Demonstration Project

May 2, 2019: Cost-Effectiveness Analysis of STOP CRC Trial Finds Wide Variation Across Health Centers

Posted on by Damon Seils

A cost-effectiveness analysis of the Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) trial, an NIH Collaboratory Trial, revealed wide variation across participating health centers. The study’s findings reflect the complexity of implementing an intervention in pragmatic research involving community health clinics with diverse patient populations, clinic structures, and resources.

The study was published recently in Preventive Medicine.

The STOP CRC trial tested a program to improve colorectal cancer screening rates in 26 clinics within 8 federal qualified health centers in California and Oregon. Intervention clinics embedded a tool in the electronic health record to identify patients who were overdue for screening and mailed a fecal immunochemical test (FIT) kit to these patients. Screening rates were higher overall in intervention clinics than in clinics that practiced usual care, despite low and highly variable rates of implementation of the program among participating clinics.

In the subsequent cost-effectiveness study, variability in program implementation was likewise a key factor in the results. Intervention delivery costs were highly variable across health centers, and the incremental cost-effectiveness of the intervention was diminished somewhat because usual care clinics generated more colonoscopies than intervention clinics after abnormal FIT results.

The study has implications for the design of implementation strategies in pragmatic trials that are embedded in diverse community health centers.

The STOP CRC trial was supported within the NIH Collaboratory by a cooperative agreement from the National Cancer Institute and received logistical and technical support from the NIH Collaboratory Coordinating Center. Download a study snapshot of the STOP CRC trial, and learn more about the NIH Collaboratory Trials.

April 19, 2019: Trauma Survivors Outcomes & Support (TSOS) Pragmatic Trial: Revisiting Effectiveness & Implementation Aims (Doug Zatzick, MD)

Posted on by Gina Uhlenbrauck

Speaker

Doug Zatzick, MD
Professor of Psychiatry
Harborview Medical Center
University of Washington School of Medicine

Topic

Trauma Survivors Outcomes & Support (TSOS) Pragmatic Trial: Revisiting Effectiveness & Implementation Aims

Keywords

Trauma outcomes; NIH Collaboratory Trial; Hybrid study design; Implementation science; Pragmatic clinical trial; Cluster randomization; Stepped-wedge design; Posttraumatic stress disorder; PRECIS-2; Mental health intervention

Key Points

  • The TSOS NIH Collaboratory Trial is a cluster-randomized, stepped-wedge trial conducted at 25 U.S. trauma centers. The intervention involves an electronic health record PTSD screen and a baseline PTSD and comorbidity assessment. TSOS is turned on at each site across 4 “waves.”
  • During the course of this hybrid effectiveness-implementation trial, two domains on PRECIS-2 (Pragmatic-Explanatory Continuum Indicator Summary) were scored as more pragmatic and one domain as more explanatory than at the outset of the study.
  • The study team developed a methodology for assessing TSOS implementation aims. Called RAPICE (Rapid Assessment Procedure Informed Clinical Ethnography), the method yielded findings around recurrent intervention and research staff turnover across sites; observations that some patients do not engage in the intervention; and ways to inform a priori secondary hypotheses that suggest per-protocol modifications to the original intention-to-treat analyses.
  • TSOS will present results at the 2020 summit of the American College of Surgeons with the potential to integrate findings into the College’s regulatory and verification processes.

Discussion Themes

Regarding the need to collect outcome data, there may be an important distinction between two aspects of “pragmatic.” That is, while collecting outcome data makes a trial more expensive (one aspect of pragmatic), it doesn’t necessarily affect relevance or generalizability (another, more important, aspect of pragmatic).

Might there be studies which, by design, are not aiming to be on the outer [more pragmatic] spokes of the PRECIS-2 wheel?

Read more about the TSOS NIH Collaboratory Trial.

Tags

#pctGR, @Collaboratory1, @PRECIS_2

April 22, 2019: TiME Trial Confirms Feasibility of Embedding Large Pragmatic Trials in Clinical Care

Posted on by Damon Seils

Laura Dember

The primary results of the Time to Reduce Mortality in End-Stage Renal Disease (TiME) trial, an NIH Collaboratory Trial, were published online this month in the Journal of the American Society of Nephrology. The study confirmed the feasibility of embedding a large pragmatic clinical trial in clinical care delivery.

Although maintenance hemodialysis has long been a staple of care for patients with end-stage renal disease, there are limited data from clinical trials to inform optimal approaches, including the optimal duration of hemodialysis sessions. The TiME trial investigators, in partnership with 2 large dialysis provider organizations, evaluated the effects of a longer hemodialysis session duration on mortality and hospitalization rate among more than 7000 patients receiving care in 266 dialysis facilities.

The TiME trial was discontinued early (median follow-up, 1.1 years) because there was an insufficient difference in mean hemodialysis session duration between the intervention group and the usual care group. The investigators observed no reduction in mortality or hospitalization rate in either group.

