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DETERMINANTS OF SUCCESSFUL IMPLEMENTATION OF SELECTIVE PREVENTION OF CARDIO-METABOLIC DISEASES ACROSS EUROPE [SPIM EU] [663309] - Project
Project coordination by lead NIVEL

Start month:1 - End month: 36

NIVEL (participant 1 and coordinator of the SPIM EU project) will take responsibility for the timely delivery of all deliverables and will secure the quality of the outputs and the consistency with th...
NIVEL (participant 1 and coordinator of the SPIM EU project) will take responsibility for the timely delivery of all deliverables and will secure the quality of the outputs and the consistency with the specific objectives. NIVEL (participant 1) will have the overall responsibility for coordinating the SPIM EU project, in close cooperation with Julius (participant 2). For the coordination of the project a steering committee will be established, which will act as management team for the SPIM EU project (task 1.1).

Task 1.1: Steering committee and consortium agreement (NIVEL)
A steering committee will be established consisting of the SPIM EU project coordinator, a representative of each project participant (preferably the WP leader), and a member of NIVEL’s management team. The steering committee will meet 6 times during the project to monitor the progress of the project, and to discuss budgetary issues, milestones and deliverables. Minutes of the meetings will be made. A first task of the steering committee will be to reach consensus about a consortium agreement to be signed by all partners involved in the SPIM EU project. The consortium agreement includes articles about e.g. responsibilities of the partners and the steering committee, (co-)authorship, and rules how to cope with potential conflicts or disagreements. Possible conflicts that cannot be solved otherwise will be decided upon by the steering committee.

Task 1.2: Logbook of activities (NIVEL and WP leaders)
On the password protected part of the website (task 2.1) for each WP a log file will be created. This log file contains actual information on all important decisions taken during the work in each WP. Each WP leader will be responsible for keeping these log files up to date. The WP leader will provide a progress report for the WP at each steering committee meeting on the basis of this log file. Moreover, the log file can also be accessed by the internal evaluator for evaluation purposes (see WP3).

Task 1.3: Project meetings (NIVEL)
The coordinator will be responsible for organising the meetings of the steering committee, the kick-off meeting (to be held in Luxemburg) and the final meeting with representatives of all SPIM EU project participants. For these meetings, the DG SanCo project officer will be invited.
During the kick-off meeting the aims and outline of the project will be discussed with attention for the planned roles and activities of all partners. Agreement will be reached on boundaries of the project, uniformity of definitions, internal communication, potential dissemination strategies, authorship of publications and financial and administrative affairs.

Task 1.4: Reporting and contact point (NIVEL)
The coordinator will be responsible for regular contacts with CHAFEA and DG SanCo, and for the interim and final report about the progress of the project, including the financial reports. If necessary, NIVEL will provide support to the other participants of the SPIM EU project in preparing their financial reports.
Dissemination by lead SDU

Start month:1 - End month: 36

The activities in this Work Package will be coordinated by SDU (participant 4), with support and input from NIVEL and Julius.
The WP2 activities focus on the dissemination of the SPIM EU project resul...
The activities in this Work Package will be coordinated by SDU (participant 4), with support and input from NIVEL and Julius.
The WP2 activities focus on the dissemination of the SPIM EU project results to the relevant stakeholders (see paragraph 3). These include citizens in EU Member States, health care professionals involved in preventive activities, and health policy makers engaged in prevention. These three different target groups need to be addressed in different ways, by different communication methods, and different information products. To ensure effective dissemination, a dissemination plan will be prepared (task 2.1), to be adopted by the steering committee of the SPIM EU project. This dissemination plan will guide all activities during the SPIM EU project aimed at distributing the project results.

Task 2.1: Dissemination plan (Julius)
A dissemination plan will be prepared which will describe all activities to be undertaken to promote the SPIM EU project, to share the outcomes with relevant stakeholders and with public authorities. For each dissemination activity, the plan will describe the target group, how they will be reached, and the timing of the activity within the project. The dissemination plan also includes a plan for publications from the project using various media (Internet [website], social media, scientific journals, professional journals, presentations at conferences and stakeholder meetings when appropriate). Special attention will be paid to the sustainability of the results by specifically addressing those stakeholders who are expected to profit from the results of the SPIM EU project, e.g. national colleges of general practitioners. Especially the toolbox (see task 2.4) will be an important element for dissemination as the use of this toolbox is expected to contribute to a successful implementation of selective prevention programs. At all dissemination activities the visibility of EU co-funding will be taken into account.

Task 2.2: Project website (NIVEL)
A project website will be established and maintained with a public and a password protected part. The public part will contain public information about the project and contact details of the partners. The protected part will only be accessible for the project partners and is meant to facilitate the communication between partners, as archive of project documents and databases, documents related to project meetings, and official reports (see also WP1, task 1.2).

