Dr. Sebastian Tong and Dr. Kushang Patel, principal investigators for AIM-CP
The study design paper for AIM-CP has been published online in PLoS One. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!
The AIM-CP trial is testing the implementation of a nurse care management program, consisting of care coordination, cognitive behavioral therapy, and referral to a remotely delivered exercise program, to address disparate access to nonpharmacological treatments for chronic pain in rural populations. The study team recently reported the results of a pilot study showing that their integrated nurse care management approach is feasible and effective.
The study is being led by Sebastian Tong and Kushang Patel of the University of Washington and is supported through the NIH HEAL Initiative by a grant from the National Institute of Nursing Research.
The NIH Pragmatic Trials Collaboratory is excited to announce the availability of AMA PRA Category .75 Credit™ and JA credit AH for the Pragmatic Clinical Trials Study Design learning pathway through the Duke University Health System’s Department of Clinical Education and Professional Development.
This interactive learning path provides researchers with essential knowledge to choose the most appropriate study design for their pragmatic clinical trial. The self-paced modules include expert video by Liz Turner, cochair of the NIH Collaboratory’s Biostatistics and Study Design Core, reference materials, and knowledge checkpoints.
These learning activities are free and require about 1 hour to complete. To access the learning path, visit the NIH Collaboratory Training Resource page and learn more about the Pathways to Learning options. Simply click “get this course” and then “sign up” to create an account in our learning management system.
Continuing Education Credits
In support of improving patient care, the Duke University Health System’s Department of Clinical Education and Professional Development is accredited by the American Nurses Credentialing Center (ANCC), the Accreditation Council for Pharmacy Education (ACPE), and the Accreditation Council for Continuing Medical Education (ACCME), to provide continuing education for the health care team.
Physician Credit: Duke University Health System Department of Clinical Education and Professional Development designates this Pragmatic Clinical Trial Study Design learning path activity for a maximum of .75 AMA PRA Category .75 Credit™. Physicians should claim only credit commensurate with the extent of their participation in the activity.
Nurse Credit: Duke University Health System Department of Clinical Education and Professional Development designates this Pragmatic Clinical Trial Study Design learning path activity for up to .75 credit hour for nurses. Nurses should claim only credit commensurate with the extent of their participation in this activity.
Older adults are often overprescribed medications or prescribed potentially inappropriate medications like benzodiazepines, non-benzodiazepine sedative hypnotics, or strongly anticholinergic medications with long-term use associated with a 30% increased risk of hospitalizations and falls.
Medication management or optimization in older adults is often difficult due to a tendency to maintain the status quo, time constraints, patient preference, or diffusion of responsibility, and existing interventions for medication management are highly resource intensive.
Behavioral science techniques employed in the NUDGE-EHR and NUDGE-HER-2 trials may enhance the effectiveness of electronic health record (EHR) tools to alert clinicians to inappropriate medications during patient visits.
NUDGE-EHR was a 16 arm two-stage adaptive pragmatic trial among 216 primary care providers and older adult patients conducted from October 2020 to August 2022 examining 14 promising EHR tools using 9 different behavioral principles with deprescribing as a primary outcome.
The 2 most promising tools were included in the second 3 parallel arm pragmatic trial, NUDGE-EHR-2, in a different health system from November 2022 to March 2024. EHR tools used pop-up windows to suggest deprescribing. The study provided a set of helpful options to providers including a tapering algorithm, instructions for patients, orders for alternative medications, and referrals to behavioral health providers to make this process faster and easier.
Deprescribing increased by 6.5% to 10.4% over usual care. Active discontinuation by primary care providers appeared to drive the results.
Discussion Themes
The adaptive trial design of the first NUDGE-EHR study helped inform the more traditional confirmation trial NUDGE-EHR-2.
The way EHR tools are used varies widely from provider to provider. Tools may be adapted over time so the tool works best for the individual provider.
The study design paper for Chat 4 Heart Health has been published online in Trials. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!
The Chat 4 Heart Health trial is testing the comparative effectiveness of 3 text messaging delivery strategies that have been shown to improve individuals’ self-management health behaviors, including physical activity and medication adherence. The study will provide evidence regarding the best population-based strategy for universal delivery to engage patients in self-management to improve the American Heart Association’s “Life’s Essential 8” measures for improving and maintaining cardiovascular health.
