SPOT Archives - Rethinking Clinical Trials

July 26, 2022: Three NIH Collaboratory Trials Share Progress on Planning, Implementation, and Completion

Posted on July 26, 2022January 16, 2024 by Damon Seils

At this year’s annual meeting of the NIH Pragmatic Trials Collaboratory Steering Committee, we interviewed investigators from 3 NIH Collaboratory Trials in different phases of the trial life cycle. IMPACt-LBP launched last fall and is completing its 1-year planning phase. ACP PEACE is nearing the end of its implementation phase. SPOT ended last year and published its main outcomes in February.

Learn more about these innovative NIH Collaboratory Trials in the brief video updates below.

IMPACt-LBP, currently in the 1-year planning phase, will evaluate implementation of the American College of Physicians guideline for low back pain, which involves multidisciplinary collaborative care that includes doctors of chiropractic and physical therapists. The study will measure the effects of first-contact patient referral to these clinicians on physical function, pain, opioid prescriptions, and other patient-level outcomes. The study is administered by the National Center for Complementary and Integrative Health with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development. The project is led by Drs. Christine Goertz, Adam Goode, and Hrishikesh Chakraborty of Duke University and Dr. Jon Lurie of Dartmouth Hitchcock Medical Center. Learn more about IMPACt-LBP.

ACP PEACE, currently in the implementation phase, is testing an advance care planning program that combines clinician communication skills training and patient video decision aids. ACP PEACE is focused on patients with advanced cancer and their clinicians in oncology settings. The study is administered by the National Institute on Aging and is led by Drs. Angelo Volandes and James Tulsky of Harvard Medical School. Learn more about ACP PEACE.

SPOT, a recently completed pragmatic trial that published its main outcomes earlier this year, compared 2 low-intensity outreach programs—care management and dialectical behavior therapy skills training—to usual care in adults at risk of self-harm or suicidal behavior. The study was administered by National Institute of Mental Health and was led by Dr. Greg Simon of the Kaiser Permanente Washington Health Research Institute. Learn more about SPOT.

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 February 28, 2022January 16, 2024 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.

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.

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.

December 14, 2021: A Year of New Insights From the NIH Collaboratory

Posted on December 14, 2021January 16, 2024 by Damon Seils

Collage of journal covers NIH Collaboratory researchers in 2021 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced 3 dozen articles in the peer-reviewed literature, including the primary results of the PPACT and TSOS trials, the study design of the Nudge and OPTIMUM studies, insights into the COVID-19 pandemic from the EMBED and ACP PEACE studies, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

Antidopaminergic-antiparkinsonian medication prescribing cascade in persons with Alzheimer’s disease

ACP PEACE NIH Collaboratory Trial

BackInAction NIH Collaboratory Trial

Acupuncture intervention protocol: consensus process for a pragmatic randomized controlled trial of acupuncture for management of chronic low back pain in older adults: an NIH Heal Initiative funded project

EMBED NIH Collaboratory Trial

GRACE NIH Collaboratory Trial

Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study

HiLo NIH Collaboratory Trial

Design and rationale of HiLo: a pragmatic, randomized trial of phosphate management for patients receiving maintenance hemodialysis

LIRE NIH Collaboratory Trial

Nudge NIH Collaboratory Trial

OPTIMUM NIH Collaboratory Trial

The design and methods of the OPTIMUM study: a multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain

PPACT NIH Collaboratory Trial

A primary care-based cognitive behavioral therapy intervention for long-term opioid users with chronic pain: a randomized pragmatic trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

TSOS NIH Collaboratory Trials

September 17, 2021: Population-based Outreach to Prevent Suicidal Behavior: A Pragmatic Randomized Trial (Gregory Simon, MD, MPH; Susan M Shortreed, PhD)

Posted on September 17, 2021March 31, 2022 by terren.green@duke.edu

Speaker

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

Susan M Shortreed, PhD
Senior Investigator, Biostatistics Unit
Kaiser Permanente Washington Health Research Institute
Affiliate Professor, Department of Biostatistics
University of Washington

Keywords

Care Management; Dialectical Behavior Therapy; Patient engagement; Suicide prevention

Key Points

The SPOT trial was a pragmatic randomized clinical trial comparing care management and dialectical behavioral therapy skills training to usual care in adults at risk of self-harm or suicidal behavior.

Dialectical Behavior Therapy skills training (DBT) was delivered online and supported by coaching.

A care management intervention was intended to facilitate and maintain engagement in effective outpatient care.

Adult outpatients who reported suicidal ideation on a mental health questionnaire were randomized to one of 3 study groups: continued usual care, offer of Care Management program, offer of DBT skills Training program.

Patients were sent a message expressing care and concern through an online system and invited to participate in the study.

Patients were followed for 18 months and fatal or non-fatal self-harm events were recorded as the primary outcome measure.

Interim analysis detected a signal of possible serious outcome in April/May 2019, but upon analysis rerun, the signal dropped below threshold and the DSMB recommended the trial continue.

Patients offered care management had no reduction in Risk of self-harm behavior compared to usual care. Patients offered DBT had significantly increased risk of self-harm compared to usual care.

Discussion Themes

Real-time feedback from potential subjects is important to ascertain if recruitment efforts or intervention is affecting patients negatively.

The inclusion of the usual care group allowed us to determine more than just care management works better than DBT.

Read more about the SPOT trial and study results.

September 15, 2021: PCT Grand Rounds to Announce Primary Results of NIH Collaboratory’s Suicide Prevention Outreach Trial (SPOT)

Posted on September 15, 2021January 16, 2024 by Damon Seils

Side-by-side headshots of Dr. Greg Simon and Dr. Susan Shortreed In this Friday’s PCT Grand Rounds, investigators from the Suicide Prevention Outreach Trial (SPOT), an NIH Collaboratory Trial, will announce the study’s primary results.

Principal investigator Dr. Greg Simon and biostatistician Dr. Susan Shortreed, both of the Kaiser Permanente Washington Health Research Institute, will present “Population-Based Outreach to Prevent Suicidal Behavior: A Pragmatic Randomized Trial (SPOT NIH Collaboratory Trial).” The Grand Rounds session will be held on Friday, September 17, at 1:00 pm eastern. Join the online meeting.

The SPOT NIH Collaboratory Trial is a pragmatic clinical trial embedded in Mental Health Research Network sites to test suicide prevention strategies among adult patients who have serious thoughts of suicide. The trial tested 2 strategies: a collaborative care management approach for depression, and an online skills training method designed to help people manage painful emotions and stressful situations. Both strategies were compared with usual care.

SPOT is supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Mental Health.

December 15, 2020: A Year of Results and New Insights From the NIH Collaboratory

Posted on December 15, 2020January 17, 2024 by Damon Seils

Collection of Journal Covers NIH Collaboratory researchers in 2020 reported study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced more than 3 dozen articles in the peer-reviewed literature, including the primary results of the PROVEN and LIRE trials, the study design of ACP PEACE, insights into the COVID-19 pandemic from TSOS and EMBED, and more:

December 18, 2019: NIH Collaboratory Shares New Findings and Fresh Insights in 2019

Posted on December 18, 2019January 17, 2024 by Damon Seils

NIH Collaboratory researchers in 2019 continued to generate new knowledge and research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, large-scale analyses of data from the NIH Collaboratory Distributed Research Network, and results and innovative methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced nearly 3 dozen articles in the peer-reviewed literature, including the primary results of the ABATE Infection trial, confirmation by the TiME trial of the feasibility of embedding large pragmatic trials in clinical care, and more: