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Supported by a supplement to our Clinical and Translational Science Award, we studied the feasibility of implementing clinical research in Northern Manhattan community practices that primarily serve Hispanic patients.
We applied a mixed methods approach (surveys, focus groups, interviews) based upon the PRECEDE-PROCEED model to determine the level of interest in clinical research among community clinicians (Practice-based Research Network (PBRN) and non-PBRN members), the perceived barriers that hamper participation in clinical research, and the perceived facilitators for conducting research in such practices.
Survey and qualitative data indicated strong interest in clinical research among current and potential PBRN members if it was relevant to improving quality of care in their practice or community. They also identified important perceived barriers (lack of time, inadequate training in research methods, lack of collaborators and support staff, institutional review board hurdles, and community distrust of research) and the necessary requirements for overcoming barriers to conducting research in busy clinical settings: collaborators, mentors, research support staff, and trusting patient-clinician relationship.
It is feasible to conduct clinical research studies in urban community medical practices if the topics are relevant to the community and appropriate enabling structures and processes are put into place.
The National Institutes of Health (NIH) Roadmap program has developed initiatives related to building clinical research capability in community medical practices so that patients can participate in such studies at their primary point of contact with the healthcare system.[1-5] Roadmap initiatives are designed to improve the access of patients to NIH-type clinical research, increase the racial and ethnic diversity of participants, and enhance the translation of research into practice. The last objective, in particular, is consistent with the role played by practice-based research networks (PBRNs).[7-9] In addition, a 2007 survey of 89 PBRNs reported that patients of minority race, Hispanic ethnicity, and low socioeconomic status were overrepresented in PBRNs as compared to the general population and those seeking health care. In a recent commentary regarding transformation of health care at the front line, Conway and Clancy note that the “testing, scaling, and spreading of interventions to improve quality and efficiency needs to be performed via learning networks led by clinicians and other stakeholders.” These factors suggest that PBRNs play an important role in achieving Roadmap objectives.
Although some concern has been expressed regarding a perceived shift in strategic direction at the federal level from “direct funding of a harmonized national infrastructure of cooperating networks to a model of local engagement of primary care clinics performing practice-based research under the aegis of regional academic health centers through Clinical and Translational Science Awards” (p. 229) , our perspective is that the Clinical and Translational Science Award (CTSA) approach and the historical role of PBRNs can be complementary efforts. Consequently, through a supplement to our CTSA, we studied the feasibility of implementing clinical research in urban community practices in Northern Manhattan. We applied a mixed methods approach informed by the Predisposing, Reinforcing, and Enabling constructs of the PRECEDE-PROCEED model  to collect data from clinicians in community practices to determine the level of interest in clinical research, the perceived barriers that hamper the participation of community medical practices in clinical research, and the perceived facilitators for conducting research in such practices.
This report primarily focuses on physicians in Ambulatory Care Network (ACN) sites in Northern Manhattan, New York City. The ACN was registered as a PBRN, the Ambulatory Care Research Network (ACRN), in the Agency for Healthcare Research and Quality database in 2006. In addition, where relevant, we contrast the ACN data with that of clinicians from community practices with potential to serve as research sites. We also discuss possible solutions to key perceived barriers in the ACN and potential research sites drawing upon the PBRN literature and our experience in the conduct of multi-site clinical trials.
The ACN is a large network of primary care and specialty clinics affiliated with NewYork-Presbyterian Hospital, which serves the greater New York area. In Northern Manhattan (Washington Heights, Inwood, and Harlem), there are eight ACN community primary care practice sites, six of which have Internal Medicine or Family Medicine clinicians. ACN physicians are faculty members at the College of Physicians and Surgeons, Columbia University and their role expectations include resident training and clinical scholarship in addition to clinical responsibilities. Annual ACN outpatient visits total approximately 750,000 in New York City; about one-third occur at Northern Manhattan clinics. The majority of primary care patients are covered by Medicaid programs (25% fee-for-service Medicaid and 40% Medicaid Managed Care). The main area served by the Northern Manhattan ACN clinics (Washington Heights/Inwood) is primarily Hispanic (74.1%).
The primary sample for this report was ACN physicians. Two additional groups of clinicians from potential community research sites participated in either a focus group or interview: Hispanic physicians not affiliated with the ACN and doctorally-prepared nurse practitioners (DNP) from the faculty practice of the Columbia University School of Nursing, Columbia Advanced Practice Nurse Associates. These clinicians had research qualifications similar to the ACN physicians and were recruited for an earlier phase of our research. They are included as a contrast to ACN physicians.
The study was approved by Columbia University Medical Center IRB. Participants provided verbal consent for participation after reviewing an information sheet and were compensated for focus group or interview participation, but not for completing the survey.
