Practice-based Research Network Study Research Articles

PBRN CONFERENCE A SUCCESS

On June 21-22, 2012, NAPCRG tried something new. It worked. On these dates NAPCRG held its first annual practice-based research network (PBRN) conference. This meeting was supported by a conference grant from AHRQ, who has a longstanding interest in PBRN work, and who, until now had put on an annual PBRN conference. This meeting therefore represents a new, formal relationship with AHRQ, a new annual meeting for NAPCRG, and a chance to work with a whole new set of scientists, educators, and clinicians who care about practice-based research. Over 200 registrants attended the conference, from 6 countries. Japan! Romania! Brazil! Australia! And 30 investigators from Canada! Under NAPCRG's stewardship, this conference could well become—most likely will become—a world forum for PBRN work. Moreover, a broad range of disciplines were represented, including family medicine, general internal medicine, pediatrics, nursing, public health, dentistry, pharmacy, psychology, and social work. All of this is good, but the real news has to do with how PBRNs are evolving. For 3 decades, practice-based research networks have been a core resource in the primary care research armamentarium, and a preferred platform for describing practices and clinical conditions, as well as for testing clinical interventions. At this PBRN meeting we heard about: Networks of networks linked together with elegant, efficient, lean infrastructures to answer difficult clinical or services questions Very large networks of practices linked together by their electronic health records. Some of these networks are large enough to tackle detailed comparative effectiveness trials Hybrid PBRN/CBPR networks that incorporate community resources, community boards, and deep community partnerships. These networks can test interventions that make use of public health, community health, and primary care resources PBRNs whose datasets are linked to very large administrative datasets, or claims datasets, that can produce complete services data PBRNs that cut across disciplines (eg, primary care, public health, dentistry, behavioral health) to address health and heath care issues that occur across these multiple sectors Multinational PBRNs that take nesting to a whole higher level—that afford comparisons of similar clinical conditions in different systems of care PBRNs that are taking on questions of practice redesign and system change, and are proving useful even with the sophisticated designs required of quality improvement efforts, during which interventions are continuously evolving; and PBRNs that are used as platforms for disseminating innovations and keeping practitioners close to practice improvement research Two additional highlights of this meeting merit mention: the 2 plenaries. The first was delivered by Joe Selby, Executive Director of PCORI, who described how well suited PBRNs are to addressing patient-centered outcomes research. The second was a panel discussion presented by Larry Green, Jon Kerner, Jim Mold, and Jack Westfall, who discussed the intersection of public health and primary care, and how PBRNs have begun to address this interface as it applies to cancer prevention, asthma control, and health and health care extension in a statewide network. During an all-attendees evaluation and suggestion session at the conclusion of the conference, participants strongly endorsed this conference as a standing event, and suggested that we should consider expanding the international participation, deepening the interprofessional conversation, fostering additional opportunities for funders and researchers to engage with one another, continuing to explore the innovative ways researchers are designing PBRNs and PBRN studies, offering special events or sessions for PBRN staff, and above all, expanding the venues at which research results could be showcased. Practice-based research networks have come of age, and are now capable of answering difficult, complex, and important questions. This conference demonstrated that to good effect. At the end of the conference, NAPCRG's Board of Directors concluded as much and recommended that efforts begin immediately to seek support and plan improvements for next year's PBRN conference.

