Antibiotic Resistance, Methicillin-Resistant Staphylococcus Aureus, Recurrence, Staphylococcal Skin Infections
Conditions
Keywords
Methicillin-Resistant Staphylococcus aureus, Recurrence, Practice Based Research Network, Community Health Workers/Promotoras, Decolonization and Decontamination, Staphylococcal Skin Infections, Household Transmission
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.
Interventions
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.
OTHERChlorhexidine wash
Index patients and consenting household members will daily daily for five days with chlorhexidine wash.
BEHAVIORALHygiene 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.
Sponsors
Rockefeller University
Patient-Centered Outcomes Research Institute
Clinical Directors Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SSTI Recurrence Rate | 3 months | 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). |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Clinical Response Questionnaire | 1, 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 |
| Short Form 36 Health Survey | Baseline, 3, 6, and 12 months |
Countries
United States
Contacts
Primary ContactJonathan N Tobin, PhD
Backup ContactChamanara Khalida, MD, MPH
Outcome results
None listed