Community Engagement Strategies in the Original and Renewal Applications for CTSA Grant Funding

Purpose

The Clinical and Translational Science Award (CTSA) program has highlighted community engagement in research by requiring institutions to develop bidirectional relationships with communities to obtain funding. Little is known about how institutions have operationalized that requirement. This study aimed to describe the strategies proposed by the first institutions to receive CTSA funding and to undergo the CTSA renewal process.

Methods

The authors conducted a qualitative document analysis of the community engagement section of 12 original and 10 renewal grant applications of the 12 institutions awarded CTSA funding in 2006 and renewed in 2010.

Results

Institutions employed ‐ and research engagement strategies. Capacity‐building strategies included education, pilot grants, connecting potential partners, and community research centers. Research engagement strategies ranged from those that allowed for very little input from communities, such as announcements, to those that allowed for a high amount of input from communities, such as community‐researcher teams.

Conclusion

CTSA funding has supported capacity‐building for institutions and communities to partner. Engagement strategies employed by the institutions are largely known from prior community‐engaged research. Based on the grants from these institutions, the CTSA funding has largely enabled institutions to develop capacity to engage.     

Faculty Perceptions of How Community‐Engaged Research Is Valued in Tenure,Promotion, and Retention Decisions

Purpose

We assessed the perceptions of community core faculty in academic medical center institutions that received Clinical and Translational Science Awards (CTSA) about how these institutions consider community‐engaged scholarship (CES) when tenure, promotion, and retention decisions are made.

Method

An assessment tool was adapted to create an 18‐item survey that was sent during November and December 2011 via the Internet to the 369 members of the community‐engagement core mailing list of the CTSA.

Results

Fifty‐nine responses were received which represented 37 of the possible 60 different funded institutions. The mean score was 48.14 (SD = 11.18); range of 23–74; and Cronbach''s alpha was .91 About half reported that support for CES and its inclusion in the academic decision process increased since the institution was awarded a CTSA. Open‐ended responses indicated some confusion with terminology although a definition of CES had been provided in the instrument instructions.

Conclusion

Respondents overall agreed there was moderate support for CES in tenure, promotion, and retention decisions which may have been influenced by the CTSA application requirements. This survey could be used to identify if there are differences in institutional and departments and measure changes over time.     

Understanding the Supports of and Challenges to Community Engagement in the CTSAs

Background

The Clinical and Translational Science Award (CTSA) program has raised the profile and the available funding for engagement in biomedical research. Such increased funding and attention may address known barriers to engagement. However, little work has been done to describe experiences across multiple CTSAs, especially how the CTSA structure supports or challenges engagement.

Objective

We sought to understand the supports and challenges experienced by multiple CTSAs as they pursued community engagement. This knowledge may help guide future efforts to support and enhance community engagement in biomedical research.

Methods

We conducted semi‐structured, in‐depth interviews with CTSA community engagement core leaders and staff from the 2006 cohort of CTSAs (n = 12).

Results

A total of 17 interviews with respondents from nine institutions identified three support themes, including: funding, existing relationships with communities, and leadership and a partnership approach at the institution. Six challenge themes arose: need for capacity development, lack of positive relationships with communities, lack of leadership, funding constraints, time and staff constraints, and unsustainable models.

Conclusion

The CTSAs have brought much‐needed attention to community engagement in research, but more can be done to adequately support engagement. Challenges remain that need to be addressed to achieve the potential benefits of engagement.     

Promotion and Tenure for Community‐Engaged Research: An Examination of Promotion and Tenure Support for Community‐Engaged Research at Three Universities Collaborating through a Clinical and Translational Science Award

Introduction

Community‐engaged health research, an approach to research which includes the participation of communities, promotes the translation of research to address and improve social determinants of health. As a way to encourage community‐engaged research, the National Institutes of Health required applicants to the Clinical and Translational Science Award (CTSA) to include a community engagement component. Although grant‐funding may support an increase in community‐engaged research, faculties also respond to the rewards and demands of university promotion and tenure standards. This paper measures faculty perception of how three institutions funded by a CTSA support community‐engaged research in the promotion and tenure process.

Methods

At three institutions funded by a CTSA, tenure track and nontenure track faculty responded to a survey regarding perceptions of how promotion and tenure committees value community‐engaged research.

