Results Summary
What was the research about?
Staphylococcus aureus, or staph, is a type of bacteria found on people’s skin. MRSA and MSSA are types of staph infections that are hard to treat. They can lead to serious infections or even death. These infections can come back or spread to other people.
In this study, the research team compared two ways to help patients keep MRSA and MSSA infections from coming back. In both, doctors tested the infection for staph at a health center or emergency room, or ER, and treated it. Doctors gave patients antibiotics to take at home.
All patients also had a home visit from a community health worker specially trained to teach people about getting rid of staph. In the first way, the community health worker shared a pamphlet about living with MRSA. In the second way, the community health worker shared the pamphlet and gave instructions and materials for a five-day home hygiene plan for the patient and other willing household members. The plan included
- Using antibiotic cream in the nose
- Bathing with a strong soap that kills most bacteria
- Wiping down home surfaces with bleach
- Instructions for doing laundry and washing hands
The research team looked at whether the skin infections came back and patients’ pain levels, symptoms of depression, satisfaction with social activities, and satisfaction with care.
What were the results?
After six months, the rate of infections that came back didn’t differ between patients who received the home hygiene plan and those who didn’t. Overall, skin infections came back in about 11 percent of patients.
Patients who received the home hygiene plan and those who didn’t reported similar
- Pain levels
- Symptoms of depression
- Satisfaction with social activities
- Satisfaction with care
Who was in the study?
This study included 119 patients with MRSA or MSSA infections. Patients received care at one of three health centers or three ERs in New York City. Of the patients, 24 percent were black, 10 percent were white, and 6 percent were more than one race or ethnicity or didn’t report it; also, 60 percent were Hispanic. The average age was 38, and 61 percent were men.
What did the research team do?
The research team assigned patients by chance to receive the home visit with or without the home hygiene plan.
To see if infections came back within six months, the research team looked at patients’ health records. At the start of the study and again one and six months later, patients reported by phone about their pain, depression, satisfaction with activities, and satisfaction with care.
Primary care clinicians, scientists, community health workers, patients, and community members were involved in all parts of the study.
What were the limits of the study?
The hygiene plan lasted five days, which may be too short to keep skin infections from coming back. Results may have been different if the hygiene plan was longer or was repeated to keep the original bacteria from coming back or new bacteria from coming into the home.
Future research could look at whether repeating the home hygiene plan or making it longer keeps these infections from coming back.
How can people use the results?
Health centers and ERs can use these results when considering ways to help patients keep MRSA and MSSA infections from coming back.
Professional Abstract
Objective
To evaluate the effectiveness of a comprehensive home hygiene program with instructions for household decolonization and environmental decontamination for reducing skin soft tissue infection (SSTI) recurrence due to community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) or methicillin-susceptible Staphylococcus aureus (CA-MSSA)
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 119 patients with confirmed CA-MRSA or CA-MSSA SSTIs |
| Interventions/ Comparators |
|
| Outcomes |
Primary: SSTI recurrence Secondary: patient-reported outcomes, including pain, depression, satisfaction with social role participation, and satisfaction with care |
| Timeframe | 6-month follow-up for primary outcome |
This randomized controlled trial evaluated the effectiveness of a home hygiene program and instructions for reducing colonization and environmental contamination delivered by community health workers on reducing the recurrence of CA-MRSA and CA-MSSA SSTIs and improving patient-centered outcomes.
Researchers randomized patients to either the intervention or control group. Patients in both groups received Centers for Disease Control and Prevention guidelines-based usual care at a health center or emergency department (ED), which may have included draining the infection and prescribing antibiogram-selected oral antibiotics. Both groups also received a home visit from a community health worker who assessed household colonization and environmental contamination and provided an educational pamphlet about living with MRSA. In the intervention group, the home visit also included a home hygiene program with materials and detailed instructions for a five-day in-home regimen of applying nasal mupirocin ointment, bathing with chlorhexidine, decontaminating surfaces with bleach-containing disinfecting wipes, and specific laundering and handwashing techniques.
The study included 119 patients with microbiologically confirmed CA-MRSA or CA-MSSA infections receiving care at one of three Federally Qualified Health Centers or three EDs in New York City. Of these, 24% were black, 10% were white, and 6% were more than one race or ethnicity or did not report race or ethnicity; also, 60% were Hispanic. The average age was 38, and 61% were male.
Researchers reviewed patients’ electronic health records to document SSTI recurrence within six months. At baseline and again at one and six months after the home visit, patients completed a telephone survey to assess pain, depression, satisfaction with social role participation, and satisfaction with care.
Primary care clinicians, microbiologists, clinical researchers, community health workers, patients, and community members were involved in all aspects of the study.
Results
After six months, patients in the two groups did not differ significantly in CA-MRSA and CA-MSSA SSTI recurrence rates, which were around 11% in both groups.
The two groups did not differ significantly on reports of pain, depression, satisfaction with social roles, or satisfaction with care. Neither group showed improvements in these outcomes over six months.
Limitations
The prevalence of CA-MRSA infections was higher in the intervention group than in the control group, which may have influenced the study results. The five-day in-home regimen may not have been long enough to reduce SSTI recurrence. Results may differ if patients extend or repeat the home hygiene program to prevent the spread of the original bacteria or the introduction of new bacteria.
Conclusions and Relevance
In this study, patients who received a comprehensive home hygiene program from a community health worker did not have lower SSTI recurrence rates than patients who did not receive the home hygiene program.
Future Research Needs
Future studies could examine the relative effectiveness of increasing exposure to the home hygiene program by extending its duration or by repeating it. Balancing randomization between CA-MSSA and CA-MRSA infections could also help assessments of relative effectiveness.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked for greater clarity on when participants were randomly assigned to the intervention versus control groups because in some places the report indicated that group allocation occurred prior to the baseline home visit. The researchers explained that the study’s statistician randomized assignments upon confirming each patient’s eligibility, and study staff and participants found out patients’ study group assignments at the baseline home visit after the baseline measures had been collected.
- The reviewers then noted that out of the 186 individuals randomized to the intervention versus control groups before the baseline home visit, 120 completed the baseline visit. The reviewers recommended that the researchers conduct intent-to-treat analyses that included all 186 individuals, rather than only analyses on the 120 who completed baseline visits. The researchers added these analyses and presented a more in-depth series of tables and figures based on this reanalysis, which they said revealed no difference in treatment effect. At the reviewers’ recommendation, the researchers also added a comment about the large drop-out number in describing their study limitations.
- The reviewers questioned the approaches taken to address missing data and asked the researchers to clarify their strategies and to include their sensitivity analyses in the report. The researchers revised the report to explain that they came to a belief that the missing data in their study were missing at random because there were no external occurrences that could have affected which data were missing and when. In addition, their sensitivity analyses tested whether the results for skin and soft tissue recurrence changed if the missing values were all set to yes or all set to no. The researchers presented these results, which demonstrated no significant changes in the results based on these analyses.