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

Recurrence Clinical Trial

— CAMP-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02566928
• Other study ID #: CER-1402-10800
• Status: Recruiting
• Phase: Phase 4
• First received: September 30, 2015
• Last updated: July 18, 2017
• Start date: October 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2017
• Source: Clinical Directors Network
• Contact: Jonathan N Tobin, PhD
• Email: JNTobin[@]CDNetwork.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 278
• Est. completion date: December 31, 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistance
• Communicable Diseases
• Infection
• Methicillin-Resistant Staphylococcus Aureus
• Recurrence
• Skin Diseases, Infectious
• Staphylococcal Infections
• Staphylococcal Skin Infections

Intervention

Drug:
• 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.

Other:
• Chlorhexidine wash
Index patients and consenting household members will daily daily for five days with chlorhexidine wash.

Behavioral:
• 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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Clinical Directors Network	Patient-Centered Outcomes Research Institute, Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Clinical Response Questionnaire		1, 3, 6, and 12 months
Secondary	Subsequent SSTI Self-Report		1, 3, 6, and 12 months
Secondary	Medication Adherence Scale		1, 3, 6, and 12 months
Secondary	Satisfaction with Participating in Social Roles		Baseline, 3, 6, and 12 months
Secondary	Depression Short Form		Baseline, 3, 6, and 12 months
Secondary	Pain Interference Short Form		Baseline, 3, 6, and 12 months
Secondary	Short Form 36 Health Survey		Baseline, 3, 6, and 12 months
Secondary	Hygiene Score		Baseline, 1, 3, 6, and 12 months
Secondary	Household Crowding Index		Baseline and 3 months
Secondary	Number of participants with adverse events		Baseline, 1, 3, 6, and 12 months
Secondary	Incidence of Mupirocin Resistance		Baseline and 3 months