January 18, 2019: Pragmatic Trials in End-stage Renal Disease (ESRD): HiLo (Myles Wolf, MD, MMSc)

Speaker

Myles Wolf, MD, MMSc
Charles Johnson, MD, Professor of Medicine
Chief, Duke Nephrology
Duke University School of Medicine

Topic

Pragmatic Trials in End-stage Renal Disease (ESRD): HiLo

Keywords

Pragmatic clinical trial; HiLo; End-stage renal disease; ESRD; Kidney disease; Hypophosphatemia; Serum phosphate; Hemodialysis; A vs B trials; Clinical equipoise; National Institute of Diabetes and Digestive and Kidney Diseases; NIDDK

Key Points

  • With high event rates and few proven therapies, patients with end-stage renal disease (ESRD) are in desperate need of clinical innovation.
  • The NIH Collaboratory’s HiLo Demonstration Project is a pragmatic, multicenter, cluster-randomized, open-label, noninferiority outcomes trial that will compare effects of two different phosphate management strategies in patients with ESRD.
  • The study hypothesizes that, compared with strict phosphate control, less stringent control will yield noninferior rates of all-cause hospitalization among patients with ESRD undergoing hemodialysis, as well as reduce the risk of all-cause mortality, enhance markers of diet and nutrition, and improve quality of life.

Discussion Themes

Dialysis clinic dieticians will have a pivotal role in implementing HiLo. They have established a rapport with patients and are among the most motivated caregivers on dialysis teams.

Individual patient-level informed consent for the HiLo trial will be via internet-linked tablets, paper forms, and educational materials including a video. Benefits of obtaining consent include promoting adherence, direct study updates and newsletters to participants, and ability to collect additional data without involving onsite study staff.

HiLo will be the first definitive clinical trial-grade evidence for opinion-based guidelines for phosphate management. Thus, results of HiLo have the potential to rapidly influence ESRD clinical practice.

Read more about the HiLo Demonstration Project in the Living Textbook.

Tags

#ESRD, #pctGR, @Collaboratory1, @DCRINews, @DukeKidney

January 11, 2019: Nudge: Text Messaging at Scale in Diverse Health Systems to Support Adherence to Cardiac Medication (Sheana Bull, PhD, MPH, Michael Ho, MD, PhD)

Speakers

Sheana Bull, PhD, MPH
Professor, Colorado School of Public Health
Director, mHealth Impact Lab

Michael Ho, MD, PhD
Professor of Medicine, University of Colorado School of Medicine
Staff Cardiologist, Eastern Colorado Health Care System (Denver Veterans Affairs)

Topic

Nudge: Text Messaging at Scale in Diverse Health Systems to Support Adherence to Cardiac Medication

Keywords

Nudge; Cardiovascular disease; Mobile technology; Digital technology; Health promotion; Artificial intelligence; mHealth; Behavioral economics

Key Points

  • Medication non-adherence causes one-third of medicine-related hospitalizations. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges.”
  • The Nudge Demonstration Project will use population-level pharmacy data to deliver “nudges” via mobile phone text messaging and artificially intelligent chat bots. The nudges provide the patient with a reminder that their medicine refill is due.
  • The Nudge study team plans to engage patients, providers, and health system stakeholders in designing, refining, and implementing the pilot intervention within 3 diverse health systems.

Discussion Themes

There are overlapping notions between “nudge” theory and other socioeconomic theories. The study team relied on supporting literature as well as input from patient stakeholders to design the content of the nudge messages.

“Text message fatigue” is a potential concern that could affect study participation. Investigators relied on guidance from stakeholders to gauge the most appropriate frequency of messages.

Details about the use of a personal cell phone as the primary device messaging system, as well as privacy parameters, are explained in the opt-out letter presented to study participants.


For more information, visit the Nudge Demonstration Project on the Living Textbook.

Tags

#cardiovasculardisease, #pctGR, #mobile, #digitaltechnologies, #healthpromotion, #artificialintelligent, @Collaboratory1, @texhern, @lmhcurtis

January 4, 2019: TRANSFORMing Research for Patients With Heart Failure (Robert Mentz, MD, Kevin Anstrom, PhD, Eric Eisenstein, DBA, Stephen Greene, MD, Eric Velazquez, MD)

Speakers

Robert J. Mentz, MD
Associate Professor of Medicine
Duke University School of Medicine

Kevin J. Anstrom, PhD
Professor of Biostatistics and Bioinformatics
Director of Biostatistics, Duke Clinical Research Institute
Duke University School of Medicine

Eric Eisenstein, DBA
Associate Professor in Medicine
Duke University School of Medicine

Stephen J. Greene, MD
Fellow, Division of Cardiology and Duke Clinical Research Institute
Duke University School of Medicine

