 6 months and would include both patients referred from CHEO as well as the community. Participation will be documented.

• The education day will include:

  • Formal introduction to ACHD team including nurses and physicians
  • Tour of UOHI facility including clinic/ echo lab
  • Education session emphasizing need for lifelong follow-up, regular exercise, monitoring of alarm symptoms. Session facilitated by dietitian, social worker, psychologist, physiotherapist
  • Networking
  • Option for in-person and virtual component 4) Combined Pediatric cardiology and ACHD handover video calls.
• Allows effective and efficient handover of patient care from pediatric to adult care team.
• Will occur after the patient's last pediatric cardiology appointment. This component of the transfer program cannot be offered to patients referred from the community.

Variables to be collected:

Within the first month of being on the ACHD waitlist the following will be completed for all patients (whether or not consenting to participate in the voluntary survey):

• Electronic Quick glance diagnosis summary created on Epic MyChart (described above)
• ACHD nurse check via phone and documented on Epic (described above)

During the 1 month ACHD nurse check in, the following information will be collected in the form of a survey (in addition to the standard ACHD nurse check in template) only from those consenting to participate (details attached separately):

• Age/ date of birth (mm/yyyy)
• Sex/gender
• Ethnicity/ race
• Socioeconomic status (student/ employed/ unemployed)
• Access to family physician
• Knowledge assessment related to CHD

• Initial patient reported outcomes (PROS):

  • Quality-of-life score on linear analog scale9 during the waiting period
  • Patient Health Questionnaire (PHQ9) score10,11 for depression
  • General Anxiety Disorder (GAD-7) score12,13 for anxiety
  • Satisfaction with life survey score14

At time of first ACHD clinic appointment after completing wait list, the following variables will be collected:

• From chart review (all patients):

  • Duration on wait list
  • Date of first ACHD clinic appointment
  • Number of non-planned ED visits during the wait period
  • Number of unexpected hospital admissions during the wait period
  • Number of family physician visits related to CHD during the wait period
  • Number of urgent interventions planned.

• From patient survey (in patients consenting to complete the surveys)

  • Assessment of emotional distress related to wait period
  • Knowledge assessment related to CHD
  • Repeat patient reported outcomes (PROS) collected in the form of surveys:
• Quality-of-life score on linear analog scale9 during the waiting period
• Patient Health Questionnaire (PHQ9) score10,11 for depression
• General Anxiety Disorder (GAD-7) score12,13 for anxiety
• Satisfaction with life survey score14

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Joanne N Joseph, MD; Phone Number: 613-261-9316; Email: joajoseph@ottawaheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y4W7
      • Recruiting
      • University of Ottawa Heart Institute
      • Contact: Markus Schwerzmann, MD; Phone Number: 613-696-7209; Email: mschwerzmann@ottawaheart.ca
      • Contact: Keren Mbondo Kasuku, HBSc; Email: kmbondo@ottawaheart.ca
      • Principal Investigator: Markus Schwerzmann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with congenital heart disease (CHD) referred from the pediatric hospital and the community to the University of Ottawa Heart Institute.

Description

Inclusion Criteria:

• All new patients with congenital heart disease referred from the pediatric hospital and the community

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with congenital heart disease referred to the University of Ottawa Heart Institute; We aim to include all the patients referred to the UOHI ACHD program in our multipronged transfer program. This will include patients from the pediatric hospital (CHEO) and community referrals.

Other: Multi-pronged transfer program; There are 4 components of the transfer program. Groups of patients will be staggered so that the first 50 patients receive 1+2, next 50 patients receive 1+2+3 and the rest of the patients receive 1+2+3+4 as listed below: ACHD nurse check-in; Quick glance diagnosis summary; ACHD patient education day; Combined pediatric cardiology and ACHD handover video call at time of transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalizations	Number of unexpected hospitalizations related to patient's cardiac condition during the wait period.	2 years
Doctor visits related to cardiac conditions	Number of family physician visits related to patient's cardiac condition during the wait period.	2 years
Unexpected urgent intervention	Number of urgent intervention related to the cardiac conditions during the wait period.	2 years
Emergency Room Visits	Number of non-planned emergency department visits related to patient's cardiac condition during the wait period.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Questionnaire (PHQ9) score for depression	Patient reported outcomes, scored form 0-27, with higher scores indicating greater severity	2 years
Change in General Anxiety Disorder (GAD-7) score for anxiety	Patient reported outcomes, scored from 0 to 21, with higher scores indicating greater severity.	2 years
Change in Satisfaction With Life Survey (SWLS) score	Patient reported outcomes, scored from 5 to 25, with higher scores indicating greater life satisfaction.	2 years

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Collaborators: University of Ottawa Heart Institute, Canada

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Transition of care; Adult Congenital Heart Disease; Transfer of care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: QI - 212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No