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

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.

Use of animal-assisted interventions in relieving pain in healthcare settings: A systematic review.

BACKGROUND AND OBJECTIVE: Therapeutic interaction with animals for patients coping with physical and mental health conditions is a growing interest among healthcare providers and researchers. We aimed to comprehensively summarize and evaluate the current state of evidence examining the use of animal-assisted interventions [AAI] for pain relief in healthcare settings. DESIGN: Systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement. METHODS: Two researchers independently assessed publications dated before February 5, 2021 in OVID Medline, CINAHL, and PsychINFO databases, and used the Delphi list to evaluate the quality of the evidence. RESULTS: Of the 109 studies screened, a total of 24 studies totaling 1,950 participants were ultimately included. Studies varied in design, including single group trials (8), controlled trials with at least two groups (6), and randomized controlled trials (10). The most common form of pain measurement was the visual or numeric rating scale. For the 18 studies that reported data on changes in pain severity from pre-to-post-test, 13 reported a significant reduction; using the converted common metric we created, these reductions ranged from 0.20 to 3.33 points on a 10-point numeric rating scale. CONCLUSIONS: AAI may be considered a promising approach in need of further, more rigorous research. Available evidence supporting AAI remains weak due to issues of study quality and design, thereby impeding our ability to draw reliable conclusions on the utility of AAI in relieving pain. Given the rapidly increasing availability of these interventions in hospitals, it is important to better understand its effectiveness.

Telerehabilitation for Headache Management.

Headache is one of the most disabling conditions in the world. Despite plentiful evidence supporting rehabilitation strategies, headache is significantly underassessed and undertreated. Obstacles to headache care include lack of available expertise in headache management, few available resources for effective assessment and treatment, and cost and disability that preclude treatment seeking in patients with headache. Telerehabilitation can allow providers to access expert consultation and gives patients easier access to assessment and treatment. This article covers existing telerehabilitation options for headache management and explores the strength of evidence supporting these approaches. Risks of telerehabilitation and recommendations for future development are discussed.

A test of the fear avoidance model to predict chronic pain outcomes in a polytrauma sample.

BACKGROUND: Chronic musculoskeletal pain is a complex problem, particularly for individuals with head injury and comorbid psychiatric conditions. The Fear Avoidance Model offers one of the strongest opportunities to conceptualize comorbid traumatic injury and pain, but this model is largely untested. OBJECTIVE: This study tests the Fear Avoidance Model of chronic pain using a sample from a study of polytrauma patients in a large Department of Veterans Affairs facility who participated in a federally-funded study of interdisciplinary chronic pain management. METHODS: The present study comprises a secondary analysis of 93 veterans with chronic pain, head injury, posttraumatic stress symptoms and a history of persistent opioid use. Standardized measures of Fear Avoidance Model risk factors (e.g., pain catastrophizing, fear avoidance beliefs, anxiety, depression) were examined as cross-sectional predictors of pain-related disability. RESULTS: Secondary data analysis revealed that Fear Avoidance Model factors accounted for almost 40% of the variance in pain-related disability, with pain catastrophizing and depression demonstrating the strongest relationships with disability. A summary variable combining all four factors revealed a 6% increase in disability for each factor that was clinically significant for the sample patients. CONCLUSIONS: This study represents the first attempt to examine a complex, theoretical model of pain in a comorbid pain and TBI sample. Findings revealed a strong relationship between this model and pain-related disability that outperforms pain intensity ratings. This model could be used to guide better treatment for comorbid pain and TBI.

Confronting challenges to opioid risk mitigation in the U.S. health system: Recommendations from a panel of national experts.