Expanding Delivery System Research in Public Health Settings

Delivery system research to identify how best to organize, finance, and implement health improvement strategies has focused heavily on clinical practice settings, with relatively little attention paid to public health settings-where research is made more difficult by wide heterogeneity in settings and limited sources of existing data and measures. This study examines the approaches used by public health practice-based research networks (PBRNs) to expand delivery system research and evidence-based practice in public health settings. Practice-based research networks employ quasi-experimental research designs, natural experiments, and mixed-method analytic techniques to evaluate how community partnerships, economic shocks, and policy changes impact delivery processes in public health settings. In addition, network analysis methods are used to assess patterns of interaction between practitioners and researchers within PBRNs to produce and apply research findings. Findings from individual PBRN studies elucidate the roles of information exchange, community resources, and leadership and decision-making structures in shaping implementation outcomes in public health delivery. Network analysis of PBRNs reveals broad engagement of both practitioners and researchers in scientific inquiry, with practitioners in the periphery of these networks reporting particularly large benefits from research participation. Public health PBRNs provide effective mechanisms for implementing delivery system research and engaging practitioners in the process. These networks also hold promise for accelerating the translation and application of research findings into public health settings.

Coordinating Centers and Multi-Practice-based Research Network (PBRN) Research

Practice-based research networks (PBRNs) have emerged as laboratories in which to address important primary care challenges. In 2011, the Agency for Healthcare Research and Quality's PBRN database included more than 130 networks, most regional and some national, with member practices in every state. Regional networks may have certain advantages over national networks with respect to practice recruitment and project quality control because of closer relationships and shorter distances. However, national networks often can achieve larger numbers of practices with greater diversity, resulting in broader generalizability of results. Increasingly, regional networks are collaborating on multinetwork projects, but this creates significant study coordination challenges. A potential solution is to incorporate PBRN coordinating centers similar to those used in many National Institutes of Health and industry-sponsored multi-center clinical trials. In this article, we discuss the potential functions of a coordinating center in multi-region PBRN studies based on our experience with 2 recent studies.

Reports of Persistent Change in the Clinical Encounter Following Research Participation: A Report From the Primary Care Multiethnic Network (PRIME Net)

Following anecdotal reports of unexpected patient and/or clinician behavior change in the primary care encounter in a previous study, we conducted this study to learn more about the short- and long-term effects on clinician and/or patient behavior from participation in a practice-based research network (PBRN) study. Clinicians in two PBRN studies of Acanthosis nigricans were surveyed and interviewed 3 to 6 months following one study and surveyed 3 to 5 years following a second study. We gathered data on clinicians' reports of behavior change in the encounter, the persistence of those changes, and the likely causes of reported changes. Eighty-six percent of clinicians in the short-term and 79% in the long-term samples reported more frequent diagnostic efforts, and 68% and 54%, respectively, reported more frequent preventive counseling after participation in the studies. Interview data suggested that several factors contributed to this reported behavior change: increased clinician knowledge, availability of a feasible tool to support counseling, change in patient receptivity/motivation, and creation of a new context for counseling. Reports of behavior change in the primary care encounter associated with a PBRN study suggest that PBRNs may be effective vehicles for education, translation, and practice change in addition to their value in research.

The Influence of Research Compensation Options on Practice-based Research Network (PBRN) Physician Participation: A North Texas (NorTex) PBRN Study

To study the effect of two compensation approaches, continuing medical education (CME) credits (5 hours) or monetary ($150), on the participation rate of a physician needs assessment study. Physicians representing family medicine, internal medicine, pediatric, and geriatrics specialties, and practicing in ambulatory primary care clinics affiliated with the North Texas Primary Care (NorTex) PBRN clinics, were recruited to complete a survey relevant to their subspecialty and to conduct a self-audit/abstraction of five medical records. Physicians were recruited from four health care systems, and the recruiting methods varied by system. Study outcome was the rate of study completion by type of incentive. One hundred five of 211 (49.8%) physicians approached to participate gave consent and 84 (39.8%) completed the study. There was no difference in the number of physicians randomly assigned to monetary compared with CME compensation for giving consent to participate (adjusted odds ratio = 1.42, confidence interval = 0.69, 2.93). However, physicians in the monetary compensation group were more likely to complete the study after giving consent (adjusted odds ratio = 4.70, confidence interval = 1.25, 17.58). This monetary effect was also significant from the perspective of all physicians approached initially (adjusted odds ratio = 2.78, confidence interval = 1.16, 6.67). This study suggests that future PBRN investigators should receive monetary compensation for the opportunity cost of adding research activities to their already busy practices. This compensation may be especially vital for PBRNs to complete more ambitious projects requiring a significant time commitment from the participating physicians.

