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Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence (CAMP-2)

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ClinicalTrials.gov Identifier: NCT02566928
Recruitment Status : Unknown
Verified July 2017 by Clinical Directors Network.
Recruitment status was:  Recruiting
First Posted : October 2, 2015
Last Update Posted : July 21, 2017
Sponsor:
Collaborators:
Rockefeller University
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Clinical Directors Network

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.

Condition or disease Intervention/treatment Phase
Methicillin-Resistant Staphylococcus Aureus Recurrence Staphylococcal Skin Infections Antibiotic Resistance Drug: 2% mupirocin ointment Other: Chlorhexidine wash Behavioral: Hygiene protocol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence
Study Start Date : October 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 31, 2018


Arm Intervention/treatment
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.
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 Names:
  • Bacitracin
  • Bactroban

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

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.

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.



Primary Outcome Measures :
  1. SSTI Recurrence Rate [ Time Frame: 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).

  2. SSTI Recurrence Rate [ Time Frame: 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).

  3. SSTI Recurrence Rate [ Time Frame: 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 Outcome Measures :
  1. Clinical Response Questionnaire [ Time Frame: 1, 3, 6, and 12 months ]
  2. Subsequent SSTI Self-Report [ Time Frame: 1, 3, 6, and 12 months ]
  3. Medication Adherence Scale [ Time Frame: 1, 3, 6, and 12 months ]
  4. Satisfaction with Participating in Social Roles [ Time Frame: Baseline, 3, 6, and 12 months ]
  5. Depression Short Form [ Time Frame: Baseline, 3, 6, and 12 months ]
  6. Pain Interference Short Form [ Time Frame: Baseline, 3, 6, and 12 months ]
  7. Short Form 36 Health Survey [ Time Frame: Baseline, 3, 6, and 12 months ]
  8. Hygiene Score [ Time Frame: Baseline, 1, 3, 6, and 12 months ]
  9. Household Crowding Index [ Time Frame: Baseline and 3 months ]
  10. Number of participants with adverse events [ Time Frame: Baseline, 1, 3, 6, and 12 months ]
  11. Incidence of Mupirocin Resistance [ Time Frame: Baseline and 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566928


Contacts
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Contact: Jonathan N Tobin, PhD JNTobin@CDNetwork.org
Contact: Chamanara Khalida, MD, MPH CKhalida@CDNetwork.org

Locations
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United States, New York
NYU Lutheran Family Health Centers Recruiting
Brooklyn, New York, United States, 11220
Contact: William Pagano, MD, MPH         
NYU Lutheran Medical Center Emergency Department Recruiting
Brooklyn, New York, United States, 11220
Contact: Paula Clemons, PA         
Coney Island Hospital Recruiting
Brooklyn, New York, United States, 11235
Contact: Regina Hammock, DO         
Community Healthcare Network Recruiting
New York, New York, United States, 10010
Contact: Satoko Kanahara, MD         
Metropolitan Hospital Center Recruiting
New York, New York, United States, 10029
Contact: Getaw Worku Hassen, MD         
Urban Health Plan Recruiting
The Bronx, New York, United States, 10459
Contact: Tracie Urban, RN, BSN         
Sponsors and Collaborators
Clinical Directors Network
Rockefeller University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Jonathan N Tobin, PhD Clinical Directors Network
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Responsible Party: Clinical Directors Network
ClinicalTrials.gov Identifier: NCT02566928    
Other Study ID Numbers: CER-1402-10800
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinical Directors Network:
Methicillin-Resistant Staphylococcus aureus
Recurrence
Practice Based Research Network
Community Health Workers/Promotoras
Decolonization and Decontamination
Staphylococcal Skin Infections
Household Transmission
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Staphylococcal Infections
Cellulitis
Skin Diseases, Infectious
Staphylococcal Skin Infections
Recurrence
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Suppuration
Connective Tissue Diseases
Inflammation
Skin Diseases
Skin Diseases, Bacterial
Chlorhexidine
Chlorhexidine gluconate
Bacitracin
Mupirocin
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action