Design, methods, and recruitment outcomes of the Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study.

The Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study is a 12-month pragmatic randomized comparative effectiveness trial conducted at ten United States Veterans Affairs (VA) health care sites. The overall goal was to test interventions to improve pain while reducing opioid use among VA patients with moderate-severe chronic pain despite treatment with long-term opioid therapy (LTOT). Aims were 1) to compare lower-intensity telecare collaborative pain management (TCM) versus higher-intensity integrated pain team management (IPT), and 2) to test the option of switching to buprenorphine (versus no option) in a high-dose subgroup. Recruitment challenges included secular trends in opioid prescribing and the COVID-19 pandemic. Participants were recruited over 3.5 years. Of 6966 potentially eligible patients, 4731 (67.9%) were contacted for telephone eligibility interview; of those contacted, 3398 (71.8%) declined participation, 359 (7.6%) were ineligible, 821 (24.2%) enrolled, and 820 (24.1%) were randomized. The most common reason for declining was satisfaction with pain care (n = 731). The most common reason for ineligibility was not having moderate-severe chronic pain (n = 110). Compared with the potentially eligible population, randomized participants were slightly younger, more often female, had similar prescribed opioids, and had similar or higher rates of pain and mental health diagnoses. The enrolled patient number was lower than the original target, but sufficient to power planned analyses. In conclusion, the VOICE trial enrolled a diverse sample similar to the population of VA patients receiving LTOT. Results will add substantially to limited existing evidence for interventions to improve pain while reducing opioid use. ClinicalTrials.gov identifier: NCT03026790.

"Not all groups come together, but this one just clicks": Ten Tips for Sustaining an Engagement Panel.

In 2017, ten veteran patients with the shared experience of living with chronic pain united to form a Veteran Engagement Panel (VEP) to support the Patient-Centered Outcomes Research Institute® (PCORI®)funded Veterans Pain Care Organizational Improvement Comparative Effectiveness (VOICE) Study. The study, conducted at ten Veterans Affairs (VA) sites, compares two team-based approaches to improve pain management and reduce potential harms of opioid therapy. The panel shares ten best practices for sustaining a successful engagement partnership.

Complementary, Integrative, and Nondrug Therapy Use for Pain Among US Military Veterans on Long-term Opioids.

BACKGROUND: Long-term opioid therapy for chronic pain arose amid limited availability and awareness of other pain therapies. Although many complementary and integrative health (CIH) and nondrug therapies are effective for chronic pain, little is known about CIH/nondrug therapy use patterns among people prescribed opioid analgesics. OBJECTIVE: The objective of this study was to estimate patterns and predictors of self-reported CIH/nondrug therapy use for chronic pain within a representative national sample of US military veterans prescribed long-term opioids for chronic pain. RESEARCH DESIGN: National two-stage stratified random sample survey combined with electronic medical record data. Data were analyzed using logistic regressions and latent class analysis. SUBJECTS: US military veterans in Veterans Affairs (VA) primary care who received ≥6 months of opioid analgesics. MEASURES: Self-reported use of each of 10 CIH/nondrug therapies to treat or cope with chronic pain in the past year: meditation/mindfulness, relaxation, psychotherapy, yoga, t'ai chi, aerobic exercise, stretching/strengthening, acupuncture, chiropractic, massage; Brief Pain Inventory-Interference (BPI-I) scale as a measure of pain-related function. RESULTS: In total, 8891 (65%) of 13,660 invitees completed the questionnaire. Eighty percent of veterans reported past-year use of at least 1 nondrug therapy for pain. Younger age and female sex were associated with the use of most nondrug therapies. Higher pain interference was associated with lower use of exercise/movement therapies. Nondrug therapy use patterns reflected functional categories (psychological/behavioral, exercise/movement, manual). CONCLUSIONS: Use of CIH/nondrug therapies for pain was common among patients receiving long-term opioids. Future analyses will examine nondrug therapy use in relation to pain and quality of life outcomes over time.

