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临床试验/NCT06176131
NCT06176131
招募中
不适用

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

University Hospital Bispebjerg and Frederiksberg1 个研究点 分布在 1 个国家目标入组 300 人2024年1月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Heart Failure,Congestive
发起方
University Hospital Bispebjerg and Frederiksberg
入组人数
300
试验地点
1
主要终点
Days out-of-hospital
状态
招募中
最后更新
3个月前

概览

简要总结

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.

详细描述

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

注册库
clinicaltrials.gov
开始日期
2024年1月1日
结束日期
2026年12月31日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

发起方
University Hospital Bispebjerg and Frederiksberg
责任方
Principal Investigator
主要研究者

Helena DOMINGUEZ

Consultant, Associate Professor

University Hospital Bispebjerg and Frederiksberg

入排标准

入选标准

  • 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.

排除标准

  • Patients who
  • have refused to share their data for health-quality projects
  • have already ongoing telemedicine management for heart failure

结局指标

主要结局

Days out-of-hospital

时间窗: six months

Number of days out of hospital from date of discharge for the index event until the next re-admission with acute decompensated heart failure

次要结局

  • Quality of care - Medicines(six months)
  • Symptom-based quality of care(six months)
  • Number of readmissions(six months)

研究点 (1)

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