Making a Case for Defining Osteonecrosis of the Jaw

Making a Case for Defining Osteonecrosis of the Jaw

ONJ in Two Dental Practice-Based Research Network Regions

The incidence of osteonecrosis of the jaw (ONJ) in the population is low, but specifics are unknown. Potential risk factors include bisphosphonate treatment, steroid treatment, osteoporosis, and head/neck radiation. This Dental Practice-Based Research Network study estimated ONJ incidence and odds ratios from bisphosphonate exposure and other risk factors using a key word search and manual chart reviews of electronic records for adults aged ≥ 35 yrs enrolled during 1995–2006 in two large health-care organizations. We found 16 ONJ cases among 572,606 cohort members; seven additional cases were identified through dental plan resources. Among 23 cases (0.63 per 100,000 patient years), 20 (87%) had at least one risk factor, and six (26%) had received oral bisphosphonates. Patients with oral bisphosphonates were 15.5 (CI, 6.0–38.7) more likely to have ONJ than non-exposed patients; however, the sparse number of ONJ cases limits firm conclusions and suggests that the absolute risks for ONJ from oral bisphosphonates is low.

Practice Benefit from Participating in a Practice-based Research Network Study of Postpartum Depression: A National Research Network (NRN) Report

At the midpoint of a large clinical trial taking place in a practice-based research network (PBRN), we asked leaders of the enrolled practices about the impact of participating in a PBRN study. Using semistructured interviews, the lead study nurse and physician from each site were queried about the impact of study participation on issues related to the study topic of postpartum depression (PPD) as well as any other impacts on the practice not directly related to PPD. From the results, initial themes were identified by 3 of the investigators (BPY, SB, MK) and confirmed by all the authors. Interviewee responses were grouped by theme. Forty-eight study leaders from 28 solo, moderately sized group and residency practices were interviewed during a period of 60 days. Practices were located in 20 different states, and 54% were in rural communities. Six major themes emerged. Study participation led to: ((1)) the recognition of the need for systematic approaches; ((2)) more effective teamwork and communication within the practice; ((3)) adaptation and extension of the PPD study tools and a systematic approach to the care of other chronic conditions; ((4)) increased professional self-worth and community recognition; ((5)) opportunity and support for staff members to "stretch" into new roles; and ((6)) increased research literacy within the practice. Participating in a PBRN research study can provide advantages to practices that extend beyond the study's specific purpose and content. These results provide further support for the value of PBRN research funding.

Chronic Opioid Therapy and Preventive Services in Rural Primary Care: An Oregon Rural Practice-based Research Network Study

For clinicians, using opioid therapy for chronic noncancer pain (CNCP) often gives rise to a conflict between treating their patients' pain and fears of addiction, diversion of medication, or legal action. Consequent stresses on clinical encounters might adversely affect some elements of clinical care. We evaluated a possible association between chronic opioid therapy (COT) for CNCP and receipt of various preventive services. We conducted a retrospective cohort study in 7 primary care clinics within the Oregon Rural Practice-based Research Network (ORPRN). Using medical records of 704 patients, aged 35 to 85 years, seen during a 3-year period, we compared the receipt of 4 preventive services between patients on COT for CNCP and patients not on chronic opioid therapy (non-COT). We used multivariate log-binomial regression analyses to estimate the relative risk of receipt of each preventive service. After adjustment for plausible confounders, we found that patients using COT had a statistically significantly lower relative risk (RR) of receipt of cervical cancer screening (RR = 0.60; 95% confidence interval [CI], 0.47-0.76) and colorectal cancer screening (RR = 0.42; 95% CI, 0.22-0.80) when compared with non-COT patients. The RR was reduced, without statistical significance, for lipid screening (RR = 0.77; 95% CI, 0.54-1.10), and not notably reduced for smoking cessation counseling (RR = 0.95; 95% CI, 0.78-1.15). Patients using COT for CNCP were less likely to receive some preventive services. Research is needed to better understand barriers to and improved methods for providing preventive services for these patients.