The evaluating prescription opioid changes in veterans (EPOCH) study: Design, survey response, and baseline characteristics.

In the United States (US), long-term opioid therapy has been commonly prescribed for chronic pain. Since recognition of the opioid overdose epidemic, clinical practice guidelines have recommended tapering long-term opioids to reduced doses or discontinuation. The Effects of Prescription Opioid Changes for veterans (EPOCH) study is a national population-based prospective observational study of US Veterans Health Administration primary care patients designed to assess effects of evolving opioid prescribing practice on patients treated with long-term opioids for chronic pain. A stratified random sampling design was used to identify a survey sample from the target population of patients treated with opioid analgesics for ≥ 6 months. Demographic, diagnostic, visit, and pharmacy dispensing data were extracted from existing datasets. A 2016 mixed-mode mail and telephone survey collected patient-reported data, including the main patient-reported outcomes of pain-related function (Brief Pain Inventory interference; BPI-I scores 0-10, higher scores = worse) and health-related quality of life. Data on survey participants and non-participants were analyzed to assess potential nonresponse bias. Weights were used to account for design. Linear regression models were used to assess cross-sectional associations of opioid treatment with patient-reported measures. Of 14,160 patients contacted, 9253 (65.4%) completed the survey. Participants were older than non-participants (63.9 ± 10.6 vs. 59.6 ± 13.0 years). The mean number of bothersome pain locations was 6.8 (SE 0.04). Effectiveness of pain treatment and quality of pain care were rated fair or poor by 56.1% and 45.3%, respectively. The opioid daily dosage range was 1.6 to 1038.2 mg, with mean = 50.6 mg (SE 1.1) and median = 30.9 mg (IQR 40.7). Among the 73.2% of patients who did not receive long-acting opioids, the mean daily dosage was 30.4 mg (SE 0.6) and mean BPI-I was 6.4 (SE 00.4). Among patients who received long-acting opioids, the mean daily dosage was 106.2 mg (SE 2.8) and mean BPI-I was 6.8 (SE 0.07). Higher daily dosage was associated with worse pain-related function and quality of life among patients without long-acting opioids, but not among patients with long-acting opioids. Future analyses will use follow-up data to examine effects of opioid dose reduction and discontinuation on patient outcomes.

Family caregiver satisfaction with inpatient rehabilitation care.

INTRODUCTION: Informal family caregivers play an increasingly important role in healthcare. Despite their role in ongoing management and coordination of care, caregiver satisfaction with the healthcare services care recipients receive has been understudied. We sought to assess what influences caregiver satisfaction with inpatient care provided to their care recipient among caregivers of veterans with traumatic brain injury (TBI) and polytrauma. METHODS: Data from the Family and Caregiver Experience Survey, a national survey of caregivers of veterans with TBI and polytrauma, was used to explore factors associated with caregiver satisfaction with the care his/her care recipient received while an inpatient at a US Department of Veterans Affairs (VA) Polytrauma Rehabilitation Center. Caregiver and care recipient demographic and injury factors and potential addressable factors including social support, caregiver training received, and caregiver perceptions of being valued by the VA were evaluated for their associations with caregivers' satisfaction with their care recipients' healthcare. RESULTS: The majority of the 524 caregivers reported being mostly or very satisfied with their care recipient's inpatient care (75%, n = 393). Higher satisfaction with inpatient care was significantly associated with greater caregiver social support, receipt of training from the VA, and perceptions of being valued by the VA, both on univariate analysis and after controlling for care recipient TBI severity and caregiver's relationship to the care recipient. CONCLUSIONS: Results suggest that supporting a strong social network for caregivers, providing caregiver training, and employing practices that communicate that family caregiving is valued by providers and healthcare organizations are promising avenues for improving caregiver satisfaction.