Eric J. Velazquez. MD, FACP, FACC, FASE, FAHA
Robert W. Berliner Professor of Medicine, Yale University
Chief, Cardiovascular Medicine, Yale New Haven Hospital
Physician-in-Chief, Heart and Vascular Center, Yale New Haven Health

Topic

TRANSFORMing Research for Patients With Heart Failure

Keywords

Pragmatic clinical trial; Heart failure; PRECIS-2; Hospitalization; TRANSFORM-HF; Clinical equipoise; Electronic health records; National Heart, Lung, and Blood Institute (NHLBI)

Key Points

  • The traditional approach to conducting clinical trials is unsustainable in many respects, including operational complexities, low enrollment rates, high costs, and failure to leverage existing resources. Incorporating pragmatic elements in the design of trials may improve efficiencies and conduct.
  • TRANSFORM-HF is a pragmatic trial evaluating torsemide versus furosemide treatment for long-term clinical outcomes among patients hospitalized for heart failure. Study randomization is 1:1, and the primary endpoint is all-cause mortality.
  • Advantages of trials with pragmatic designs include real-world effectiveness; broad patient/provider groups; reduced number and complexity of visits; streamlined data collection; potential for faster results; and results that will be more generalizable.

Discussion Themes

The clinical question involving starting a treatment (Should we start with furosemide or torsemide?) versus switching a treatment (Should we attempt to switch patients from furosemide to torsemide?) would seem to lead to different study designs.

While the peer review process for funding TRANSFORM-HF was challenging and required modifying the approach, it ultimately led to a better design.

Read more about PRECIS-2 domains along the explanatory-pragmatic continuum of a clinical trial in the Living Textbook.

Tags

#HeartFailure, #pctGR, @Collaboratory1, @robmentz, @SJGreene_md, @YaleCardiology, @ericjvelazquez

December 14, 2018: Guiding Good Choices for Health (GGC4H): Testing Feasibility and Effectiveness of Universal Parent-Focused Prevention in Three Healthcare Systems (Richard F. Catalano, PhD, Margaret Kuklinski, PhD, Stacy Sterling, DrPH, MSW)

Speakers

Richard F. Catalano, PhD, MPI GGC4H
Co-Founder, Social Development Research Group
Professor, School of Social Work
University of Washington

Margaret Kuklinski, PhD, MPI GGC4H
Research Scientist
Social Development Research Group
School of Social Work
University of Washington

Stacy Sterling, DrPH, MSW, MPI GGC4H
Research Scientist
Drug and Alcohol Research Team
Behavioral Health Research Initiative
Kaiser Permanente Northern California Division of Research

Topic

Guiding Good Choices for Health (GGC4H): Testing Feasibility and Effectiveness of Universal Parent-Focused Prevention in Three Healthcare Systems

Keywords

Guiding Good Choices; GGC4H; Healthcare systems; Pediatric primary care; Adolescent health; Evidence-based parenting programs; Pragmatic clinical trial; Demonstration Project

Key Points

  • By the time they leave high school, 20% to 25% of adolescents will meet criteria for depression, while many others will engage in health-compromising behaviors like delinquency and violence—with consequences for their long-term health.
  • Guiding Good Choices is a parenting program for parents of early adolescents ages 11-14 that has been evaluated in 2 randomized clinical trials and shown to reduce adolescent alcohol, tobacco, and marijuana use; depression; and delinquent behavior. It also strengthened parenting practices and parent–adolescent relationship quality.
  • The GGC4H Demonstration Project is a cluster-randomized trial that will use the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to test the feasibility and effectiveness of implementing Guiding Good Choices. GGC4H will engage in a novel multisite partnership between Guiding Good Choices developers and 3 large, integrated healthcare systems.

Discussion Themes

Although there is overwhelming evidence that the GGC4H program will work, stakeholders have not yet begun implementing. As ongoing conversations with clinical leaders and stakeholders take place, outcomes, services utilization, and cost analysis can help strengthen the case for implementation.

Enrollment is controlled by the investigative team so that the possibility of crossover from families in the control arm is diminished.

There may be other programs similar to Guiding Good Choices, promoted by the CDC as well as local communities and schools, that may influence the findings of this trial. The study team is making an effort to gain perspective on the impact of GGC4H specifically and reduce the possibility of contamination from other programs.

For more information, visit the GGC4H Demonstration Project on the Living Textbook.

