Ignite Creation Date:
2024-05-06 @ 7:35 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02566928
Status:
UNKNOWN
Last Update Posted:
2017-07-21
First Post:
2015-09-30
Brief Title:
Patient-Centered Comparative Effectiveness Research CER Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence
Sponsor:
Clinical Directors Network
Organization:
Clinical Directors Network
Study Overview
Official Title:
Patient-Centered Comparative Effectiveness Research CER Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMP-2
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 researchpatient centered outcomes research builds upon a highly stakeholder-engaged community-academic research and learning collaborative including practicing clinicians patients clinical and laboratory researchers and barbersbeauticians 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 CHWPromotora-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 behaviorsadherence 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None