Despite ending early, the trial met important objectives for informing the implementation of large pragmatic clinical trials embedded in health care systems. In a large multicenter study with no onsite research personnel, the investigators quickly and efficiently enrolled a large number of participants using an opt-out consent approach. The study data were obtained entirely from the electronic health and administrative records of the partnering dialysis provider organizations and were generated from routine clinical care delivery.

“The TiME trial provides an important foundation for future pragmatic trials in dialysis as well as in other settings,” said Dr. Laura M. Dember of the University of Pennsylvania Perelman School of Medicine, the principal investigator of the TiME trial.

The TiME trial was supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Diabetes and Digestive and Kidney Diseases and received logistical and technical support from the NIH Collaboratory Coordinating Center. Download a study snapshot about the TiME trial, and learn more about the NIH Collaboratory Trials.

April 9, 2019: EMBED Awarded Continuation From Planning to Implementation Phase

Posted on by Karen Staman

The investigators of EMBED, an NIH Collaboratory Trial, have received approval to move from the planning phase to the implementation phase of their study. Congratulations to Dr. Ted Melnick, Dr. Gail D’Onofrio, and the EMBED study team for their excellent work!

“The opioid crisis is taking a devastating toll on Americans, their families, and their communities. The EMBED project leverages the urgency of our nation’s opioid crisis to bring together leaders in human-centered design, clinical informatics, data coordination, emergency medicine, and addiction medicine to provide an integrated, user-friendly solution to emergency clinicians caring for people with opioid addiction.”   —Dr. Edward Melnick, Co-PI of EMBED

EMBED (Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder) is designed to evaluate the effect of computerized clinical decision support on rates of emergency department-initiated buprenorphine/naloxone (BUP), which is a well-established outpatient treatment for people with opioid use disorder. BUP can only be prescribed by appropriately trained physicians. Although patients with opioid use disorder often seek medical care in emergency departments, the practice of initiating BUP in the emergency department is not common.

“Initiating buprenorphine in the emergency department has the potential to improve and save so many lives, but currently adoption rates are close to 0%. We believe that the EMBED intervention will be a crucial part of getting this evidence-based practice into routine emergency care.”   —Dr. Edward Melnick, Co-PI of EMBED

NIH Collaboratory Trials begin with a 1-year, milestone-driven planning phase. Projects become eligible to move to the implementation phase after an administrative review of progress toward scientific milestones and feasibility requirements.

In the planning phase, the EMBED study team developed the clinician decision support tools intended to facilitate the management of people with untreated opioid use disorder who seek care in emergency departments. In the next phase, the team will implement the trial and test the effect of the clinical decision support tool compared to usual care on outcomes in patients with opioid use disorder who seek care in emergency departments.

EMBED was supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Drug Abuse. The study also received logistical and technical support from the NIH Collaboratory Coordinating Center through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

 

April 1, 2019: Pre-Conference Seminar on Essentials of ePCTs Offered at AcademyHealth’s June 2019 Annual Research Meeting in D.C.

Posted on by Gina Uhlenbrauck

The NIH Collaboratory is partnering with AcademyHealth to offer a full-day pre-conference seminar at the 2019 Annual Research Meeting in Washington, D.C. Essentials of Embedded Pragmatic Clinical Trials will provide an introduction to the investigative opportunities for embedded health systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy. Firsthand ePCT experiences and case studies from the NIH Collaboratory will support and illustrate the topics presented. Speakers will include program officers and senior staff from NIH Institutes and Centers and senior investigators from the NIH Collaboratory Trials and Coordinating Center.

Learning objectives include:

  • To clarify the definition of ePCTs and explain their utility.
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing ePCTs within diverse health care systems.
  • To increase the capacity of health services researchers to address important clinical questions with ePCTs.
Seminar Details & Registration
Saturday, June 1, 2019
8 am to 5 pm
Walter E. Washington Convention Center
Washington, D.C.

March 13, 2019: PROVEN Publishes Study of Nursing Home Characteristics Associated With Implementation of an Advance Care Planning Video Intervention

Posted on by Gina Uhlenbrauck

The NIH Collaboratory Trial Pragmatic Trial of Video Education in Nursing Homes (PROVEN) is testing the effectiveness of a novel advance care planning (ACP) video education program in 360 nursing homes within 2 large nursing home healthcare systems. The investigators of PROVEN recently published a study that examines the characteristics of nursing homes associated with implementation of the video. They found that lower quality nursing homes (rated 1 star) had lower offer rates than higher quality nursing homes, suggesting that ongoing support might be necessary in these settings, as well as engagement with a local champion.

ACP is a process by which individuals define their future goals and preferences for medical treatment at the end of life and discuss these goals with their family and healthcare providers. ACP is especially important for nursing home residents, who often receive unnecessary care and experience burdensome transitions at the end of life. The ACP intervention in PROVEN is delivered by an onsite champion at the facility—usually a social worker with structured training in how and when to offer and show the ACP videos to residents and families.

 “These results have implications for future pragmatic trials in the NH [nursing home] setting because ongoing engagement between research and NH staff appears crucial for successful integration of interventions into routine clinical practice. Future research is needed to understand how to best engage NHs in implementation and encourage communication between NHs to share pragmatic strategies for improving clinical practice without the support of research staff.”

