Recruiting

CHW Intervention

Sponsor:

Clinical Directors Network

Code:

NCT02566928

Conditions

Methicillin-Resistant Staphylococcus Aureus

Recurrence

Staphylococcal Skin Infections

Antibiotic Resistance

Eligibility Criteria

Sex: All

Age: 7 - 70

Healthy Volunteers: Not accepted

Interventions

2% mupirocin ointment

Chlorhexidine wash

Hygiene protocol

Study Details

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 ID

NCT02566928

Start date

Oct, 2015

Status verified date

Jul, 2017

Completion date

Dec 31, 2018

Anticipated

Primary completion date

Nov, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

278 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Chlorhexidine wash

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

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.

Primary outcome measure

  • SSTI Recurrence Rate [ Time Frame: 3 months ]
  • SSTI Recurrence Rate [ Time Frame: 6 months ]
  • SSTI Recurrence Rate [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Jonathan N Tobin, PhD

JNTobin@CDNetwork.org

Chamanara Khalida, MD, MPH

CKhalida@CDNetwork.org

Locations

NYU Lutheran Family Health Centers

Recruiting

Brooklyn, New York, United States, 11220

NYU Lutheran Medical Center Emergency Department

Recruiting

Brooklyn, New York, United States, 11220

Coney Island Hospital

Recruiting

Brooklyn, New York, United States, 11235

Community Healthcare Network

Recruiting

New York, New York, United States, 10010

Metropolitan Hospital Center

Recruiting

New York, New York, United States, 10029

Urban Health Plan

Recruiting

The Bronx, New York, United States, 10459

More Information

Sponsor

Clinical Directors Network

Last update posted

Jul 21, 2017

Last verified

Jul, 2017

Keywords

  • Methicillin-Resistant Staphylococcus aureus
  • Recurrence
  • Practice Based Research Network
  • Community Health Workers/Promotoras
  • Decolonization and Decontamination
  • Staphylococcal Skin Infections
  • Household Transmission

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clinical Directors Network on 2017-07-21.