Research is increasingly conducted through multi-institutional consortia, and best practices for establishing multi-site research collaborations must be employed to ensure efficient, effective, and productive translational research teams. In this manuscript, we describe how the Population-based Research to Optimize the Screening Process Lung Research Center (PROSPR-Lung) utilized evidence-based Science of Team Science (SciTS) best practices to establish the consortium's infrastructure and processes to promote translational research in lung cancer screening. We provide specific, actionable examples of how we: (1) developed and reinforced a shared mission, vision, and goals; (2) maintained a transparent and representative leadership structure; (3) employed strong research support systems; (4) provided efficient and effective data management; (5) promoted interdisciplinary conversations; and (6) built a culture of trust. We offer guidance for managing a multi-site research center and data repository that may be applied to a variety of settings. Finally, we detail specific project management tools and processes used to drive collaboration, efficiency, and scientific productivity.
Approximately 70% of American Indian/Alaska Native (AI/AN) individuals reside in urban areas. Urban Indian Health Organizations (UIHOs) provide culturally engaged primary care for AI/AN patients and members of other racial and ethnic groups who have experienced disparities in diabetes and hypertension care, and are commonly affected by social and economic barriers to care. We assessed whether disparities were present between the racial and ethnic groups served by the largest UIHO in the USA. We developed retrospective cohorts of patients with hypertension or diabetes receiving primary care from this UIHO, measuring differences between AI/AN, Spanish-preferring Latinx, English-preferring Latinx, Black, and White patients in mean systolic blood pressure (SBP) and mean hemoglobin A1c (A1c) as primary outcomes. To assess processes of care, we also compared visit intensity, missed visits, and medication treatment intensity in regression models adjusted for sociodemographic and clinical characteristics. For hypertension (n = 2148), adjusted mean SBP ranged from 135.8 mm Hg among Whites to 141.3 mm Hg among Blacks (p = 0.06). For diabetes (n = 1211), adjusted A1c ranged from 7.7% among English-preferring Latinx to 8.7% among Blacks (p = 0.38). Care processes for both hypertension and diabetes varied across groups. No group consistently received lower-quality care. This UIHO provided care of comparable quality for hypertension and diabetes among urban-dwelling AI/ANs and members of other racial, ethnic, and language preference groups. Systematic assessments of care quality in UIHOs may help demonstrate the importance of their role in providing care and improve the quality of care.
Diabetes Mellitus , Hypertension , Humans , United States , Retrospective Studies , Glycated Hemoglobin , Racial Groups , Diabetes Mellitus/therapy , Hypertension/therapy
Interpreting results from deprescribing interventions to generate actionable evidence is challenging owing to inconsistent and heterogeneous outcome definitions between studies. We sought to characterize deprescribing intervention outcomes and recommend approaches to measure outcomes for future studies. A scoping literature review focused on deprescribing interventions for polypharmacy and informed a series of expert panel discussions and recommendations. Twelve experts in deprescribing research, policy, and clinical practice interventions participating in the Measures Workgroup of the US Deprescribing Research Network sought to characterize deprescribing outcomes and recommend approaches to measure outcomes for future studies. The scoping review identified 125 papers reflecting 107 deprescribing studies. Common outcomes included medication discontinuation, medication appropriateness, and a broad range of clinical outcomes potentially resulting from medication reduction. Panel recommendations included clearly defining clinically meaningful medication outcomes (e.g., number of chronic medications, dose reductions), ensuring adequate sample size and follow-up time to capture clinical outcomes resulting from medication discontinuation (e.g., quality of life [QOL]), and selecting appropriate and feasible data sources. A new conceptual model illustrates how downstream clinical outcomes (e.g., reduction in falls) should be interpreted in the context of initial changes in medication measures (e.g., reduction in mean total medications). Areas needing further development include implementation outcomes specific to deprescribing interventions and measures of adverse drug withdrawal events. Generating evidence to guide deprescribing is essential to address patient, caregiver, and clinician concerns about the benefits and harms of medication discontinuation. This article provides recommendations and an initial conceptual framework for selecting and applying appropriate intervention outcomes to support deprescribing research.
Deprescriptions , Drug-Related Side Effects and Adverse Reactions , Humans , Polypharmacy , Quality of Life
Interactive voice response and text message (IVR-T) technology may improve hypertension control in under-resourced settings. We conducted a randomized clinical trial to determine whether an IVR-T intervention would improve blood pressure (BP), medication adherence and visit keeping among adults with hypertension from multiple racial and ethnic groups in primary care at an Urban Indian Health Organization in Albuquerque, New Mexico. Two hundred and ninety-five participants were randomly assigned to IVR-T (N = 148) or to usual care (N = 147). The IVR-T arm received reminders for clinic visits, messages to reschedule missed clinic visits, monthly medication refill reminders, weekly motivational messages, and a blood pressure cuff. The usual care arm received no messages. The primary outcome was change in systolic BP (SBP) between baseline and 12 months. Secondary outcomes included change in SBP between baseline and 6 months, change in diastolic BP (DBP) at 6 and 12 months, self-reported adherence at 6 months, and the proportion of missed primary care clinic appointments. The intervention did not affect SBP or DBP at 6 or 12 months. The 12-month change in SBP/DBP was 1.66/1.10 mm Hg in usual care and 0.23/1.34 mm Hg in the intervention group (P values = .57 and .88, respectively). Self-reported medication adherence improved comparably in both groups, and there was no difference in percentage of kept visits. Several features of study design, clinic operations, and data transfer were barriers to demonstrating effectiveness.