Task 2.3: Project leaflet (SDU)
A project leaflet will be prepared describing the project, its objectives and activities, and the partners involved. This leaflet will be used for promotion of the project at conferences and meetings where relevant. Also, this leaflet will be used by primary care professionals when implementing the feasibility studies (see WP8).

Task 2.4: Toolbox (SDU)
On the basis of the results of WP4, WP5, WP6 and WP8 a toolbox will be created to support tailoring of selective prevention programs to the national context in EU Member States. This toolbox will contain a synthesis of all insights gained
- from the literature (WP4);
- from the strengths and weaknesses of existing selective prevention programs (WP5);
- from the results of the surveys among the general population and primary care professionals (WP6), and
- from the feasibility studies of implementing a selective prevention program (WP8).
This toolbox will be a core deliverable of the SPIM EU project. SDU (participant 4) will be responsible for creating this toolbox, which will be an ongoing activity during the SPIM EU project. The final version of the toolbox will be adopted by the steering committee of the SPIM EU project, thereby ensuring consensus among all project participants.

Evaluation of the project implementation by lead UMC UTRECHT

Start month:1 - End month: 36

The evaluation of the SPIM EU project will be carried out by the Julius Center for Health Sciences as Work Package leader of WP3. To avoid conflicts of interests, the department of Public Health of th...
The evaluation of the SPIM EU project will be carried out by the Julius Center for Health Sciences as Work Package leader of WP3. To avoid conflicts of interests, the department of Public Health of the Julius Center will carry out the evaluation. In all other Work Packages, the Department of General Practice will be involved.
The evaluator will be responsible for evaluating the progress and effects of the SPIM EU project by using its own observations and input from other partners. The evaluator will join all steering committee meetings and the kick-off and final project meeting. The evaluation results will be described in an interim and a final report to the EC. An evaluation plan will guide all evaluation activities undertaken in the SPIM EU project (see task 3.1).

Task 3.1: Evaluation plan
The evaluator will create an evaluation plan focusing on process, output and outcomes. The plan will include:
- inferring conclusions from the logbook (see task 1.2);
- listing countable output on process, output and outcome indicators (see paragraph 2.2), deliverables and milestones reached (on time or delayed);
- systematic critical scrutiny of all outputs from each Work Package and ensuring appropriateness of quality and relevance;
- undertaking systematic evaluation among partners about the attainment of goals.
The evaluation plan will be presented, to be adopted by the Steering Committee. The evaluation plan includes a description of the methods for the evaluation, indicators, and measures of verification. The starting point for the evaluation is the description of the Work Packages, the deliverables and milestones, and the project planning.

Task 3.2: Evaluation
To carry out its evaluation activities, the evaluator will participate in the meetings of the steering committee (see WP1, task 1.1), and will have access to the protected part of the project website (see WP2, task 2.2). During each steering committee meeting, the evaluator will be invited to share its observations on the progress of the SPIM EU project, and – if necessary – immediate actions can be proposed and discussed. On the protected part of the SPIM EU website, log files on the progress of all WPs will be created, and will be made accessible for the evaluator in order to monitor and evaluate the progress of the project.

Task 3.3: Evaluation reports
The evaluator will write an interim and final report on the evaluation of the project, including progress, outcomes, and dissemination of the results. This report will be presented at the final project meeting (see WP1, milestone 1.3).

Mapping existing selective prevention programs by lead NIVEL

Start month:1 - End month: 24

An EU wide inventory of existing models and programs for selective prevention of cardio-metabolic diseases, and a systematic analysis of their strengths and weaknesses will be carried out with support...
An EU wide inventory of existing models and programs for selective prevention of cardio-metabolic diseases, and a systematic analysis of their strengths and weaknesses will be carried out with support of national contact points. Coordinators of identified selective prevention programs will be invited to complete a short questionnaire on the programs in order to obtain standardized information on the existing selective prevention programs.

Task 4.1: Development of questionnaire (NIVEL)
A questionnaire will be drafted to systematically collect data about the characteristics, and success and failure factors of existing selective prevention programs in EU Member States. When possible, existing, validated instruments will be included in this questionnaire. The questionnaire will be tested by all SPIM EU project participants by completing the questionnaire for one existing selective prevention program in their respective country. The final version of the questionnaire will be converted to an online questionnaire. The length of the questionnaire should allow completion in maximally 15 minutes.

Task 4.2: Identifying selective prevention programs (NIVEL)
To identify existing selective prevention programs for cardio-metabolic diseases, national experts in all EU Member States will be identified and contacted. Each participant in the SPIM EU project will seek for national experts in 5-6 EU Member States. Existing networks (see paragraph 14 for Collaborating stakeholders) will be approached to identify national experts. They will be invited to submit a list of selective prevention programs in their respective country, including the contact details. Inclusion criteria for selective prevention programs include: national or regional coverage, formalised well established program, aimed at identifying persons at high risk for cardio-metabolic diseases among persons without any known disease or risk factor.

