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

NCT02566928 — Phase 4, Unknown, 278 participants, Clinical Directors Network

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Registry	NCT02566928, acronym CAMP-2
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	278 (Estimated)
Sponsor	Clinical Directors Network (Network); collaborators: Rockefeller University, Patient-Centered Outcomes Research Institute
Conditions	Methicillin-Resistant Staphylococcus Aureus, Recurrence, Staphylococcal Skin Infections, Antibiotic Resistance
Interventions	2% mupirocin ointment, Chlorhexidine wash, Hygiene protocol (Drug, other, behavioral)
Dates	start 2015-10-01, primary completion 2018-11-01 (estimated), completion 2018-12-31 (estimated), first posted 2015-10-02, last updated 2017-07-21
Locations	6 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Decolonization and Decontamination	Experimental	Drug: 2% mupirocin ointment; Other: Chlorhexidine wash; Behavioral: Hygiene protocol	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.
Usual Care	No intervention		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.

2% mupirocin ointment (Drug), also known as Bacitracin, Bactroban: 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 (Other), also known as Hibiclens: Index patients and consenting household members will daily daily for five days with chlorhexidine wash.
Hygiene protocol (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.

+Outcome measures

Primary outcomes

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).
SSTI Recurrence Rate [6 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).
SSTI Recurrence Rate [12 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 outcomes

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]

+Eligibility

Sex: All, ages: 7 Years to 70 Years

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

+Locations (6)

Facility	City	Country	Status
NYU Lutheran Family Health Centers	Brooklyn, New York	United States	Recruiting
NYU Lutheran Medical Center Emergency Department	Brooklyn, New York	United States	Recruiting
Coney Island Hospital	Brooklyn, New York	United States	Recruiting
Community Healthcare Network	New York, New York	United States	Recruiting
Metropolitan Hospital Center	New York, New York	United States	Recruiting
Urban Health Plan	The Bronx, New York	United States	Recruiting

+Publications

Results publication: 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. PMID 35342110

+Investigators

Jonathan N Tobin, PhD, Principal investigator, Clinical Directors Network

My Notes

Public

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