BACKGROUND: Amid the ongoing U.S. opioid crisis, achieving safe and effective chronic pain management while reducing opioid-related morbidity and mortality is likely to require multi-level efforts across health systems, including the Military Health System (MHS), Department of Veterans Affairs (VA), and civilian sectors. OBJECTIVE: We conducted a series of qualitative panel discussions with national experts to identify core challenges and elicit recommendations toward improving the safety of opioid prescribing in the U.S. DESIGN: We invited national experts to participate in qualitative panel discussions regarding challenges in opioid risk mitigation and how best to support providers in delivery of safe and effective opioid prescribing across MHS, VA, and civilian health systems. PARTICIPANTS: Eighteen experts representing primary care, emergency medicine, psychology, pharmacy, and public health/policy participated. APPROACH: Six qualitative panel discussions were conducted via teleconference with experts. Transcripts were coded using team-based qualitative content analysis to identify key challenges and recommendations in opioid risk mitigation. KEY RESULTS: Panelists provided insight into challenges across multiple levels of the U.S. health system, including the technical complexity of treating chronic pain, the fraught national climate around opioids, the need to integrate surveillance data across a fragmented U.S. health system, a lack of access to non-pharmacological options for chronic pain care, and difficulties in provider and patient communication. Participating experts identified recommendations for multi-level change efforts spanning policy, research, education, and the organization of healthcare delivery. CONCLUSIONS: Reducing opioid risk while ensuring safe and effective pain management, according to participating experts, is likely to require multi-level efforts spanning military, veteran, and civilian health systems. Efforts to implement risk mitigation strategies at the patient level should be accompanied by efforts to increase education for patients and providers, increase access to non-pharmacological pain care, and support use of existing clinical decision support, including state-level prescription drug monitoring programs.

Opioid Use Patterns Among Active Duty Service Members and Civilians: 2006-2014.

Introduction: Between 2001 and 2009, opioid analgesic prescriptions in the Military Health System quadrupled to 3.8 million. The sheer quantity of opioid analgesics available sets the stage for issues related to misuse, abuse, and diversion. To address this issue, the Department of Defense implemented several directives and clinical guidelines to improve access to appropriate pain care and safe opioid prescribing. Unfortunately, little has been done to characterize changing patterns of opioid use in active duty service members (ADSM), so little is known about how combat operations and military health care policy may have influenced this significant problem. We examined changes in opioid use for ADSM between 2006 and 2014, compared trends with the civilian population, and explored the potential role of military-specific factors in changes in opioid use in the Military Health System. Materials and Methods: After obtaining Institutional Review Board approval, administrative prescription records (Pharmacy Data Transaction Records) for non-deployed ADSM were used to determine the number of opioid prescriptions dispensed each year and the proportion of ADSM who received at least one prescription per month between 2006 and 2014. Based on the observation and the literature, we identified December 2011 as the demarcation point (the optimal point to identify the downturn in opioid use) and used it to compare opioid use trends before and after. We used an autoregressive forecast model to verify changes in opioid use patterns before and after 2011. Several interrupted time series models examined whether military system-level factors were associated with changes in opioid use. Results: Between 2006 and 2014, 1,516,979 ADSM filled 7,119,945 opioid prescriptions, either in military treatment facilities or purchased through TRICARE. Both active duty and civilian populations showed signs of decreasing use after 2011, but this change was much more pronounced among ADSM. The forecast model showed a significant difference after 2011 between the projected and actual proportion of ADSM filling an opioid prescription, confirming 2011 as a point of divergence in opioid use. Interrupted time series models showed that the deflection point was associated with significant decreases. A significant increase of 0.261% in opioid prescriptions was seen for every 1,000 wounded in action service members in a given month. Troops returning from Operation Enduring Freedom, Operation Iraqi Freedom, or Operation New Dawn did not appear to influence the rates of use. Even after accounting for returning troops from Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn and wounded in action counts, the deflection point was associated with a lower proportion of ADSM who filled an opioid prescription, leading to a decrease of 1.61% by the end of the observation period (December 2014). Conclusion: After December 2011, opioid use patterns significantly decreased in both civilian and ADSM populations, but more so in the military population. Many factors, such as numbers of those wounded in action and the structural organization of the Military Health System, may have caused the decline, although more than likely the decrease was influenced by many factors inside and outside of the military, including policy directives and cultural changes.

Implementing prescription drug monitoring and other clinical decision support for opioid risk mitigation in a military health care setting: a qualitative feasibility study.

