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

NCT ID: NCT02566928

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-12-31

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.

Conditions

Methicillin-Resistant Staphylococcus Aureus; Recurrence; Staphylococcal Skin Infections; Antibiotic Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

2% mupirocin ointment

Intervention Type: DRUG

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.

Chlorhexidine wash

Intervention Type: OTHER

Index patients and consenting household members will daily daily for five days with chlorhexidine wash.

Hygiene protocol

Intervention Type: BEHAVIORAL

Index patients and consenting household members will be given educational materials and instructed to in the use of hand-washing, surface disinfection, and laundering.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Chlorhexidine wash

Index patients and consenting household members will daily daily for five days with chlorhexidine wash.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Bacitracin; Bactroban; Hibiclens

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rockefeller University

OTHER

Sponsor Role: collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Clinical Directors Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan N Tobin, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Directors Network

Locations

NYU Lutheran Family Health Centers

Brooklyn, New York, United States

Site Status: RECRUITING

NYU Lutheran Medical Center Emergency Department

Brooklyn, New York, United States

Site Status: RECRUITING

Coney Island Hospital

Brooklyn, New York, United States

Site Status: RECRUITING

Community Healthcare Network

New York, New York, United States

Site Status: RECRUITING

Metropolitan Hospital Center

New York, New York, United States

Site Status: RECRUITING

Urban Health Plan

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jonathan N Tobin, PhD

Role: CONTACT

JNTobin@CDNetwork.org

Chamanara Khalida, MD, MPH

Role: CONTACT

CKhalida@CDNetwork.org

Facility Contacts

William Pagano, MD, MPH

Role: primary

Paula Clemons, PA

Role: primary

Regina Hammock, DO

Role: primary

Satoko Kanahara, MD

Role: primary

Getaw Worku Hassen, MD

Role: primary

Tracie Urban, RN, BSN

Role: primary

References

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.

Reference Type: DERIVED

PMID: 35342110 (View on PubMed)

Other Identifiers

CER-1402-10800

Identifier Type: -

Identifier Source: org_study_id