Sherry Holcomb

Practice-based research network studies in the age of HIPAA.

PURPOSE We wanted to explore potential effects of the Health Insurance Portability and Accountability Act (HIPAA) on research activities of practice-based research networks (PBRNs). METHODS To understand the approaches PBRNs are using to advance their research while adhering to HIPAA standards, we combined a literature review, our experiences, and discussions with local HIPAA officers, PBRN researchers in the United States, and individuals involved in drafting HIPAA. RESULTS HIPAA requires researchers to pay special attention to how they handle patients’ protected health information (PHI). For researchers working within PBRNs, which collect information from patients and health care professionals in multiple institutions, the HIPAA Privacy Rule presents additional challenges. PBRN researchers can obtain patient authorization to use PHI, but this process is difficult and may taint the findings of some research studies. Some institutions may allow patients to provide a blanket authorization for study recruitment. PBRNs additionally can collect only “de-identified” data (data with identifying information removed) or, with a data use agreement, can work with a limited data set. PBRNs that blend quality improvement and research can work with PHI, but the researcher and practices must enter into a business agreement. PBRN researchers may need to play active, educational roles in institutional privacy boards to facilitate their research. CONCLUSIONS There are a number of ways for PBRN researchers to comply with HIPAA short of obtaining patient consent and authorization for every study. Careful planning and consideration of HIPAA issues during study design can go a long way toward reducing frustration later.

Exploring Patient Reactions to Pen-Tablet Computers: A Report from CaReNet

PURPOSE We wanted to study patient receptivity to using pen-tablet computers for collecting data in a practice-based research network. METHODS We analyzed exit interviews and field notes collected by trained research assistants as part of a larger Colorado Research Network (CaReNet) study comparing pen-tablet and paper-pencil methods to collect data for the Primary Care Network Survey (PRINS). RESULTS A total of 168 patients completed a patient exit interview after completion of the pen-tablet–based survey instrument. Analyses of these brief interviews and field notes indicated that patients had favorable reactions to using pen-tablet computers. The most common barriers were related to glitches in the technology; the voice recognition software was the most problematic, with patients (as well as clinicians) finding this feature to be frustrating. CONCLUSIONS Patients were able and willing to use pen-tablet computers for completing forms within busy primary care offices. Increasing patient involvement in practice-based research may be even more practicable through the use of this novel technology, which can allow patient-directed data collection at a single point in time as well as longitudinally.

Matching Anonymous Pre-Posttests Using Subject-Generated Information:

Sensitive research issues call for anonymous questionnaires. This makes accurately matching pretests with posttests difficult or impossible. Various subject-generated coding schemes have been developed, but their accuracy has been unknown. This anonymous study, with 745 students, used subject-generated coding to match pretests with posttests. The matching was verified for accuracy with the use of a collateral, anonymous, sticker identification system. The coding system was able to accurately match 75.2% of all the pretest-posttest pairs. An additional 22.1% of the pairs were left unmatched and only 2.7% were matched incorrectly. Subject-generated coding systems can be very effective where confidentiality is important to protect.

Evaluating Sample Medications in Primary Care: A Practice-Based Research Network Study

BACKGROUND No reports have objectively evaluated safety of samples in primary care practices. A study was conducted to determine adherence to the Institute for Safe Medication Practices (ISMP) recommendations for safe distribution of medication samples to minimize medication errors. METHODS In 2004, 17 urban and rural primary care practices participated in a two-phase observational study: (1) a site visit to collect inventory data and perform assessment of medication sample dispensing procedures and (2) a survey questionnaire for providers and patients upon sample medication provision. RESULTS No practices were compliant with all seven ISMP recommendations. Twelve of 17 practices had policies for sample medication dispensing, and 7 had policies for labeling. Sample medication use was evaluated for 585 office visits and 27 patient surveys. Fifty-eight sample medications were dispensed during 55 of 585 patient visits. Common reasons for using sample medications included availability and need for a short-term trial for a chronic medication. Verbal communication only was provided most of the time for patient education regarding appropriate sample medication use and side effects. DISCUSSION Primary care practices in this research network did not follow safe and appropriate sample medication dispensing procedures as outlined by ISMP. Both labeling and patient instructions were inadequate and may increase the risk for medication errors.