2022
Completed work areas including a short summary of results and reference to new publications
The follow-up survey in study part A was completed. A total of 132 patients* were included in the re-survey. This corresponds to 48% of the patients who had agreed to be re-contacted at the time of MenDis-CHD I. The remaining 52% could not be included. The remaining 52% could not be included because they were either no longer available (moved, no response), died in the meantime, or refused to participate for various reasons, including, for example, too high a burden due to their own illness situation or illness in their family environment.
For the implementation of the GP-centered intervention, a total of 6 GP practices were included and instructed in the intervention and materials during an approximately 90-minute training session. Recruitment took place during events, by e-mail and via a newsletter from HAFO.NRW. All participating physicians* received the questionnaire for the survey of organizational characteristics.
The ethics application for “Subproject C – Patient* Survey” was approved on 05.04.2022.
Current processes / preparations
Currently, the data from the follow-up survey in study part A are being read in. An analysis plan meeting has already been held, and a detailed, written analysis plan is now being prepared based on this meeting. At this meeting, various publication proposals in the individual project parts were also discussed and responsibilities in MenDis-CHD II and OrgValue II were defined.
After completion of training in study part C, the intervention will now run for six months. After three months, there will be another proactive contact with the practices to remind them of the study if necessary, to clarify open questions, and to supply missing material. However, the members of the study team are always available as contact persons for the practices.
Furthermore, the recruitment of facilities for the patient survey has begun. We are looking for facilities that display the QPS in their offices and thus make it accessible to patients with CHD. Four facilities have already been recruited to display the QPS. A questionnaire for the quantitative evaluation of the Question Prompt Sheets for patients is currently being finalized.
Outlook on next steps
As soon as the data from study part A are available, the data analysis of the follow-up study will start.
After the intervention phase in study part C has been completed, the data will be exported to the practices and then processed. We expect the data to be complete in January 2023.
The recruitment of the facilities for the patient survey is to be completed promptly, and a pre-test of the questionnaire for the quantitative evaluation of the QPS with patients is also planned.
Completed work areas including a short summary of results and reference to new publications
The ethics application for the GP-centered intervention (study part C) was positively evaluated by the Ethics Committee of the Medical Faculty of the University of Cologne on 07.01.2022. The draft contract as legal framework for the implementation of the study participation was also finalized and reviewed from a data protection perspective. The pre-tests for the implementation of the encrypted data export were successfully completed.
The ethics application for “Subproject C – Patient Survey” was submitted to the Ethics Committee in January, the review is still pending.
Current processes / preparations
For study part C, interested practices are currently being recruited for the intervention and included in the study. At the current time, three practices have been recruited to participate in the study. Training sessions in the practices are planned for March/April as a prelude to the intervention phase. The content of the training is currently being adapted on the basis of the results from study part B. In addition, the questionnaires for the survey are being developed. Furthermore, the questionnaires to survey the organizational characteristics of the participating practices are being printed and prepared for distribution.
A meeting was also held with the PMV research group to discuss a Socio-Economic Impact Assessment (SEIA) model based on experience-based estimates that can be used in the future for comparison with the project results.
Outlook on next steps
The focus in the coming weeks will be on launching the primary care physician-centered intervention. This includes the recruitment of further interested general practitioners as well as the implementation of trainings as a starting point of the intervention phase. Six months after the training, anonymous treatment data will then be exported from the practice information systems, which should provide information about a possible change in physician behavior as a result of the intervention. For the planned interviews at the end of the intervention, guidelines for discussions with physicians and patients will also be prepared.
2021
Completed work areas including a short summary of results and reference to new publications
For study part A, all 274 patients from MenDis-CHD I who had agreed to be contacted again at that time were contacted by telephone or mail. 108 persons had already returned the study documents in full. In contrast, 101 patients could no longer be contacted, declined to participate, or died in the meantime. All patients who showed evidence of mental or cognitive complaints were invited for further diagnostics.
In study part B, the intervention materials, which were developed on the basis of the interviews with general practitioners and patients, were revised and discussed and agreed upon by the research team. These include the Question Prompt Sheets for patients, which are intended to serve as a discussion aid in the doctor-patient conversation. For general practitioners, a booklet with information on the disease as well as coat cards with screenings were created. The intervention materials were visually prepared by a graphics office and are now ready for printing.
With regard to the implementation of the study intervention in study part C, an ethics application was submitted in October, which is currently being reviewed by the Ethics Committee of the Medical Faculty of the University of Cologne. In parallel, a draft contract was prepared by the Legal Department of the University Hospital of Cologne, which is to form the legal framework for the participation of the practices in the study as well as for the data export. Furthermore, a training concept was developed based on the results of study part B, which is to be used for the training of the practices at the beginning of the intervention. Regarding the data export, several pre-tests were conducted to test the implementation of the export file and the processes of encrypted sending.
Current processes / preparations
While the initial contact has been completed as part of the follow-up investigation (study part A), work is ongoing to complete the data to be collected. This mainly concerns the further diagnostics, which are offered in case of indications of psychological or cognitive complaints and take place either by telephone or in the premises of the Clinic and Polyclinic for Psychiatry and Psychotherapy or the Clinic and Polyclinic for Psychosomatics and Psychotherapy.
The ethics application for “Subproject C – Patient Survey” has been separated from study part C and is in the process of finalization.
Currently, the result of the review of the ethics application for study part C by the ethics committee is expected. At the same time, the final confirmation of the draft contract by the data protection commissioners is pending. In order to be able to start the implementation of the intervention in a timely manner, interested practices are already being approached for participation.
Outlook on next steps
For study part A, data collection is to be completed by the end of the year as part of the follow-up investigation. In view of the pre-Christmas period and the increasing number of corona patients, there are scheduling difficulties or concerns on the part of the patients to visit the clinic, so that some appointments for diagnostics can only take place at the beginning of next year.
