Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence (CAMP-2)

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 Overview

• Status: Unknown
• Conditions: Recurrence; Staphylococcal Skin Infections; Antibiotic Resistance; Methicillin-Resistant Staphylococcus Aureus
• Intervention / Treatment: Drug: 2% mupirocin ointment; Other: Chlorhexidine wash; Behavioral: Hygiene protocol

• Study Type: Interventional
• Enrollment (Anticipated): 278
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11235
      • Recruiting
      • Coney Island Hospital
      • Contact: Regina Hammock, DO
    • Brooklyn, New York, United States, 11220
      • Recruiting
      • NYU Lutheran Family Health Centers
      • Contact: William Pagano, MD, MPH
    • Brooklyn, New York, United States, 11220
      • Recruiting
      • NYU Lutheran Medical Center Emergency Department
      • Contact: Paula Clemons, PA
    • New York, New York, United States, 10029
      • Recruiting
      • Metropolitan Hospital Center
      • Contact: Getaw Worku Hassen, MD
    • New York, New York, United States, 10010
      • Recruiting
      • Community Healthcare Network
      • Contact: Satoko Kanahara, MD
    • The Bronx, New York, United States, 10459
      • Recruiting
      • Urban Health Plan
      • Contact: Tracie Urban, RN, BSN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decolonization and Decontamination; Index Patients will receive: 1) guidelines-directed care, which may consist of incision, drainage, oral antibiotics, and antibiogram-based antibiotic prescribing, and 2) a home-based intervention implemented by Community Health Workers/Promotoras that includes index patient and household member education and instructions to complete a decolonization and decontamination regimen, along with printed materials describing a standard hygiene protocol for reducing household contamination. Index patients and consenting household members will complete a decolonization regimen consisting of twice-daily application of 2% mupirocin ointment to the anterior nares with a clean cotton applicator for five days, as well as daily bathing with chlorhexidine wash for five days. The household decontamination hygiene protocol includes the use of hand-washing, surface disinfection, and laundering.	Drug: 2% mupirocin ointment; Index patients and consenting household members will complete a decolonization regimen consisting of twice-daily application of mupirocin ointment to the anterior nares with a sterile cotton applicator for five days.; Other Names: Bactroban; Bacitracin; Other: Chlorhexidine wash; Index patients and consenting household members will daily daily for five days with chlorhexidine wash.; Other Names: Hibiclens; Behavioral: Hygiene protocol; Index patients and consenting household members will be given educational materials and instructed to in the use of hand-washing, surface disinfection, and laundering.
No Intervention: Usual Care; Index Patients will receive: 1) guidelines-directed care, which may consist of incision, drainage, and oral antibiotics, as well as antibiogram-based antibiotic prescribing, and 2) printed materials describing a standard hygiene protocol for reducing household contamination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SSTI Recurrence Rate	Defined as having one or more discrete clinical SSTIs at the same or new site in addition to the baseline infection. Defined by self-report and review of patients' medical records for evidence of one or more of the following: (1) new SSTIs for which the patient presents for medical care, (2) the initial SSTI which failed to heal despite treatment (including I&D and/or antibiotic prescription), (3) a new laboratory-confirmed culture of MRSA or Methicillin Sensitive Staphylococcus aureus (MSSA).	3 months
SSTI Recurrence Rate	Defined as having one or more discrete clinical SSTIs at the same or new site in addition to the baseline infection. Defined by self-report and review of patients' medical records for evidence of one or more of the following: (1) new SSTIs for which the patient presents for medical care, (2) the initial SSTI which failed to heal despite treatment (including I&D and/or antibiotic prescription), (3) a new laboratory-confirmed culture of MRSA or Methicillin Sensitive Staphylococcus aureus (MSSA).	6 months
SSTI Recurrence Rate	Defined as having one or more discrete clinical SSTIs at the same or new site in addition to the baseline infection. Defined by self-report and review of patients' medical records for evidence of one or more of the following: (1) new SSTIs for which the patient presents for medical care, (2) the initial SSTI which failed to heal despite treatment (including I&D and/or antibiotic prescription), (3) a new laboratory-confirmed culture of MRSA or Methicillin Sensitive Staphylococcus aureus (MSSA).	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Response Questionnaire	1, 3, 6, and 12 months
Subsequent SSTI Self-Report	1, 3, 6, and 12 months
Medication Adherence Scale	1, 3, 6, and 12 months
Satisfaction with Participating in Social Roles	Baseline, 3, 6, and 12 months
Depression Short Form	Baseline, 3, 6, and 12 months
Pain Interference Short Form	Baseline, 3, 6, and 12 months
Short Form 36 Health Survey	Baseline, 3, 6, and 12 months
Hygiene Score	Baseline, 1, 3, 6, and 12 months
Household Crowding Index	Baseline and 3 months
Number of participants with adverse events	Baseline, 1, 3, 6, and 12 months
Incidence of Mupirocin Resistance	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Clinical Directors Network
• Collaborators: Patient-Centered Outcomes Research Institute; Rockefeller University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Recurrence; Staphylococcal Skin Infections; Methicillin-Resistant Staphylococcus aureus; Practice Based Research Network; Community Health Workers/Promotoras; Decolonization and Decontamination; Household Transmission
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Inflammation; Disease Attributes; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Suppuration; Skin Diseases, Bacterial; Infections; Communicable Diseases; Recurrence; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections; Staphylococcal Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Disinfectants; Mupirocin; Chlorhexidine; Chlorhexidine gluconate; Bacitracin
• Other Study ID Numbers: CER-1402-10800

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No