"I Was a Little Surprised": Qualitative Insights From Patients Enrolled in a 12-Month Trial Comparing Opioids With Nonopioid Medications for Chronic Musculoskeletal Pain.

Chronic musculoskeletal pain is a major public health problem. Although opioid prescribing for chronic pain has increased dramatically since the 1990s, this practice has come under scrutiny because of increases in opioid-related harms and lack of evidence for long-term effectiveness. The Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial was a pragmatic 12-month randomized trial comparing the benefits and harms of opioid versus nonopioid medications for chronic musculoskeletal pain. The current qualitative study was designed to better understand trial results by exploring patients' experiences, including perceptions of medications, experiences with the intervention, and whether expectations were met. Thirty-four participants who were purposefully sampled based on treatment group and intervention response participated in semistructured interviews. The constant comparison method guided analysis. Results revealed that participants often held strong beliefs about opioid medications, which sometimes changed during the trial as they gained experience with medications; participants described a wide variety of experiences with treatment effectiveness, regardless of study group or their response to the intervention; and participants highly valued the personalized pain care model used in SPACE. PERSPECTIVE: SPACE trial results indicated no advantage for opioid over nonopioid medications. Qualitative findings suggest that, for both treatment groups, preexisting expectations and anticipated improvement in pain shaped experiences with and responses to medications. The personalized pain care model was described as contributing to positive outcomes in both groups.

Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial.

Importance: Limited evidence is available regarding long-term outcomes of opioids compared with nonopioid medications for chronic pain. Objective: To compare opioid vs nonopioid medications over 12 months on pain-related function, pain intensity, and adverse effects. Design, Setting, and Participants: Pragmatic, 12-month, randomized trial with masked outcome assessment. Patients were recruited from Veterans Affairs primary care clinics from June 2013 through December 2015; follow-up was completed December 2016. Eligible patients had moderate to severe chronic back pain or hip or knee osteoarthritis pain despite analgesic use. Of 265 patients enrolled, 25 withdrew prior to randomization and 240 were randomized. Interventions: Both interventions (opioid and nonopioid medication therapy) followed a treat-to-target strategy aiming for improved pain and function. Each intervention had its own prescribing strategy that included multiple medication options in 3 steps. In the opioid group, the first step was immediate-release morphine, oxycodone, or hydrocodone/acetaminophen. For the nonopioid group, the first step was acetaminophen (paracetamol) or a nonsteroidal anti-inflammatory drug. Medications were changed, added, or adjusted within the assigned treatment group according to individual patient response. Main Outcomes and Measures: The primary outcome was pain-related function (Brief Pain Inventory [BPI] interference scale) over 12 months and the main secondary outcome was pain intensity (BPI severity scale). For both BPI scales (range, 0-10; higher scores = worse function or pain intensity), a 1-point improvement was clinically important. The primary adverse outcome was medication-related symptoms (patient-reported checklist; range, 0-19). Results: Among 240 randomized patients (mean age, 58.3 years; women, 32 [13.0%]), 234 (97.5%) completed the trial. Groups did not significantly differ on pain-related function over 12 months (overall P = .58); mean 12-month BPI interference was 3.4 for the opioid group and 3.3 for the nonopioid group (difference, 0.1 [95% CI, -0.5 to 0.7]). Pain intensity was significantly better in the nonopioid group over 12 months (overall P = .03); mean 12-month BPI severity was 4.0 for the opioid group and 3.5 for the nonopioid group (difference, 0.5 [95% CI, 0.0 to 1.0]). Adverse medication-related symptoms were significantly more common in the opioid group over 12 months (overall P = .03); mean medication-related symptoms at 12 months were 1.8 in the opioid group and 0.9 in the nonopioid group (difference, 0.9 [95% CI, 0.3 to 1.5]). Conclusions and Relevance: Treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months. Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain. Trial Registration: clinicaltrials.gov Identifier: NCT01583985.

Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial.