Qualitative interview guides and written questionnaires are being developed to evaluate the intervention. Once a positive vote is received from the ethics committee for “Subproject C – Patient Survey”, recruitment of facilities through which patients with CHD can be reached will occur.
After receipt of the ethics vote for study part C and the consent of the primary care physicians, the training will be carried out in the primary care practices and the intervention period will begin.
Completed work areas including a short summary of results and reference to new publications
For study part A, the follow-up examination of the patients from MenDis-CDH I, 190 persons have already been contacted by telephone or mail in the past weeks. About 112 agreed to participate again. 44 declined to participate for personal reasons, could no longer be reached, or have died in the meantime. In April, an internal team training on how to conduct the Structured Clinical Interview for DSM-IV (SKID) was also held.
In study part B, the qualitative data collection of the modelling phase was successfully completed. In total, interviews were conducted with 7 patients and 3 patient representatives as well as interviews with 10 general practitioners. Participants were asked about their experiences in the health care process regarding coronary artery disease and accompanying psychological/cognitive symptoms as well as possible suggestions for improving these processes. In addition, they were asked to provide an assessment of the planned intervention in general practitioners. Particular attention was paid to factors and barriers relevant to successful implementation of the intervention. The interviews were transcribed and analysed in three rounds by four research assistants using pre-developed categories.
Simultaneously to the activities mentioned above, intensive work was carried out on the implementation of subproject C. On the one hand, this concerned the definition of inclusion and exclusion criteria for participating practices, and on the other hand, the specification of criteria for the export of routine data from the physician information systems. The focus was also on the design of a data protection concept in close coordination with the CoRe-Net trust center, which regulates the handling of the data sources in subproject C and ensures that the project is carried out in compliance with data protection requirements. A trial run for data provision by the company contracted for data export was also completed. The study protocol was completed and the documents prepared for submission to the ethics committee.
Current processes / preparations
The follow-up examination for study part A is progressing continuously. After receipt of the questionnaires, if there are indications of existing psychological or cognitive anomalies, more in-depth diagnostics are carried out, either by telephone or on the premises of the Clinic and Polyclinic for Psychiatry and Psychotherapy or the Clinic and Polyclinic for Psychosomatics and Psychotherapy.
In study part B, the interview results will be used to develop an implementation concept that considers barriers and facilitating factors for successful implementation of the intervention in general practice. In addition, the structural questionnaires for patients and general practitioners will be revised based on the statements of patients and experts.
To ensure that the data export complies with data protection law, there is an ongoing intensive exchange with the data protection commissioner of the University of Cologne and the University Hospital Cologne as well as with the legal department in order to be able to submit subproject C to the ethics committee in a timely manner. The contractual form of the cooperation with the general practitioners is also currently being worked out. For the evaluation of the patient perspective, a recruitment concept is currently being developed and a corresponding ethics application is being prepared. Meanwhile, the programming of the export tool by an external service provider is almost completed.
Outlook on next steps
For study part A, the further recruitment of patients is planned, as well as the offered psychological and cognitive testing in case of abnormal test results. In study part B, the implementation concept will be presented and discussed in the research group with experienced scientists. In addition, the structural questionnaire for patients and general practitioners will be finalized.
Furthermore, the ethics application for study part C will be submitted, so that a continuation of the study can be ensured. In addition, work is to be done primarily on the data protection-compliant implementation of the data export from the general practitioners as well as on the contractual design.
Completed work areas including a short summary of results and reference to new publications
In February, study parts A and B were positively evaluated by the ethics committee of the University of Cologne. As a result, it was possible to start contacting the patients from MenDis-CHD I to inform them about the continuation of the project and to obtain their consent to participate in the follow-up survey. General practitioners in Cologne were also identified and contacted as potential interview partners. Seven interviews have already been conducted online. First interviews with patient representatives were also conducted. The recruitment of patients for the qualitative interviews will be done from the patients of the first project phase MenDis-CHD I.
In the past weeks, the Question Prompt Sheets for general practitioners and patients were revised and graphically prepared so that these drafts can now be used and evaluated in the interviews.
The application for conversion of third-party funds for the implementation of project part C in cooperation with the company axaris – software & systeme GmbH was approved by the DLR. There were ongoing further discussions regarding the technical implementation and the selection of the relevant data for the data export from the general practitioners in study part C in cooperation with OrgValue II.
Current processes / preparations
Recruitment in study parts A and B has started. Currently, patients who participated in MenDis-CHD I are contacted and asked to participate again in the follow-up survey. They will receive a questionnaire asking about changes relevant to care since the last survey and current perceptions of quality of care, as well as possible mental or cognitive disorders. A short cognitive test is also administered by telephone. At the same time, interviews will be conducted with general practitioners, patient representatives, and patients in order to incorporate the results into the design of the intervention in Study Part C.
Currently, a pseudonymization concept for study part C is being developed, which will be submitted for a data protection review. For this purpose, we are in contact with the CoRe-Net trust center to ensure a data flow in compliance with data protection law. Furthermore, a structural questionnaire is being developed, which will be used as an interface to OrgValue II to record organizational characteristics of the participating general practitioners.
Outlook on next steps
According to the study plan, the continuation of the follow-up survey in study part A is planned for the coming months. Patients who show indications of psychological or cognitive abnormalities in the survey will be offered further diagnostics. The qualitative interviews are also to be completed by the end of the first year of the project. Based on this, the training materials, Trigger Question and Question Prompt Sheets for the intervention in study part C will then be developed or adapted. Furthermore, the documents for the ethics submission in study part C will be finalized and submitted.
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.