Characteristics of nurse practitioners interested in participating in a practice-based research network

Practice-based Research Networks (PBRNs) have emerged as key laboratories for generating new knowledge that reflects community-based practice; however, the representativeness of nurse practitioners (NPs) interested in PBRN participation is not known. This study describes characteristics of NP members interested in participating in a regional PBRN in comparison with state and national data. All 1016 NPs in northeast (NE) Ohio were surveyed by mail and Internet. The survey captured NP demographics, practice characteristics, and gauged interest in participating in future PBRN studies. Survey respondent's data were compared with Ohio and national data obtained from the 2004 AANP National Nurse Practitioner Sample Survey. NE Ohio NPs were similar to an Ohio and national sample of NPs. Northeast Ohio NPs practicing in ambulatory settings who were interested in participating in subsequent PBRN studies were not significantly different from non-interested NPs. NPs interested in participation in a PBRN appear to be representative of the NE Ohio population of ambulatory practice NPs and are similar demographically to a national sample of NPs. Findings from studies conducted in the NE Ohio PBRN may generalize to other NPs practicing in the region and across the country.

Effects of Local Institutional Review Board Review on Participation in National Practice-Based Research Network Studies

To describe the process and outcomes of local institutional review board (IRB) review for 2 Pediatric Research in Office Settings (PROS) studies. Pediatric Research in Office Settings conducted 2 national studies concerning sensitive topics: (1) Child Abuse Recognition Experience Study (CARES), an observational study of physician decision making, and (2) Safety Check, a violence prevention intervention trial. Institutional review board approval was secured by investigators' sites, the American Academy of Pediatrics, and practices with local IRBs. Practices were queried about IRB rules at PROS enrollment and study recruitment. Pediatric Research in Office Settings practices in 29 states. Eighty-eight PROS practices (75 IRBs). Main Exposure Local IRB presence. Local IRB presence, level of PROS assistance, IRB process, study participation, data collection completion, and minority enrollment. Practices requiring additional local IRB approval agreed to participate less than those that did not (CARES: 33% vs 52%; Safety Check: 41% vs 56%). Of the 88 practices requiring local IRB approval, 55 received approval, with nearly 50% needing active PROS help, many requiring consent changes (eg, contact name additions, local IRB approval stamps), and 87% beginning data collection. Median days to obtain approval were 81 (CARES) and 109 (Safety Check). Practices requiring local IRB approval were less likely to complete data collection but more likely to enroll minority patients. Local IRB review was associated with lower participation rates, substantial effort navigating the process (with approval universally granted without substantive changes), and data collection delays. When considering future reforms, the national human subject protections system should consider the potential redundancy and effect on generalizability, particularly regarding enrollment of poor urban children, related to local IRB review.

Practice-based Research Network Studies and Institutional Review Boards: Two New Issues

Practice-based research network (PBRN) study investigators must interface with multiple Institutional Review Boards (IRBs), many of which are unfamiliar with PBRN research. To present 2 IRB-related issues that have not appeared in the literature but occurred during the course of a large 5-year PBRN study involving 32 sites dispersed around the United States. Our study required IRB approval from a total of 19 local, hospital, academic center, and professional organization-based IRBs that reviewed a protocol of postpartum depression screening and follow-up completed in English or Spanish. Initial approval of the protocol and consent forms proceeded with only the usual barriers of submitting 19 different forms, and no protocol amendments were required. However, 2 unanticipated IRB issues provided significant additional work for the study team and the local practice sites. First, several IRBs required staff to repeat human subjects training every 1 to 2 years, resulting in 92 practicing physicians, residents, and members of the nursing staff spending time completing the exact same human subjects' training at least twice during the course of this study. Second, 17 of the 19 IRBs required that the patient be given consent forms that were newly stamped and dated each year, requiring the central site to reprint and replace consent forms yearly. Because not all IRBs returned the newly stamped and dated forms in a timely fashion, study enrollment with valid consent forms was interrupted in 4 sites for periods of 2 to 13 weeks. IRB requirements not directly responsive to federal regulations can add significant costs, frustrations, and burdens to PBRN studies. Non-federally mandated IRB requirements should be based on an identified need with evidence to support the solution.