This manuscript describes the study protocol, recruitment outcomes, and baseline participant characteristics for the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. SPACE is a pragmatic randomized comparative effectiveness trial conducted in multiple VA primary care clinics within one VA health care system. The objective was to compare benefits and harms of opioid therapy versus non-opioid medication therapy over 12months among patients with moderate-to-severe chronic back pain or hip/knee osteoarthritis pain despite analgesic therapy; patients already receiving regular opioid therapy were excluded. Key design features include comparing two clinically-relevant medication interventions, pragmatic eligibility criteria, and flexible treat-to-target interventions. Screening, recruitment and study enrollment were conducted over 31months. A total of 4491 patients were contacted for eligibility screening; 53.1% were ineligible, 41.0% refused, and 5.9% enrolled. The most common reasons for ineligibility were not meeting pain location and severity criteria. The most common study-specific reasons for refusal were preference for no opioid use and preference for no pain medications. Of 265 enrolled patients, 25 withdrew before randomization. Of 240 randomized patients, 87.9% were male, 84.1% were white, and age range was 21-80years. Past-year mental health diagnoses were 28.3% depression, 17% anxiety, 9.4% PTSD, 7.9% alcohol use disorder, and 2.6% drug use disorder. In conclusion, although recruitment for this trial was challenging, characteristics of enrolled participants suggest we were successful in recruiting patients similar to those prescribed opioid therapy in usual care.

Couple and family involvement in adult mental health treatment: a systematic review.

We reviewed randomized controlled trials conducted in the United States from January, 1996 through December, 2011 that examined family interventions for adult mental health conditions. We identified 51 articles (39 trials) evaluating 21 different family interventions. Findings for behavioral couple or family therapy (BCT/BFT) and community reinforcement and training (CRAFT) for substance use disorders were each pooled separately for examination in meta-analyses. Findings suggest BCT/BFT reduced substance use (small-to-moderate effects) and improved relationship adjustment (large effects) compared to individually-oriented treatments. CRAFT increased treatment initiation three-fold but did not improve substance use or family functioning over alternative family interventions. Family focused therapy for bipolar disorder improved symptoms over less intensive treatments with mixed findings when compared to equally intensive treatments. For both bipolar disorder and schizophrenia spectrum disorders, the few trials meeting our search criteria and heterogeneity among trials precluded generating broader conclusions regarding which family interventions are most effective for US populations. Overall, trials were limited in their methodological quality, and many interventions were evaluated in one trial. Future research is needed to replicate findings for these single trials, examine relationship distress as a moderator of outcome, and examine BCT/BFT among dual substance using couples and outside the research group frequently represented.

Caregiver reports of subsequent injuries among veterans with traumatic brain injury after discharge from inpatient polytrauma rehabilitation programs.

OBJECTIVE: : We examined prevalence of, and potential risk factors for, nonfatal injuries among Veterans with traumatic brain injury (TBI) postdischarge from Veterans Affairs inpatient polytrauma rehabilitation programs. METHODS: : We surveyed caregivers of patients who had military service anytime from 2001 to 2009, sustained polytrauma including TBI, received Veterans Affairs inpatient care from 2001 to 2009, were discharged at least 3 months before the study, and were alive when the study was fielded about caregiver and patient health, including patients' medically treated "accidents/new injuries" since discharge. We examined prevalence and source(s) of subsequent injuries and estimated patients' injury risk in reference to hypothesized risk factors. Odds ratios and 95% confidence intervals were calculated using multivariate logistic regression. RESULTS: : Caregivers reported that nearly one-third (32%) of patients incurred medically treated injuries after discharge; most were associated with falls (49%) and motor vehicles (37%). Odds of subsequent injury were associated with select demographics, initial injury characteristics, and postdischarge health and functioning. Characteristics of caregivers, including physical and mental health, were also associated with patients' odds of subsequent injury. CONCLUSIONS: : A significant number of caregivers reported subsequent nonfatal injuries among patients treated for TBI/polytrauma in inpatient rehabilitation settings. Enhanced injury prevention efforts may be beneficial for this population.

