Clinical trial NCT02566928: Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence
Official title: Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Methicillin-Resistant Staphylococcus Aureus
Recurrence
Staphylococcal Skin Infections
Antibiotic Resistance
Keywords: Methicillin-Resistant Staphylococcus aureus
Recurrence
Practice Based Research Network
Community Health Workers/Promotoras
Decolonization and Decontamination
Staphylococcal Skin Infections
Household Transmission
Lead sponsor: Clinical Directors Network
Sponsor class: NETWORK
Collaborators: name: Rockefeller University
name: Patient-Centered Outcomes Research Institute
First posted: 2015-10-02
Enrollment: 278
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal of the project is to develop and evaluate a home-based intervention to prevent re-infection and transmission of Community-Acquired Methicillin-resistant Staphylococcus aureus (CA-MRSA) in patients presenting to primary care with skin or soft tissue infections (SSTIs). Centers for Disease Control (CDC) CA-MRSA guidelines include incision and drainage, antibiotic sensitivity testing and antibiogram-directed prescribing. Re-infections are common, ranging from 16% to 43%, and present significant challenges to clinicians, patients and their families. Several decolonization and decontamination interventions have been shown to reduce Hospital-Acquired MRSA (HA-MRSA) re-infection and transmission in intensive care units. Few studies examine the feasibility and effectiveness of these infection prevention interventions into primary care settings, and none employ Community Health Workers (CHWs) or "promotoras" to provide home visits for education and interventions about decolonization and decontamination. This comparative effectiveness research/patient centered outcomes research builds upon a highly stakeholder-engaged community-academic research and learning collaborative, including practicing clinicians, patients, clinical and laboratory researchers, and barbers/beauticians. Clinical Directors Network (CDN), an established, NIH-recognized best practice Federally Qualified Health Center (FQHC) Practice-based Research Network (PBRN), and The Rockefeller University propose to address this question through the completion of four aims: (1) To evaluate the comparative effectiveness of a CHW/Promotora-delivered home intervention (Experimental Group) as compared to Usual Care (Control Group) on the primary patient-centered and clinical outcome (SSTI recurrence rates) and secondary patient-centered and clinical outcomes (pain, depression, quality of life, care satisfaction) using a two-arm randomized controlled trial (RCT). (2) To understand the patient-level factors (CA-MRSA infection prevention knowledge, self-efficacy, decision-making autonomy, prevention behaviors/adherence) and environmental-level factors (household surface contamination, household member colonization, transmission to household members) that are associated with differences in SSTI recurrence rates. (3) To understand interactions of the intervention with bacterial genotypic and phenotypic variables on decontamination, decolonization, SSTI recurrence, and household transmission. (4) To explore the evolution of stakeholder engagement and interactions among patients and other community stakeholders with practicing community-based clinicians and academic laboratory and clinical investigators over the duration of the study period.


Eligibility criteria: Inclusion Criteria:

* between 7 to 70 years of age
* fluent in English or Spanish
* plans to receive care in the Community Health Center during the next year
* presents with signs and symptoms of a SSTI
* willing/able to provide informed consent

Exclusion Criteria:

* The patient is unwilling to provide informed consent
* acutely sick (for example, crying, wheezing, bleeding, screaming or shaken)
* unable to participate in a discussion about the study

Primary outcomes:
measure: SSTI Recurrence Rate
timeFrame: 3 months
measure: SSTI Recurrence Rate
timeFrame: 6 months
measure: SSTI Recurrence Rate
timeFrame: 12 months
Secondary outcomes:
measure: Clinical Response Questionnaire
timeFrame: 1, 3, 6, and 12 months
measure: Subsequent SSTI Self-Report
timeFrame: 1, 3, 6, and 12 months
measure: Medication Adherence Scale
timeFrame: 1, 3, 6, and 12 months
measure: Satisfaction with Participating in Social Roles
timeFrame: Baseline, 3, 6, and 12 months
measure: Depression Short Form
timeFrame: Baseline, 3, 6, and 12 months
measure: Pain Interference Short Form
timeFrame: Baseline, 3, 6, and 12 months
measure: Short Form 36 Health Survey
timeFrame: Baseline, 3, 6, and 12 months
measure: Hygiene Score
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: Household Crowding Index
timeFrame: Baseline and 3 months
measure: Number of participants with adverse events
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: Incidence of Mupirocin Resistance
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NYU Lutheran Family Health Centers
state: New York
city: Brooklyn
country: United States
facility: NYU Lutheran Medical Center Emergency Department
state: New York
city: Brooklyn
country: United States
facility: Coney Island Hospital
state: New York
city: New York
country: United States
facility: Community Healthcare Network
state: New York
city: New York
country: United States
facility: Metropolitan Hospital Center
state: New York
city: The Bronx
country: United States
facility: Urban Health Plan
state: New York
Study officials:
affiliation: Clinical Directors Network
name: Jonathan N Tobin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Orazio B, Ramachandran J, Khalida C, Gonzalez J, Kost RG, Vasquez KS, Evering TH, Holder T, Hassen GW, Hammock R, Nguyen R, Davis R, Millan K, Johnson V, Parola C, Coller BS, Tobin JN. Stakeholder Engagement In a Comparative Effectiveness/Implementation Study to Prevent Staphylococcus Aureus Infection Recurrence: CA-MRSA Project (CAMP2). Prog Community Health Partnersh. 2022;16(1):45-60. doi: 10.1353/cpr.2022.0005.