Tags

@Collaboratory1, @UW, @KPShare, #healthcare, #depression, #adolescents, #clinicaltrials, #pctGR

December 7, 2018: Cluster Randomized Trials in Health Care Delivery Systems: Lessons from STIC2IT (Niteesh K. Choudhry, MD, PhD)

Speaker

Niteesh K. Choudhry, MD, PhD
Professor, Harvard Medical School
Executive Director, Center for Healthcare Delivery Sciences, Brigham and Women’s Hospital

Topic

Cluster Randomized Trials in Health Care Delivery Systems: Lessons from STIC2IT

Keywords

STIC2IT; Pragmatic clinical trial; Learning health system; Cluster randomization; Medication adherence; Telepharmacy; Electronic health record; Stakeholder engagement

Key Points

  • STIC2IT, a pragmatic, cluster-randomized trial, evaluated a telepharmacy intervention to improve medication adherence for people with chronic diseases.
  • Pragmatic aspects of STIC2IT included outcomes assessed using routinely collected data, cluster randomization by physician practice, intention-to-treat analysis, and use of the EHR to collect research data.
  •  While medication adherence did improve in the STIC2IT intervention group, secondary clinical outcomes did not improve. Future trials within health systems should incorporate multilevel engagement across the health system, physicians and staff, and patients.

Discussion Themes

It is important to do ongoing outreach at the health system leadership level to ensure understanding and commitment to the study and keep providers aware of the trial. Study teams should be mindful of the priorities of their partner health system.

Using the EHR for research data required some upfront work building special modules and generating custom reports.

For more information on conducting PCTs in health delivery systems, visit the Living Textbook chapter on engaging stakeholders and building partnerships.

Tags

@Collaboratory1, #pctGR, #HarvardMed, #telepharmacy

November 30, 2018: Validating a Computable Phenotype: Should Results Change a Trial’s Pre-Specified Primary Outcome? (Gregory E. Simon, MD, MPH, Susan M. Shortreed, PhD)

Speakers

Gregory E. Simon, MD, MPH
Senior Investigator, Kaiser Permanente Washington Health Research Institute

Susan M. Shortreed, PhD
Associate Investigator
Biostatistics Unit, Kaiser Permanente Washington Health Research Institute

Topic

Validating a Computable Phenotype: Should Results Change a Trial’s Pre-Specified Primary Outcome?

Keywords

Phenotype; Suicide prevention; Pragmatic trial; Ecode reporting

Key Points

  • The Suicide Prevention Outreach Trial (SPOT) design was used to conduct a pragmatic trial of two outreach programs to prevent suicide attempts and was used as example for validating computable phenotypes.
  • In the transition to ICD-10, there were changes in coding of injuries and poisonings, from “undetermined” to “self-inflicted” categories of events, leading to potential for miscoding and possible false positives or false negatives.

Discussion Themes

Assumptions about the applicability of data based on present interpretations are often applied to the future. However, data are always shifting and this fluidity should be taken into account when designing a trial.

Randomization can get rid of data biases but not data “noise.”

Providing complete transparency in reporting is the most important characteristic of valuable pragmatic clinical trial data in ascertaining the outcome.

Tags

@Collaboratory1, @GregSimonKPWHRI, @sshortreed, #pctGR, #phenotype, #suicideprevention, #pragmatictrial

November 16, 2018: Primary Palliative Care for Emergency Medicine (PRIM-ER) (Corita Grudzen, MD, MSHS)

Speaker

Corita R. Grudzen, MD, MSHS, FACEP
Vice Chair for Research
Associate Professor of Emergency Medicine and Population Health
Ronald O. Perelman Department of Emergency Medicine
NYU School of Medicine

Topic

Primary Palliative Care for Emergency Medicine (PRIM-ER)

Keywords

PRIM-ER; Emergency department; Palliative care; Demonstration project; Pragmatic trial; Stepped-wedge study design; Clinical decision support; Best practice alerts; Advance care planning

Key Point

  • The PRIM-ER trial is a pragmatic, cluster-randomized, stepped wedge Demonstration Project that will implement primary palliative care in emergency medicine across a diverse group of 35 emergency departments (EDs).
  • PRIM-ER’s clinical decision support intervention is tailored to each ED site. The study aims to enable system, organizational, and provider change in the emergency department workflow.
  • The study team is identifying and preparing site champions by conducting communication skills training in serious illness for emergency physicians and staff using the EM Talk program.

Discussion Themes

It is important to consider sustainability of the intervention during the planning phase of the trial. Plan for staff turnover and how new staff will be educated and oriented to the intervention.

The volume and sophistication of best practice alerts (BPAs) received by physicians varies across U.S. emergency departments. Alert “fatigue” can be a concern.

For more information on the PRIM-ER Demonstration Project, visit the PRIM-ER website on the Living Textbook.