– Loomer et al. Journal of the American Medical Directors Association

March 6, 2018: Results of the Active Bathing to Eliminate (ABATE) Infection Trial Published in The Lancet

Posted on by Karen Staman

The Active Bathing to Eliminate (ABATE) Infection trial compared routine bathing to decolonization with universal chlorhexidine and targeted nasal mupirocin in non-critical-care units. Similar interventions have been found to reduce multidrug-resistant pathogens and bloodstream infections in intensive care units (ICUs), and this was the first large-scale trial in non-critical-care units. The primary outcome was methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococcus (VRE) clinical cultures attributed to participating units.

“We found that universal decolonization did not reduce infection in the overall population, but in post-hoc analyses of patients with medical devices the regimen was associated with significant reductions in all-cause bloodstream infections and MRSA or VRE clinical cultures.” —Huang et al. The Lancet 2019

The ABATE Infection trial was a large-scale pragmatic trial involving approximately189,000 patients in the baseline period and 340,000 patients in the intervention period across 194 non-critical-care units in 53 hospitals. The trial was one of the first NIH Collaboratory Trials, and in keeping with the Collaboratory’s mission, the investigators have helped expand the knowledge base about the design, conduct, and dissemination of pragmatic clinical trials.

February 1, 2019: Promoting Effective Advance Care Planning Communication in the Elderly: The ACP-PEACE Trial (James Tulsky, MD, Angelo Volandes, MD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

James Tulsky, MD
Chair, Department of Psychosocial Oncology and Palliative Care
Dana-Farber Cancer Institute
Professor of Medicine, Harvard Medical School
Chief, Division of Palliative Medicine
Brigham and Women’s Hospital

Angelo Volandes, MD, MPH
Associate Professor of Medicine
Massachusetts General Hospital
Harvard Medical School

Topic

Promoting Effective Advance Care Planning Communication in the Elderly: The ACP-PEACE Trial

Keywords

Pragmatic clinical trial; Advance care planning; ACP PEACE; Dana-Farber Cancer Institute; National Institute on Aging; Palliative care; Video declarations; Goal-concordant care; Patient preferences

Key Points

  • Many people with serious illness die without receiving goal-concordant care, and patients over the age of 65 with cancer experience this disproportionately. Helping patients engage in advance care planning (ACP) can empower them to express and record their goals so that their care can be aligned with their preferences.
  • The ACP PEACE NIH Collaboratory Trial is a pragmatic, stepped-wedge, randomized trial of a comprehensive ACP program in oncology clinics at 3 health systems. It will involve a combination of 2 evidence-based programs:
    • VitalTalk teaches clinicians important communication skills in having empathic conversations with seriously ill patients.
    • ACP Decisions uses videos to promote planning and decision-making by patients and families.
  • The ACP PEACE study will monitor long-term outcomes to evaluate whether patients received the care they planned for and wanted.

Discussion Themes

The last element of the ACP PEACE trial is a video declaration (ViDec), recorded by a subset of patients. In recording the ViDec, patients are prompted by questions assessing their confidence with their decision, satisfaction, decisional regret, and patient-provider experience.

The ACP PEACE study team has a scaling strategy in place if the intervention proves effective. Implementing the intervention as standard of care will involve a culture shift from what is currently expected in health systems.

Read more about the ACP PEACE NIH Collaboratory Trial in the Living Textbook.

Tags

#AdvanceCarePlanning, #pctGR, @Collaboratory1 @VitalTalk, @ACPDecisions

January 22, 2019: New Self-Paced ePCT Training Course Available

Posted on by Gina Uhlenbrauck

The NIH Collaboratory is pleased to announce the availability of a new self-paced, 10-module introductory course on how to design, conduct, and disseminate embedded PCTs (ePCTs). This course presents condensed material from the inaugural ePCT Training Workshop held in 2018 and provides users with important things to know and do when designing an ePCT, along with helpful links to additional learning resources within the Living Textbook.

Also available in the Living Textbook are links to videocast workshops hosted by the NIH on a range of ePCT topics including:

  • Embedded PCTs of therapeutic A versus B interventions
  • Unique opportunities for disseminating, implementing, and sustaining evidence-based practices into clinical care
  • Ethical and regulatory issues of PCTs

For these and other ePCT resources, visit the Training Resources webpage.

January 18, 2019: NIH Collaboratory Investigators Respond to FDA’s Proposed Rule on Informed Consent

Posted on by Karen Staman

NIH Collaboratory leadership and NIH Collaboratory Trial Principal Investigators have responded to the U.S. Food and Drug Administration’s (FDA’s) proposed rule to allow for a waiver or alteration of informed consent.

“We applaud the proposed rule to allow for a waiver or alteration of informed consent for clinical investigations posing no more than minimal risk to a human participant and including appropriate safeguards.

We agree about the broad benefits described in the proposed rule—healthcare advances, reduction in burden from harmonizing FDA’s regulations with the Common Rule, and reduced burden and costs for the IRB…”

The full letter is available for download and includes the list of signatories.