Results

Faculty view support for community‐engaged research with some reserve. Only 36% agree that community‐engaged research is valued in the promotion and tenure process.

Discussion

Encouraging community‐engaged scholarship requires changing the culture and values behind promotion and tenure decisions. Institutions will increase community‐engaged research and more faculty will adopt its principles, when it is rewarded by promotion and tenure committees.     

Developing the Translational Research Workforce: A Pilot Study of Common Metrics for Evaluating the Clinical and Translational Award KL2 Program

Purpose

This pilot study describes the career development programs (i.e., NIH KL2 awards) across five Clinical and Translational Science Award (CTSA) institutions within the University of California (UC) system, and examines the feasibility of a set of common metrics for evaluating early outcomes.

Methods

A survey of program administrators provided data related to the institutional environment within which each KL2 program was implemented. Application and progress report data yielded a combined data set that characterized KL2 awardees, their initial productivity, and early career outcomes.

Results

The pilot project demonstrated the feasibility of aggregating common metrics data across multiple institutions. The data indicated that KL2 awardees were an accomplished set of investigators, both before and after the award period, representing a wide variety of disciplines. Awardees that had completed their trainee period overwhelmingly remained active in translational research conducted within an academic setting. Early indications also suggest high rates of success with obtaining research funding subsequent to the KL2 award.

Conclusion

This project offers a model for how to collect and analyze common metrics related to the education and training function of the CTSA Consortium. Next steps call for expanding participation to other CTSA sites outside of the University of California system.     

Developing Future Clinician Scientists while Supporting a Research Infrastructure

Background

Supporting clinical research is a national priority. Clinician scientists are rare and clinical trials in academic medical centers (AMC) often fail to meet enrollment goals. Undergraduate students interested in biomedical careers often lack opportunities to perform clinical research.

Objective

Describe an innovative undergraduate course that supports clinical research in an AMC.

Methods

The course, Clinical Research Methods and Practice, offers undergraduate students the opportunity to learn clinical research through didactic and practical experiences. The students in turn support clinician scientists’ conduct of clinical studies in an AMC. Clinician scientists receive research support and participate in mentoring sessions for students.

Results

Over seven semesters, 128 students have assisted in 21 clinical studies located in outpatient and inpatient units of two hospitals. Students identified and screened eligible patients, collected clinical data, assisted in obtaining informed consent, and transported specimens. Many of the clinician scientists have met their enrollment goals and several have been top‐enrollers in multicenter clinical trials as a result of student support.

Conclusions

The Clinical Research Methods and Practice class addresses barriers to clinical research in AMC. This may be a model for institutions committed to mentoring students early in their career and to developing infrastructures for clinical research. Clin Trans Sci 2013; Volume 6: 94–97     

Community Representatives’ Involvement in Clinical and Translational Science Awardee Activities

Objectives

To understand the formal roles of community representatives (CRs) in Clinical and Translational Science Awardee (CTSA) activities, to evaluate the extent of integration into the organizational and governance structures and to identify barriers to effective integration.

Methods

The inventory tool was distributed to each of the 60 CTSAs using a secure web application.

Results

Forty‐seven (78%) completed the inventory. The mean number of CRs per CTSA is 21.4 (SD: 14.8). Most CTSAs had community advisory boards (89%) and 94% included CRs in Community Engagement (CE) cores. Only 11% reported a CR being a member of the CTSA leadership team and 19% reported that CRs advise core programs beyond CE.CRs are compensated by 79% of CTSAs. Mean annual compensation is $753 (median: $400). Compensation directly correlated with the number of hours that CRs worked in CTSA activities (r = 0.64; P = 0.001).

Conclusions

This inventory allows CTSAs to better understand how CRs have engaged in activities and brings attention to the limited representation among cores and in leadership roles. CTSAs should, with substantive input from CRs, develop strategies to provide the resources and compensation necessary to better integrate the community in CTSA activities and fully realize the goals of the CTSA vision.     

Impact of Professional Student Mentored Research Fellowship on Medical Education and Academic Medicine Career Path

Context

This study explores the long‐term impact of the Professional Student Mentored Research Fellowship (PSMRF) program at the University of Kentucky College of Medicine (UKCOM) on medical students’ research productivity and career paths.

