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.

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.

Clinical decisions regarding HbA1c results in primary care: a report from CaReNet and HPRN.

OBJECTIVE: To describe decisions made by primary care providers on elevated HbA(1c) results and their reasons for not intensifying therapy. RESEARCH DESIGN AND METHODS: In this cross-sectional study, a provider survey was administered in two practice-based research networks when HbA(1c) results were reviewed on all nonpregnant patients >18 years old with type 2 diabetes. Univariate and Mantel-Hantel analyses assessed associations between patient characteristics and clinical decisions. RESULTS: A total of 483 surveys were completed by at least 88 providers at 19 clinics. Most patients were female (62.5%), mean age was 60 years, and 28.6% were Hispanic. The overall action rate on HbA(1c) results >/=7% (n = 294) was 70.7%. Patients who were black or had Medicare without medication insurance had lower rates of action on HbA(1c) >/=7 and >/=8%, respectively (P < 0.05). The most common reasons providers reported for inaction were "patient improving/doing well," "competing demands," and "hypoglycemic risk." CONCLUSIONS: Primary care providers generally adhere to national glycemic control guidelines, although there may be disparities in black patients and patients without medication insurance coverage. A variety of reasons were given when control was not intensified.

Computer-using patients want Internet services from family physicians.

Patients are increasingly using the Internet to obtain medical information. Few practice Web sites provide services beyond information about the clinic and common medical diseases. We surveyed computer-using patients at 4 family medicine clinics in Denver, Colorado, by assessing their desire for Internet services from their providers. Patients were especially interested in getting e-mail reminders about appointments, online booking of appointments in real time, and receiving updates about new advances in treatment. Patients were also interested in virtual visits for simple and chronic medical problems and for following chronic conditions through virtual means. We concluded that computer-using patients desire Internet services to augment their medical care. As growth and communication via the Internet continue, primary care physicians should move more aggressively toward adding services to their practices' Internet Web sites beyond the simple provision of information.

Tobacco cessation counseling among underserved patients: a report from CaReNet.

OBJECTIVES: The purpose of our study was to determine the frequency of smoking cessation counseling in relation to insurance status in a practice-based research network. STUDY DESIGN: We administered a modified National Ambulatory Medical Care Survey (NAMCS), with an additional payment category to identify uninsured patients, quarterly to 100 random patients at each practice site for 1 year. POPULATION: The study population included the patients at the 7 practices within the Colorado Research Network (CaReNet), associated with the Department of Family Medicine, University of Colorado Health Science Center. OUTCOMES MEASURED: We measured the prevalence of smoking and the frequency of cessation counseling. RESULTS: Of 2773 visits analyzed, 1443 were made by adults who were either was uninsured (39%), had Medicaid (22%), or had private or a health maintenance organization insurance (private/HMO; 40%). Smoking prevalence was significantly greater in uninsured patients (30%) and Medicaid patients (31%), compared with private/HMO patients (22%) (P =.008). However, those smokers with private/HMO insurance were more likely to receive tobacco counseling (50%) than Medicaid (41%) and uninsured (25%) patients (P <.001). After controlling for potential confounders, this difference remained significant. CONCLUSIONS: Although smoking is more common among Medicaid and uninsured patients, these smokers are less likely to receive counseling. Possible explanations for this disparity include lack of access to cessation interventions or lower quality of care for underserved patients. This finding may have implications for achieving national public health goals on smoking cessation.

Provider deferred decisions on hemoglobin A1c results: a report from the Colorado Research Network (CaReNet) and the High Plains Research Network (HPRN).

BACKGROUND: Hemoglobin A1c (HbA1c) results are generally reviewed several days after office visits. The clinical decisions on elevated HbA1cs may be complex and are rarely urgent. Providers may elect to defer the decision or its implementation to a future clinical encounter. OBJECTIVE: To determine the occurrence rate, predictors, and eventual decision outcomes for HbA1c deferred decisions. DESIGN: Provider questionnaire completed when HbA1c results from type 2 diabetes patients were reviewed, followed by a chart review on deferred cases 6 months later. PARTICIPANTS: Providers at 19 Colorado primary care clinics. MEASUREMENTS: For HbA1c > or =7%, whether the decision or its implementation was deferred. In deferred cases, whether a clinical decision was eventually made. RESULTS: Of the 311 HbA1cs > or =7%, 31 (10.0%) had deferred decisions. In multivariate analysis, deferred decisions were more likely in African Americans (odds ratio [OR] 4.91, 95% CI 1.81, 13.3) and less likely when the patient's usual provider reviewed the HbA1c (OR 0.40, 95% CI 0.18, 0.90). In the chart review, for deferred cases (n = 18), a clinical decision was made in 14 cases, usually at the next clinical encounter. In 4 cases, the HbA1c was never addressed. CONCLUSION: Deferred decisions on HbA1c results are infrequent, and usually the HbA1c is eventually addressed.

Validation of the EQ-5D quality of life instrument in patients after myocardial infarction.

BACKGROUND: We assessed cross-sectional validity of EQ-5D after myocardial infarction (MI). METHODS: We compared EQ-5D, SF-36, quality of life After MI (QLMI), and Canadian Cardiovascular Society Anginal Classification (CCSG) scores. Correlation and regression techniques were used to assess convergent validity. SF-36 and alternate Rand-36 scoring were compared. CCSG class was used to evaluate discriminative validity and clinical difference in health state scores. RESULTS: Of 99 patients: mean age 64; median 176.5 days post-MI; 80% had one MI; 74% were CCSG I. 1/3 to 1/2 reported mobility, self-care, pain, and emotional difficulties on EQ-5D. Median health state was 0.73. EQ-5D and SF-36 (or Rand-36) strongly correlate in overall health (0.75), emotional health (0.75), pain (0.68), and activity/functional (0.5-0.63). EQ-5D and QLMI strongly correlate in activities/self esteem (0.56), emotional health (0.64), anxiety/ depression--restriction (0.53), and overall health (0.5-0.57). EQ-5D self-care correlates weakly with all domains. Domain scores from each general instrument contributed to each other's overall health score (adjusted R2 0.61-0.69) and to disease specific score (0.45 adjusted R2). EQ-5D discriminates among CCSG classes (p < 0.000). Physicians detected a 0.16 difference in health state scores. CONCLUSION: The EQ-5D provides valid general HrQOL measurement post-MI.

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.