Abstract

Poor clinical trial (CT) recruitment is a significant barrier to translating basic science discoveries into medical practice. Improving support for primary care provider (PCP) referral of patients to CTs may be an important part of the solution. However, implementing CT referral support in primary care is not only technically challenging, but also presents challenges at the person and organization levels. The objectives of this study were (1) to characterize provider and clinical supervisor attitudes and perceptions regarding CT research, recruitment, and referrals in primary care and (2) to identify perceived workflow strategies and facilitators relevant to designing a technology-supported primary care CT referral program. Focus groups were conducted with PCPs, directors, and supervisors. Analysis indicated widespread support for the intrinsic scientific value of CTs, while at the same time deep concerns regarding protecting patient well-being, perceived loss of control when patients participate in trials, concern about the impact of point-of-care referrals on clinic workflow, the need for standard processes, and the need for CT information that enables referring providers to quickly confirm that the burdens are justified by the benefits at both patient and provider levels. PCP suggestions pertinent to implementing a CT referral decision support system are reported. The results from this work contribute to developing an implementation approach to support increased referral of patients to CTs.

Highlights

  • Poor clinical trial (CT) recruitment is a significant barrier to translating basic science discoveries into medical practice

  • The results are organized into two parts: thematic analysis and specific functional requirements identified by participants

  • Six themes emerged from the qualitative analysis: (1) protection of patient well-being is paramount, (2) concern over loss of control of patient care decisions, (3) distrust in CT quality and relevance and the need for clinic-level oversight, (4) lack of time to locate and evaluate trial information, (5) need for standardized processes and consistency in clinical workflow, and (6) motivation increases with professional relevance, “What’s in it for me?” Examples of the participant statements that exemplify these discussion points are included below

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Summary

Introduction

Poor clinical trial (CT) recruitment is a significant barrier to translating basic science discoveries into medical practice. Improving support for primary care provider (PCP) referral of patients to CTs may be an important part of the solution. Results: Analysis indicated widespread support for the intrinsic scientific value of CTs, while at the same time deep concerns regarding protecting patient well-being, perceived loss of control when patients participate in trials, concern about the impact of point-of-care referrals on clinic workflow, the need for standard processes, and the need for CT information that enables referring providers to quickly confirm that the burdens are justified by the benefits at both patient and provider levels. Conclusion: The results from this work contribute to developing an implementation approach to support increased referral of patients to CTs. Clinical trials (CTs) use the most rigorous standard scientific validation process to ascertain the effectiveness and safety of medical interventions [1]. Expanding the role of PCPs to include more frequent referral of patients to CTs may significantly improve recruitment efficiency

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