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

Primary Purpose

Methicillin-Resistant Staphylococcus Aureus, Recurrence, Staphylococcal Skin Infections

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
2% mupirocin ointment
Chlorhexidine wash
Hygiene protocol
Sponsored by
Clinical Directors Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Methicillin-Resistant Staphylococcus Aureus focused on measuring Methicillin-Resistant Staphylococcus aureus, Recurrence, Practice Based Research Network, Community Health Workers/Promotoras, Decolonization and Decontamination, Staphylococcal Skin Infections, Household Transmission

Eligibility Criteria

7 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Lutheran Family Health CentersRecruiting
  • NYU Lutheran Medical Center Emergency DepartmentRecruiting
  • Coney Island HospitalRecruiting
  • Community Healthcare NetworkRecruiting
  • Metropolitan Hospital CenterRecruiting
  • Urban Health PlanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Decolonization and Decontamination

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

Clinical Response Questionnaire
Subsequent SSTI Self-Report
Medication Adherence Scale
Satisfaction with Participating in Social Roles
Depression Short Form
Pain Interference Short Form
Short Form 36 Health Survey
Hygiene Score
Household Crowding Index
Number of participants with adverse events
Incidence of Mupirocin Resistance

Full Information

First Posted
September 30, 2015
Last Updated
July 18, 2017
Sponsor
Clinical Directors Network
Collaborators
Rockefeller University, Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02566928
Brief Title
Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence
Acronym
CAMP-2
Official Title
Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Directors Network
Collaborators
Rockefeller University, Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methicillin-Resistant Staphylococcus Aureus, Recurrence, Staphylococcal Skin Infections, Antibiotic Resistance
Keywords
Methicillin-Resistant Staphylococcus aureus, Recurrence, Practice Based Research Network, Community Health Workers/Promotoras, Decolonization and Decontamination, Staphylococcal Skin Infections, Household Transmission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
278 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decolonization and Decontamination
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
2% mupirocin ointment
Other Intervention Name(s)
Bacitracin, Bactroban
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Chlorhexidine wash
Other Intervention Name(s)
Hibiclens
Intervention Description
Index patients and consenting household members will daily daily for five days with chlorhexidine wash.
Intervention Type
Behavioral
Intervention Name(s)
Hygiene protocol
Intervention Description
Index patients and consenting household members will be given educational materials and instructed to in the use of hand-washing, surface disinfection, and laundering.
Primary Outcome Measure Information:
Title
SSTI Recurrence Rate
Description
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).
Time Frame
3 months
Title
SSTI Recurrence Rate
Description
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).
Time Frame
6 months
Title
SSTI Recurrence Rate
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical Response Questionnaire
Time Frame
1, 3, 6, and 12 months
Title
Subsequent SSTI Self-Report
Time Frame
1, 3, 6, and 12 months
Title
Medication Adherence Scale
Time Frame
1, 3, 6, and 12 months
Title
Satisfaction with Participating in Social Roles
Time Frame
Baseline, 3, 6, and 12 months
Title
Depression Short Form
Time Frame
Baseline, 3, 6, and 12 months
Title
Pain Interference Short Form
Time Frame
Baseline, 3, 6, and 12 months
Title
Short Form 36 Health Survey
Time Frame
Baseline, 3, 6, and 12 months
Title
Hygiene Score
Time Frame
Baseline, 1, 3, 6, and 12 months
Title
Household Crowding Index
Time Frame
Baseline and 3 months
Title
Number of participants with adverse events
Time Frame
Baseline, 1, 3, 6, and 12 months
Title
Incidence of Mupirocin Resistance
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan N Tobin, PhD
Email
JNTobin@CDNetwork.org
First Name & Middle Initial & Last Name or Official Title & Degree
Chamanara Khalida, MD, MPH
Email
CKhalida@CDNetwork.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan N Tobin, PhD
Organizational Affiliation
Clinical Directors Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Lutheran Family Health Centers
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Pagano, MD, MPH
Facility Name
NYU Lutheran Medical Center Emergency Department
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Clemons, PA
Facility Name
Coney Island Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Hammock, DO
Facility Name
Community Healthcare Network
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satoko Kanahara, MD
Facility Name
Metropolitan Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Getaw Worku Hassen, MD
Facility Name
Urban Health Plan
City
The Bronx
State/Province
New York
ZIP/Postal Code
10459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracie Urban, RN, BSN

12. IPD Sharing Statement

Citations:
PubMed Identifier
35342110
Citation
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.
Results Reference
derived

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

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