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

NCT06593704 | Enrolling By Invitation

• 2 other identifiers: 23-305010140302110018
• Study Type: interventional
• Target: 848
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiovascular Diseases

Keywords

Primary Care; Population Health Management; Implementation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Perceived shared decision making (in subset only)

  immediately after the intervention

• Perceived shared decision making (in subset only)

  immediately after the intervention

• Decisional Conflict (in subset only)

  immediately after the intervention

• Implementation outcome: fidelity

  At month 4 and 10

• Implementation outcome: fidelity

  At month 4 and 10

Study Arms (2)

PROSPERA

EXPERIMENTAL

The PROSPERA-program

Other: PROSPERA-program

Control

NO INTERVENTION

Primary cardiovascular care-as-usual, according to national and international applicable guidelines.

Interventions

PROSPERA-program OTHER

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.

PROSPERA

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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')

Sponsors & Collaborators

• Leiden University Medical Center: lead
• UMC Utrecht: collaborator

Study Sites (1)

Department of Public Health and Primary Care

The Hague, South Holland, 2511PL, Netherlands

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator R.C. Vos

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: February 17, 2025
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): July 9, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)