Methods

Demographic characteristics, academic profiles, number of publications and residency placements from 2007 to 2012 were used to assess 119 PSMRF graduates against a comparison cohort of 898 UKCOM (non‐PSMRF) students.

Results

PSMRF students had higher MCAT scores at admission (31.5 ± 0.6 vs. 30.6 ± 0.2, p = 0.007) and achieved higher USMLE Step 1 scores (228 ± 4.2 vs. 223 ± 1.5, p = 0.03) than comparison group. PSMRF students were more likely to publish PubMed‐indexed papers (36.7% vs. 17.9%, p < 0.0001), achieve AOA status (19.3% vs. 8.5%, p = 0.0002) and match to top 25 US News and World Report residency programs (23.4% vs. 12.1%, p = 0.008). A greater proportion of PSMRF fellows matched to top tier competitive specialties (23% vs. 14.2%, p = 0.07), however this difference was not statistically significant.

Conclusions

The PSMRF program shows a significant increase in enrollment, as well as positive associations with indicators of success in medical school and subsequent quality of residency program.     

Enhancing Dissemination,Implementation, and Improvement Science in CTSAs through Regional Partnerships

Background and Importance

Challenges in healthcare policy and practice have stimulated interest in dissemination and implementation science. The Institute of Medicine Committee on the Clinical Translational Science Award (CTSA) program recommended expanding the CTSA program''s investment and activity in this domain. Guidance is needed to facilitate successful growth of DII science infrastructure, activity and impacts.

Objectives

Several CTSAs in Southern California collaborated to identify and respond to local challenges and opportunities to expand dissemination, implementation and improvement research by strengthening capacity and relationships between DII researchers and community, health system, and population health partners.

Main outcomes

Planning and outreach by the Southern California CTSAs increased awareness and interest in DII research and generated recommendations for growth. Recommendations include: increasing strong partnerships with healthcare and population health systems to guide policy research agendas and collaborative DII science; promoting multi‐sector partnerships that involve researchers and delivery systems throughout DII processes; bringing together multiple disciplines; and addressing national and international barriers as well as opportunities in DII science.

Implications

CTSAs through regional collaboration can increase their contributions to improved community health via skill‐building, partnership development and enhanced outreach to local healthcare and public health agencies and delivery systems.     

Public Participation in,and Awareness about,Medical Research Opportunities in the Era of Clinical and Translational Research

Context

In the United States, levels of public participation in medical research in the era of Clinical and Translational Science Awards (CTSAs) are unknown.

Methods

In 2011, a household survey was administered to a sample of U.S. adults, asking whether they (and children <18 years old) had participated, or were aware of opportunities to participate, in medical research. Respondents living within 100 miles of CTSA sites were identified. Regression analyses of participation and awareness (PA) were performed, applying sampling weights to permit nationally representative inferences.

Results

Overall, 2,150 individuals responded (completion rate = 60%); 65% of adults and 63% of families with children resided within 100 miles of ≥1 CTSA location. Research participation rates were 11% among adults and 5% among children. Among nonparticipants, awareness rates were 64% among adults and 12% among parents of children. PA among adults was associated with higher income and education, older age, presence of chronic conditions, and living within 100 miles of four specific CTSA locations. For children, PA was associated with higher household income and parents’ chronic health conditions.

Conclusions

PA of medical research opportunities is substantially higher for adults than children. Higher PA levels near specific CTSAs merit investigation to identify their successful approaches.     

A Data‐Rich Recruitment Core to Support Translational Clinical Research

Background

Underenrollment of clinical studies wastes resources and delays assessment of research discoveries. We describe the organization and impact of a centralized recruitment core delivering comprehensive recruitment support to investigators.

Methods

The Rockefeller University Center for Clinical and Translational Science supports a centralized recruitment core, call center, Research Volunteer Repository, data infrastructure, and staff who provide expert recruitment services to investigators. During protocol development, consultations aim to optimize enrollment feasibility, develop recruitment strategy, budget, and advertising. Services during study conduct include advertising placement, repository queries, call management, prescreening, referral, and visit scheduling. Utilization and recruitment outcomes are tracked using dedicated software.