Task 4.3: Data collection and reporting (NIVEL)
Coordinators of all identified selective prevention programs in EU Member States will be invited to complete the online questionnaire (see task 4.1). A database will be generated which will allow the statistical analyses of the quantitative data and qualitative analyses of the qualitative data. A final report will be made, and a manuscript summarizing the results, to be submitted as article in a scientific journal.

Literature review by lead KI

Start month:1 - End month: 18

In this Work Package, a systematic literature review will be performed to provide insight into the
existing knowledge and evidence regarding determinants of uptake and compliance with selective
prev...
In this Work Package, a systematic literature review will be performed to provide insight into the
existing knowledge and evidence regarding determinants of uptake and compliance with selective
prevention programs (focusing on healthy persons at potential high risk). This includes
determinants of uptake of and compliance with selective prevention programs by health
professionals as well as by the target group in the population. A distinction will be made between
determinants of short-term and long-term compliance and participation. The literature review will
complement the existing review of Koopmans et al (2012b) on determinants of non-compliance.
The methodology of the systematic literature review will be based on guidelines of the Cochrane
Collaboration and the EPOC (Cochrane Effective Practice and Organisation of Care Group) and will
include a quality assessment of the publications included in the review. Bibliographic databases as
PubMed (Medline), CINAHL and EMBASE will be used to search for relevant publications with an
identical search strategy. If possible, meta-analyses will be carried out to quantify the impact of
determinants on uptake and compliance. The literature review will be reported as a manuscript to be
submitted to a scientific journal. Moreover, the results of the review will be included in the knowledge
synthesis (see WP7). KI will carry out the literature review; the review protocol will be submitted to the
steering committee for approval. Other SPIM EU participants will participate in the selection and data
extraction of relevant publications.

Task 5.1: Develop protocol for systematic literature review
Task 5.2: Selection of relevant publications and data extraction
Task 5.3: Analysis and reporting

Acceptability of selective prevention actions by lead UMC UTRECHT

Start month:7 - End month: 21

To assess the attitude towards selective prevention of both the target group and health care professionals and the target group two surveys will be conducted in the five EU Member States of the proje...
To assess the attitude towards selective prevention of both the target group and health care professionals and the target group two surveys will be conducted in the five EU Member States of the project participants:
a) among primary health care professionals: attitudes towards selective prevention, actual involvement in selective prevention, facilitating and hampering factors for implementation in their practice
b) among a sample of the target population for selective prevention which will be patients of the practices of the primary health care professionals (participants in survey a).

A) Survey among professionals
In this survey we will assess the attitude and experience with programs for selective prevention among primary care physicians in each of the five participating EU countries (SWE, DNK, NLD, CZE, GRE). The aim of this survey is to get an overview of key determinants of success, of potential obstacles and to identify cultural or system factors that need to be taken into account when tailoring selective prevention programs. These factors will finally be included in the tool box see WP2).

Task 6.1 Development of the questionnaire (M7-M12)
Based on experiences in other international studies we consider the following four themes of paramount importance to be included in the questionnaire:
- Knowledge among professionals of preventive programs and their potential benefit;
- Involvement in preventive programs in clinical practice;
- Attitude towards prevention in general and towards participation in prevention programs specifically;
- System and context related determinants of success and failure of implementation of preventive programs in primary care practice (practice related factors, financial factors, workload).
The questionnaire will be designed around these themes. The WP leader will perform a literature review to identify the detailed determinants on each of these four themes as reported in the scientific literature. The draft questionnaire will be developed around these themes. This draft will be reviewed and discussed with the SPIM EU project participants. Based on their comments the questionnaire will be converted into a prefinal format. The prefinal questionnaire will be pilot tested by 5 primary care physicians in each country represented in the SPIM EU project. Based on the evaluation the questionnaire will be put in a final format and converted to an online version.

Task 6.2: Data collection
The survey will be internet based, which will facilitate efficient data handling. It will be translated into the national languages for optimal understanding. In each of the five countries represented by the SPIM EU participants a random sample of 250 primary care physicians will be drawn using data and membership lists from national colleges, research networks or other primary care physicians’ organisations. An invitational letter will be sent to the selected physicians by the respective representative in the SPIM EU project on behalf of the SPIM EU consortium. In this letter the aims of the SPIM EU project will be explained, participation requested and a link to the website with the online questionnaire be provided. Non-responders will be reminded after 4 and 8 weeks.