Objective: Chronic noncancer pain is a highly prevalent condition among service members returning from deployment overseas. The US Army has a higher rate of opioid misuse than the civilian population. Although most states and many health care systems have implemented prescription drug monitoring programs (PDMPs) or other clinician decision support (CDS) to aid providers in delivering guideline-recommended opioid therapy, similar tools are lacking in military health settings. Materials and Methods: We conducted a pre-implementation feasibility and needs assessment guided by the Promoting Action Research in Health Services framework. Twenty-six semistructured interviews were conducted with providers from a large military health system (MHS) to assess baseline knowledge and practices in opioid risk mitigation and providers' preferences and needs for a military-based PDMP or other CDS. Results: Military health care providers reported complex decision-making around opioid prescribing and monitoring, varied knowledge and use of existing clinical informatics, and concerns about the feasibility of implementing a military-based PDMP in their context. However, providers indicated a need for training and CDS to support opioid risk mitigation for their patients. Discussion: This article describes providers' knowledge and behaviors around opioid risk mitigation in the MHS, and views on the potential usefulness of a military-based PDMP or other CDS. This pre-implementation study provides a model for using qualitative methods to assess feasibility and inform planning and development of CDS in complex health care settings. Conclusion: Military providers were skeptical regarding the feasibility of MHS-based PDMP implementation, but provided important recommendations for CDS to support safe and appropriate opioid prescribing in military health care.

Evaluating the impact of prescription drug monitoring program implementation: a scoping review.

BACKGROUND: Prescription drug monitoring programs (PDMPs) have been implemented in 49 out of 50 states in an effort to reduce opioid-related misuse, abuse, and mortality, yet the literature evaluating the impact of PDMP implementation remains limited. We conducted a scoping review to: (1) describe available evidence regarding impact of PDMPs in the U.S.; and (2) propose a conceptual model to inform future PDMP implementation and evaluation efforts. METHODS: Scoping systematic review following Arksey and O'Malley's (2005) methodology. We identified 11 relevant studies based on inclusion criteria using a PubMed database search of English-language studies published 1/1/2000-5/31/16. Data were extracted and thematic analysis conducted to synthesize results. RESULTS: Extant evidence for the impact of PDMPs as an opioid risk mitigation tool remains mixed. Thematic analysis revealed four domains of opioid-related outcomes frequently examined in original studies evaluating PDMP implementation: (1) opioid prescribing; (2) opioid diversion and supply; (3) opioid misuse; and (4) opioid-related morbidity and mortality. An evaluation framework incorporating these domains is presented that highlights significant gaps in empirical research across each of these domains. CONCLUSIONS: Evidence for the impact of state-level PDMPs remains mixed. We propose a conceptual model for evaluating PDMP implementation toward the goals of clarifying PDMP mechanisms of impact, identifying characteristics of PDMPs associated with best outcomes, and maximizing the utility of PDMP policy and implementation to reduce opioid-related public health burden.

The evaluation and treatment of comorbid pain and PTSD in a military setting: an overview.

The present article reviews the growing prevalence of comorbid pain and post-traumatic stress disorder (PTSD) in the military. This has been caused by the ongoing military conflicts in Iraq and Afghanistan, where new combat conditions/strategies are causing these comorbid conditions. Fortunately, comprehensive interdisciplinary treatment programs, originally developed for a civilian population and in academic settings, are being successfully "translated" or utilized in the military environment. Recent data demonstrating this translational clinical intervention are presented. Finally, challenges encountered when translating these interventions in a military environment are also discussed.

A randomized clinical trial of treatment for lumbar segmental rigidity.

