Pragmatic clinical trial

March 25, 2022: A Telehealth-Delivered Pragmatic Trial of Mindfulness for Persons with Chronic Low Back Pain (Natalia Morone, MD, MS)

Posted on by terren.green@duke.edu

Speaker

Natalia E. Morone, MD, MS
Associate Professor of Medicine
Boston University/Boston Medical Center

Keywords

Chronic pain; Mindfulness; Stress Reduction; Low back pain; OPTIMUM; The Pain, Enjoyment of Life and General Activity (PEG) Scale; HEAL Initiative

Key Points

  • Chronic back pain is very common across all racial and ethnic groups. Doctors treat chronic back pain with non-pharmacologic methods before resorting to pharmacologic treatments.
  • Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM) is a randomized study of mindfulness for low back pain operating in 3 health settings: Boston Medical Center; UPMC, Pittsburgh, PA; and University of North Carolina, Chapel Hill in partnership with Piedmont Health Services.
  • Participation in the OPTIMUM study requires 8 weekly 90 minute group-based sessions of mindfulness meditation training delivered in primary care through a telehealth medical visit with follow up assessments at 6 and 12 months.
  • Four methods of mindfulness meditation are taught: Walking meditation, body scan, breath focused meditation, and mindful stretching.
  • The OPTIMUM study uses the PEG scale as the main outcome measure at the 6 and 12 month follow up assessments.
  • Group tele-health visits provide a variety of benefits for patients including more time with a clinician, better medication adherence, and more patient satisfaction.

Discussion Themes

Primary care usually consists of 1 provider and 1 patient, but family medicine evolved to see patients in a group. This group setting model may have unexpected benefits.

OPTIMUM is part of the PRISM project and is collecting data on participant use of opioids along with all PRISM projects.

Recruiting minority participants has been a priority in the OPTIMUM trial. Targeting recruitment advertisements to zip codes where more minorities live makes a difference in recruiting a diverse population.

 

Read more about the OPTIMUM trial.

 

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#pctGR, @Collaboratory1

Grand Rounds April 1: ICD-Pieces: Improving Care for CKD, Diabetes and Hypertension in Health Systems (Miguel A. Vazquez, MD; George (Holt) Oliver, MD, PhD)

Speakers:

Miguel A. Vazquez, MD
Professor of Medicine
University of Texas Southwestern Medical Center
Dallas, TX

George (Holt) Oliver, MD, PhD
Vice President Clinical Informatics
Parkland Center for Clinical Innovation
Dallas, TX

 

Topic: ICD-Pieces: Improving Care for CKD, Diabetes and Hypertension in Health Systems

Date: Friday, April 1, 2022, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

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March 11, 2022: Understanding a Patient’s Daily Experience Through Mobile Devices and Wearables: Lessons Learned From the 8,000 Patient MIPACT Study and Implementation in a National Pragmatic Trial (Sachin Kheterpal, MD, MBA; Jessica Golbus, MD; Nicole Pescatore, MPH)

Posted on by terren.green@duke.edu

Speakers

Sachin Kheterpal, MD, MBA
Professor of Anesthesiology
Associate Dean for Research IT
PI for MIPACT and Co-PI for THRIVE University of Michigan

Jessica Golbus, MD
Clinical Instructor, Cardiovascular Medicine
Co-I for MIPACT
University of Michigan

Nicole Eyrich, MPH
MIPACT Clinical Research Project Manager University of Michigan

Keywords

MIPACT; Patient-reported outcomes; Virtual recruitment; Cohort Identification Toolkit; VALENTINE study; THRIVE study; Wearable data research; Propofol

Key Points

  • The MIPACT study combined patient reported outcome data with electronic health record data and data collected from wearable devices.
  • The MIPACT study followed over 7,000 participants for 3 years. Both in-person and virtual recruitment had similar success rates. Participant diversity was a priority during recruitment.
  • The VALENTINE Study was a prospective randomized controlled study using mobile wearable devices to enhance cardiac rehabilitation.
  • Older participants in the VALENTINE study were receptive and capable of using wearable technology to assist data collection for the study.
  • THRIVE is pragmatic clinical trial studying Propofol anesthesia in 22 states and 2 countries.

Discussion Themes

Economic barriers to participation may be present when using wearable device technology as an inclusion criteria for a study. There are various methods to reduce these barriers, such as providing participants with the wearable device and a minimal data plan.

There may be limits to the types of participant reported outcomes that can be collected remotely. Ideally, participants will decide what data researchers will have access to.

Read more about MIPACT, VALENTINE, and THRIVE study.  Read results from MIPACT and VALENTINE.

