Clinical trial NCT06593704: Proactive Population Health Management of Cardiovascular Disease in Primary Care Using the PROSPERA-program.
Official title: Proactive Population Health Management of Cardiovascular Disease in Primary Care Using a Multilevel Guideline Adherence Toolkit (the PROSPERA-program).
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Primary Care
Population Health Management
Implementation
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
First posted: 2024-09-19
Enrollment: 848
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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')

Primary outcomes:
measure: The proportion of individuals who have achieved all protocol-defined cardiovascular prevention goals.
timeFrame: At 0 and 18 months
Secondary outcomes:
measure: Perceived shared decision making (in subset only)
timeFrame: immediately after the intervention
measure: Perceived shared decision making (in subset only)
timeFrame: immediately after the intervention
measure: Decisional Conflict (in subset only)
timeFrame: immediately after the intervention
measure: Implementation outcome: fidelity
timeFrame: At month 4 and 10
measure: Implementation outcome: fidelity
timeFrame: At month 4 and 10
measure: Implementation outcome: penetration
timeFrame: At month 10
measure: Healthcare professional's satisfaction on usability of the PROSPERA-program
timeFrame: At month 10
measure: Cost-effectiveness
timeFrame: immediately after the intervention and at month 18
Other outcomes:
Locations:
Study officials:
affiliation: LUMC
name: Rimke C Vos
role: PRINCIPAL_INVESTIGATOR
affiliation: LUMC
name: Mattijs E Numans
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Jannick AN Dorresteijn
role: PRINCIPAL_INVESTIGATOR
affiliation: LUMC
name: Hendrikus JA van Os
role: PRINCIPAL_INVESTIGATOR
References: