Cardiovascular Diseases
Conditions
Keywords
Primary Care, Population Health Management, Implementation
Brief summary
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: * Receive a consultation with their general practitioner or practice nurse according to the PROSPERA-program. * Have their routinely collected healthcare data used for evaluation. * Be asked to complete a questionnaire or participate in an interview (for a subset of patients).
Interventions
OTHERPROSPERA-program
The PROSPERA-program consists of the following components: 1. Health care provider training and education about U-Prevent and cardiovascular risk communication. 2. Risk stratification: proactive selection of cardiovascular patients through the PROSPERA-empanelment procedure - for the population with increased cardiovascular risk, prior to consultation. 3. Decision support tools: use of the Lifestylecheck and the U-Prevent clinical decision support tool to guide motivated shared decision making towards appropriate care matched to the care complexity of the patient - for the individual patient, during consultation.
Sponsors
Leiden University Medical Center
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 40 years and ≤ 90 years * Patient in a primary care practice enrolled in this study * Included in the cardiovascular disease (CVD), increased vascular risk (IVR) or diabetes mellitus (DM) Dutch Integrated Care programs * Additional criteria for subgroup that receives questionnaires: able to communicate in the Dutch and/or English language
Exclusion criteria
* Patients with Diabetes Mellitus type I * Patients receiving palliative care * Patients with any form of cognitive impairment diseases such as Dementia or Alzheimer * Patients who are treated in other Integrated Care programs because of their frailty (e.g. elderly who are treated in the 'Kwetsbare Ouderen Chronische Zorgprogramma')
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of individuals who have achieved all protocol-defined cardiovascular prevention goals. | At 0 and 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived shared decision making (in subset only) | immediately after the intervention | 9-item Shared Decision Making Questionnaire (SDM-Q-9) |
| Decisional Conflict (in subset only) | immediately after the intervention | The Decisional Conflict Scale (DCS) |
| Implementation outcome: fidelity | At month 4 and 10 | 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. |
| Implementation outcome: penetration | At month 10 | 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. |
| Healthcare professional's satisfaction on usability of the PROSPERA-program | At month 10 | System Usability Scale |
| Cost-effectiveness | immediately after the intervention and at month 18 | Cost-effectiveness of the PROSPERA-program in Quality-Adjusted Life Years (QALYs) as calculated in a cost-effectiveness analysis |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORRimke C Vos
LUMC
PRINCIPAL_INVESTIGATORMattijs E Numans
LUMC
PRINCIPAL_INVESTIGATORJannick AN Dorresteijn
UMC Utrecht
PRINCIPAL_INVESTIGATORHendrikus JA van Os
LUMC
Outcome results
None listed