Hypertension , Text Messaging , Adult , Blood Pressure , Humans , Hypertension/diagnosis , Hypertension/drug therapy , Medication Adherence , Primary Health Care
BACKGROUND: Efficient and effective strategies for treating chronic health conditions such as hypertension are particularly needed for under-resourced clinics such as Urban Indian Health Organizations (UIHOs). OBJECTIVE: The objective of the Controlling Blood Pressure Trial is to assess the impact of an interactive voice response and text message (IVR-T) intervention compared with usual care among individuals with hypertension receiving care at a UIHO in Albuquerque, New Mexico. This manuscript presents the baseline characteristics of individuals enrolled in the trial and compares their characteristics with those in the hypertension registry who did not enroll in the trial. METHODS: A hypertension registry developed from the clinic's electronic health record was used for recruitment. Potentially eligible participants were contacted by letter and then by phone. Those who expressed interest completed an in-person baseline visit that included a baseline survey and blood pressure measurement using standardized procedures. Individuals randomized to the intervention group could opt to receive either automated text messages or automated phone calls in either English or Spanish. The messages include reminders of upcoming appointments at First Nations Community HealthSource, requests to reschedule recently missed appointments, monthly reminders to refill medications, and weekly motivational messages to encourage self-care, appointment keeping, and medication taking for hypertension. Individuals in the IVR-T arm could opt to nominate a care partner to also receive notices of upcoming and missed appointments. Individuals in the IVR-T arm were also offered a home blood pressure monitor. Follow-up visits will be conducted at 6 months and 12 months. RESULTS: Over a 9.5-month period from April 2017 to January 2018, 295 participants were enrolled from a recruitment list of 1497 individuals. The enrolled cohort had a mean age of 53 years, was 25.1% (74/295) American Indian or Alaska Native and 51.9% (153/295) Hispanic, and 39.0% (115/295) had a baseline blood pressure greater than or equal to 140/90 mmHg. Overall, the differences between those enrolled in the trial and patients with hypertension who were ineligible, those who could not be reached, or those who chose not to enroll were minimal. Enrolled individuals had a slightly lower blood pressure (129/77 mmHg vs 132/79 mmHg; P=.04 for systolic blood pressure and P=.01 for diastolic blood pressure), were more likely to self-pay for their care (26% vs 10%; P<.001), and had a more recent primary care visit (164 days vs 231 days; P<.001). The enrolled cohort reported a high prevalence of poor health, low socioeconomic status, and high levels of basic material needs. CONCLUSIONS: The Controlling Blood Pressure Trial has successfully enrolled a representative sample of individuals receiving health care at a UIHO. Trial follow-up will conclude in February 2019. TRIAL REGISTRATION: ClinicalTrials.gov NCT03135405; http://clinicaltrials.gov/ct2/show/NCT03135405 (Archived by WebCite http://www.webcitation.org/76H2B4SO6). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11794.
CONTEXT.: The laboratory total testing process includes preanalytic, analytic, and postanalytic phases, but most laboratory quality improvement efforts address the analytic phase. Expanding quality improvement to preanalytic and postanalytic phases via use of medical data warehouses, repositories that include clinical, utilization, and administrative data, can improve patient care by ensuring appropriate test utilization. Cross-department, multidisciplinary collaboration to address gaps and improve patient and system outcomes is beneficial. OBJECTIVE.: To demonstrate medical data warehouse utility for characterizing laboratory-associated quality gaps amenable to preanalytic or postanalytic interventions. DESIGN.: A multidisciplinary team identified quality gaps. Medical data warehouse data were queried to characterize gaps. Organizational leaders were interviewed about quality improvement priorities. A decision aid with elements including national guidelines, local and national importance, and measurable outcomes was completed for each gap. RESULTS.: Gaps identified included (1) test ordering; (2) diagnosis, detection, and documentation, and (3) high-risk medication monitoring. After examination of medical data warehouse data including enrollment, diagnoses, laboratory, pharmacy, and procedures for baseline performance, high-risk medication monitoring was selected, specifically alanine aminotransferase, aspartate aminotransferase, complete blood count, and creatinine testing among patients receiving disease-modifying antirheumatic drugs. The test utilization gap was in monitoring timeliness (eg, >60% of patients had a monitoring gap exceeding the guideline recommended frequency). Other contributors to selecting this gap were organizational enthusiasm, regulatory labeling, and feasibility of a significant laboratory role in addressing the gap. CONCLUSIONS.: A multidisciplinary process facilitated identification and selection of a laboratory medicine quality gap. Medical data warehouse data were instrumental in characterizing gaps.
Data Warehousing/methods , Laboratories/standards , Laboratory Proficiency Testing/methods , Quality Assurance, Health Care/methods , Humans
PURPOSE: Multi-institutional collaborations are necessary in order to create large and robust data sets that are needed to answer important comparative effectiveness research (CER) questions. Before scientific work can begin, a complex maze of administrative and regulatory requirements must be efficiently navigated to avoid project delays. INNOVATION: Staff from research, regulatory, and administrative teams involved in three HMO Research Network (HMORN) multi-institutional collaborations developed and employed novel approaches: to secure and maintain Institutional Review Board (IRB) approvals; to enable data sharing, and to expedite subawards for two data-only minimal risk studies. These novel approaches accelerated required processes and approvals while maintaining regulatory, human subjects, and institutional protections. CREDIBILITY: Outcomes from the processes described here are compared with processes outlined in the research and regulatory literature and with processes that have been used in previous multisite research collaborations. CONCLUSION AND DISCUSSION: Research, regulatory, and administrative staff are essential contributors to the success of multi-institutional collaborations. Their flexibility, creativity, and effective communication skills can lead to the development of efficient approaches to achieving the necessary oversight for these complex projects. Elements of these specific strategies can be adapted and used by other research networks. Other efforts in these areas should be evaluated and shared. The processes that help develop a "learning research system" play an important and complementary role in sustaining multi-institutional research collaborations.