STUDY DESIGN: A randomized single-blind clinical trial of facet injections plus exercise, versus exercise alone, in chronic disabling work-related lumbar spinal disorders (CDWRLSD), accompanied by pilot interrater reliability and facet syndrome prevalence studies. OBJECTIVES: To systematically investigate the use of facet injections as an adjunct to supervised lumbar stretching exercises in regaining lumbar range of motion (ROM) following prolonged deconditioning after work-related lumbar injuries. To assess interrater reliability of visual assessment of segmental rigidity (SR), and to evaluate the prevalence of facet syndrome in cases of lumbar SR. SUMMARY OF BACKGROUND DATA: Corticosteroid joint injections have often been used to reduce musculoskeletal inflammation to facilitate joint mobilization in the presence of degenerative arthritis. Lumbar segmental rigidity is a recently described entity usually associated with painful chronic spinal disorders and postoperative spine surgery. Previous work has shown that SR and lumbar ROM improves with a brief intervention consisting of facet injections followed by specific stretching exercises. No systematic study has investigated the potential benefits of a combination of facet injections and exercise over supervised exercises alone to treat lumbar SR. Similarly, no study has assessed the association between SR and the facet syndrome. METHODS: From a group of consecutive patients (n = 421) with CDWRLSD referred for tertiary rehabilitation between November 1999 and January 2001, 70 were noted to have SR on intake physical examination. The first part of this study assessed interrater reliability for detecting SR, and intrarater reliability for 3-segment true lumbar ROM measurements. Patients randomly assigned to participate in supervised stretching exercises with the addition of fluoroscopically guided bilateral facet injections at the involved levels (Group A, n = 36) also underwent facet syndrome prevalence assessment at the time of injection. They were compared to a randomly allocated comparison group (Group B, n = 34) undergoing exercises alone in a single-blind design. Physical therapists saw patients an average of twice per week, providing supervision of a progressive home stretching program. Inclinometric joint ROM was measured at the time of group allocation, and again 5 to 7 weeks later. Validated questionnaires of pain (intensity VAS) and disability (Million VAS) related to the CDWRLSD were provided before and after the interventions. RESULTS: Part 1 reliability and facet syndrome prevalence work revealed that interrater reliability for experienced examiners to detect rigid segments was excellent (Pearson's r = 0.97, P < 0.01). Intrarater 3-joint motion measurement reliability was also good for all sagittal/coronal ROM (Pearson's r = 0.95-0.99, P < 0.01). Only 5 of 29 subjects with SR met criteria for facet syndrome (17%), consistent with prior prevalence studies of unselected patients with low back pain. In Part 2, a large majority of patients in both groups improved from the initial to the post-treatment ROM measurements (the primary outcome criterion of the study). However, a higher proportion of Group A (injection) patients (87%-95%) showed ROM improvement, compared to Group B (exercise only) patients (64%-79%). Group A patients showed a significantly greater ROM improvement in all sagittal and coronal movements, both in absolute terms and percent of initial measurement. No significant differences in pain or disability self-report were found between groups, pre- or postintervention, but both groups showed significant improvement from pre- to postintervention in pain and disability assessments. CONCLUSIONS: The detection of SR and measurement of 3-segment true lumbar ROM by experienced examiners is highly reliable. Only 17% of CDWRLSD patients with lumbar SR met criteria for the facet syndrome, a rate approximately equal to that of unselected low back pain cohorts. This indicates that lumbar SR may be found whether or not pain of facet joint origin is present. In the randomized trial, facet injections significantly increased the percentage of patients with SR showing ROM improvement, as well as the degree of improvement in lumbar mobility after treatment. There is no evidence that facet injections increase the improvements in pain/disability report noted in both groups.

Relevance of aerobic capacity measurements in the treatment of chronic work-related spinal disorders.

STUDY DESIGN: Prospective cohort study of rehab program completers, comparing aerobic capacity data of chronic lumbar spinal disorder patients (CLSD) to that of chronic cervical spinal disorder (CCSD), collected from a tertiary care facility. OBJECTIVE: We evaluated whether CLSD is associated with different pre- and postrehabilitation aerobic capacity deficits than CCSD, and whether such deficits affect functional restoration outcomes. SUMMARY OF BACKGROUND DATA: Chronic spinal disorder patients are thought to lose aerobic fitness as a component of the deconditioning syndrome. Patients with CLSD often restrict aerobic activities because of back or leg pain, while CCSD patients generally do so to a lesser degree. We hypothesized that those with CLSD would have greater deficits in tests of aerobic fitness than patients with CCSD both before and after treatment. METHODS: From a consecutive cohort of 683 patients with work-related spinal disorders, two groups were identified: patients with CLSD (n = 504; age 40.1 years; 68% male); and patients with CCSD (n = 179; 41.3 years; 43% male). All patients completed an intensive, medically supervised functional restoration program. Before and after the program, patients completed a submaximal bicycle ergometer aerobic capacity test and a psychosocial test battery. A structured clinical interview to determine socioeconomic outcomes was conducted 1 year after the program completion. RESULTS: Of CLSD patients 33% and 11% of CCSD patients (P < 0.001) either failed to produce any torque or could not complete at least 2 stages on the bicycle on preprogram tests (invalid tests). However, all patients had valid bicycle tests at program completion. Nearly two-thirds of the subjects with initially invalid tests in the lumbar group failed to develop any torque, while only one-third of subjects with invalid tests of the cervical group had a similar result. Thus, CLSD is associated with greater prerehabiliation aerobic fitness deficits than CCSD. Overall, there was no significant change in pre to postrehab aerobic capacities for the initially valid test subjects. The initially invalid test subjects achieved similar postrehabilitation scores compared to the valid test subjects, although CLSD patients with initially valid tests performed slightly better at the posttest. Socioeconomic outcomes were the same one year after the program for valid and invalid test subjects. CLSD patients had higher preprogram self reports of disability. The subgroup of the initially invalid test subjects that produced no torque whatsoever (19.3% of CLSD and 3.9% of CCSD) did not differ from the subgroup that failed to complete 2 stages in the pretest of aerobic performance on depression. They had higher pretest self-reported disability. CONCLUSIONS: Although mean aerobic fitness levels for all patients improved during rehabilitation, the improvement is almost entirely accounted for by initially invalid tests becoming valid. Aerobic capacity testing measured with submaximal bicycle ergometry may frequently be invalid when fear-avoidance limits effort, particularly in CLSD. Psychosocial fear-avoidance, as it applies to bicycle ergometry, can be overcome in virtually all patients motivated to complete a tertiary rehabilitation program. As such, prerehabilitation aerobic capacity testing is a poor differentiator of postrehabilitation outcomes.