Recruitment methods varied depending upon the method judged as most appropriate for the target group of participants. ACN physicians, the primary sample for this report, were recruited through an email invitation to complete the survey. Those that completed the survey were subsequently invited to participate in a focus group in one of three ACN sites. A purposive sample of five community-based Hispanic physicians was nominated by a member of the research team (RAL) and personally invited to participate in an individual interview. DNPs were recruited through an email invitation for focus group or interview participation.
We used the Predisposing, Reinforcing, and Enabling constructs of the PRECEDE-PROCEED model as the theoretical basis for developing quantitative and qualitative questions related to clinical research participation. Although the model is more typically applied to health behaviors, we considered clinical research participation as a clinician behavior and felt that our understanding of barriers and facilitators could be informed by the model. Predisposing factors precede a behavior and can be thought of as motivation or “wanting to do”. For our study, this was characterized as clinician interest. Enabling factors are those related to “being able to do” and for this study were the skills and resources required to conduct clinical research. Reinforcing factors are “rewards for doing” and included positive (e.g., monetary or academic incentives) and negative (e.g., concerns about clinical productivity) feedback received as a result of clinical research participation. Conceptualizing barriers and facilitators for clinical research in this way provides guidance for a hierarchy of potential interventions or solutions starting from strengthening interest through enabling and rewarding clinical research participation.
Based on the model, existing surveys, and our prior experience, we constructed a 40-item survey that collected information on: provider demographics, clinical and research training, previous research experience, their current clinical practice and research activity, level of interest in future clinical research, barriers and incentives to participation in clinical research, and the kinds of clinical research the providers most want to conduct. Questions related to interest, barriers, and incentives were rated on a 5-point Likert scale from strongly agree to strongly disagree. (Questionnaire is available by request to the corresponding author.)
Focus group and interview questions were open-ended and targeted perceptions of barriers and facilitators related to conducting research in their setting. Questions were preceded by a general introduction to the CTSA initiative and the specific study purpose. Although general questions remained consistent during the data collection, probes were updated to reflect themes identified as the data collection and analysis evolved.
ACN physicians completed the survey online using SurveyMonkey (SurveyMonkey, Portland, OR) prior to participation in a focus group. We conducted three focus groups with Internal Medicine and Family Medicine physicians in the ACN. Prior to the data collection in the ACN, we also conducted one focus group and six individual interviews with clinicians from potential community research sites in an initial phase of the research. All focus groups and interviews were led by the same investigator (SB) and lasted about 1-1.5 hours.
Survey responses were summarized using descriptive statistics. Data analysis of the qualitative data began with peer debriefing among research team members at the conclusion of the interviews or focus groups. Subsequently, transcripts of the focus groups were iteratively coded and analyzed by one investigator (SB) to generate major themes and categories. Other research team members reviewed themes and categories and the assignment of utterances to themes and categories. Suggestions for revisions were discussed among team members and final decisions were based upon consensus. For the ACN physicians, qualitative data were compared with survey data to determine instances in which the qualitative data expanded upon survey responses and instances in which the qualitative data contributed information not identified through the survey. Because the focus of this paper is on PBRNs, qualitative data from clinicians in potential community research sites are only included in the reported results when they illustrate a new theme that was not identified from the ACN data or strongly confirm ACN data.
Fifty-four surveys were distributed and 14 Internal Medicine and 10 Family Medicine ACN physicians completed the survey. Response rate was 44%. The average age of the participants was 43 and 76% were female. Self-reported race was 48% White, 16% Asian, 12% Black; 24% selected other or declined to state. Twenty-four percent were of Hispanic ethnicity. Three-fourths were married or partnered and half had children. Twenty-five percent of the ACN physicians were foreign medical graduates. Practice activity is summarized in Table 1.
Twenty-five percent of the ACN physicians had formal research training and 75% had some research experience (Table 2). Only 21% had clinical research training certification. Most (81%) of the clinicians with previous research experience found it a positive experience. Thirty-eight percent were currently involved in a clinical research project, primarily sponsored by NIH or health services agencies.
Focus group and interview participants included 13 ACN physicians (8 Internal Medicine and 5 Family Medicine), five community-based Hispanic physicians (4 male and 1 female, all board-certified in one or more specialties), and all DNPs (n=4) in the faculty practice (all female; all board-certified in specialty).
Survey, focus group, and interview data strongly support clinician interest in research, an essential predisposing factor for research participation. A key motivation was the relevance of the research topic to quality of care in their setting. Top-ranked types of clinical research in terms of ACN physician interest were: health services/outcomes research (88%), behavioral intervention (73%), observational (71%), retrospective (58%), dissemination (48%), and clinical trials (26%). All focus group and interview participants expressed some level of interest in research ranging from research facilitation to serving as a site investigator for multi-site clinical trials. Eighty percent of the ACN survey respondents indicated a willingness to deliver an intervention per research protocol. All DNPs had completed research course requirements as part of their clinical doctorate program.
