Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory.
Joseph AliMargaret AntonelliLori BastianWilliam BeckerCynthia A BrandtDiana J BurgessAmy BurnsSteven P CohenAlison F DavisChristopher L DearthJim DziuraRob EdwardsJoe ErdosShawn FarrokhiJulie FritzMary GedaSteven Z GeorgeChristine GoertzJeffrey GoodieSusan N HastingsAlicia HeapyBrian M IlfeldLily KatsovichRobert D KernsTassos C KyriakidesAllison LeeCynthia R LongStephen L LutherSteve MartinoMichael E MathenyDon McGearyAmanda MidboePaul PasquinaPeter PeduzziMichael RaffanelloDaniel RhonMarc RosenElizabeth Russell EspositoDylan ScartonSusan N HastingsKaren SealNorman SillikerSakasha TaylorStephanie L TaylorMegan TsuiFred S WrightSteven ZeliadtPublished in: Military medicine (2021)
Pragmatic clinical trials (PCTs) are well-suited to address unmet healthcare needs, such as those arising from the dual public health crises of chronic pain and opioid misuse, recently exacerbated by the COVID-19 pandemic. These overlapping epidemics have complex, multifactorial etiologies, and PCTs can be used to investigate the effectiveness of integrated therapies that are currently available but underused. Yet individual pragmatic studies can be limited in their reach because of existing structural and cultural barriers to dissemination and implementation. The National Institutes of Health, Department of Defense, and Department of Veterans Affairs formed an interagency research partnership, the Pain Management Collaboratory. The partnership combines pragmatic trial design with collaborative tools and relationship building within a large network to advance the science and impact of nonpharmacological approaches and integrated models of care for the management of pain and common co-occurring conditions. The Pain Management Collaboratory team supports 11 large-scale, multisite PCTs in veteran and military health systems with a focus on team science with the shared aim that the "whole is greater than the sum of the parts." Herein, we describe this integrated approach and lessons learned, including incentivizing all parties; proactively offering frequent opportunities for problem-solving; engaging stakeholders during all stages of research; and navigating competing research priorities. We also articulate several specific strategies and their practical implications for advancing pain management in active clinical, "real-world," settings.
Keyphrases
- pain management
- chronic pain
- public health
- healthcare
- clinical trial
- study protocol
- quality improvement
- randomized controlled trial
- palliative care
- phase ii
- phase iii
- global health
- open label
- primary care
- health information
- systematic review
- risk assessment
- spinal cord injury
- mental health
- double blind
- health promotion
- infectious diseases