The invisible side of war: families caring for US service members with traumatic brain injuries and polytrauma.

OBJECTIVES: : To (1) identify informal caregivers to injured US service members following acute rehabilitation for polytraumatic injuries, principally traumatic brain injury (TBI), and (2) describe the prevalence and variation of care recipient and caregiver experiences. DESIGN: : Cross-sectional survey of caregivers. PARTICIPANTS: : Caregivers (N = 564) of service members with TBI who received inpatient rehabilitation care in a Veterans Affairs' Polytrauma Rehabilitation Center between 2001 and 2009. MAIN OUTCOME MEASURES: : Questions about caregiver and patient characteristics, type, and quantity of care currently being provided. RESULTS: : Caregiving responsibilities fall primarily on women (79%), typically a parent (62%) or spouse (32%). After a median 4 years since injury, 22% of patients still required assistance with activities of daily living and instrumental activities of daily living. An additional 48% required assistance with only instrumental activities of daily living. Nearly 25% of caregivers reported more than 40 h/wk of care and another 20% reported 5 to 40 h/wk of care. Of caregivers providing assistance with activities of daily living, 49% provided care ≥ 80 h/wk. Nearly 60% of caregivers were solely responsible for the caregiving. Most caregivers also reported providing other help, including managing emotions and navigating health and legal systems. CONCLUSIONS: : Caregivers who provide assistance with either activities of daily living or instrumental activities of daily living may need additional resources to meet the long-term needs of their injured family member.

Is policy well-targeted to remedy financial strain among caregivers of severely injured U.S. service members?

U.S. military service members have sustained severe injuries since the start of the wars in Iraq and Afghanistan. This paper aims to determine the factors associated with financial strain of their caregivers and establish whether recent federal legislation targets caregivers experiencing financial strain. In our national survey, 62.3% of caregivers depleted assets and/or accumulated debt, and 41% of working caregivers left the labor force. If a severely injured veteran needed intensive help, the primary caregiver faced odds 4.63 times higher of leaving the labor force, and used $27,576 more in assets and/or accumulated debt compared to caregivers of veterans needing little or no assistance.

Perceived stigma, strain, and mental health among caregivers of veterans with traumatic brain injury.

BACKGROUND: Family caregivers of individuals with stigmatized conditions can experience stigma-by-association and discrimination. Moderate-to-severe traumatic brain injury (TBI) may elicit a stigma response if there are visible physical or neurobehavioral effects of the injury. Stigma is a considerable source of stress and may contribute to caregiver strain and stress-related mental health outcomes. We measured the frequency of perceived stigma and discrimination among caregivers of veterans with TBI and examined whether perceived stigma and discrimination are associated with caregiver strain, social isolation, depression, and anxiety. METHODS: Seventy caregivers of veterans with TBI completed a mailed survey that assessed perceptions of discrimination toward themselves or their care recipient, stigma associated with caregiving, and whether they felt the need to cover up or provide an explanation for their care recipient's injury. Caregiver strain, social isolation, depression, and anxiety were also assessed via the questionnaire. Multivariate linear regression was used to test the associations between stigma and discrimination measures and outcomes, controlling for potential confounders and other caregiver or care recipient characteristics. RESULTS: Both perceptions of caregiver discrimination and stigma associated with caregiving were significantly associated with caregiver strain, social isolation, depression, and anxiety. Perceived discrimination against the individual with TBI was associated with caregiver strain and social isolation. CONCLUSIONS: Our findings suggest that perceived discrimination and stigma experienced by caregivers of individuals with TBI are stressors that may lead to poor caregiver mental health outcomes. In order to promote both caregiver and care recipient health, we suggest that mental health support services consider these important stressors.