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Enrolling by invitation NCT06593704

Proactive Population Health Management of Cardiovascular Disease in Primary Care Using the PROSPERA-program.

No phase Interventional Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PROSPERA-program.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases. Basic parameters: 40 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Proactive Population Health Management of Cardiovascular Disease in Primary Care Using a Multilevel Guideline Adherence Toolkit (the PROSPERA-program).

Overview

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

  • Other PROSPERA-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

Primary outcome measures

  • The proportion of individuals who have achieved all protocol-defined cardiovascular prevention goals. [Time frame: At 0 and 18 months]
Secondary outcome measures (8)
  • Perceived shared decision making (in subset only) [Time frame: immediately after the intervention]
  • Perceived shared decision making (in subset only) [Time frame: immediately after the intervention]
  • Decisional Conflict (in subset only) [Time frame: immediately after the intervention]
  • Implementation outcome: fidelity [Time frame: At month 4 and 10]
  • Implementation outcome: fidelity [Time frame: At month 4 and 10]
  • Implementation outcome: penetration [Time frame: At month 10]
  • Healthcare professional's satisfaction on usability of the PROSPERA-program [Time frame: At month 10]
  • Cost-effectiveness [Time frame: immediately after the intervention and at month 18]

Eligibility criteria

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')

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Netherlands · 1 center
  • Department of Public Health and Primary Care — The Hague

Identifiers

NCT: NCT06593704 · 23-3050 · 10140302110018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