Inappropriate medication use in the elderly: Results from a quality improvement project in 99 primary care practices

Background: The use of potentially inappropriate medications (PIMs) in the elderly population is common. Interventions to decrease PIM use in primary care settings are needed. Objective: This study was designed to assess the time trends in use of always inappropriate and rarely appropriate medications in primary care patients aged ≥65 years during a quality improvement project. Methods: A 4-year, prospective demonstration project was delivered to 99 primary care practices that use a common electronic medical record and are members of the Practice Partner Research Network. Each participating practice received quarterly performance reports on the use of always inappropriate and rarely appropriate medications in the elderly. Optional interventions included biannual on-site visits and annual network meetings for performance review, academic detailing, and quality improvement planning. General linear mixed regression models were used to analyze the change in prescribing rates over time. Results: Across 42 months of project exposure, 124,802 active patients (61% women, 39% men) aged ≥65 years were included in the analyses. Among the 33 practices that participated in all 42 months of the intervention, the proportion of patients with a prescription for an always inappropriate medication decreased from 0.41% to 0.33%, and the proportion of patients with a prescription for a rarely appropriate medication decreased from 1.48% to 1.30%. Across all 99 practices, the adjusted absolute annual declines for the comprehensive categories of always inappropriate medications (00.018%, P = 0.03) and rarely appropriate medications (0.113%, P = 0.001) were statistically significant. Propoxyphene was the only individual medication that decreased significantly in use over time (baseline proportion, 0.72%; adjusted absolute annual decline, 0.072% [ P = 0.001]). Conclusions: Always inappropriate and rarely appropriate medication use decreased over time in this practice-based research network study. Additional studies of robust interventions for improving medication use in the elderly are warranted.

Strategies for Planning and Launching PBRN Research Studies: A Project of the Academy of Family Physicians National Research Network (AAFP NRN)

Research conducted in a practice-based research network (PBRN) differs from other multisite research and presents particular planning challenges. The American Academy of Family Physicians National Research Network (AAFP NRN) has developed a number of procedures used for planning and implementing studies, which address the challenges of national PBRN studies. In this study, we highlight challenges common to PBRN research and describe the methods used by the AAFP NRN to address those challenges. The following tasks were identified as important to implementing PBRN research studies: (1) selecting fundable, feasible studies that interest members and have the potential to improve quality of care; (2) creating a practical budget that covers the costs of the study; (3) composing study teams and securing written agreements between team members; (4) recruiting and selecting study sites; and (5) training practice staff and physicians. Striking the balance of scientific rigor with practical application of PBRN studies must be addressed throughout these tasks. Proper planning for PBRN studies significantly affects the success of study implementation. Although developed by a national PBRN, the planning procedures described in this study may be adapted for state or regional PBRNs.

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

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. 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. 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. 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.

