What are the goals of PAICAP and who is funding this study?
The goal of PAICAP (Preventing Avoidable Infectious Complications by Adjusting Payment) is to assess the serial impact of the Centers for Medicare and Medicaid Service's (CMS) payment policies that target certain healthcare-associated infections (HAIs) on U.S. hospitals and patients. PAICAP is funded by the Agency for Healthcare Research and Quality (AHRQ) and led by researchers at Harvard Medical School & Harvard Pilgrim Health Care Institute.
Why are you conducting this study?
The use of financial rewards and penalties as mechanisms for improving quality of care have become widely used. We hope to provide evidence to policymakers about the impact of these payment policies on hospitals and the patients they serve.
Who is conducting this study?
Researchers at Harvard Medical School and Harvard Pilgrim Health Care Institute are conducting this study. Our collaborators include leadership at the Association for Professionals in Infection Control and Epidemiology, Inc. (APIC), Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), the Institute for Healthcare Improvement (IHI) and the Society for Healthcare Epidemiology of America (SHEA).
Who are you recruiting for the PAICAP study?
The PAICAP study is recruiting National Healthcare Safety Network (NHSN) hospitals that are affected by the CMS policy in the U.S. Certain types of facilities that are not affected by the CMS policy will not be included in the study, such as federal hospitals, long-term care facilities, hospitals that only focus on cancer care, inpatient rehabilitation facilities, and psychiatric hospitals. Please contact us if you are interested and we can provide you with more information and help determine if your hospital is eligible for our study.
What do I need to do?
The only thing you need to do for this study is join the PAICAP NHSN User Group. You do not need to do any data collection for this study. We will only use data that your hospital already collects for NHSN. Your time commitment will be 15-20 minutes in total to join our PAICAP user group.
If you are interested in participating and your facility is already a member of the PAICAP NHSN User Group, simply confer rights to the new template the next time you log in.
In order to keep you informed about how these data are being used, we will provide annual updates of any interim study findings to PAICAP participants via webinar or newsletter during this multi-year study.
What data will you need for the PAICAP study?
We are asking hospitals to share their existing NHSN data on any of the following types of infections and other conditions:
- Central line-associated bloodstream infections (CLABSI)
- Catheter-associated urinary tract infections (CAUTI)
- Surgical site infections (SSI) occurring after certain procedures, such as coronary artery bypass graft (CABG), orthopedic procedures, abdominal/pelvic procedures, neurosurgical procedures, or other pacemaker devices
- Methicillin resistant Staphylococcus aureus (MRSA) infection
- Clostridium difficile infection (CDI)
- Ventilator-associated events (VAE) or ventilator-associated pneumonia (VAP)
You do not need to collect any additional data to be a part of the PAICAP study. We are only interested in aggregate data from hospital units being monitored in NHSN. For example, for device-associated infections, we only need to look at the total number of infections, device days and patient days occurring in a particular location in each month that surveillance was performed.
Do I need to share patient identifiers with the PAICAP group?
This study does not require patient identifiers. To join our group, you must choose to NOT share patient identifiers with us. Our confer rights template excludes all patient identifiers. We will monitor the rights conferred to our PAICAP group and if we find that any patient identifiers are inadvertently included, we will reject your membership and ask you to rejoin our group without patient identifiers to minimize any risks to patient confidentiality.
When will my hospital data be accessed?
After you join, we will check your hospital data to make sure that we have the correct information and that patient identifiers have not been included. After we confirm that your hospital has correctly joined our PAICAP NHSN User Group, we will only need to access the data approximately 1-2 times per year during the study period. We will notify you in advance each time we will be accessing your hospital data in the PAICAP User Group. We are minimizing the number of times we access hospital data through the PAICAP group in order to minimize any risks to confidentiality.
What are the benefits of participating?
Although there is no direct benefit to your hospital, we hope that the findings from this research will assist policymakers in making informed policy decisions in the future. We will provide annual updates to participating hospitals on the progress of the study and preliminary results.
top ↑We haven't joined NHSN yet, but plan to do so – can we still participate?
Hospitals that are in the process of joining NHSN can still participate in the project if they meet the other eligibility criteria. We cannot enroll you until you have joined NHSN, but we can touch base with you around the time you think your enrollment will be completed to finalize participation in the PAICAP project.
I am the NHSN administrator for multiple hospitals – can I just sign up once?
If you report for multiple hospitals using one unique NHSN ID number, then you will only need to confer rights once. However, if each of your hospitals has a unique ID number then you will have to confer rights for each facility separately.
Who has access to my data?
Hospitals that join our group will NOT be able to see data from other hospitals in the PAICAP group. Your hospital data will only be visible to NHSN PAICAP group administrators, such as Dr. Grace Lee (principal investigator) and Melisa Rett (project manager). Our restrictive policy will ensure that any data provided by hospitals will only be available to IRB-approved study staff and will only be used for the purposes of this study. No collaborators will have access to the NHSN PAICAP group to avoid any unnecessary or unauthorized breech of user privacy
top ↑How will you minimize risks to confidentiality?
We recognize that the information handled by the NHSN system includes sensitive information about member facilities. In addition to the steps described above, we will also do the following to minimize risks to confidentiality of PAICAP NHSN data. First, we will manage and protect all system authentication related controls (passwords, SAMS, etc.) related to the PAICAP group. Second, after generating an analytic dataset, all hospital identifiers will be removed and hospitals will be assigned a random, unique study ID. A cross-walk between study IDs and hospital identifiers will be stored separately from the analytic dataset in a secure, password protected location and will only be accessible by authorized PAICAP study staff. The record linking the study ID number to your hospital will be destroyed once the study is complete. Risks to confidentiality will be further minimized by the use of password-protected computers and databases secured behind multiple firewalls. Finally, all data will be reported in aggregate, and hospitals will not be identified in any presentations or publications resulting from the study (unless your hospital specifically requests to be formally recognized by name). Information which would permit identification of any hospital will not be disclosed or released to any outside entity without the prior consent of the institution, unless required by law.
Do I need IRB approval?
The PAICAP study is IRB approved by the Harvard Pilgrim Health Care IRB, documentation of approval is available upon request. PAICAP staff is available for consultation and assistance with any issues that arise for your hospital, as we want to ensure that we minimize your time burden.
