The Northwest Participant and Clinical Interactions Network: Increasing opportunities for patients to participate in research across the Northwestern United States.

INTRODUCTION: The Institute of Translational Health Sciences (ITHS) promotes and supports translational research collaboration between clinicians, communities, and investigators across the five-state Washington, Wyoming, Alaska, Montana, and Idaho (WWAMI) region. The ITHS has developed a collaborative regional clinical research network, the Northwest Participant & Clinical Interactions Network (NW PCI), involving 12 diverse clinical health systems and academic institutions. METHODS: This descriptive article details NW PCI's development, infrastructure and governance, tools, characteristics, and initial outcomes. RESULTS: Regional NW PCI sites are conducting largely industry-sponsored studies; they are interested in including more grant-funded research. Regional NW PCI sites had over 1,240 open studies involving over 6700 patients in 2016. NW PCI trials are largely industry-sponsored; NW PCI sites are interested in including more grant-funded research. In its first three years, the NW PCI Coordinating Center facilitated regional sites' participation in 34 new grant and contract applications across diverse topics. CONCLUSION: The NW PCI model supports the goals of the developing CTSA Trial Innovation Network by increasing access to cutting-edge research across the Northwestern U.S., by supporting investigators seeking diverse populations, including those with rare diseases, for their research studies, and by providing settings to test implementation and dissemination of effective interventions.

Assessment of clinical trial participant patient satisfaction: a call to action.

BACKGROUND: As patient satisfaction scores become increasingly relevant in today's health care market, we sought to evaluate satisfaction of the unique subset of patients enrolling in clinical trials in a research facility embedded within a community hospital system. METHODS: We developed and deployed a patient satisfaction survey tailored to clinical trial patients who consented to and/or completed a clinical trial in our research institute in the prior year. The survey was distributed to 222 patients. Likert scale responses were analyzed using top box and percentile rank procedures. Correlation analysis was used to evaluate associations between the clinical trial experience and intent to return to our system for routine care. RESULTS: Ninety surveys were returned in the 6 months following the mailing for a 41 % response rate; the bulk of these (N = 81) were returned within 6 weeks of the mailing. The questions with the highest ranking responses were related to interactions with staff (84th percentile or higher). Fifty-one point one percent of patients (64th percentile) strongly agreed that they would seek future care in our system. Patient intent to return to the provider seen during the clinical trial was most highly correlated with intent to seek future care within our system (r = 0.54, p < 0.0001). Reasons cited for clinical trial enrollment were generally altruistic. CONCLUSIONS: Querying this special patient population is feasible and yields valuable insight into their experience with healthcare system-based clinical trials and the relationship between clinical trial participation and perception of the healthcare system as a desirable resource for routine medical care. We argue that this work is invaluable to the research community and submit a call to action to our peers to begin systematic evaluation of clinical trial patient satisfaction.

Quality improvement measures in pulse-oximetry newborn heart screening: a time series analysis.

BACKGROUND AND OBJECTIVES: The use of pulse-oximetry screening to detect critical congenital heart defects in newborns has gained national and international momentum in the past decade. Our hospital system began screening in 2008. Since then, our program has undergone leadership changes and multiple quality improvement interventions. The aims of this study are to evaluate the evolution of our pulse-oximetry program and to provide insights from lessons learned over the course of a long-standing program. METHODS: We reviewed 6 years of screening data and evaluated trends of missed screens, false-positives, protocol violations, and parental decline of screening. We implemented 3 quality improvement interventions (change in protocol, redesign of an electronic medical record documentation system to autocalculate results, and transition from research to standard-of-care) and reviewed the impact of a rigorous quality assurance review process. We used linear regression and statistical process control charts to evaluate the data. RESULTS: A total of 18,363 newborns were screened; we identified 5 critical cases. We observed a significant decrease in missed (P < .001) and false-positive (P = .03) screens over time but found no significant trend in the rate of percentage of protocol violations (P = .26) or decline of screening (P = .99). Each metric showed behavior attributable to at least 1 quality improvement intervention. CONCLUSIONS: We established a sustainable pulse-oximetry screening program in our community hospital system, and the screening has now become routine. The quality of our screening was influenced by choice of screening protocol, rigor of quality assurance reviews, and the process used to interpret screening results.