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| ID | Type | Description | Link |
|---|---|---|---|
| 10140302110018 | Other Grant/Funding Number | ZonMw |
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| Name | Class |
|---|---|
| UMC Utrecht | OTHER |
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The PROSPERA-program is a complex multilevel approach that includes training for healthcare providers, a risk assessment process, and decision support tools to help match patients with the appropriate treatment based on their care needs.
The goal of this clinical trial is to determine if the PROSPERA-program can improve the cardiovascular risk profile in patients aged 40-90 years enrolled in primary care programs for increased cardiovascular risk, such as cardiovascular disease, increased vascular risk, or diabetes.
The main question it aims to answer is:
• Does the cardiovascular risk profile improve for patients using the PROSPERA-program?
Researchers will compare the PROSPERA-program with standard cardiovascular care to see if the program enhances cardiovascular population health in primary care.
Additionally, the study will assess how well the PROSPERA-program fits into the workflow of primary care providers and supports shared decision-making.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROSPERA | Experimental | The PROSPERA-program |
|
| Control | No Intervention | Primary cardiovascular care-as-usual, according to national and international applicable guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROSPERA-program | Other | The PROSPERA-program consists of the following components:
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of individuals who have achieved all protocol-defined cardiovascular prevention goals. | Protocol-defined treatment goals are in line with local prevention targets (including treatment targets such as Systolic Blood Pressure, LDL-cholesterol, Antithrombotic therapy, HbA1c, SGTL2 inhibitors and/or GLP1-receptor agonists). The sample size is based on the minimum number of subjects (patients) who will complete the component of the intervention conducted during consultation (= the clinical decision tools). A subset will receive additional questionnaires. The primary outcome will be compared among the complete study population as well as in the subgroup. | At 0 and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived shared decision making (in subset only) | 9-item Shared Decision Making Questionnaire (SDM-Q-9) | immediately after the intervention |
| Perceived shared decision making (in subset only) | Patient interviews (qualitative) |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rimke C Vos | LUMC | Principal Investigator |
| Mattijs E Numans | LUMC | Principal Investigator |
| Jannick AN Dorresteijn | UMC Utrecht | Principal Investigator |
| Hendrikus JA van Os | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Public Health and Primary Care | The Hague | South Holland | 2511PL | Netherlands |
Due to the nature of the study, blinding is not possible. Therefore, the data might contain privacy sensitive information and only restricted access can be granted for parts of the collected data. It has yet to be decided which data can be acquired through restricted access.
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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|
| immediately after the intervention |
| Decisional Conflict (in subset only) | The Decisional Conflict Scale (DCS) | immediately after the intervention |
| Implementation outcome: fidelity | Percentage of target population that has received the U-Prevent component of the PROSPERA-program during the study duration as measured by the U-Prevent logbook. | At month 4 and 10 |
| Implementation outcome: fidelity | Fidelity checklist by HCPs . | At month 4 and 10 |
| Implementation outcome: penetration | The number of health care professionals who deliver the PROSPERA-program on an individual patient level (component 2) divided by the number of health care professionals who are expected to deliver this service. | At month 10 |
| Healthcare professional's satisfaction on usability of the PROSPERA-program | System Usability Scale | At month 10 |
| Cost-effectiveness | Cost-effectiveness of the PROSPERA-program in Quality-Adjusted Life Years (QALYs) as calculated in a cost-effectiveness analysis | immediately after the intervention and at month 18 |