Results

For protocols receiving recruitment services during 2009–2013: median time from initiation of recruitment to the first enrolled participant was 10 days; of 4,047 first‐time callers to the call center, 92% (n = 3,722) enrolled in the Research Volunteer Repository, with 99% retention; 23% of Repository enrollees subsequently enrolled in ≥1 research studies, with 89% retention. Of volunteers referred by repository queries, 49% (280/537) enrolled into the study, with 92% retained.

Conclusions

Provision of robust recruitment infrastructure including expertise, a volunteer repository, data capture and real‐time analysis accelerates protocol accrual. Application of recruitment science improves the quality of clinical investigation.     

Improving the Proficiency of Research Consent Administrators

Objective:

To describe the development and testing of a module to improve consent administrators’ skills when obtaining research consent from culturally and linguistically diverse and low literacy populations.

Design:

Development and psychometric testing of video module including community vignettes.

Methods:

Following initial content, face, and construct validity testing by experts, a field trial was conducted with pre‐ and postknowledge tests and satisfaction surveys completed by 112 consent administrators.

Results:

Mean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t‐test 95% confidence interval of difference: –0.18 to –0.88; two‐tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0–35), but years of experience was not significantly associated with either pre‐ or posttest scores (p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made.

Conclusion:

Although pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training.     

Report on CTSA Consortium Use of the Community Engagement Consulting Service

Introduction

The CTSA Community Engagement Consultative Service (CECS) is a national partnership designed to improve community engaged research (CEnR) through expert consultation. This report assesses the feasibility of CECS and presents findings from 2008 to 2009.

Methodology

A coordinating center and five regional coordinating sites managed the service. CTSAs identified a primary previsit CE best practice for consultants to address and completed self‐assessments, postvisit evaluations, and action plans. Feasibility was assessed as the percent of CTSAs participating and completing evaluations. Frequencies were calculated for evaluation responses.

Results

Of the 38 CTSAs, 36 (95%) completed a self‐assessment. Of these 36 sites, 83%, 53%, and 44% completed a consultant visit, evaluation, and action plan, respectively, and 56% of the consultants completed an evaluation. The most common best practice identified previsit was improvement in CEnR (addressing outcomes that matter); however, relationship building with communities was most commonly addressed during consulting visits. Although 90% of the consultants were very confident sites could develop an action plan, only 35% were very confident in the CTSAs’ abilities to implement one.

Conclusions

Academic medical centers interested in collaborating with communities and translating research to improve health need to further develop their capacity for CE and CEnR within their institutions. Clin Trans Sci 2013; Volume 6: 34–39     

A Social Network Analysis of 140 Community‐Academic Partnerships for Health: Examining the Healthier Wisconsin Partnership Program

Introduction:

Social Network Analysis (SNA) provides an important, underutilized approach to evaluating Community Academic Partnerships for Health (CAPHs). This study examines administrative data from 140 CAPHs funded by the Healthier Wisconsin Partnership Program (HWPP).

Methods:

Funder data was normalized to maximize number of interconnections between funded projects and 318 non‐redundant community partner organizations in a dual mode analysis, examining the period from 2003–2013.Two strategic planning periods, 2003–2008 vs. 2009–2014, allowed temporal comparison.

Results:

Connectivity of the network was largely unchanged over time, with most projects and partner organizations connected to a single large component in both time periods. Inter‐partner ties formed in HWPP projects were transient. Most community partners were only involved in projects during one strategic time period. Community organizations participating in both time periods were involved in significantly more projects during the first time period than partners participating in the first time period only (Cohen''s d = 0.93).

Discussion:

This approach represents a significant step toward using objective (non‐survey) data for large clusters of health partnerships and has implications for translational science in community settings. Considerations for government, funders, and communities are offered. Examining partnerships within health priority areas, orphaned projects, and faculty ties to these networks are areas for future research.     

Patient Engagement in Neurological Clinical Trials Design: A Conference Summary

Objectives

The conference objectives included educating patients and advocates about clinical trials, educating the clinical research community about patient perspectives on participating in clinical trial design, and identifying strategies to increase participation in clinical trial design for neurological disorders.

Design

Observations were noted during a 1‐day conference attended by patients, patient advocates, clinical trial staff, and investigators. The conference offered didactic sessions, small, and large group discussions.