Unremitting health-care-utilization outcomes of tertiary rehabilitation of patients with chronic musculoskeletal disorders.

BACKGROUND: Unremitting health-care-seeking behaviors have only infrequently been addressed in the literature as an outcome of treatment for chronic disabling work-related musculoskeletal disorders. The limited research has never focused on the patient as the "driver" of health-care utilization, to our knowledge. As a result, little attention has been paid to the differences between treated patients who seek additional health care from a new provider and those who do not. The purpose of this project was to examine the demographic and socioeconomic outcome variables that characterize patients with a chronic disabling work-related musculoskeletal disorder who pursue additional health-care services from a new provider following the completion of a tertiary rehabilitation treatment program. A prospective comparison cohort design was employed to assess characteristics and outcomes of these patients, all of whom were treated with the same interdisciplinary protocol. METHODS: A cohort of 1316 patients who had been consecutively treated with a rehabilitation program for functional restoration was divided into two groups on the basis of whether they had sought treatment from a new health-care provider in the year following completion of treatment. Group 0 (966 patients) did not visit a new health-care provider for treatment of their original occupational injury, and Group 1 (350 patients) visited a new provider on at least one occasion. A structured clinical interview to assess socioeconomic outcomes was carried out one year after discharge from the treatment program; this interview addressed pain, health-care utilization, work status, recurrent injury, and whether the Workers' Compensation case had been closed. RESULTS: The percentage of Group-0 patients who had undergone pre-rehabilitation surgery was significantly lower than the percentage of Group-1 patients who had done so (12% compared with 21%, odds ratio = 1.9 [95% confidence interval = 1.3, 2.7]; p < 0.001). One year after treatment, 90% of the Group-0 patients had returned to work compared with only 78% of the Group-1 patients (odds ratio = 2.6 [95% confidence interval, 1.9, 3.6]; p < 0.001). Similarly, 88% of the Group-0 patients were still working at one year compared with only 62% of the patients in Group 1 (odds ratio = 4.5 [95% confidence interval, 3.3, 6.0]; p < 0.001). Whereas 96% of the Group-0 patients had resolved all related legal and/or financial disputes by one year, only 77% of the Group-1 patients had done so (odds ratio = 6.9 [95% confidence interval, 4.5, 10.5]; p < 0.001). Only a negligible percentage (0.4%) of the patients in Group 0 had undergone a new operation at the site of the original injury, whereas 12% of the Group-1 patients had done so (odds ratio = 31.0 [95% confidence interval, 11.0, 87.3]; p < 0.001). When the above outcome variables were analyzed by dividing Group 1 according to the number of visits to a new service provider, there was a trend for poorer socioeconomic outcomes to be associated with an increasing number of health-care visits. CONCLUSIONS: To our knowledge, the present study represents the first large-scale examination of patients with a chronic disabling work-related musculoskeletal disorder who persist in seeking health-care following the completion of tertiary rehabilitation. The results demonstrate that about 25% of patients with a chronic disabling work-related musculoskeletal disorder pursue new health-care services after completing a course of treatment, and this subgroup accounts for a significant proportion of lost worker productivity, unremitting disability payments, and excess health-care consumption. LEVEL OF EVIDENCE: Prognostic study, Level I-1 (prospective study). See Instructions to Authors for a complete description of levels of evidence.