 

 Tags

#pctGR, @Collaboratory1

March 4, 2022: ACP COVID: A Trial to Evaluate an Advance Care Planning Video and Communication Skills Training Intervention for Older Adults During an Evolving Pandemic (Angelo E. Volandes, MD, MPH; James A. Tulsky, MD; Sophia N. Zupanc, BA)

Posted on by terren.green@duke.edu

Speaker

Angelo E. Volandes, MD, MPH
Associate Professor, Harvard Medical School and Massachusetts General Hospital

James A. Tulsky, MD
Chair, Department of Psychosocial Oncology and Palliative Care
Dana-Farber Cancer Institute
Professor of Medicine, Harvard Medical School

Sophia N. Zupanc, BA
Dana-Farber Cancer Institute

Keywords

Advanced Care Planning; VitalTalk; ACP DECISIONS; Unstructured data; Patient engagement; Clinician engagement

Key Points

  • ACP COVID combines the VitalTalk program and ACP DECISIONS videos to help patients and families navigate difficult decisions around advanced care planning.
  • VitalTalk is a non-profit organization providing evidence-based communication training. VitalTalk trained health care providers to communicate advanced care planning options with patients.
  • The ACP COVID study compared advanced care planning documentation rates at three specific timepoints: 6 months prior to COVID-19(control period, Sep 2019-Mar 2020), during the first wave of COVID-19(control period, March 2020-Sep 2020), and during the time period when vaccines were first rolled out in New York state(intervention period, Dec 2020-June 2021).
  • Advanced care planning conversations best happen in the outpatient setting, not in the hospital right before intubation.
  • Almost 24% of patients in the intervention period had Advance Care Planning conversations which was significantly higher than the control periods.

Discussion Themes

The clinician training program gave clinicians the skills to cope with the implications of the pandemic and led to increased clinician engagement.

 

 

Read more about ACP-COVID.

 

 Tags

#pctGR, @Collaboratory1

February 28, 2022: SPOT Finds No Reduction in Suicide Risk for At-Risk Adults Offered Care Management, Higher Risk for Those Offered Dialectical Behavior Therapy Skills Training

Posted on by terren.green@duke.edu

Offering care management to adult outpatients experiencing suicidal ideation did not reduce their risk of self-harm compared to usual care. Patients offered dialectical behavior therapy (DBT) skills training had significantly greater risk of self-harm compared to usual care.

These were the main findings of the Suicide Prevention Outreach Trial (SPOT), an NIH Pragmatic Trials Collaboratory Trial.

Dr. Greg Simon

The report was published this month in JAMA.

SPOT, a pragmatic randomized clinical trial embedded in 4 healthcare systems, compared 2 low-intensity outreach programs—care management and DBT skills training—to usual care in adults at risk of self-harm or suicidal behavior.

More than 18,000 patients participated in the study from March 2015 to March 2020. Adult outpatients who reported suicidal ideation on a mental health questionnaire were randomly assigned to 1 of 3 study groups: continued usual care, offer of a care management intervention program, and offer of a DBT skills training program.

“The inclusion of a usual care group was an important aspect of our study,” said Dr. Gregory Simon of Kaiser Permanente Washington Health Research Institute, SPOT’s principal investigator. “This control group allowed us to not only compare the effectiveness of one intervention to another, but also allowed us to determine the value of implementing either intervention.”

Patients in the care management intervention group received regular screening for suicide risk followed by guideline-based care appropriate to the patient’s assessed risk level for up to 12 months after enrollment. Care managers reported the patients’ risk level to outpatient clinicians who made decisions regarding further treatment. The care management intervention was intended to facilitate and maintain engagement in effective outpatient care.

Patients in the DBT skills training group received online video instruction on 4 specific DBT skills: mindfulness, mindfulness of current emotion, opposite action, and paced breathing. Skills coaches sent digital messages encouraging continued practice of the DBT skills for up to 12 months after enrollment.

Source: JAMA. 2022;327(7):630-638.

Researchers followed participant outcomes for 18 months after enrollment. The percentage of fatal or nonfatal self-harm events was 3.1% for those receiving usual care, 3.3% for those offered care management, and 3.9% for patients offered DBT skills training.

Additional analysis of patient subgroups found that the risk of self-harm varied with patients’ level of intervention participation. In both intervention groups, patients who actively declined intervention services had the lowest risk of self-harm. Patients who did not respond to the invitation to participate or who actively participated for more than 3 months had intermediate risk. Patients who initially participated in the intervention but continued for less than 3 months had the highest risk.

