News in MenDis-CHD II

2020

Completed work areas including a short summary of results and reference to new publications
The two main publications of MenDis-CHD I were submitted to two journals. The first main publication was successfully submitted to the journal PLOS ONE and will now be published in the next issue. The first main publication deals with the quantitative results of the patient examinations, which primarily describes the current care situation of CHD patients in Cologne. The second article deals with both quantitative and qualitative results in the patient survey of MenDis-CHD I. The manuscript was submitted to the journal BMJ Open, currently a response from the journal is still waiting.
Since the start of the follow-up project MenDis-CHD II, intensive work has been done on the preparation of the individual project parts. For study parts A and B, a review by the ethics committee of the University of Cologne took place, so that the written vote is expected soon. In the case of a positive vote, pre-testing and the start of recruitment in the two project parts can begin. A log book for a clear recruitment organisation for sub-project A could be created. In project part B, the interview guidelines and drafts of the prompt sheets were developed. For project part C, a cooperation with the company axaris – software & systeme GmbH for data export from the GP practices was established in several working meetings. The company has many years of experience in the field of scientific projects. Currently, a conversion application regarding third-party funding is being prepared for the DLR.

Furthermore, regular internal project meetings took place in direct cooperation with OrgValue in order to plan the project process in detail and to define the interfaces to other CoRe-Net projects. Together, the results of MenDis-CHD I and the study flow of MenDis-CHD II were put together to prepare a presentation for the first CoRe-Net general meeting on 09.12.2020.

We are also happy about the support of Katharina Pfaff, who has been working as a study nurse in MenDis-CHD II since 01.10.2020, as well as the support of Anne Greis as research assistant.

Current processes / preparations
Currently, the study documents for project part C are being prepared, which provides for an intervention in GP practices to improve the quality of care in the diagnosis and therapy of mental and cognitive comorbidities in CHD patients. In recent months, important aspects of the intervention, such as the definition of the target variables and the technical implementation, have been clarified, so that a study protocol is now being written. At the same time, the documents for the application to the Ethics Committee of the Medical Faculty of the University of Cologne and, if necessary, the Ethics Committee of the North Rhine Medical Association are being prepared.
At the same time, the final preparations for study parts A and B are underway, so that implementation can begin upon positive ethical approval. The corresponding questionnaires are being printed and subjected to a pre-test together with the interview guidelines. The drafts of the prompt sheets are also being finalised so that initial feedback can be gathered in the interviews.

Outlook on next steps
We plan to start conducting study parts A and B at the beginning of 2021. For this purpose, the patients who participated in MenDis-CHD I will be contacted and asked for their consent for a follow-up survey. In addition, interview partners will be recruited to conduct the qualitative interviews. The results of these parts of the project, especially the qualitative interviews, will flow into the further design of the intervention, which will be conducted continuously in the coming months.

Completed work areas including a short summary of results and reference to new publications
For the previous project MenDis-CHD I a final report was prepared, which showed the achieved goals and milestones as well as an overview of the results of the research project. The report will now be sent to CoRe-Net in time and the MenDis-CHD I project will thus be terminated.
Furthermore the two main publications of MenDis-CHD I could be submitted to two journals. The first main publication deals with the quantitative results of patient examinations, which primarily describes the current care situation of CHD patients in Cologne. The publication was submitted to the journal PLoS One and is currently undergoing peer review. The feedback from the journal reviewers is currently being processed. As soon as the publication has been published, a corresponding reference will be displayed here.
The second article deals with both quantitative and qualitative results in the patient survey of MenDis-CHD I. The manuscript was submitted to the journal BMJ Open, currently feedback from the journal is still pending. Since the start of the follow-up project MenDis-CHD II, intensive work has been done on the preparation of the individual project parts.

MenDis-CHD II is divided into 3 subprojects:
In subproject A a follow-up examination of CHD patients who have participated in MenDis-CHD I will be conducted. In subproject B, qualitative interviews with family doctors, patients and patient representatives will be conducted to collect experiences, attitudes and expectations regarding the development of a family doctor-based intervention to improve the care of patients with CHD and mental/cognitive disorders. The results of these subprojects will be incorporated into the design of a pilot intervention for general practitioners, which will be evaluated in subproject C.
Regular internal project meetings in direct cooperation with OrgValue took place to plan the project in detail and to define the interfaces to other CoRe-Net projects. For subprojects A and B the ethics proposal and a study protocol were prepared. In addition, the study documents for subprojects A and B (questionnaires, patient information, consent forms, interview guidelines) were prepared and the documents for submission to the Ethics Committee were finalised and a procedural directory was created.

Current processes / preparations
Currently, the submission of subprojects A and B to the Ethics Committee is being finalized in order to start conducting the follow-up study and the qualitative interviews as soon as possible. These will provide valuable information on the implementation of a tailored intervention to improve the care of patients with CHD and mental/cognitive disorders in general practice.
In subproject C, it is planned to collect data on the care of CHD patients in general practitioners’ offices before and after the pilot intervention, which will make the impact of the intervention measurable. Different methods of data extraction are currently being tested. At the same time, a data set description is being worked on to define the relevant variables for patient care and to describe processes and organizational factors as an interface to OrgValue. Potentially, a collaboration with an external company for data extraction is also possible. For this purpose a first consultation has taken place. Now it shall be explored whether a future collaboration is possible.
A first meeting for socio-economic impact assessment took place, with the goal to create a cost-benefit analysis for MenDis-CHD II (Part C). This requires the definition of actors and indicators for the model.
Furthermore, interviews were held for the appointment o1f a study nurse, who will join the MenDis-CHD team on October 1, 2020.

Outlook on next steps
The next steps will primarily involve the logistical preparations for the implementation of subprojects A and B as soon as a positive ethics vote has been obtained. In addition, the focus is on clarifying technical and data protection aspects of data extraction in subproject C and contacting family doctors’ practices and the medical association regarding a further ethics proposal.

Finished work areas including a short summary of results and reference to new publications:
The data from the large quantitative data set on the care of patients with coronary heart disease (CHD) and the data from interviews with patients were written down. Two major main publications have been written on the patient data, which are currently being revised by the project managers. In one article we describe the current care situation of CHD patients with/without mental comorbidity and an article on access, barriers and our qualitative data. Cross-sectional results from our previous study MenDis-CHD I indicate that guidelines for the treatment of CHD patients and mental/cognitive comorbidity are not sufficiently implemented. Unrecognized and untreated comorbid mental/cognitive disorders in CHD patients have a negative impact on health-related outcomes. General practitioners were identified in MenDis-CHD I as a determining factor for the coordination of health care in this patient population.

Current processes/preparations and Outlook on following steps:
The follow-up project MenDis-CHD II started on May 4. The focus of MenDis-CHD II is on improving the management of GPs for CHD patients with mental/cognitive disorders. MenDis-CHD II will also generate data for an economic evaluation of the health care situation of CHD patients in cooperation with another subproject of CoRe-Net (OrgValue). The design of the intervention will be based on a follow-up study of the MenDis-CHD I cohort and qualitative interviews with family doctors. For this purpose, project meetings will be held soon, which will herald the start of the project and implement the project planning. A first CoRe-Net meeting took place on 08.05.2020, at which a pragmatic organisational structure for the further course of the project was developed. Furthermore, a first MenDis-CHD II meeting will take place shortly in direct cooperation with OrgValue II.