Tags

@Collaboratory1, #pctGR, #EmergencyMedicine

November 9, 2018: Data Linkage Within, Across, and Beyond PCORnet (Thomas W. Carton, PhD, MS, Keith Marsolo, PhD)

Speakers

Thomas W. Carton, PhD, MS
Chief Data Officer, Louisiana Public Health Institute
PI, REACHnet

Keith Marsolo, PhD
Instructor
Department of Population Health Sciences
Duke University School of Medicine

Topic

Data Linkage Within, Across, and Beyond PCORnet

Keywords

PCORnet; Data linkage; Hashed linkage; Clinical Data Research Networks (CDRNs); Health Plan Research Networks; DataMarts; Salt; Electronic health records; Common Data Model

Key Points

  • The PCORnet network provides opportunities for data linkage within the network, across the network, and beyond the network. The formation of PCORnet 2.0 provides additional opportunities for linkage.
  • PCORnet 2.0’s structure includes 9 Clinical Data Research Networks and 2 Health Plan Research Networks.
  • The patient overlap between CDRNs and HPRNs is unknown but expected to be high. The patient overlap between CDRN and HPRN DataMarts is unknown but expected to be low in most cases (expect select markets).

Discussion Themes

Hash codes are not considered private health information because they are an encrypted identifier that cannot be linked back to the patient.

The primary challenges of the hashed data linkage system lie in the differences of opinion in how data are best interpreted. Working through the governance and regulatory components have been the most difficult.

Contending with differences in data coding that are present among systems can create different hash codes. However, there are ways to make the process consistent so that parameters can be established around the program.

Tags

@Collaboratory1, @PCORnetwork, @REACHnetCDRN, @DukeMedSchool, #medicare, #datalinkage, #pctGR

November 2, 2018: EMBED Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (Ted Melnick, MD, Gail D’Onofrio, MD)

Speakers

Ted Melnick, MD, MHS
Assistant Professor of Emergency Medicine
Program Director, ACGME Clinical Informatics Fellowship
Yale School of Medicine

Gail D’Onofrio, MD
Professor and Chair of Emergency Medicine, Yale School of Medicine
Physician-in-Chief of Emergency Services Yale-New Haven Hospital

Topic

EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder

Keywords

EMBED; Embedded PCT; Pragmatic clinical trial; Opioid use disorder; Clinical decision support; Emergency department; Buprenorphine

Key Points

  • The EMBED pragmatic trial is evaluating a clinical decision support tool designed to automatically identify and facilitate management of eligible patients with opioid use disorder in the emergency department (ED).
  • From July 2016 to Sep 2017, there was a 30% increase in visits to the ED for opioid overdose (Morbidity and Mortality Weekly Report, March 9, 2018).
  • With medication-assisted treatment, patients are 2 times more likely to be engaged in addiction treatment at 30 days.
  • EMBED’s user-centered design aims to streamline workflows, address barriers to adoption, embed ED-initiated buprenorphine into routine ED care, and optimize adoption, dissemination, implementation, and scalability.

Discussion Themes

Poor usability of health information technology (HIT) is major source of frustration for clinicians. Electronic health record usability is a fundamental barrier to implementation of evidence-based medicine.

The science of usability in healthcare is still in the early stages. The EMBED study wants to improve the HIT experience.

How much does the study rely on EHR data for outcomes, and how detailed are the pilot outcomes data requested from each system? How do you plan to verify the accuracy of those data?

For more information on treatment of opioid use disorder in the emergency department, visit the National Institute on Drug Abuse (NIDA) website’s Initiating Buprenorphine Treatment in the Emergency Department.

Tags

@Ted_Melnick, @DonofrioGail, @yaleem2, @YaleMed, @Collaboratory1, #pctGR, #EmergencyMedicine

October 26, 2018: Making Measurements Meaningful (Brian J. Zikmund-Fisher, PhD)

Speaker

Brian J. Zikmund-Fisher, PhD
Associate Professor of Health Behavior and Health Education
University of Michigan
Associate Director of the UM Center for Bioethics and Social Sciences in Medicine

Topic

Making Measurements Meaningful

Keywords

Health data; Return of results; Health measurements; Health communication

Key Points

  • Patients receive a variety of health measurements when visiting with their physicians; however, they may find it difficult to determine what the measurements mean. Incorporating objective numbers with clear graphics can be helpful.
  • “Out of range” test results can sometimes be difficult to depict for patients reviewing their health records. The online tool Icon Array was developed by the presenter to aid in the process.
  • When thinking about how to communicate health data effectively to patients, remember to “design for the way people are, not the way we wish they were.” (source: Holly Witteman)

Discussion Themes

Action thresholds are actively used in environmental communication, such as the Environmental Protection Agency (EPA). The challenge in incorporating a similar system in a clinical setting is that patients are buried in their situations, and clinical judgement can be objective. The problem this creates is that many patients are left to interpret numbers that they don’t understand.

Communicating research results in an impactful and clear way can help in understanding how to do the same thing in a clinical setting.

Professional consensus and practical implementation are two main challenges of adopting new ways of communicating health measurements.

Tags

#healthdata, #pctGR, @PCTGrandRounds, @Collaboratory1, @bzikmundfisher, @UM_IHPI, @umichsph