“A patient’s willingness to engage in an intervention can have a significant impact on its effectiveness,” Dr. Simon said. “When you attempt to deliver an intervention with no real-time feedback, there’s no way to know how that message is being received by the patient. A study team should not continue to reach out to a patient who finds it unhelpful. We believe that real-time feedback is essential to ensure patients are engaged so that the intervention can be implemented effectively,” said Dr. Simon.

SPOT was supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute of Mental Health and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

Watch Dr. Simon and colleague Dr. Susan Shortreed discuss the outcomes of SPOT in this NIH Pragmatic Trials Collaboratory PCT Grand Rounds presentation.

February 4, 2022: SPIRRIT-HFpEF: Opportunities and Challenges in a Large Registry-Based Randomized Clinical Trial(Adam DeVore, MD, MHS; Lars Lund, MD, PhD)

Posted on by terren.green@duke.edu

Speakers

Adam DeVore, MD, MHS
Associate Professor of Medicine
Duke University Medical Center
Duke Clinical Research Institute

Lars Lund, MD, PhD
Professor of Cardiology
Karolinska Institutet
Karolinska University Hospital

Topic

SPIRRIT-HFpEF: Opportunities and Challenges in a Large Registry-based Randomized Clinical Trial

Keywords

Heart Failure; SPIRRIT-HFpEF; Randomized clinical trial; Spironolactone; Eplerenone; Swedish Heart Failure Registry (SwedeHF)

Key Points

  • The SPIRRIT-HFpEF trial, conducted Sweden and the US, was a randomized pragmatic clinical trial of spironolactone or eplerenone in heart failure.
  • Death from heart disease is decreasing while death from Heart Failure is increasing.
  • The SPIRRIT-HFpEF trial focused on improving the trajectory for the growing heart failure population.
  • Patients treated with Spironolactone had a modest but not statistically significant improvement over placebo, but total hospitalizations were less.
  • Patients with a lower ejection fraction were more likely to benefit than patients with a higher ejection fraction.
  • The Swedish Heart Failure Registry (SwedeHF) has been collecting data from HF patients since 2000.’

Discussion Themes

The hardest aspect of a clinical trial is recruitment and enrollment. Patients are spread out over the health care system. The challenge is getting staff and personnel to do the work of screening and prescreening.

In the SPIRRIT-HFpEF, the drawbacks of not blinding were small and the costs of blinding would have been huge.

 

Learn more about the SPIRRIT-HFpEF trial and the Swedish Heart Failure Registry.  Read about the SPIRRIT-HFpEF trial results.

 

Tags

#pctGR, @Collaboratory1

January 21, 2022: Primary Palliative Care for Emergency Medicine (Corita R. Grudzen, MD, MSHS, FACEP)

Posted on by terren.green@duke.edu

Speaker

Corita R. Grudzen, MD, MSHS, FACEP
Professor, Emergency Medicine and Population Health
Associate Dean, Clinical Sciences
Deputy Director, Clinical and Translational Science Institute
Vice Chair for Research, Emergency Medicine
Ronald O. Perelman Department of Emergency Medicine
NYU Grossman School of Medicine

Keywords

Palliative Care; Stepped-Wedge study design; Emergency Department (ED); Gagne Index; PRIM-ER

 

Key Points

  • The Emergency Department is increasingly seeing older adults with serious illness rather than patients with acute trauma.
  • Primary Palliative Care for Emergency Medicine (PRIM-ER) is a stepped-wedge study partnership of 18 health systems in 33 EDs designed to change the culture and norms of emergency care to promote palliative care at home or hospice rather than admittance to the hospital.
  • The study used the Gagne Index greater than 6 to identify patients at high risk of short-term mortality. Patients with dementia did not need to meet the Gagne Index criteria to be included in the study.
  • A baseline survey, training of 2,470 emergency providers, and study intervention has been completed at all 33 sites.
  • Only .2% of ED patients in the study were admitted to hospice after their ED visit.  At 12 months post ED visit, 30% of dementia patients had died whereas 15.6% of the non-dementia chronic disease patients had died. Data analysis is ongoing.

Discussion Themes

Stepped-wedge studies present timing issues and COVID-19 increased these problems. A cluster randomized design may have been easier to implement.

 

The PRIM-ER study was considered quality improvement by the IRB, so no human subjects approval from the IRB was required.

 

The PRIM-ER next step will be developing tools for patients with dementia regarding palliative care in the ED.

 

Learn more about the PRIM-ER study.