Tables 3 and and44 display ACN study results related to barriers and facilitators (enabling and reinforcing factors) in three parts: items found in both the survey and focus groups, survey responses only, and additional thematic categories from the focus group data. In terms of perceived barriers (Table 3), clinician time and training appeared in both survey and focus group data whereas support staff-related barriers (e.g., time, compensation, training) were identified only in the survey. Lack of time/competing demands for time was the top-ranked barrier (92%) in the survey and 80% of ACN clinicians agreed that their lack of appropriate training was a barrier. Four thematic categories emerged only in the focus group data: difficulty filling clinical sessions to enable release for compensated research time, lack of collaborators to sustain research, difficulties overcoming IRB hurdles, and community distrust of research.
Potential researchers from community sites described several barriers that did not surface in the ACN focus groups. The comments of Hispanic physician respondents reflected the financial responsibility associated with their independent practices and highlighted the need to have the research studies fit into clinical workflow and not negatively affect the bottom line. For instance, one physician said:
“Anything that makes me move in one direction, more than one iota….can decrease the efficiency to the point that actually patient care starts to suffer…there's no fat in private practice – we basically deal with bare bones.”
Hispanic physicians in independent community practices also described additional sociocultural issues including language, literacy, complexity of patients' lives, and the research protocol challenges related to community members who travel between New York and the Dominican Republic.
ACN clinicians described the importance of enabling factors such as collaborators, mentors, and research support staff to overcome the barriers to conducting research in busy clinical settings (Table 4). The data from the Hispanic physicians was consistent with the ACN in the need for funded research support staff, but also mentioned the importance of a respectful relationship between research partners from academia and those in the community. For example,
“I guess one of the most important things when you want to do this – especially with people who never had any experience –a good rapport… treat others with respect, it's something very important.”
The ACN physicians, Hispanic physicians and DNPs all described the important role of the patient-provider relationship in overcoming patients' reluctance for research participation. For example, one Hispanic physician commented “…the Hispanic patient will do most of the time whatever you ask them to do because they still they have the physician in very high regard – this guy is not going to do anything to harm me…” A DNP noted that “…if there is interest in the practitioners … patients might follow through.” During focus group discussions, ACN physicians also identified several specific strategies for engaging patients/community in research (Table 4).
Clinicians from potential research sites including the DNP practice described the important role of information systems, particularly electronic health records in facilitating research primarily to search for potential research, subjects and to retrieve data related to research variables.
Although respondents from all three groups (ACN, independent Hispanic physician practices, and DNPs) addressed the importance of compensation for time spent for research-related tasks, a unique category that emerged from the Hispanic physician data was the need for a stable revenue stream from research: “Neither do we want our funding to be episodic.”
In terms of reinforcing factors, all ACN clinicians identified the possibility of improving the quality of care in their practice site and contributing to knowledge development as incentives for research participation (Table 4). Other important incentives were professional development, continuing medical education, collaboration with academic researchers, and recognition as a PBRN member or research collaborator. Both ACN survey respondents (60%) and Hispanic physicians in community sites identified authorship as an incentive with one Hispanic physician stating “…sooner or later everybody (physicians) wants to see their name [in print].”
The survey and qualitative data provide evidence for the presence of clinician interest in participating in the current and future PBRN sites and highlights great interest and motivation (predisposing factors) for studies that are closely linked to improving the quality of care in the practice or target important health problems in the community. This is consistent with the American Academy of Family Physicians National Research Network (AAFP NRN) recommendation to select studies that interest PBRN members and have the potential to improve quality of care. The high level of interest may reflect the fact that clinicians with some interest in clinical research were more likely to participate in our survey and focus groups or interviews and that research was a faculty role expectation of the ACN physicians. About one-third of our clinician sample was Hispanic and the level of interest contrasts with the findings of a national survey of randomly selected physicians that found that Hispanic physicians were less likely than White, non-Hispanic physicians to be involved in clinical trials, enroll their patients in a treatment trial, and consider clinical trials to be of value. This difference is likely a result of our purposive rather than random sampling method.
Most of what we learned in our study related to skills and resources (enabling factors) for conducting clinical research since the participants were already predisposed to research participation. Many clinicians felt that they lacked adequate research skills and identified the need for research training in general and for particular tasks. Most ACN clinicians were unaware of local institutional resources such as the CTSA-supported research training and design and biostatistics consultation services that could meet these learning needs for clinicians who want to lead studies. Settings that lack such core resources may access external educational resources.[16-19]
Clinicians identified a number of other potential enablers to decrease barriers and improve their ability to participate in research including: compensated time for research, academic collaborators, research support staff, mentorship, and electronic health records. Several factors primarily relate to one of the key strategies from AAFP NRN: creating a practical budget that covers the cost of the study. Part of the selection of projects for a PBRN is to make reasonably accurate estimates of the staff effort that will be needed for the project based on the protocol and to secure a budget that will adequately support the staff. When the geographic dispersion of practices and/or clinics permits, some of the personnel can work at more than one site, permitting the sites to share the financial burden of personnel. To make such arrangements work, AAFP NRN recommends securing written agreements among team members and provides policies and model agreements.
