Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory

Ali, Joseph; Antonelli, Margaret; Bastian, Lori A.; Becker, William C.; Brandt, Cynthia; Burgess, Diana J.; Burns, Amy; Cohen, Steven P.; Davis, Alison F.; Dearth, Christopher L.; Dziura, Jim; Edwards, Richard E.; Erdos, Joe; Farrokhi, Shawn; Fritz, Julie M.; Geda, Mary; George, Steven Z.; Goertz, Christine; Goodie, Jeffrey L.; Hastings, Susan; Heapy, Alicia; Ilfeld, Brian M.; Katsovich, Lily; Kerns, Robert D.; Kyriakides, Tassos C.; Lee, Allison; Long, Cynthia R.; Luther, Stephen L.; Martino, Steve; Matheny, Michael E.; McGeary, Don; Midboe, Amanda M.; Pasquina, Paul F.; Peduzzi, Peter; Raffanello, Michael; Rhon, Daniel I.; Rosen, Marc I.; Esposito, Elizabeth Russell; Scarton, Dylan; Seal, Karen H.; Silliker, Norman; Taylor, Sakasha; Taylor, Stephanie L.; Tsui, Megan; Wright, Fred S; Zeliadt, Steven B.

doi:10.1093/milmed/usab458

Cited by 3 publications

(1 citation statement)

References 17 publications

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“… 1 , 2 These trial designs use existing clinical staff and workflows to deliver core components of a trial intervention while allowing sites flexibility to organize care based on local resources, staff arrangements, and institutional policies. 3 In doing so, ePCTs have the potential to answer important questions about outcomes, scalability, and treatment uptake that explanatory randomized controlled trials cannot answer. 4 , 5 ePCTs are particularly well suited to study novel ways of organizing and delivering care, such as hybrid models that integrate telehealth with traditional in-person care.…”

Section: Introductionmentioning

confidence: 99%

If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain

Lentz,

Coffman,

Cope

et al. 2023

Physical Therapy

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Objective The purpose of this study was to describe the referrals and use of a hybrid care model for low back pain that includes on-site care by physical therapists, physical activity training, and psychologically informed practice (PiP) delivered by telehealth in the Improving Veteran Access to Integrated Management of Low Back Pain (AIM-Back) trial. Methods Data were collected from November 2020 through February 2023 from 5 Veteran Health Administration clinics participating in AIM-Back, a multisite, cluster-randomized embedded pragmatic trial. The authors extracted data from the Veteran Health Administration Corporate Data Warehouse to describe referral and enrollment metrics, telehealth use (eg, distribution of physical activity and PiP calls), and treatments used by physical therapists and telehealth providers. Results 701 veterans were referred to the AIM-Back trial with 422 enrolling in the program (consult-to-enrollment rate = 60.2%). After travel restrictions were lifted, site visits resulted in a significant increase in referrals and a number of new referring providers. At initial evaluation by on-site physical therapists, 92.2% of veterans received pain modulation (eg, transcutaneous electrical nerve stimulation, manual therapy). Over 81% of enrollees completed at least 1 telehealth physical activity call, with a mean of 2.8 (SD = 2.0) calls out of 6. Of the 167 veterans who screened as medium to high risk of persistent disability, 74.9% completed at least 1 PiP call, with a mean of 2.5 (SD = 2.0) calls out of 6. Of those who completed at least 1 PiP call (n = 125), 100% received communication strategies, 97.6% received pain coping skills training, 89.6% received activity-based treatments, and 99.2% received education in a home program. Conclusion In implementing a hybrid care pathway for low back pain, the authors observed consistency in the delivery of core components (ie, pain modulation, use of physical activity training, and risk stratification to PiP), notable variability in telehealth calls, high use of PiP components, and increased referrals with tailored provider engagement. Impact These findings describe variability occurring within a hybrid care pathway and can inform future implementation efforts.

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Section: Introductionmentioning

confidence: 99%

If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain

Lentz,

Coffman,

Cope

et al. 2023

Physical Therapy

Self Cite

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Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement

Hohenschurz-Schmidt,

Cherkin,

Rice

et al. 2024

Pain

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Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required. Trials aligned with routine practice pose several challenges, such as determining and enrolling appropriate study participants, deciding on the appropriate level of flexibility in treatment delivery, integrating information on concomitant treatments and adherence, and choosing comparator conditions and outcome measures. Ensuring data quality in real-world clinical settings is another challenging goal. Furthermore, current trials in the field would benefit from analysis methods that allow for a differentiated understanding of effects across patient subgroups and improved reporting of methods and context, which is required to assess the generalizability of findings. At the same time, a range of novel methodological approaches provide opportunities for enhanced efficiency and relevance of pragmatic trials to stakeholders and clinical decision making. In this study, best-practice considerations for these and other concerns in pragmatic trials of pain treatments are offered and a number of promising solutions discussed. The basis of these recommendations was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks.

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The promises and challenges of pragmatism: lesson from of a recent clinical trial

Yao¹,

Noseworthy²

2022

Ann Transl Med

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Pragmatic trials aim to answer the question "Can the intervention work under usual conditions?", whereas explanatory trials aim to answer "Can the intervention work under ideal conditions?" (1). Pragmatic trials, undertaken in routine practice settings, may provide more relevant evidence to support decision making for most stakeholders, such as patients, clinicians, health systems, payers, and policymakers. Furthermore, pragmatic trials leverage existing clinical infrastructure and can be implemented at a fraction of the cost of typical explanatory trials. As such, one might expect that pragmatic trials should be conducted more frequently. The reality is quite the opposite. The number of explanatory trials substantially outweigh that of pragmatic trials, although the level of pragmatism increased moderately over the past two decades (2-5).There are few purely explanatory or pragmatic trials (6). The pragmatism is a continuum assessed by the PRECIS-2 tool based on 9 dimensions. Each dimension can be rated from 1 (very explanatory) to 5 (very pragmatic). The PRECIS-2 tool is intended to be used at the trial design stage to help trialists make the purpose of the trial explicit and to ensure that the design choices are concordant with their intended purpose. In this letter, we rated a pivotal trial recently completed by our team to illustrate how the design choices we made affect the pragmatism.The example used here is electrocardiogram (ECG) artificial intelligence (AI)-Guided Screening for Low Ejection Fraction (EAGLE) trial, which is a pragmatic randomized controlled trial (RCT) that assessed an AIpowered clinical decision support tool for enabling early Cite this article as: Yao X, Noseworthy PA. The promises and challenges of pragmatism: lesson from of a recent clinical trial.

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Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory

Cited by 3 publications

References 17 publications

If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain

If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain

Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement

The promises and challenges of pragmatism: lesson from of a recent clinical trial

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