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



Status:Recruiting
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:7 - 70
Updated:4/21/2016
Start Date:October 2015
End Date:December 2017
Contact:Jonathan N Tobin, PhD
Email:JNTobin@CDNetwork.org

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
6
sites
Brooklyn, New York 11235
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
506 Lenox Avenue
New York, New York 10037
?
mi
from
New York, NY
Click here to add this to my saved trials
Bronx, New York 10459
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Brooklyn, New York 11220
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials