Design, creation, and use of the Test Us Bank (TUB) COVID-19 sample biorepository.

Shortly after the first case of SARS-CoV-2 was diagnosed a public health emergency (PHE) was declared and a multi-agency response was initiated within the US federal government to create and propagate testing capacity. As part of this response, an unprecedented program designated Rapid Acceleration of Diagnostics (RADx) Tech was established by the National Institutes of Health (NIH) to facilitate the development of point-of-care tests for the COVID-19. The RADx Tech Clinical Studies Core (CSC), located at the University of Massachusetts Chan Medical School (UMass Chan), with partnering academic, private, and non-governmental organizations around the country, was tasked with developing clinical studies to support this work.

Study protocol: Collaboration Oriented Approach to Controlling High blood pressure (COACH) in adults - a randomised controlled trial.

Introduction: Hypertension, the clinical condition of persistent high blood pressure (BP), is preventable yet remains a significant contributor to poor cardiovascular outcomes. Digital self-management support tools can increase patient self-care behaviours to improve BP. We created a patient-facing and provider-facing clinical decision support (CDS) application, called the Collaboration Oriented Approach to Controlling High BP (COACH), to integrate home BP data, guideline recommendations and patient-centred goals with primary care workflows.

Frequency of newborn bathing in the first 9 weeks of life and related factors: An observational study in a community-based sample from Meta-LARC.

Purpose: Environmental factors such as bathing may play a role in atopic dermatitis (AD) development. This analysis utilized data from the Community Assessment of Skin Care, Allergies, and Eczema (CASCADE) Trial (NCT03409367), a randomized controlled trial of emollient therapy for AD prevention in the general population, to estimate bathing frequency and associated factors within the first 9 weeks of life.

Methods: Data were collected from 909 parent/newborn dyads recruited from 25 pediatric and family medicine clinics from the Meta-network Learning and Research Center (Meta-LARC) practice-based research network (PBRN) consortium in Oregon, North Carolina, Colorado, and Wisconsin for the CASCADE trial.

Development and Evaluation of Serious Illness Conversation Training for Interprofessional Primary Care Teams.

Early advance care planning (ACP) conversations are essential to deliver patient-centered care. While primary care is an ideal setting to initiate ACP, such as Serious Illness Conversations (SICs), many barriers exist to implement such conversations in routine practice. An interprofessional team approach holds promises to address barriers.

Continuous Glucose Monitoring in Primary Care: Understanding and Supporting Clinicians' Use to Enhance Diabetes Care.

Purpose: Diabetes affects approximately 34 million Americans and many do not achieve glycemic targets. Continuous glucose monitoring (CGM) is associated with improved health outcomes for patients with diabetes. Most adults with diabetes receive care for their diabetes in primary care practices, where uptake of CGM is unclear.

Integrating Patient-generated Digital Health Data into Electronic Health Records (EHRs) in Ambulatory Care Settings: EHR Vendor Survey and Interviews.

Data traditionally collected in a clinic or hospital setting is now collected electronically in everyday environments from patients, known as patient-generated health data (PGHD). We conducted informal interviews and collected survey data from major ambulatory care EHR vendors that serve the majority of the U.S.

Improving Quality Improvement Capacity and Clinical Performance in Small Primary Care Practices.

Purpose: We undertook a study to assess whether implementing 7 evidence-based strategies to build improvement capacity within smaller primary care practices was associated with changes in performance on clinical quality measures (CQMs) for cardiovascular disease.

Methods: A total of 209 practices across Washington, Oregon, and Idaho participated in a pragmatic clinical trial that focused on building quality improvement capacity as measured by a validated questionnaire, the 12-point Quality Improvement Capacity Assessment (QICA). Clinics reported performance on 3 cardiovascular CQMs-appropriate aspirin use, blood pressure (BP) control (<140/90 mm Hg), and smoking screening/cessation counseling-at baseline (2015) and follow-up (2017).

Integration of Improvement and Implementation Science in Practice-Based Research Networks: a Longitudinal, Comparative Case Study.

Background: Implementation science (IS) and quality improvement (QI) inhabit distinct areas of scholarly literature, but are often blended in practice. Because practice-based research networks (PBRNs) draw from both traditions, their experience could inform opportunities for strategic IS-QI alignment.

Objective: To systematically examine IS, QI, and IS/QI projects conducted within a PBRN over time to identify similarities, differences, and synergies.

Prognostic Indices for Advance Care Planning in Primary Care: A Scoping Review.

Background: Patient identification is an important step for advance care planning (ACP) discussions.

Objectives: We conducted a scoping review to identify prognostic indices potentially useful for initiating ACP.

Methods: We included studies that developed and/or validated a multivariable prognostic index for all-cause mortality between 6 months and 5 years in community-dwelling adults.

Protocol for a Cluster Randomized Trial Comparing Team-Based to Clinician-Focused Implementation of Advance Care Planning in Primary Care.

For many patients, primary care is an appropriate setting for advance care planning (ACP). ACP focuses on what matters most to patients and ensuring health care supports patient-defined goals. ACP may involve interactions between a clinician and a patient, but for seriously ill patients ACP could be managed by a team.

Practice-Based Research Networks Ceding to a Single Institutional Review Board: A Report From the INSTTEPP Trial and Meta-LARC Consortium.

Historically, a single research project involving numerous practice-based research networks (PBRNs) required multiple institutional review boards (IRBs) to be involved in approval of the project. However, to avoid redundancies, federal IRB regulations now allow cooperative research projects that involve more than one institution to use reasonable methods of cooperative IRB review and to cede authority for review and oversight of the project to a single lead IRB. Through ceding, a lead IRB has the authority for review and oversight of the project delegated by all participating sites' IRBs and becomes the IRB of record for the ceded sites.

Adapting Boot Camp Translation Methods to Engage Clinician/Patient Research Teams Within Practice-Based Research Networks: A Report From the INSTTEPP Trial and Meta-LARC Consortium.

Purpose: Boot camp translation is a proven process to engage community members and health professionals in translating and disseminating evidence-based "best practices" models for health prevention and chronic illness care. Primary care practice improvement studies, particularly involving patient-driven change, as seen with self-management support (SMS), require engaged practice teams that include patients. Models of engagement such as boot camp translation may be effective.

How to Translate Self-Management Support Tools Into Clinical Practice: A Report From the INSTTEPP Trial and Meta-LARC Consortium.

Purpose: Patient self-management is an inevitable part of the work of being a patient, and self-management support (SMS) has become increasingly important in chronic disease management. However, the majority of SMS resources available in the Agency for Healthcare Research and Quality SMS Resource Library were developed without explicit collaboration between clinicians and patients.

Methods: Translation of SMS tools derived from the library into primary care practices occurred utilizing boot camp translation in four different practice-based research networks (PBRNs).

Implementing Community-Created Self-Management Support Tools in Primary Care Practices: Multimethod Analysis From the INSTTEPP Study.

Purpose: With one-half of Americans projected to be living with at least one chronic condition before 2020, enhancing patient self-management support (SMS) may improve health-related behaviors and clinical outcomes. Routine SMS implementation in primary care settings is difficult. Little is known about the practice conditions required for successful implementation of SMS tools.

Impact of a Boot Camp Translation Intervention on Self-Management Support in Primary Care: A Report From the INSTTEPP Trial and Meta-LARC Consortium.

Purpose: Self-management support (SMS) is a pillar of the well-established chronic care model and a key component of improving outcomes for patients with chronic illnesses. The Implementing Networks' Self-management Tools Through Engaging Patients and Practices (INSTTEPP) trial sought to determine whether a boot camp translation process could assist small to medium-sized primary care practices with care managers implement SMS tools.

Methods: INSTTEPP used a stepped-wedge design across 16 practices from 4 practice-based research networks over 12 months.

Defining High Value Elements for Reducing Cost and Utilization in Patient-Centered Medical Homes for the TOPMED Trial.

Introduction: Like most patient-centered medical home (PCMH) models, Oregon's program, the Patient-Centered Primary Care Home (PCPCH), aims to improve care while reducing costs; however, previous work shows that PCMH models do not uniformly achieve desired outcomes. Our objective was to describe a process for refining PCMH models to identify high value elements (HVEs) that reduce cost and utilization.

Methods: We performed a targeted literature review of each PCPCH core attribute.

Developing Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program in a Latino-Based Community Health Center.

Introduction: Colon cancer is the second leading cause of cancer death in the United States, and screening rates are disproportionately low among Latinos. One factor thought to contribute to the low screening rate is the difficulty Latinos encounter in understanding health information, and therefore in taking appropriate health action. Therefore, we used Boot Camp Translation (BCT), a patient engagement approach, to engage Latino stakeholders (ie, patients, clinic staff) in refining the messages and format of colon cancer screening reminders for a clinic-based direct mail fecal immunochemical testing (FIT) program.

The Burden of Childhood Atopic Dermatitis in the Primary Care Setting: A Report from the Meta-LARC Consortium.

Background: Little is known about the burden of atopic dermatitis (AD) encountered in US primary care practices and the frequency and type of skin care practices routinely used in children.

Objective: To estimate the prevalence of AD in children 0 to 5 years attending primary care practices in the United States and to describe routine skin care practices used in this population.

Design: A cross-sectional survey study of a convenience sample of children under the age of 5 attending primary care practices for any reason.

A Randomized Trial of High-Value Change Using Practice Facilitation.

Purpose: To understand how focused versus general practice facilitation can impact goal setting, action planning, and team performance in primary care transformation.

Background: Practice transformation in primary care is a crucial part of health reform, but can fatigue teams, leading to variable results. Practice facilitation may reduce primary care fatigue to help teams reach challenging transformation goals, but may require a more focused approach than previous studies suggest.

Quality of Colonoscopy Performed in Rural Practice: Experience From the Clinical Outcomes Research Initiative and the Oregon Rural Practice-Based Research Network.

Purpose: Colon cancer screening is effective. To complete screening in 80% of individuals over age 50 years by 2018 will require adequate colonoscopy capacity throughout the country, including rural areas, where colonoscopy providers may have less specialized training. Our aim was to study the quality of colonoscopy in rural settings.

Effect of a Pragmatic, Cluster-randomized Controlled Trial on Patient Experience With Care: The Transforming Outcomes for Patients Through Medical Home Evaluation and reDesign (TOPMED) Study.

Background: Health reform programs like the patient-centered medical home are intended to improve the triple aim. Previous studies on patient-centered medical homes have shown mixed effects, but high value elements (HVEs) are expected to improve the triple aim.

Objective: The aim of this study is to understand whether focusing on HVEs would improve patient experience with care.

Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain.

Objective: To assess reliability, validity, and responsiveness of a 29-item short-form version of the Patient Reported Outcomes Measurement Information System (PROMIS) and a novel “impact score” calculated from those measures.

Design: Prospective cohort study.

Setting: Rural primary care practices.

Team Science Approach to Developing Consensus on Research Good Practices for Practice-Based Research Networks: A Case Study.

Using peer learning strategies, seven experienced PBRNs working in collaborative teams articulated procedures for PBRN Research Good Practices (PRGPs). The PRGPs is a PBRN-specific resource to facilitate PBRN management and staff training, to promote adherence to study protocols, and to increase validity and generalizability of study findings. This paper describes the team science processes which culminated in the PRGPs.

Mammography Decision Aid Reduces Decisional Conflict for Women in Their Forties Considering Screening.

Background: Clinical guidelines recommend a personalized approach to mammography screening for women in their forties; however, methods to do so are lacking. An evidence-based mammography screening decision aid was developed as an electronic mobile application and evaluated in a before-after study.

Methods: The decision aid (Mammopad) included modules on breast cancer, mammography, risk assessment, and priority setting about screening.