Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence
Public ClinicalTrials.gov record NCT02566928. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02566928
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 278 participants
Conditions and interventions
Conditions
Interventions
- 2% mupirocin ointment Drug
- Chlorhexidine wash Other
- Hygiene protocol Behavioral
Drug · Other · Behavioral
Eligibility (public fields only)
- Age range
- 7 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2015
- Primary completion
- Oct 31, 2018
- Completion
- Dec 30, 2018
- Last update posted
- Jul 20, 2017
2015 – 2018
United States locations
- U.S. sites
- 6
- U.S. states
- 1
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NYU Lutheran Family Health Centers | Brooklyn | New York | 11220 | Recruiting |
| NYU Lutheran Medical Center Emergency Department | Brooklyn | New York | 11220 | Recruiting |
| Coney Island Hospital | Brooklyn | New York | 11235 | Recruiting |
| Community Healthcare Network | New York | New York | 10010 | Recruiting |
| Metropolitan Hospital Center | New York | New York | 10029 | Recruiting |
| Urban Health Plan | The Bronx | New York | 10459 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02566928, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2017 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02566928 live on ClinicalTrials.gov.