Measurement and Validation of the Comprehensive Score for Financial Toxicity (COST) in a Population With Diabetes.

OBJECTIVE: The Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) is a validated instrument measuring financial distress among people with cancer. The reliability and construct validity of the 11-item COST-FACIT were examined in adults with diabetes and high A1C. RESEARCH DESIGN AND METHODS: We examined the factor structure (exploratory factor analysis), internal consistency reliability (Cronbach α), floor/ceiling effects, known-groups validity, and predictive validity among a sample of 600 adults with diabetes and high A1C. RESULTS: COST-FACIT demonstrated a two-factor structure with high internal consistency: general financial situation (7-items, α = 0.86) and impact of illness on financial situation (4-items, α = 0.73). The measure demonstrated a ceiling effect for 2% of participants and floor effects for 7%. Worse financial toxicity scores were observed among adults who were women, were below the poverty line, had government-sponsored health insurance, were middle-aged, were not in the workforce, and had less educational attainment (P < 0.01). Worse financial toxicity was observed for those engaging in cost coping behaviors, such as taking less or skipping medicines, delaying care, borrowing money, "maxing out" the limit on credit cards, and not paying bills (P < 0.01). In regression models for the full measure and its two factors, worse financial toxicity was correlated with higher A1C (P < 0.01), higher levels of diabetes distress (P < 0.01), more chronic conditions (P < 0.01), and more depressive symptoms (P < 0.01). CONCLUSIONS: Findings support both the reliability and validity of the COST-FACIT tool among adults with diabetes and high A1C levels. More research is needed to support the use of the COST-FACIT tool as a clinically relevant patient-centered instrument for diabetes care.

Influence of Digital Intervention Messaging on Influenza Vaccination Rates Among Adults With Cardiovascular Disease in the United States: Decentralized Randomized Controlled Trial.

BACKGROUND: Seasonal influenza affects 5% to 15% of Americans annually, resulting in preventable deaths and substantial economic impact. Influenza infection is particularly dangerous for people with cardiovascular disease, who therefore represent a priority group for vaccination campaigns. OBJECTIVE: We aimed to assess the effects of digital intervention messaging on self-reported rates of seasonal influenza vaccination. METHODS: This was a randomized, controlled, single-blind, and decentralized trial conducted at individual locations throughout the United States over the 2020-2021 influenza season. Adults with self-reported cardiovascular disease who were members of the Achievement mobile platform were randomized to receive or not receive a series of 6 patient-centered digital intervention messages promoting influenza vaccination. The primary end point was the between-group difference in self-reported vaccination rates at 6 months after randomization. Secondary outcomes included the levels of engagement with the messages and the relationship between vaccination rates and engagement with the messages. Subgroup analyses examined variation in intervention effects by race. Controlling for randomization group, we examined the impact of other predictors of vaccination status, including cardiovascular condition type, vaccine drivers or barriers, and vaccine knowledge. RESULTS: Of the 49,138 randomized participants, responses on the primary end point were available for 11,237 (22.87%; 5575 in the intervention group and 5662 in the control group) participants. The vaccination rate was significantly higher in the intervention group (3418/5575, 61.31%) than the control group (3355/5662, 59.25%; relative risk 1.03, 95% CI 1.004-1.066; P=.03). Participants who were older, more educated, and White or Asian were more likely to report being vaccinated. The intervention was effective among White participants (P=.004) but not among people of color (P=.42). The vaccination rate was 13 percentage points higher among participants who completed all 6 intervention messages versus none, and at least 2 completed messages appeared to be needed for effectiveness. Participants who reported a diagnosis of COVID-19 were more likely to be vaccinated for influenza regardless of treatment assignment. CONCLUSIONS: This personalized, evidence-based digital intervention was effective in increasing vaccination rates in this population of high-risk people with cardiovascular disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT04584645; https://clinicaltrials.gov/ct2/show/NCT04584645.

Impacts of the COVID-19 pandemic on unmet social needs, self-care, and outcomes among people with diabetes and poor glycemic control.

