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

Study Overview
=================
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.

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

Conditions
-----------------
Methicillin-Resistant Staphylococcus Aureus, Recurrence, Staphylococcal Skin Infections, Antibiotic Resistance

Intervention / Treatment
-----------------
* Drug: 2% mupirocin ointment
* Other: Chlorhexidine wash
* Behavioral: Hygiene protocol


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decolonization and Decontamination<br>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<br>* 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.<br>* Other names: Bactroban;Other: Chlorhexidine wash<br>* Index patients and consenting household members will daily daily for five days with chlorhexidine wash.<br>* Other names: Hibiclens;Behavioral: Hygiene protocol<br>* Index patients and consenting household members will be given educational materials and instructed to in the use of hand-washing, surface disinfection, and laundering.<br>|
| No Intervention: Usual Care<br>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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methicillin-Resistant Staphylococcus aureus, Recurrence, Practice Based Research Network, Community Health Workers/Promotoras, Decolonization and Decontamination, Staphylococcal Skin Infections, Household Transmission