Task 6.3: Data analysis and reporting
Based on experience with international surveys in primary care across Europe we expect a response rate of 40% . In total we will have 100 respondent per country (total N=500), which will be an adequate sample to analyse the key questions and establish differences between countries. The data will be collected online and analysed by the WP leader. Results will be reported in frequency tables, differences will be assessed and reported with significance level. A final report and scientific publication will be written by the WP leader together with the other SPIM EU participants.

B) Population survey
This survey aims at identifying the attitude of the general population in the countries represented
Design of tailored selective prevention actions by lead CUNI

Start month:19 - End month: 24

The design of a generic stepwise program for identifying people at high risk for cardio-metabolic diseases and the tailoring of this design to the country-specific contexts in five EU Member States wi...
The design of a generic stepwise program for identifying people at high risk for cardio-metabolic diseases and the tailoring of this design to the country-specific contexts in five EU Member States will be established during a 1-day consensus workshop of representatives from the SPIM EU participants and a group of 5 internationally respected experts in the field of selective prevention of cardio-metabolic diseases. The group of experts will include expertise in cardiology, public health, and prevention.
In preparation of this workshop, the WP leader (CUNI) will provide a synthesis of the results obtained in WP4, WP5 and WP6, with the focus on possible measures to be taken for a successful implementation of a selective prevention program in the primary health care setting. These measures cover factors at different levels:
a) structural factors related to the role of primary care in the health care system (gatekeeper role, list system, accessibility, remuneration of preventive services);
b) factors related to the attitude and (perceived) tasks of primary care professionals;
c) social, cultural and ethical factors at the level of the population related to the acceptability of being approached for preventive actions and of being recommended to change lifestyle and/or starting preventive medication.
This synthesis of knowledge will be used as a basis for the discussions during the consensus workshop (to be organised in M22, and which will be led by the WP leader.

Task 7.1: Prepare knowledge synthesis on the basis of the results of WP4, WP5 and WP6
Task 7.2: Organise and lead 1-day consensus workshop

Feasibility studies of selective prevention actions by lead UOC

Start month:22 - End month: 34

Design and protocol for the feasibility studies
A feasibility study will be carried out in primary care practices from five European Member States (Sweden, Denmark, the Netherlands, Czech Republic and...
Design and protocol for the feasibility studies
A feasibility study will be carried out in primary care practices from five European Member States (Sweden, Denmark, the Netherlands, Czech Republic and Greece). The implementation of the selective prevention program for the feasibility study will be tailored to the context in each country, which is the result of WP7. The implementation will be tested in a feasibility study in five EU Member States for which a study protocol will be developed and approved by the SPIM EU steering committee before the start of the feasibility study.

Participants
For establishing the feasibility of tailored selective prevention programs, in each Member State a maximum of ten (10) primary care practices will be invited to participate. The selection of practices will be based on criteria to ensure that different practice settings are represented (public/private, solo/group, different urbanisation levels). Professionals (i.e. primary care physicians and nurses) working in each setting/practice will be invited to participate, and in each practice a random sample of 20 persons attending each practice will be recruited out of the group of persons attending who are deemed to be eligible for the selective prevention program, on the basis of the information available in their medical record.

Training
A one-day training workshop will be organised in each participating EU Member State to inform the participating primary care professionals about the selective prevention program (tailored to the national context) and the feasibility study. The training will include the implementation of the selective prevention program in the practice, and the collection of data to establish the feasibility. It will also emphasize aspects such as recruitment criteria for eligibility (i.e. selection for prevention on the basis of previous medical history, other risk factors recorded in the records), as well as accuracy in data collection.

Outcome measures and measurements
The feasibility of the implementation of the tailored selective prevention programme includes the acceptability by the professionals and the participants, and the actual participation and compliance with the program. The feasibility of the program will be established by questionnaires, to be filled in by the participating professionals (primary care physicians and nurses) and by the invited participants.

Questions for professionals regard the feasibility of implementing the selective prevention program in their practice, the time estimated and allocated to implement the program, the disciplines involved, and whether they consider the program as an important element of their services. An additional item will focus on eliciting preferences on integrating selective prevention actions in the usual standard of care provided. To ensure sustainability, the aforementioned feasibility questions will address both short- and long-term implementation.
Questions for participants will include the acceptability of being invited for establishing a risk profile, as well as experiences with its content. The actual participation rate (number of respondents in different phases of the selective prevention program) will be measured by a careful administration in each practice. The compliance with the program will be established by a questionnaire to all invited participants to measure to what extent participants completed the selective prevention program and to what extent they consider the program as useful, as relevant for their health status, whether they intend to undertake risk reducing actions and what barriers they experience in understanding such actions. The Theory of Planned Behaviour as it has been utilised in previous studies (Lionis et al, 2014) will guide towards the development of the questionnaire.

Analyses
The feasibility of the tailored selective prevention program will be established first for each Member State separately. In addition, an overall analysis