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Patient-centered comparative effectiveness research (CER) of home-based interventions to prevent CA-MRSA infection recurrence
Investigator (PI): Tobin, Jonathan
Performing Organization (PO): (Current): Clinical Directors Network / (212) 382-0699
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2015
Final Year: 2019
Record Source/Award ID: PCORI/CER-1402-10800
Funding: Total Award Amount: $2,667,028
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background: Skin or soft tissue infections (SSTI) may be caused by community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA), a bacteria that cannot be cured with most antibiotic drugs. Current recommendations for treatment of these infections include surgery to remove any pus, along with a doctor's prescribing oral antibiotics. Most infections go away after taking antibiotics; however, some infections keep coming back, and may be caused by patients coming into contact with the same bacteria in the home. Others in the home may also catch a similar infection. Discussions held with patients who have CA-MRSA infections that get their health care from NYC health centers told us that patients are interested in understanding how MRSA is spread, and in learning what they can do to prevent infections from coming back again and from spreading to others who live in the same home. An important study that was conducted in hospital intensive care units (called REDUCE MRSA Trial) has proven that there are things that can be done to prevent infections from returning and from spreading to others. Specifically, applying a medication (Mupirocin) into the nostrils of people who may carry the bacteria (decolonization), as well as bathing with a strong soap (Chlorhexidine), combined with rigorous household cleaning practices (using Clorox bleach) (decontamination), can reduce the chances of the infection returning or spreading to others. A study conducted by the Rockefeller University Center for Clinical and Translational Science (CCTS), Clinical Directors Network (CDN), and 6 NY health centers called the CA-MRSA Project (CAMP1) built a partnership among clinicians, patients, and researchers to better understand how MRSA infections are treated in the primary care doctor's office. Objectives: This study will work with a research network of primary care doctors' offices (CDN) and a research institution (Rockefeller) to 1) engage clinicians and their patients in identifying and developing English and Spanish language health education materials about the infection; 2) improve the delivery of a home visit program to be done by community health workers (CHWs)/promotoras from the health centers to improve things that patients care most about (infections returning, spread to others); and 3) deliver and compare how well these two types of cares work: standard care (UC) versus UC plus CHW/promotora home visits and household decolonization and decontamination (EXP). Methods: A Patient Stakeholder Advisory Committee (PSAC), including patients and family community members, will work alongside clinicians and research staff to review decolonization and decontamination approaches, develop the home-visit intervention, and develop patient education materials. A total of 278 patients with CA-MRSA-suspected SSTIs will be recruited from 5 health centers. Since we don't yet know which treatment is better, patients will be assigned via the flip of a coin to the UC or EXP group. Patient outcomes: The specific aims of this study are to 1) evaluate the effectiveness of a CHW/promotora-delivered home intervention (EXP) as compared to usual care; 2) understand which patient and household factors are related to the risk of the infection coming back; and 3) study how the bacteria is related to decontamination, decolonization, and to the risks of the infection coming back and for somebody else in the house catching the infection. Patient and stakeholder engagement: Stakeholders include health centers, practicing clinicians/staff, patients, and clinical/laboratory researchers. Monthly meetings are conducted, during which all stakeholders will participate in all steps of the project, from its design, doing the study, and telling everybody about the results of the study when it is completed. The Patient Stakeholder Advisory Committee (PSAC) will include one patient participant and one CHW from each CHC, as well as one community-based stakeholder who has worked with us collaborator since 2012. The PSAC will also meet on its own without the researchers, and CDN/Rockefeller will cover all of the meeting arrangements (space, photocopying, telephone, refreshments). The PSAC will be equal members in finalizing the design of the CHW home intervention and protocol for the collection of data, and will work with the team to ensure that the outcomes are meaningful to patients and their caregivers. Anticipated impact: The projected outcomes and goals we aim to accomplish are 1) the development of the intervention, a study manual, training materials, internet-based training for clinicians, and ways to make sure the right care is given; (2) a protocol for finding patients who need this care, and making sure they get the care they need; (3) a data system that can be used everywhere on the internet; (4) participation of 5 CHCs and 278 patients, and the completion of 556 home visits; and (5) a 50% reduction in CA-MRSA infection coming back. Results will be presented to primary care professionals, infectious disease specialists, public health experts, and community audiences. The greatest potential for replication and scale-up lies in collaboration with the NYC-CDRN, a project to combine health information from over 1 million patients in NYC who get their care at large hospitals, medical centers, and health centers. This work, in turn, will provide the basis for developing and conducting MRSA recurrence and transmission prevention trials across the USA. This study can also provide information on how to study and treat other bacteria that do not respond to antibiotics. More on this project: (1) S. Balachandra, M.P. de la Gandara, S. Salvato, T. Urban, C. Parola, C. Khalida et al., Recurrent Furunculosis Caused by a Community-Acquired Staphylococcus aureus Strain Belonging to the USA300 Clone. Microbial Drug Resistance 21(2) (April 2015): 237-243. (2) M. Pardos de la Gandara, J.A. Raygoza Garay, M. Mwangi, J.N. Tobin et al., Molecular Types of MRSA and MSSA Strains Causing Skin and Soft Tissue Infections and Nasal Colonization- Identified in Community Health Centers in New York City. Journal of Clinical Microbiology. 2015 Aug;53(8):2648-58. doi: 10.1128/JCM.00591-15.
MeSH Terms:
  • Anti-Bacterial Agents /therapeutic use
  • Community Health Workers
  • Comparative Effectiveness Research /*methods
  • Cross Infection /prevention & control
  • Disinfection
  • Health Communication
  • Humans
  • Language
  • Methicillin-Resistant Staphylococcus aureus
  • Multicenter Studies as Topic
  • Mupirocin /therapeutic use
  • New York City
  • Patient-Centered Care /*organization & administration
  • Primary Health Care /organization & administration
  • Risk
  • Staphylococcal Infections /*microbiology
  • /*prevention & control
Country: United States
State: New York
Zip Code: 10018
UI: 20152196
CTgovId: NCT02286713
Project Status: Completed
Record History: ('2017: Project extended to 2019.',)