The Cardio-share Telemedicine Cross-sector Collaboration Model for Managing Vulnerable Patients With Heart Failure

Atrial Fibrillation Clinical Trial

— ADHFQUAL-BFH  

Official title:

Implementering af Cardiostafet tværsektoriel Samarbejdsmodel Med Telemedicin for Udsatte Patienter Med Hjertesvigt Som Ikke Kan Deltage i Hjerterehabilitering

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06176131
• Other study ID #: WorkZone-23072092
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: Helena DOMINGUEZ, MD,PhD,Prof
• Phone: 004522989343
• Email: mdom0002[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to explore the potential of implementing a telemedicine-based cross-sector collaboration model to manage patients with frequent admissions with decompensated heart failure. The main question(s) it aims to answer are:

• Characterization of conditions that make these patients vulnerable

• Description of key-elements that makes possible to manage the patients with the cardio-share model

Participants are:

• Patients - will be helped to use the available telemedicine tools

• General Practitioners - will be offered teleconferences with cardiologists (chat and video) on demand

• Community health workers (caregivers at the patient home or in elderly home) - will be guided to assist the patients to use the available telemedicine tools Researchers will compare readmission rates (primary outcome) and quality of life of patients where the cardio-share management model is successfully implemented one year before and after the implementation.

Description:

Consecutive patients admitted from 01.01.2024 to one single site (University Hospital Bispebjerg and Frederiksberg) with acute decompensated heart failure or with atrial fibrillation treated with loop-diuretics will be included in the project if they had one emergency admission with decompensated heart condition within the prior 3 months or two or more within the prior 6 months.

During their hospital admission patients will be helped to use the currently available telemedicine tools, which is "Min Sundhedsdplatformen Assistent" (MinSP-Ass.), which is the Danish version of the Care Companion-extension of MyChart application by EPIC, which is the platform used in East Denmark. Help is provided by the nurses in the ward, with assistance by medicine students working on a pay-per-hour basis.

The cardio-share model briefly If it is planned or the patient already is receiving home-care assistance (either at home or at an elderly home), the health-care workers will be contacted to ensure that they can assist the patient to use MinSP-Ass.

Likewise, the general practice where the patient belongs to, will be contacted to offer teleconsultation support by the hospital-based cardiologist. This support is primarily by written messages, and by teleconferences on demand (from Primary Care) before patient discharge, in both cases using MedCom standards, which is the current cross-sector communication platform in Denmark.

Through MinSP-Ass. patients can receive educational material and can report vital measurements and symptoms.

The responsibility of the management of the patient relays in the hospital cardiologist who initiates the cardio-share management. A script for a seamless switching of this responsibility between the cardiologist team and Primary Care will be developed and described throughout the project. This will include solving data-sharing across sectors since there are no current solutions easy to use for this purpose.

Data collection The electronic medical record will be explored retrospectively to record data at three time-points: After discharge (Baseline), three and six months after admission.

At baseline there will be recorded: i) demography data, ii) selected vital measurements and laboratory data and iii) heart medicines.

At month three there will be recorded whether there has been at least one readmission and the date of the first readmission and if the patient has had visits in the cardiology ambulatory. At month six there will be recorded whether there have been one or more readmissions and the date of the first readmission if it occurred after month 3.

Demography data will be collected according to the following conditions that may render the patient vulnerable:

• Speaking Danish language

• Cognitive challenges described in the medical record

• Need for help from health community workers or relatives for their daily life

• Psychiatric disease (ongoing follow-up)

• Substance abuse (alcohol or drugs)

At baseline and at month 6 there will be recorded:

• Selected vital measurements, which include blood pressure, heart rate and weight

• Laboratory data, which include hemoglobin, creatinine and pro-Brain Natriuretic Peptide (pro-BNP)

• Prescription and use of heart medicines

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients admitted with acute decompensated heart failure AND:

• with previous admission with decompensated heart failure in the three-month period prior to the current admission or

• who have two or more admissions in the 6 months prior to the current admission.

Exclusion Criteria:

• Patients who

• have refused to share their data for health-quality projects

• have already ongoing telemedicine management for heart failure

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• Heart Failure,Congestive

Intervention

Other:
• Telemedicine-based cross-sector collaboration for patient management
Telemedicine support from the hospital-based cardiology heart-failure team is provided on demand defined by the needs from Primary Care and from the patient rather than plain guideline-based targets

Locations

Country	Name	City	State
Denmark	Cardiology department Y, Bispebjerg-Frederiksberg Hospital	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Palliative care	Number of subjects with established palliative care	six months
Primary	Days out-of-hospital	Number of days out of hospital from date of discharge for the index event until the next re-admission with acute decompensated heart failure	six months
Secondary	Number of readmissions	number of emergency readmissions after discharge from the index readmission, where there have been signs of decompensated heart failure	six months
Secondary	Quality of care - Medicines	Proportion of guideline-based target medicines for heart failure that patients actually use (based on purchased medicine prescriptions). This includes angiotensin converter enzyme inhibitors(ACEi)/angiotensin receptor blockers (ARB), Betablockers, Mineralocorticoids, Angiotensin Receptor Neprilysin inhibitors (ARNi), Selective Sodium Glucose Co-Transporter-2 inhibitors (SGLT2i), Hydralazine and Nitrates.	six months
Secondary	Symptom-based quality of care	Progression of heart failure specific patient-reported outcome measures. These include weekly to monthly collected: • Out-of-breath in daily activities • Night orthopnea • Dizziness • Feeling body fluid retention (leg swelling, increased abdominal pressure, increased intake of diuretics • Tiredness • Feeling of general worsening	six months