 

Tags

#pctGR, @Collaboratory1

January 14, 2022: Searching for a Unicorn: Understanding Stakeholder Perspectives When Selecting Outcomes for Outpatient Trials (Christopher Lindsell, PhD)

Posted on by terren.green@duke.edu

Speaker

Christopher Lindsell, PhD
Professor of Biostatistics and Biomedical Informatics
Director, Vanderbilt Institute for Clinical and Translational Research (VICTR) Methods Program
Codirector, Vanderbilt Health Data Science (HEADS) Center

Topic

Searching for a Unicorn: Understanding Stakeholder Perspectives When Selecting Outcomes for Outpatient Trials

Keywords

Research outcome; Outpatient clinical trials; Patient-reported outcomes; Researcher-observed outcomes; Pragmatic trials; ACTIV-6; Days of benefit; Mean time unwell

Key Points

  • A research outcome is the main piece of data used to decide if the research intervention has failed or succeeded.
  • If the incorrect outcome is chosen, the question of whether the intervention has succeeded can’t be answered accurately. Finding the correct outcome requires asking the question ‘What matters?’
  • In studies that are designed to help you feel better faster, we may need to prioritize symptoms and signs (patient reported outcomes) over objective measures (researcher observed outcomes).
  • Outcomes should be chosen based on the purpose of the study.
  • Researchers need to balance sensitivity and specificity when choosing an outcome measure.
  • The ACTIV-6 study uses an overall symptom outcome scale to determine if patients ‘feel better faster.’
  • ACTIV-6 uses Days of Benefit and Time to Recovery/hospitalization and death as an outcome to determine if the intervention is successful.

Discussion Themes

It’s important to strive to complete the most powerful and efficient studies that we can do.

Having multiple medicines available that balance risk and benefit differently gives patients options for their treatment. Individual patients have differing levels of risk tolerance and different ideas about what is the most beneficial outcome.

 

Learn more about the ACTIV-6 study.

 

Tags

#pctGR, @Collaboratory1

Grand Rounds January 28: EMBED Trial Results: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder

Speakers:
Edward R Melnick, MD, MHS
Associate Professor of Emergency Medicine, Yale School of Medicine
Associate Professor of Biostatistics (Health Informatics), Yale School of Public Health
Program Director, Yale-VA Clinical Informatics Fellowship Program

Gail D’Onofrio, MD, MS
Albert E. Kent Professor of Emergency Medicine
Yale School of Medicine
Professor of Public Health, Chronic Disease & Epidemiology
Yale School of Public Health

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

Date: Friday, January 28, 2022, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

Click ‘Connect to Audio”
Choose ‘Computer Audio’ or ‘I will call in’.
If using the ‘call in option’, follow the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.

Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 2622 682 0537
Meeting Password: 12345

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 2622 682 0537

NOTE: For Toll-free users, the call-back (call me) services are also available.

December 10, 2021: Decentralized Trials: Naughty or Nice? (Adrian F. Hernandez, MD, MHS)

Posted on by terren.green@duke.edu

Speaker

Adrian F. Hernandez, MD, MHS
Executive Director, Duke Clinical Research Institute
Vice Dean, Duke University School of Medicine

Topic

Decentralized Trials: Naughty or Nice?

Keywords

Decentralized trials; Study design; Implementation; Patient engagement; Patient-reported data

Key Points

  • Decentralized trials have been occurring since the start of the internet and mobile devices to reach people where they are and collect data in places we were not able to in the past.
  • One key problem decentralized trials can help solve is the gap between those who wish to participate in research and those who actually do participate. Clinical trial deserts and lack of broadband widen the gap between those who wish to participate and those who are able.
  • Decentralized trials attempt to capture data remotely instead of at a site and virtually(patient-reported) rather than recorded by study personnel.
  • COVID-19 flipped the model for clinical trial visits from that of site-based visits and care to home based, virtual visits and care.
  • Enrollment can be a challenge for decentralized trials and requires engagement campaigns at various timepoints in the study to achieve desired enrollment numbers.
  • Decentralized trials can help ensure inclusion of diverse communities in your study population.
  • The HeartLine study, CHIEF-HF study, HERO-Together study, and ACTIV-6 study are taking advantage of various technologies to decentralize study design.

Discussion Themes

Decentralized methods may improve recruitment, but may not improve retention. We may need a hybrid model to keep a patient engaged.

Decentralized methods may require decisions about what data we should collect and what we could collect, but don’t need.

 

Read more about decentralized study design in Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010-2016: A Systematic Literature Review and Digitizing Clinical Trials.

 

Tags

#pctGR, @Collaboratory1