The study is being led by Mike Ho of Kaiser Permanente Colorado and Sheana Bull of the Colorado School of Public Health and is supported by a grant award from the National, Heart, Lung, and Blood Institute.
Dr. Michele Balas and Dr. Eduard Vasilevskis, principal investigators for BEST-ICU
The study design paper for BEST-ICU has been published online in Trials. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!
The BEST-ICU trial is evaluating 2 strategies grounded in behavioral economics theory and implementation science to increase adoption of the ABCDEF bundle in the intensive care unit and improve care for critically ill adults across a variety of healthcare systems. The ABCDEF bundle is a multicomponent, evidence-based intervention to improve team-based care.
The study is being led by Eduard Vasilevskis of the University of Wisconsin and Michele Balas of the University of Nebraska and is supported by a grant award from the National, Heart, Lung, and Blood Institute.
Trevor Lentz, PT, PhD Tyler Cope, PT, DPT, ACT
Duke Clinical Research Institute
Duke Department of Population Health Sciences
Durham Veterans Administration
Keywords
AIM-Back; Clinical site recruitment; Cluster randomized trial; Low back pain; Recruitment funnel
Key Points
Low back pain is an impactful condition that is more common in the veteran population. Typical low back pain care involves imaging and pharmacologic treatments that don’t always resolve pain issues and may lead to more invasive injection-based or surgical measures that often don’t result in better outcomes.
Research has shown that non-drug treatments (eg, cognitive behavioral therapy [CBT], yoga, physical therapy [PT]) are effective but not often used.
The AIM-Back trial (Improving Veteran Access to Integrated Management of Back Pain), an embedded pragmatic cluster randomized trial, sought to restructure care practices in Veteran’s Administration (VA) healthcare systems to promote and facilitate 2 clinical non-drug pathways that are supported by established guidelines as first-line treatment for low back pain.
Two care pathways were developed in coordination with VA clinicians, veterans, and care givers: (1) Sequenced Care Pathway – This pathway provided an initial onsite physical therapy evaluation and treatment session followed by weekly telehealth physical activity training for 6 weeks. The patient then saw the physical therapist again and was either discharged or provided with 6 weeks of training in psychologically-informed practices to help patients manage pain. (2) Pain Navigator Pathway – In this pathway, a local site clinician who was trained by the study team as a pain navigator discussed and facilitated alternative treatments for low back pain (eg, PT, yoga, CBT, massage). Patient follow up at both 6 and 12 weeks assessed progress and outcomes.
AIM-Back used a novel and intentional recruitment method, borrowing the concept of the business sales funnel, to generate as many site leads as possible. The recruitment process was systematic involving a 3 step framework: (1) Identify leads, (2) Approach leads, (3) Engage and select sites.
In step 1, leads were identified through Warm Market methods (sites known to the researchers), by Leveraging Data (evaluating lists of providers for potential fit), and through traditional Promotional Outreach efforts (advertising through networks and listservs). AIM-Back identified 184 leads from 53 VA healthcare systems.
Step 2 involved approaching leads through email messages. AIM-Back learned that promoting the trial in a way that helps clinicians solve their problems instead of asking clinicians to help with the research was more likely to yield the site. AIM-Back received responses from 23 VA healthcare systems.
In step 3, AIM-Back engaged personnel at all levels, from leadership to clinicians, to assess feasibility and buy-in at the site. AIM-Back selected 19 participant sites within 10 VA healthcare systems.
The Promotional Outreach strategy proved most effective with 9 (47.4%) of sites resulting from this strategy. The Leveraging Data strategy netted 6 (31.6%) sites, and 4 (21.1%) sites came from the Warm Market strategy. Site recruitment took approximately 3.6-3.8 months on average.
17 sites enrolled 1817 Veterans with most sites (n=16) meeting or exceeding the minimum enrollment goal. When sites chose not to participate, they cited a reluctance to change their existing programs, a lack of clinicians or resources, or they were already participating in similar trials.