Our experience with multi-site clinical trials indicates that, if calculated correctly, fee for service reimbursement is fair and the revenue is automatically adjusted for level of effort. Two relatively common problems can reduce the potential benefits of this method: underestimation of the time to conduct the protocol, or inefficiency in conducting the protocol thus it is vital to include practices and front-line staff early in protocol development. Central support units that negotiate large numbers of budgets are likely to correctly estimate research-related effort. Inefficient sites can expend more time than is reimbursed even when reimbursement is correctly estimated. The latter problem can be addressed by additional training, assessment, and consultations that improve workflow efficiency. Improving enrollment usually improves efficiency because greater research activity facilitates learning and retaining knowledge of the protocol. Documenting research services so that reimbursement is correct and prompt can be facilitated by software that integrates workflow support and documents research services.
Electronic health records were primarily mentioned as an enabling factor by clinicians not currently affiliated with the ACN in order to support tasks such as identification of potential research subjects and conduct health services research or epidemiological studies. This has been successful in several PBRNs. [22, 23] and a number of institutions have made this a strategy in their CTSA activities.
The willingness of community members to participate in clinical research was of major interest to our research team for several reasons including the historical lack of diversity in clinical research and the NIH Roadmap objective of increasing diversity in clinical research. Patient-related issues such as language, functional literacy, community distrust of research in general, and complex lives were identified by the clinicians. However, many clinicians, including the five Hispanic clinicians from non-ACN community practices, felt that if the research was highly relevant to the community (e.g., hypertension, diabetes, asthma, depression) and was supported by study materials appropriate in language and literacy, that the trusted relationship between clinician and patient would outweigh barriers to participation for many patients. This is consistent with the findings of two recent studies.[25, 26] Within this trusted relationship, the tenets of informed consent must be carefully followed to avoid coercion.
Our institution has undertaken an additional strategy to enable patient participation in research, the establishment of a community health and information center outside of the medical center complex. The roles of this center, which is under the auspices of our CTSA, include informing the Northern Manhattan community about clinical research, enhancing recruitment from the community, and disseminating research findings to the community including patients and families, clinicians, community organizations, community leaders, and policy makers.
The reinforcing factors identified in the survey and expressed in the focus group regarding clinicians' desire for improving care in their own practice are consistent with a key focus of many PBRNs. Rewards such as recognition as a collaborator or PBRN member and continuing medical education credit were identified as incentives by more than half the survey sample and are relatively easy and low in cost to implement.
The primary limitations of our study relate to the size of the sample and the bias inherent in a volunteer sample of clinicians choosing to participate in a survey, focus group, or interview related to clinical research. In addition, independent Hispanic physicians were purposively chosen based on their research experience and research interest. Consequently, we are uncertain about the generalizability of our study. Moreover, given the relatively small number of focus groups and interviews, it is possible that additional themes might have emerged if we had continued to collect data.
Our study findings suggest that it is feasible to implement clinical research in urban community medical practices that we studied. The ACN clinicians who participated in the survey and focus group displayed a strong interest in clinical research and the community-based Hispanic physicians and DNPs expressed sufficient research interest to warrant further exploration of their practice sites as future PBRN members. Enabling factors are a key area on which we need to focus efforts to increase the research productivity and efficiency of the existing PBRN and to recruit future sites. Concurrently, we need to create incentives that are attractive to current and future PBRN members. The lessons that we have learned may be helpful to others in similar settings.
The authors thank Martha Rodriguez for her assistance in facilitating the qualitative data collection and Dr. Chunhua Weng for her assistance in implementing the survey.
Funding: This project was funded by grants and contracts from National Institutes of Health: 5UL1RR024156, 3UL1RR024156-02S1, contract # HHSN268200455208C
Conflicts of Interest:
Dr. Bakken, none
Dr. Lantigua, none
Ms. Busacca, none
Dr. Bigger, none
Suzanne Bakken, School of Nursing and Department of Biomedical Informatics, Columbia University, New York, NY.
Rafael A. Lantigua, Division of General Internal Medicine, Department of Medicine, Columbia University.
Linda V. Busacca, Clinical Trials Network, Clinical Trials Office, Columbia University.
J. Thomas Bigger, Departments of Medicine and of Pharmacology, Columbia University, New York, NY.