Care Coordination for Cardiovascular Prevention in Psoriatic Disease

(CP3 Trial)

Recruiting at9 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

Must not be taking: Lipid lowering

Disqualifiers: Pregnancy, Cardiovascular disease, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The goal of this research is to test a novel centralized care coordinator program to assist patients with psoriatic disease in lowering their risk of cardiovascular disease through the application of standard of care approaches to improving modifiable cardiovascular risk factors.

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 data supports the effectiveness of the treatment Care Coordinator Model, Centralized Care Coordination Model, Care Coordination Program for cardiovascular prevention in psoriatic disease?

Research shows that care coordination, especially when involving frequent, in-person interactions and ongoing follow-up, can improve patient outcomes and healthcare services. This suggests that similar care coordination models could be effective for managing cardiovascular health in patients with psoriatic disease. ^{1 2 3 4 5}

Is the Care Coordination Model safe for humans?

There is no specific safety data available for the Care Coordination Model in the provided research articles. ^{6 7 8 9 10}

How does the care coordination treatment for cardiovascular prevention in psoriatic disease differ from other treatments?

This treatment is unique because it focuses on care coordination, which involves a nurse care coordinator who frequently interacts with patients, monitors their disease status, and applies behavior change principles. This approach is different from standard treatments that may not emphasize ongoing, personalized care management. ^{1 3 4 5 11}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Care Coordinator Model (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

National Psoriasis Foundation

Collaborator

Trials

12

Recruited

1,900+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Nurse Care Coordinator Role on Patient-Reported and Health Service Outcomes: A Systematic Review. [2020]

2. England 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. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Care coordination for complex cancer survivors in an integrated safety-net system: a study protocol. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The patient perspective: utilizing focus groups to inform care coordination for high-risk medicaid populations. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Patient-reported care coordination: associations with primary care continuity and specialty care use. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Challenges for synthesising data in a network of registries for systemic psoriasis therapies. [2013]

7. England 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. [2019]

8. New Zealand 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Analysis of Specialist and Patient Perspectives on Strategies to Improve Cardiovascular Disease Prevention Among Persons With Psoriatic Disease. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Risk of Cardiovascular Morbidity in Patients With Psoriatic Arthritis: A Meta-Analysis of Observational Studies. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Community care management. Advanced practice nurses as care managers. [2019]