Care Coordination for Cardiovascular Prevention in Psoriatic Disease

(CP3 Trial)

Recruiting at 9 trial locations

Overseen By Brooke Bishop, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Lipid lowering

Disqualifiers: Pregnancy, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

520 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to help people with psoriatic disease reduce their risk of heart problems. The program, called the Care Coordinator Model, employs a care coordinator to guide patients in managing factors that can lead to cardiovascular disease, such as high blood pressure or cholesterol. Eligible participants have psoriasis, are between 40 and 75 years old, and are not currently on medication to lower cholesterol. The trial aims to determine if a care coordinator can significantly improve heart health for those with psoriatic disease. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance heart health management for those with psoriatic disease.

Do I need to stop my current medications for the trial?

If you are currently taking a prescription medication to lower cholesterol, you cannot participate in this trial. For other medications, the trial protocol does not specify if you need to stop taking them.

What prior data suggests that this Care Coordinator Model is safe for patients with psoriatic disease?

Research has shown that care coordination models are safe and effective for people with chronic illnesses, improving health outcomes for conditions like diabetes and depression. A care coordinator organizes appointments, manages medications, and supports lifestyle changes, helping patients adhere to their treatment plans.

In studies on patients with psoriatic disease, a care coordination model reduced the risk of heart disease without major safety concerns. This method involves guidance through the healthcare system, is generally well-received, and does not require new medications or medical procedures. Its success in other conditions suggests it is safe for managing heart disease risks in psoriatic disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Care Coordinator Model for cardiovascular prevention in psoriatic disease because it offers a personalized approach to healthcare. Unlike standard treatments that typically focus on medication alone, this model emphasizes integrating care through a dedicated care coordinator. This approach aims to ensure that all aspects of a patient's health are managed cohesively, potentially leading to better cardiovascular outcomes. By streamlining communication and care between different healthcare providers, it addresses gaps in current treatment methods, offering a more holistic approach to managing psoriatic disease with cardiovascular risks.

What evidence suggests that the Care Coordinator Model is effective for cardiovascular prevention in psoriatic disease?

Research has shown that having a care coordinator can lower the risk of heart disease in people with psoriatic disease. In this trial, participants will join a Care Coordination arm, where a dedicated care coordinator will work to improve health outcomes. Studies have found that a dedicated care coordinator improves health for patients with long-term conditions like diabetes and depression. In a small study, this approach helped doctors check patients for heart risks and guided them on managing these risks better. The care coordinator connects patients with their doctors to ensure they receive the right advice and follow-up care. This model has increased patient involvement and could lead to better heart health. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for men and women aged 40-75 with psoriasis or psoriatic arthritis, who are currently under dermatology care. It's not open to those on prescription lipid-lowering meds, pregnant or planning pregnancy soon, or with a history of cardiovascular diseases like heart attack or stroke.

Inclusion Criteria

Willing and able to provide informed consent

I am between 40 and 75 years old.

I am seeing a skin specialist for my psoriasis.

Exclusion Criteria

Pregnant or planning pregnancy in the next 6 months

I am currently on medication to lower my cholesterol.

I have a history of heart or blood vessel diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Care Coordination Program

Participants engage in a centralized care coordinator program to manage cardiovascular risk factors

6 months

Regular check-ins with care coordinator

Follow-up

Participants are monitored for changes in cardiovascular risk factors and overall health outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Care Coordinator Model

Trial Overview The study is testing a new 'care coordinator' program designed to help patients with psoriatic disease reduce their risk of developing cardiovascular disease by following standard healthcare practices to manage risk factors.

How Is the Trial Designed?

Group I: Care Coordination Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Psoriasis Foundation

Collaborator

Trials

12

Recruited

1,900+

Published Research Related to This Trial

The care coordination model designed by advanced practice nurses for high-risk older adults resulted in a significant reduction in acute care admissions by 54% and hospital days by 42%, demonstrating its efficacy in managing chronic health issues.

Participants in the program experienced a 33% overall reduction in healthcare costs, and both physicians and patients reported high satisfaction with the APRN-based model, indicating its effectiveness and acceptance in the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community care management. Advanced practice nurses as care managers. Waszynski, CM., Murakami, W., Lewis, M.[2019]

Adding care coordination to nurses' roles showed some positive effects, particularly for patients enrolled in the program, who reported a 5% improvement in care experiences, although this was not statistically significant overall.

The program led to a significant increase in office visits for enrolled patients, indicating better access to care, but did not result in significant changes in clinician-reported teamwork or overall patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quasi-experiment assessing the six-months effects of a nurse care coordination program on patient care experiences and clinician teamwork in community health centers. Nembhard, IM., Buta, E., Lee, YSH., et al.[2020]

Collaboration among psoriasis registries in the PSONET network enhances the ability to assess long-term treatment safety by providing larger and more diverse datasets, which is crucial for understanding the effects of treatments.

However, significant challenges exist in synthesizing data due to differences in how registries code adverse events, sample populations, and manage operational governance, which can complicate collective data interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges for synthesising data in a network of registries for systemic psoriasis therapies. Ormerod, AD., Augustin, M., Baker, C., et al.[2013]

Nurse care coordinator roles can lead to improved patient-reported and health service outcomes, particularly when they involve frequent in-person interactions and ongoing follow-up, as indicated by higher quality studies.