Participants

Conference participants were patients, patient advocates, clinical trial staff, students, and investigators interested in engaging patients in clinical trial design for neurological disorders.

Measures

Conference participants were asked to consider lessons learned that could increase patient engagement in clinical trial design.

Results

We found that there is growing interest in including patients in the design of clinical trials for neurological disorders. Several themes emerged on how to move forward: networking; the multifaceted roles of advocates in research; training and education; creating patient–researcher partnerships; and clinical trials regulation issues.

Conclusions

The conference provided a forum for dialogue regarding stakeholder engagement in the design of clinical trials for neurological disorders. This experience provides a template for replication and dissemination of this conference and informs next steps to accelerate the pathway from dialogue to action.     

Sharing of Grant Funds between Academic Institutions and -Community Partners in Community‐Based Participatory Research

Objectives

To determine how grant funds are shared between academic institutions and community partners in community‐based participatory research (CBPR).

Methods

Review of all 62 investigator‐initiated R01 CBPR grants funded by the National Institutes of Health from January 2005 to August 2012. Using prespecified criteria, two reviewers independently categorized each budget item as being for an academic institution or a community partner. A third reviewer helped resolve any discrepancies.

Results

Among 49 evaluable grants, 68% of all grant funds were for academic institutions and 30% were for community partners. For 2% of funds, it was unclear whether they were for academic institutions or for community partners. Community partners’ share of funds was highest in the categories of other direct costs (62%) and other personnel (48%) and lowest in the categories of equipment (1%) and indirect costs (7%).

Conclusions

A majority of CBPR grant funds are allocated to academic institutions. In order to enhance the share that community partners receive, funders may wish to specify a minimum proportion of grant funds that should be allocated to community partners in CBPR projects.     

A Research Mentor Training Curriculum for Clinical and Translational Researchers

Purpose

To design and evaluate a research mentor training curriculum for clinical and translational researchers. The resulting 8‐hour curriculum was implemented as part of a national mentor training trial.

Method

The mentor training curriculum was implemented with 144 mentors at 16 academic institutions. Facilitators of the curriculum participated in a train‐the‐trainer workshop to ensure uniform delivery. The data used for this report were collected from participants during the training sessions through reflective writing, and following the last training session via confidential survey with a 94% response rate.

Results

A total of 88% of respondents reported high levels of satisfaction with the training experience, and 90% noted they would recommend the training to a colleague. Participants also reported significant learning gains across six mentoring competencies as well as specific impacts of the training on their mentoring practice.

Conclusions

The data suggest the described research mentor training curriculum is an effective means of engaging research mentors to reflect upon and improve their research mentoring practices. The training resulted in high satisfaction, self‐reported skill gains as well as behavioral changes of clinical and translational research mentors. Given success across 16 diverse sites, this training may serve as a national model. Clin Trans Sci 2013; Volume 6: 26–33     

Citations in Life Science Patents to Publicly Funded Research at Academic Medical Centers

Background

The contributions of Academic Medical Centers (AMCs) to biomedical innovation have been difficult to measure because of the challenges involved in tracing knowledge flows from their origin to their uses.

Methods

The authors examined patent citation linkages between AMC research funded by the National Institutes of Health (NIH) and patents. In prospective analyses, they examine the extent to which articles resulting from NIH grants to AMCs awarded between 1990 and 1995 were cited in drug and medical patents. The authors then examine the extent to which these patents are associated with marketed drugs. In retrospective analyses, they examine the share of drugs approved between 2000 and 2009 that have citation links to NIH‐funded AMC research.

Results

The prospective analyses show over a third of AMC grants resulted in publications that were cited in patents. Most the patents are drug and biotechnology patents, and are assigned to private firms. Patents citing NIH‐funded AMC publications were associated with 106 new FDA approved drugs, half of which are new molecular entities and a quarter of which are priority NMEs. The retrospective analyses showed that about half of the new molecular entities approved over the 2000–2009 period had citations links to NIH‐funded AMC research.

Conclusions

There are strong links between articles from NIH‐funded AMC research and private sector medical patenting, including drugs. More research is needed to better understand the types of links the citations represent and their implications for public policy.