A Safety-Net Antibiotic Prescription for Otitis Media: The Effects of a PBRN Study on Patients and Practitioners

Pediatricians can decrease antibiotic use by treating acute otitis media (AOM) with a safety-net antibiotic prescription (SNAP). This study assessed whether the practitioners of the Practice-Based Research Network who participated in the study continued to use the SNAP and report a 60-day follow-up of the study patients. Charts were reviewed of study patients for 60 days following study enrollment. A survey on antibiotic use for AOM was mailed to the 17 study practitioners (SP) and 30 randomly selected community pediatricians (CP). Eight of the SP used the SNAP more than 20 times over the year following the study vs 1 of the CP. Sixty-two percent of patients never received antibiotics. The recurrence/relapse rate was greater in children younger than 2 years old compared to those older, 34% vs 10%. Practitioners who participate in a Practice-Based Research Network study are more likely to use a study intervention than others.

Management of Type 2 Diabetes in the Primary Care Setting: A Practice-Based Research Network Study

We wanted to describe how primary care clinicians care for patients with type 2 diabetes. We undertook a cross-sectional study of 95 primary care clinicians and 822 of their established patients with type 2 diabetes from 4 practice-based, primary care research networks in the United States. Clinicians were surveyed about their training and practice. Patients completed a self-administered questionnaire about their care, and medical records were reviewed for complications, treatment, and diabetes-control indicators. Participating clinicians (average age, 45.7 years) saw an average of 32.6 adult patients with diabetes per month. Patients (average age, 59.7 years) reported a mean duration of diabetes of 9.1 years, with 34.3% having had the disease more than 10 years. Nearly one half (47.5%) of the patients had at least 1 diabetes-related complication, and 60.8% reported a body mass index greater than 30. Mean glycosylated hemoglobin (HbA1c) level was 7.6% (SD 1.73), and 40.5% of patients had values <7%. Only 35.3% of patients had adequate blood pressure control (<130/85 mm Hg), and only 43.7% had low-density lipoprotein cholesterol (LDL-C) levels <100 mg/dL. Only 7.0% of patients met all 3 control targets. Multilevel models showed that patient ethnicity, practice type, involvement of midlevel clinicians, and treatment were associated with HbA1c level; patient age, education level, and practice type were associated with blood pressure control; and patient ethnicity was associated with LDL-C control. Only modest numbers of patients achieve established targets of diabetes control. Reengineering primary care practice may be necessary to substantially improve care.

Multilevel Modeling and Practice-Based Research

The health care system in the United States is inherently hierarchical. Patients are "nested" within physicians who in turn are "nested" within practices. Much of the research data gathered in practice-based research networks (PBRNs) also have similar patterns of nesting (clustering). When research data are nested, statistical approaches to the data must account for the multilevel nature of the data or risk errors in interpretation. We illustrate the concept of multilevel structure and provide examples with implications for practice-based research. We present a selection of multilevel (hierarchical) models and contrast them with traditional linear regression models, using an example of a simulated observational study to illustrate increasingly complex statistical approaches, as well as to explore the consequences of ignoring clustering in data. Additionally, we discuss other types of outcome data and designs, and the effects of clustering on sample size and power. Multilevel models demonstrate that the effects of physician-level activities may differ from clinic to clinic as well as between rural and urban settings; this variability would be undetected in traditional linear regression approaches. Study conclusions differed when the data were analyzed with multilevel methods compared with traditional linear regression methods. Clustered data also affected sample size; as the intraclass correlation increased and the patients per cluster increased, the required number of patients increased dramatically. Recognizing and accounting for multilevel structure when analyzing data from PBRN studies can lead to more accurate conclusions, as well as offer opportunities to explore contextual effects and differences across sites. Accommodating multilevel structure in planning research studies can result in more appropriate estimation of required sample size.

Practice-Based Research Network Studies in the Age of HIPAA

We wanted to explore potential effects of the Health Insurance Portability and Accountability Act (HIPAA) on research activities of practice-based research networks (PBRNs). 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. 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. 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.

In this Issue: The Patient-Clinician Relationship and Practice-Based Network Research

Practice-based research networks (PBRNs) are emerging as the essential laboratory for the generation of new knowledge that is relevant to the types of problems and patients seen in primary care practice. This expanded issue features 9 PBRN studies, which help develop the methods for PBRN research