AIMS: The purpose of this study was to examine whether pandemic exposure impacted unmet social and diabetes needs, self-care behaviors, and diabetes outcomes in a sample with diabetes and poor glycemic control. METHODS: This was a cross-sectional analysis of participants with diabetes and poor glycemic control in an ongoing trial (n = 353). We compared the prevalence of unmet needs, self-care behaviors, and diabetes outcomes in successive cohorts of enrollees surveyed pre-pandemic (prior to March 11, 2020, n = 182), in the early stages of the pandemic (May-September, 2020, n = 75), and later (September 2020-January 2021, n = 96) stratified by income and gender. Adjusted multivariable regression models were used to examine trends. RESULTS: More participants with low income reported food insecurity (70% vs. 83%, p < 0.05) and needs related to access to blood glucose supplies (19% vs. 67%, p < 0.05) during the pandemic compared to pre-pandemic levels. In adjusted models among people with low incomes, the odds of housing insecurity increased among participants during the early pandemic months compared with participants pre-pandemic (OR 20.2 [95% CI 2.8-145.2], p < 0.01). A1c levels were better among participants later in the pandemic than those pre-pandemic (ß = -1.1 [95% CI -1.8 to -0.4], p < 0.01), but systolic blood pressure control was substantially worse (ß = 11.5 [95% CI 4.2-18.8, p < 0.001). CONCLUSION: Adults with low-incomes and diabetes were most impacted by the pandemic. A1c may not fully capture challenges that people with diabetes are facing to manage their condition; systolic blood pressures may have worsened and problems with self-care may forebode longer-term challenges in diabetes control.

Comparing telemedicine to in-person buprenorphine treatment in U.S. veterans with opioid use disorder.

BACKGROUND: Telemedicine-delivered buprenorphine (tele-buprenorphine) can potentially increase access to buprenorphine for patients with opioid use disorder (OUD), especially during the COVID-19 pandemic, but we know little about use in clinical care. METHODS: This study was a retrospective national cohort study of veterans diagnosed with opioid use disorder (OUD) receiving buprenorphine treatment from the Veterans Health Administration (VHA) in fiscal years 2012-2019. The study examined trends in use of tele-buprenorphine and compared demographic and clinical characteristics in patients who received tele-buprenorphine versus those who received in-person treatment only. RESULTS: Utilization of tele-buprenorphine increased from 2.29% of buprenorphine patients in FY2012 (n = 187) to 7.96% (n = 1352) in FY2019 in VHA veterans nationally. Compared to patients receiving only in-person care, tele-buprenorphine patients were less likely to be male (AOR = 0.85, 95% CI: 0.73-0.98) or Black (AOR = 0.54, 95% CI: 0.45-0.65). Tele-buprenorphine patients were more likely to be treated in community-based outpatient clinics rather than large medical centers (AOR = 2.91, 95% CI: 2.67-3.17) and to live in rural areas (AOR = 2.12, 95% CI:1.92-2.35). The median days supplied of buprenorphine treatment was 722 (interquartile range: 322-1459) among the tele-buprenorphine patients compared to 295 (interquartile range: 67-854) among patients who received treatment in-person. CONCLUSIONS: Use of telemedicine to deliver buprenorphine treatment in VHA increased 3.5-fold between 2012 and 2019, though overall use remained low prior to COVID-19. Tele-buprenorphine is a promising modality especially when treatment access is limited. However, we must continue to understand how practitioners and patient are using telemedicine and how these patients' outcomes compare to those using in-person care.

Co-Operative Pain Education and Self-management (COPES) Expanding Treatment for Real-World Access (ExTRA): Pragmatic Trial Protocol.

BACKGROUND: Given access barriers to cognitive behavioral therapy for chronic pain (CBT-CP), this pragmatic superiority trial will determine whether a remotely delivered CBT-CP intervention that addresses these barriers outperforms in-person and other synchronous forms of CBT-CP for veterans with musculoskeletal pain. DESIGN: This pragmatic trial compares an asynchronous form of CBT-CP that uses interactive voice response (IVR) to allow patients to participate from their home (IVR CBT-CP) with synchronous CBT-CP delivered by a Department of Veterans Affairs (VA) clinician. Veterans (n=764; 50% male) with chronic musculoskeletal pain throughout nine VA medical centers will participate. The primary outcome is pain interference after treatment (4 months). Secondary outcomes, including pain intensity, depression symptom severity, sleep, self-efficacy, and global impression of change, are also measured after treatment. Where possible, outcomes are collected via electronic health record extraction, with remaining measures collected via IVR calls to maintain blinding. Quantitative and qualitative process evaluation metrics will be collected to evaluate factors related to implementation. A budget impact analysis will be performed. SUMMARY: This pragmatic trial compares the outcomes, cost, and implementation of two forms of CBT-CP as delivered in the real-world setting. Findings from the trial can be used to guide future policy and implementation efforts related to these interventions and their use in the health system. If one of the interventions emerges as superior, resources can be directed to this modality. If both treatments are effective, patient preferences and health care system factors will take precedence when making referrals. Implications of COVID-19 on treatment provision and trial outcomes are discussed.