The effectiveness of nurse care coordination is inconsistent, suggesting that the specific components of these roles significantly influence their impact on patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Nurse Care Coordinator Role on Patient-Reported and Health Service Outcomes: A Systematic Review. Conway, A., O'Donnell, C., Yates, P.[2020]

In a study of 351 patients with psoriasis and psoriatic arthritis, the initiation of biological therapies significantly reduced hospitalization rates, indicating improved management of these conditions after treatment.

Before starting biological treatment, healthcare costs were highest due to hospitalizations, but these costs decreased after treatment began, suggesting that biological therapies may lead to better health outcomes and lower overall healthcare resource consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of drug utilization and health care resource consumption in patients with psoriasis and psoriatic arthritis before and after treatment with biological therapies. Esposti, LD., Perrone, V., Sangiorgi, D., et al.[2022]

Project CONNECT aims to improve care coordination for 500 complex cancer survivors with chronic conditions by implementing three evidence-based strategies, including an EHR-driven registry and co-locating a nurse practitioner within care teams.

The study will evaluate the effectiveness of these strategies on both system-level and patient-level outcomes, providing insights that could enhance care coordination in safety-net healthcare systems nationwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care coordination for complex cancer survivors in an integrated safety-net system: a study protocol. Lee, SJC., Jetelina, KK., Marks, E., et al.[2023]

A survey of 183 dermatologists revealed that strategies like clinical decision support and patient education are seen as effective ways to enhance cardiovascular disease (CVD) prevention in patients with psoriatic disease.

Among 160 patients with psoriasis and 162 with psoriatic arthritis, a significant majority expressed a willingness to engage in CVD risk screening, especially if conducted by their specialist, indicating a preference for specialist-led care in managing cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Specialist and Patient Perspectives on Strategies to Improve Cardiovascular Disease Prevention Among Persons With Psoriatic Disease. Barbieri, JS., Beidas, RS., Gondo, GC., et al.[2023]

Patients with psoriatic arthritis (PsA) have a 43% increased risk of cardiovascular diseases compared to the general population, based on a systematic review of 11 studies involving 32,973 patients.

The risk of specific cardiovascular events is notably higher, with myocardial infarction risk increased by 68%, cerebrovascular disease by 22%, and heart failure by 31%, highlighting the significant health risks associated with PsA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Cardiovascular Morbidity in Patients With Psoriatic Arthritis: A Meta-Analysis of Observational Studies. Polachek, A., Touma, Z., Anderson, M., et al.[2022]

Care coordination programs for high-risk Medicaid patients can improve outcomes, but there are significant unmet needs related to trauma, mental health, and executive function challenges that require additional support.

Focus groups revealed that while provider communication is generally positive, enhancing peer-to-peer support and addressing specific patient needs can further improve the effectiveness of care coordination efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The patient perspective: utilizing focus groups to inform care coordination for high-risk medicaid populations. Sheff, A., Park, ER., Neagle, M., et al.[2018]

In a study of Medicare enrollees with chronic conditions, better continuity of primary care was strongly associated with improved care coordination among patients who used low levels of specialty care, indicating that consistent primary care visits enhance coordination efforts.

However, for patients with high specialty care usage, there was no significant relationship between continuity and care coordination, suggesting that frequent specialty visits may hinder primary care providers' ability to effectively coordinate care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported care coordination: associations with primary care continuity and specialty care use. Liss, DT., Chubak, J., Anderson, ML., et al.[2022]

Patients with hospital-diagnosed psoriasis have a significantly higher risk of myocardial infarction (MI) compared to the general population, with hazard ratios of 1.40 in the early era (1995-2002) and 1.39 in the late era (2006-2013).

Despite the introduction of biological therapy and increased focus on cardiovascular disease prevention, the risk of MI in psoriasis patients did not decrease, indicating that psoriasis remains a significant cardiovascular risk factor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psoriasis and risk of myocardial infarction before and during an era with biological therapy: a population-based follow-up study. Leisner, MZ., Lindorff Riis, J., Gniadecki, R., et al.[2019]

Citations

1. psoriasis.org psoriasis.org/care-coordination-reduces-cvd-risk/

New NPF-Funded Research Suggests that Care ... This study, called Prevention of Cardiovascular Disease and Mortality in Patients with Psoriasis or Psoriatic Arthritis (CP3), outlines a model ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11116061/

A Care Coordination Model to Prevent Cardiovascular Events ... To address this evidence-to-practice gap, we developed and piloted a centralized care coordination model in which the dermatologist or rheumatologist educates ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05908240

Prevention of Cardiovascular Disease and Mortality in ... Care coordinators have previously been demonstrated to improve outcomes in patients with chronic diseases (such as comorbid diabetes and depression) and are now ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38184142/

A Care Coordination Model to Prevent Cardiovascular Events ... A care coordination model to prevent cardiovascular events in patients with psoriatic disease: a multicenter pilot study.

5. researchgate.net researchgate.net/publication/377168776_A_Care_Coordination_Model_to_Prevent_Cardiovascular_Events_in_Patients_with_Psoriatic_Disease_A_Multicenter_Pilot_Study

A Care Coordination Model to Prevent Cardiovascular ... A centralized care coordination model was proposed where dermatologists or rheumatologists screen psoriasis patients for CVD risk and refer ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0022202X23031962

A Care Coordination Model to Prevent Cardiovascular ... A Care Coordination Model to Prevent Cardiovascular Events in Patients with Psoriatic Disease: A Multicenter Pilot Study. Author links open overlay panel