Discussion Themes
AIM-Back messaging evolved over the course of recruitment from a more traditional trial marketing email to an email that was more personal, short, and leveraged the standing of Duke University. This more personal approach to recruitment led to better relationships with sites during the trial.
Project management software can be helpful for tracking follow up with site leads and communication during the recruitment process.
One overall goal of AIM-Back was to set up a new clinical program that could continue after the end of the trial. Sites were given training materials for the centralized study components and support from AIM-Back was stepped down slowly. Sites that chose to continue the intervention trained a physical activity/whole health coach and a PT for the psychologically informed PT portion of the intervention.
Indicators of a potentially successful site included qualitative components that reflect a high level of engagement such as high interest and excitement in the study along with a sufficient patient population.
The study design paper for ARBOR-Telehealth has been published online in BMJ Open. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!
The ARBOR-Telehealth study is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. A secondary aim of the study is to compare the effectiveness of the study’s risk-stratification approach.
The study is being led by Richard Skolasky and Kevin McLaughlin of Johns Hopkins University and is supported by a grant award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
The study design paper for IMPACt-LBP has been published online in BMJ Open. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!
IMPACt-LBP is evaluating the effect of first-contact patient referral to physical therapists and doctors of chiropractic for low back pain. The study team is seeking to determine if initial contact with these “primary spine practitioners” will improve physical function and pain, decrease opioid prescriptions, improve patient satisfaction, and reduce the costs and use of health care services in patients with low back pain when compared with usual medical care.
The study is being led by Christine Goertz, Adam Goode, and Hrishikesh Chakraborty of Duke University and Jon Lurie of Dartmouth Hitchcock Medical Center and is supported by a grant award from the National Center for Complementary and Integrative Health.
The study design paper for the MOMs Chat & Care Study has been published online ahead of print in Contemporary Clinical Trials. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!
The MOMs Chat and Care Study is testing the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black birthing people to reduce their risk for severe maternal morbidity. Patients in both study arms will receive close clinical and behavioral health monitoring and navigation to timely care and services.
The study is being led by Stephanie Fitzpatrick at the Feinstein Institutes for Medical Research and is supported by an R01 grant award from the National Institute of Nursing Research.
Researchers with PRIM-ER, an NIH Collaboratory Trial, published 2 innovative statistical techniques for evaluating intervention effects in stepped-wedge, cluster randomized trials. The new models, which use Bayesian methods, outperformed traditional analytic methods and other Bayesian approaches in simulations and real-world applications.
In cluster randomized trials with stepped-wedge designs, the clusters are randomized into several groups, and all groups start the trial in the control condition. Groups of clusters cross over to the intervention condition on a staggered timeline, and all groups receive the intervention before the end of the trial.
Stepped-wedge designs can be advantageous when simultaneous rollout of the intervention to all clusters is infeasible, or when withholding the intervention from any cluster would be unethical, or when there is a risk of contamination between intervention subjects and control subjects. However, stepped-wedge designs can also introduce confounding by time, as the intervention is rolled out to clusters in waves. Temporal trends during the study can influence the study’s outcomes.
The PRIM-ER researchers tested 2 new Bayesian hierarchical penalized spline models to improve the estimation of intervention effects in stepped-wedge trials. The first model focuses on immediate intervention effects and accounts for large numbers of clusters and time periods. The second model extends the first by accounting for time-varying intervention effects. The researchers applied both models to data from PRIM-ER.
PRIM-ER tested a multidisciplinary primary palliative care intervention in a diverse mix of emergency departments in the United States to improve the delivery of goal-directed emergency care of older adults. The study was supported by the National Institute on Aging. Learn more about PRIM-ER.
The NIH Pragmatic Trials Collaboratory is excited to announce the availability of AMA PRA Category .75 Credit™ and JA credit AH for the 
The study design paper for Chat 4 Heart Health has been 
The study design paper for ARBOR-Telehealth has been 
The study design paper for IMPACt-LBP has been 
The study design paper for the MOMs Chat & Care Study has been 
Researchers with PRIM-ER, an NIH Collaboratory Trial, published 2 innovative statistical techniques for evaluating intervention effects in stepped-wedge, cluster randomized trials. The new models, which use Bayesian methods, outperformed traditional analytic methods and other Bayesian approaches in simulations and real-world applications.