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Improving care coordination for patients with coronary heart disease - a new healthcare programme (Cardiolotse)

Organizational Data

DRKS-ID:
DRKS00020424
Recruitment Status:
Recruiting suspended on temporary hold
Date of registration in DRKS:
2020-06-18
Last update in DRKS:
2020-06-18
Registration type:
Retrospective

Acronym/abbreviation of the study

Cardiolotse

URL of the study

https://www.cardiolotse.de/

Brief summary in lay language

Healthcare systems and their actors face unique challenges when patients transit from hospital to ambulatory care. An innovative healthcare programme is developed to improve this transition, providing access to personal care managers and individualized healthcare plans that support patients with coronary heart disease post-discharge. The care manager (so-called Cardiolotse), who will be trained and qualified, plays a central role. S/he will initiate the first contact with the patient prior to leaving the hospital to establish a strong patient - care manager relationship. After discharge, the care manager will contact the patient by phone on a regularly basis. During the phone encounter the care manager enquires about the compliance with treatment recommendations or changes to prescribed medicines. In addition, the care manager will assist the patient with scheduling physician appointments and with developing exercise plans based on his/her needs. The patient has also the possibility to contact the care manager in case of any health-related questions or difficulties. Still, it is the physician who will make the final decision regarding adequate treatment. The new healthcare programme is designed as a supportive element in a fragmented healthcare system to facilitate the transition from hospital to the ambulatory care setting for seriously ill patients. Patients will be enabled to access relevant patient information, to better understand their medical condition and to effectively self-manage their illness — independent of their educational level or social status. The aim is to reduce rehospitalisation and to improve clinically relevant patient outcomes

Brief summary in scientific language

An innovative healthcare programme is developed with the objective to facilitate the transition from Hospital care to the ambulatory care setting for patients with coronary heart disease. A key element of this programme will be a specifically trained care manager (Cardiolotse) supporting the patient after discharge and helping him/her to effectively self-manage his/her health condition (independent of his/her education level or social status) by facilitating access to health-related resources and services and by jointly developing a patient-centered care plan. The care manager thereby serves as a link between the ambulatory care and hospital sector as well as between professional disciplines. The aim is to reduce rehospitalisation and to improve patient outcomes such as mortality, length of hospital stay, adherence to treatment recommendations and health-related quality of life. Besides, several process indicator will be evaluated to identify and address potential organizational and individual-level barriers.

Health condition or problem studied

ICD10:
I20-I25 - Ischaemic heart diseases
ICD10:
I47 - Paroxysmal tachycardia
ICD10:
I48 - Atrial fibrillation and flutter
ICD10:
I49 - Other cardiac arrhythmias
ICD10:
I50 - Heart failure
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Patients with CHD (coronary heart disease) receiving care coordination and transition assistance services ("Cardiolotse").
Arm 2:
Patients with CHD receiving care as usual i.e. no care coordination services.

Endpoints

Primary outcome:
Hospital readmission rate (after 12 months)
Secondary outcome:
mortality, avg. length of inpatient stays, health-related quality of life (EQ5D)

Study Design

Purpose:
No Entry
Allocation:
Randomized controlled study
Control:
  • Control group receives no treatment
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting suspended on temporary hold
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Medical center Vivantes Netzwerk für Gesundheit GmbH Berlin

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2019-01-07
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
2908
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
insured through a participating health insurance provider, age ≥ 18 years, CHD (ICD-10-GM I20-I25, I47-I50), written informed consent

Exclusion Criteria

care level ≥4, nursing home residents, cognitive or severe psychiatric disorders (ICD-10-GM F20-29; F33.3)

Addresses

Primary Sponsor

AOK Nordost - die Gesundheitskasse
Brandenburger Straße 72
14467 Potsdam
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Fachbereich Health Services Management - Ludwig-Maximilians-Universität München
Prof. Dr Leonie Sundmacher
Schackstraße 4
80539 München
Germany
Telephone:
+49 (0)89 2180-3110
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Vivantes Netzwerk für Gesundheit GmbH
Dr Sebastian Karmann
Aroser Allee 72 - 76
13407 Berlin
Germany
Telephone:
+49 30 130 111005
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Fachbereich Health Services Management - Ludwig-Maximilians-Universität München
Prof. Dr Leonie Sundmacher
Schackstraße 4
80539 München
Germany
Telephone:
+49 (0)89 2180-3110
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

DLR Projektträger - Bereich Gesundheit - als Projektträger für den Innovationsausschuss beim G-BA
Heinrich-Konen-Str. 1
53227 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Ärztekammer Berlin
Friedrichstraße 16
10696 Berlin
Germany
Telephone:
(+49)30-408062601
Fax:
(+49)30-408062298
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2018-10-10
Ethics committee number:
Eth-42/18
Vote of the Ethics Committee:
Approved
Date of the vote:
2018-12-13

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
The study protocol and the evaluation results of the study should be published and made available to the scientific community.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry