Evaluation of implementation facilitation integrated into a national mentoring programme to improve access to evidence-based psychotherapy for post-traumatic stress disorder within the veterans health administration: a quality improvement report.

Despite the resources dedicated to specialised mental healthcare for patients with post-traumatic stress disorder (PTSD) within the US Veterans Health Administration, evidence-based psychotherapies (EBPs) for PTSD have been underutilised, as evidenced by low EBP reach to patients. A research-operation collaboration evaluated whether implementation facilitation delivered by regional PTSD mentors as part of a national mentoring programme improved EBP reach compared with less-intensive quality improvement interventions. We used a non-equivalent comparison-group design that included all PTSD clinics with low EBP reach at baseline (n=51). Clinics were grouped into one of four quality improvement conditions according to self-selection by regional PTSD mentors: facilitation (n=6), learning collaborative (n=15), mentoring as usual in the regions that had facilitation-target clinics (n=15) and mentoring as usual in other regions (n=15). The primary outcome was EBP reach among therapy patients with PTSD at preintervention baseline and postintervention sustainment periods. We used the ratio of odds ratios (ROR) between the two time periods to evaluate the effectiveness of facilitation compared with the other conditions, adjusting for patient-level and clinic-level confounders. 26 126 veterans with PTSD received psychotherapy in one of 51 low-reach PTSD clinics during preintervention baseline and postintervention sustainment periods. The odds of a patient receiving an EBP increased over time across conditions. The adjusted ORs of a patient receiving an EBP from baseline to sustainment were 1.35-1.69 times larger in clinics that received facilitation compared with the three comparison conditions (adjusted RORs of comparison condition versus facilitation ranged from 0.59 (95% CI 0.47 to 0.75) to 0.74 (95% CI 0.58 to 0.94)). Implementation facilitation can be integrated into a national programme for quality improvement for PTSD specialty care and may be particularly useful when less-intensive approaches are not sufficiently effective.

Variation in Reporting of Incidental Findings on Initial Lung Cancer Screening and Associations With Clinician Assessment.

PURPOSE: The aim of this study was to quantify the distribution, frequency, and clinical significance of incidental findings (IFs) on initial lung cancer screening (LCS) and the association of report characteristics with subsequent assessment. METHODS: Health records of patients undergoing initial LCS from 2015 to 2018 in the Minneapolis VA Health Care System were retrospectively reviewed for demographics, Lung CT Screening Reporting & Data System coding, IFs, and subsequent clinical assessment. IFs were considered potentially significant if they were likely to require any follow-up. High-risk significant IFs (SIFs) were potentially malignant. The primary outcome was the SIF being addressed. Outcomes were analyzed using a mixed-effects model. RESULTS: Patients (n = 901) were primarily male (94.1%) smokers (62.1%) with a mean age of 65.2 years. IFs were extremely common (93.9%), with an average of 2.6 IFs per scan (n = 2,296). Seven hundred eighty-six IFs (34.2%) were deemed likely SIFs, of which 58 (7.4%) were high risk. Two hundred twenty-two (28.2%) were addressed by clinicians, of which 104 (13.2%) underwent testing. Reporting of SIFs varied among radiologists, with at least one SIF in the impression in 24% to 78% of low-dose CT studies with the S modifier, used to indicate the presence of a SIF, applied to 0% to 51% of reports. In the mutually adjusted model, radiologist recommendation (adjusted odds ratio [OR], 4.67; 95% confidence interval [CI], 2.23-9.76), high-risk finding (adjusted OR, 4.35; 95% CI, 1.81-10.45), and reporting in the impression (adjusted OR, 2.58; 95% CI, 1.28-5.18) were associated with increased odds of the SIF's being addressed. CONCLUSIONS: Radiologists vary in their reporting of IFs on LCS. Further standardization of reporting of SIFs may improve this process, with the simultaneous goals of generating appropriate testing when needed and minimizing low-value care.

Co-occurring implementation strategies: The effects of academic detailing for opioid use disorder campaign on the advancing pharmacological treatments for opioid use disorder (ADaPT-OUD) study.

Background: Barriers at the system, clinician, and patient level limit access to medications for opioid use disorder (MOUD). The Advancing Pharmacological Treatments for Opioid Use Disorder (ADaPT-OUD) study implemented an external facilitation strategy within the Veterans Health Administration (VHA) aimed at facility-level barriers to improve uptake of MOUD. During ADaPT-OUD, an independent Academic Detailing Services Opioid Agonist Treatment of OUD Campaign was co-occurring and aimed to increase evidence-based practice for OUD at the clinician level. While both these initiatives aim to increase MOUD reach, they address different barriers and did not intentionally collaborate. Thus, understanding the interaction between these two independent implementation initiatives and their effect on MOUD reach will further inform and mold future implementation efforts of MOUD. Methods: This was a secondary analysis of the ADaPT-OUD study that included 35 VHA facilities in the lowest quartile of MOUD reach; eight received the ADaPT-OUD external facilitation and 27 matched sites received implementation as usual. The number of academic detailing (AD) visits during ADaPT-OUD was used as a proxy for the intensity of Academic Detailing for OUD Campaign activity. The interaction between external facilitation status and AD intensity was evaluated by comparing the change in facility-level MOUD reach. Results: There was a general increase in the number of AD visits, in both external facilitation and implementation as usual sites, over the course of ADaPT-OUD's implementation period. A non-statistically significant, positively sloped, linear relationship was observed between average number of AD visits per quarter and change in MOUD reach in facilities also receiving ADaPT-OUD external facilitation that was not observed in the implementation as usual sites. Conclusion: Co-occurring initiatives focusing on different barriers to MOUD access have the potential to further increase MOUD in low-performing facilities, but further research into timing, quality, and collaboration between initiatives are warranted.

Medication treatment of opioid use disorder (MOUD) is a key element in addressing the opioid epidemic. The development, approval, and effectiveness of buprenorphine and naltrexone have expanded access to MOUD from specialty opioid treatment programs to office-based treatment. However, uptake of these evidence-based treatments across the Veterans Health Administration (VHA) is variable. To address this gap in care within the VHA, The Advancing Pharmacological Treatment for Opioid Use Disorder (ADaPT-OUD) study implemented an external facilitation strategy aimed at facility-level barriers at low-adopting VHA facilities while the VHA Pharmacy Benefits Management Academic Detailing Services Opioid Agonist Treatment of OUD Campaign implemented academic detailing with the goal to address clinician-level barriers. This article evaluates the effect these two co-occurring and independent initiatives had on each other and MOUD reach. The results suggest a trend toward a positive synergistic relationship between the two initiatives, that warrants further study and evaluation to inform further implementation efforts.

Costs of implementing a multi-site facilitation intervention to increase access to medication treatment for opioid use disorder.

BACKGROUND: The United States has been grappling with the opioid epidemic, which has resulted in over 75,000 opioid-related deaths between April 2020 and 2021. Evidence-based pharmaceutical interventions (buprenorphine, methadone, and naltrexone) are available to reduce opioid-related overdoses and deaths. However, adoption of these medications for opioid use disorder has been stifled due to individual- and system-level barriers. External facilitation is an evidence-based implementation intervention that has been used to increase access to medication for opioid use disorder (MOUD), but the implementation costs of external facilitation have not been assessed. We sought to measure the facility-level direct costs of implementing an external facilitation intervention for MOUD to provide decision makers with estimates of the resources needed to implement this evidence-based program. METHODS: We performed a cost analysis of the pre-implementation and implementation phases, including an itemization of external facilitation team and local site labor costs. We used labor estimates from the Bureau of Labor and Statistics, and sensitivity analyses were performed using labor estimates from the Veterans Health Administration (VHA) Financial Management System general ledger data. RESULTS: The average total costs for implementing an external facilitation intervention for MOUD per site was $18,847 (SD 6717) and ranged between $11,320 and $31,592. This translates to approximately $48 per patient with OUD. Sites with more encounters and participants with higher salaries in attendance had higher costs. This was driven mostly by the labor involved in planning and implementation activities. The average total cost of the pre-implementation and implementation activities were $1031 and $17,816 per site, respectively. In the sensitivity analysis, costs for VHA were higher than BLS estimates likely due to higher wages. CONCLUSIONS: Implementing external facilitation to increase MOUD prescribing may be affordable depending on the payer's budget constraints. Our study reported that there were variations in the time invested at each phase of implementation and the number and type of participants involved with implementing an external facilitation intervention. Participant composition played an important role in total implementation costs, and decision makers will need to identify the most efficient and optimal number of stakeholders to involve in their implementation plans.

What Contributes to Sustainability? Examining Access to Medications for Opioid Use Disorder in Low-Adopting VHA Facilities.

BACKGROUND: Successful implementation can increase the availability of evidence-based treatments but continued patient access can be threatened if there is not deliberate focus on sustainment. Real-world examples are needed to elucidate contributors to sustainability. OBJECTIVE: We examined sustainability of outcomes of a study which tested a 12-month external facilitation intervention. The study evaluated change in access to medications for opioid use disorder (MOUD) in Veterans Health Administration (VHA) facilities in the lowest quartile of MOUD prescribing. DESIGN: Convergent mixed-methods design. PARTICIPANTS: Thirty-nine providers and leaders from eight VHA facilities. APPROACH: Thirty-minute post-implementation telephone interviews explored whether barriers identified pre-implementation were successfully addressed, the presence of any new challenges, helpfulness of external facilitation, and plans for sustaining MOUD access. Interviews were analyzed using a rapid turn-around approach. VHA administrative data were used to characterize the facilities and assess their ratio of patients with an OUD diagnosis receiving MOUD (MOUD/OUD ratio) at the end of a 9-month sustainability period. KEY RESULTS: Commonly reported contributors to sustained MOUD access included national attention on the opioid epidemic, accountability created by study participation, culture shift in MOUD acceptability, leadership support, and plans to build on initial progress. Frequently reported barriers included staffing issues and lack of MOUD-devoted time; the need to overhaul existing policies, practices, and/or processes; and fear and anxiety about MOUD prescribing. All facilities either maintained MOUD/OUD ratio improvement (n = 2) or further improved (n = 6) at the end of sustainability. Facilities with the highest and lowest ratio at the end of sustainability used a team-based approach to MOUD delivery; however, organizational setting differences may have impacted overall MOUD access. CONCLUSIONS: Ensuring stable and consistent staff, and sufficient time dedicated to MOUD are critical to sustaining access to evidence-based treatment in low-adopting facilities. This study highlights the importance of investing in local, system-level changes to improve and sustain access to effective treatments.

Healthcare quality measures in implementation research: advantages, risks and lessons learned.

Implementation studies evaluate strategies to move evidence-based practices into routine clinical practice. Often, implementation scientists use healthcare quality measures to evaluate the integration of an evidence-based clinical practice into real-world healthcare settings. Healthcare quality measures have standardized definitions and are a method to operationalize and monitor guideline-congruent care. Implementation scientists can access existing data on healthcare quality measures through various sources (e.g. operations-calculated), or they can calculate the measures directly from healthcare claims and administrative data (i.e. researcher-calculated). Implementation scientists need a better understanding of the advantages and disadvantages of these methods of obtaining healthcare quality data for designing, planning and executing an implementation study. The purpose of this paper is to describe the advantages, risks and lessons learned when using operations- versus researcher-calculated healthcare quality measures in site selection, implementation monitoring and implementation outcome evaluation. A key lesson learned was that relying solely on operations-calculated healthcare quality measures during an implementation study poses risks to site selection, accurate feedback on implementation progress to stakeholders, and the integrity of study results. A possible solution is using operations-calculated quality measures for monitoring of evidence-based practice uptake and researcher-calculated measures for site section and outcomes evaluation. This approach provides researchers greater control over the data and consistency of the measurement from site selection to outcomes evaluation while still retaining measures that are familiar and understood by key stakeholders whom implementation scientists need to engage in practice change efforts.

Impact of different cover letter information and incentives on Veterans' emotional responses to an unsolicited mailed survey about military traumas: a randomized, 3x2x2 factorial trial.

BACKGROUND: Altering cover letter information to reduce non-response bias in trauma research could inadvertently leave survey participants unprepared for potentially upsetting questions. In an unsolicited, mailed survey, we assessed participants' change in affect post-survey after altering key cover letter information and promising different incentives. We tested direct and indirect effects of participants carefully reading the cover letter on changes in their affect post-survey. METHODS: In a 3X2X2 randomized, factorial trial, 480 male and 480 female, nationally representative Veterans who were applying for posttraumatic stress disorder disability benefits were randomized to receive one of 12 different cover letters. The cover letters provided general versus more explicit information about the survey's trauma content and how their names were selected for study; we also promised different incentives for returning the survey. The main outcome was change in affect post-survey. We examined five potential moderators: combat or military sexual trauma exposure, posttraumatic stress disorder or serious mental illness diagnosis, and recency of military service. Mediators between reading the cover letter carefully and post-survey affect included how participants rated the cover letters' information and whether they thought the cover letters prepared them for the survey's content. A Bonferroni corrected alpha of 0.003 was the threshold for statistical significance. RESULTS: One hundred ninety men and 193 women reported their pre-and post-survey affect. Across all study conditions, out of 16 possible points, the net change in affect post-survey was less than a quarter-point for men and women. Mean changes in post-survey affect did not differ statistically significantly across any of the study factors (ps > 0.06); nor were there statistically significant interactions between any of the study factors and the 5 moderators after accounting for multiple comparisons (ps > 0.02). After controlling for pre-survey affect, reading the cover letter carefully had small effects on changes in post-survey affect, with larger associations seen in the women compared to men. Mediators' effects were often in opposite directions for men and women. CONCLUSION: General descriptions of a survey's trauma content appear ethically defensible. Research on cover letters' impacts on survey participants' emotional reactions and how those impacts differ by gender is needed.

Comparative Effectiveness of Opioid Tapering or Abrupt Discontinuation vs No Dosage Change for Opioid Overdose or Suicide for Patients Receiving Stable Long-term Opioid Therapy.

Importance: Opioid dosage tapering has emerged as a strategy to reduce harms associated with long-term opioid therapy; however, evidence supporting this approach is limited. Objective: To identify the association of opioid tapering or abrupt discontinuation with opioid overdose and suicide events among patients receiving stable long-term opioid therapy without evidence of opioid misuse. Design, Setting, and Participants: This comparative effectiveness study with a trial emulation approach used a large US claims data set of individuals with commercial insurance or Medicare Advantage who were aged 18 years or older and receiving stable long-term opioid therapy without evidence of opioid misuse between January 1, 2010, and December 31, 2018. Statistical analysis was performed from January 17, 2020, through November 12, 2021. Interventions: Three opioid dosage strategies: stable dosage, tapering (dosage reduction ≥15%), or abrupt discontinuation. Main Outcomes and Measures: Time to opioid overdose or suicide event identified from International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnosis codes in medical claims over 11 months of follow-up. Inverse probability weighting was used to adjust for baseline confounders. The primary analysis used an intention-to-treat approach; follow-up after assignment regardless of changes in opioid dose was included. A per-protocol analysis was also conducted, in which episodes were censored for lack of adherence to assigned treatment. Results: A cohort of 199 836 individuals (45.1% men; mean [SD] age, 56.9 [12.4] years; and 57.6% aged 45-64 years) had 415 123 qualifying, long-term opioid therapy episodes; 87.1% of episodes were considered stable, 11.1% were considered a taper, and 1.8% were considered abrupt discontinuation. The adjusted cumulative incidence of opioid overdose or suicide events 11 months after baseline was 0.96% (95% CI, 0.92%-0.99%) with a stable dosage strategy, 1.10% (95% CI, 0.99%-1.22%) with a tapered dosage strategy, and 1.28% (95% CI, 0.93%-1.38%) with an abrupt discontinuation strategy. The risk difference between a taper and a stable dosage was 0.15% (95% CI, 0.03%-0.26%), and the risk difference between abrupt discontinuation and a stable dosage was 0.33% (95% CI, -0.03% to 0.74%). Results were similar using the per-protocol approach. Conclusions and Relevance: This study identified a small absolute increase in risk of harms associated with opioid tapering compared with a stable opioid dosage. These results do not suggest that policies of mandatory dosage tapering for individuals receiving a stable long-term opioid dosage without evidence of opioid misuse will reduce short-term harm via suicide and overdose.

Impact of different cover letter content and incentives on non-response bias in a sample of Veterans applying for Department of Veterans Affairs disability benefits: a randomized, 3X2X2 factorial trial.

BACKGROUND: Non-random non-response bias in surveys requires time-consuming, complicated, post-survey analyses. Our goal was to see if modifying cover letter information would prevent non-random non-response bias altogether. Our secondary goal tested whether larger incentives would reduce non-response bias. METHODS: A mailed, survey of 480 male and 480 female, nationally representative, Operations Enduring Freedom, Iraqi Freedom, or New Dawn (OEF/OIF/OND) Veterans applying for Department of Veterans Affairs (VA) disability benefits for posttraumatic stress disorder (PTSD). Cover letters conveyed different information about the survey's topics (combat, unwanted sexual attention, or lifetime and military experiences), how Veterans' names had been selected (list of OEF/OIF/OND Veterans or list of Veterans applying for disability benefits), and what incentive Veterans would receive ($20 or $40). The main outcome, non-response bias, measured differences between survey respondents' and sampling frame's characteristics on 8 administrative variables, including Veterans' receipt of VA disability benefits and exposure to combat or military sexual trauma. Analysis was intention to treat. We used ANOVA for factorial block-design, logistic, mixed-models to assess bias and multiple imputation and expectation-maximization algorithms to assess potential missing mechanisms (missing completely at random, missing at random, or not random) of two self-reported variables: combat and military sexual assault. RESULTS: Regardless of intervention, men with any VA disability benefits, women with PTSD disability benefits, and women with combat exposure were over-represented among respondents. Interventions explained 0.0 to 31.2% of men's variance and 0.6 to 30.5% of women's variance in combat non-response bias and 10.2 to 43.0% of men's variance and 0.4 to 31.9% of women's variance in military sexual trauma non-response bias. Non-random assumptions showed that men's self-reported combat exposure was overestimated by 19.0 to 28.8 percentage points and their self-reported military sexual assault exposure was underestimated by 14.2 to 28.4 percentage points compared to random missingness assumptions. Women's self-reported combat exposure was overestimated by 8.6 to 10.6 percentage points and military sexual assault exposure, by 1.2 to 6.9 percentage points. CONCLUSIONS: Our interventions reduced bias in some characteristics, leaving others unaffected or exacerbated. Regardless of topic, researchers are urged to present estimates that include all three assumptions of missingness.

Advancing Pharmacological Treatments for Opioid Use Disorder (ADaPT-OUD): an Implementation Trial in Eight Veterans Health Administration Facilities.

BACKGROUND: Identifying effective strategies to improve access to medication treatments for opioid use disorder (MOUD) is imperative. Within the Veterans Health Administration (VHA), provision of MOUD varies significantly, requiring development and testing of implementation strategies that target facilities with low provision of MOUD. OBJECTIVE: Determine the effectiveness of external facilitation in increasing the provision of MOUD among VHA facilities with low baseline provision of MOUD compared to matched controls. DESIGN: Pre-post, block randomized study designed to compare facility-level outcomes in a stratified sample of eligible facilities. Four blocks (two intervention facilities in each) were defined by median splits of both the ratio of patients with OUD receiving MOUD and number of patients with OUD not currently receiving MOUD (i.e., number of actionable patients). Intervention facilities participated in a 12-month implementation intervention. PARTICIPANTS: VHA facilities in the lowest quartile of MOUD provision (35 facilities), eight of which were randomly assigned to participate in the intervention (two per block) with twenty-seven serving as matched controls by block. INTERVENTION: External facilitation included assessment of local barriers/facilitators, formation of a local implementation team, a site visit for action planning and training/education, cross-facility quarterly calls, monthly coaching calls, and consultation. MAIN MEASURES: Pre- to post-change in the facility-level ratio of patients with an OUD diagnosis receiving MOUD compared to control facilities. KEY RESULTS: Intervention facilities significantly increased the ratio of patients with OUD receiving MOUD from an average of 18% at baseline to 30% 1 year later, with an absolute difference of 12% (95% confidence interval [CI]: 6.6%, 17.0%). The difference in differences between intervention and control facilities was 3.0% (95% CI: - 0.2%. 6.7%). The impact of the intervention varied by block, with smaller, less complex facilities more likely to outperform matched controls. CONCLUSIONS: Intensive external facilitation improved the adoption of MOUD in most low-performing facilities and may enhance adoption beyond other interventions less tailored to individual facility contexts.

Early impacts of a multi-faceted implementation strategy to increase use of medication treatments for opioid use disorder in the Veterans Health Administration.

BACKGROUND: Despite the risk of negative sequelae from opioid use disorder (OUD) and clinical guidelines for the use of effective medication treatment for OUD (M-OUD), many Veterans Health Administration (VHA) providers and facilities lag in providing M-OUD. An intensive external facilitation intervention may enhance uptake in low-adopting VHA facilities by engaging stakeholders from multiple clinical settings within a facility (e.g., mental health, primary care, pain specialty clinic, substance use disorder clinics). Our study identified pre-intervention determinants of implementation through qualitative interviews, described strategies employed during the first 6 months of intensive external facilitation, and explored patterns of implementation determinants in relation to early outcomes. METHODS: Guided by the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, we interviewed stakeholders at low-adopting VHA facilities prior to external facilitation, employed a rapid qualitative analytic process, presented findings during facility visits, and collaboratively created facilitation action plans to achieve goals set by the facilities that would increase M-OUD uptake. The primary outcome was the Substance Use Disorder (SUD)-16, which is a VHA facility-level performance metric consisting of the percent of patients receiving M-OUD among those with an OUD diagnosis. We examined the relationship between pre-implementation factors and 6-month SUD-16 outcomes. RESULTS: Across eight VHA facilities, we interviewed 68 participants. Implementation determinants included barriers and facilitators across innovation, context, and recipients constructs of i-PARIHS. Each facility selected goals based on the qualitative results. At 6 months, two facilities achieved most goals and two facilities demonstrated progress. The SUD-16 from baseline to 6 months significantly improved in two facilities (8.4% increase (95 % confidence interval [CI] 4.4-12.4) and 9.9% increase (95% CI 3.6-16.2), respectively). Six-month implementation outcomes showed that the extent to which M-OUD aligns with existing clinical practices and values was a primary factor at all facilities, with six of eight facilities perceiving it as both a barrier and facilitator. External health system barriers were most challenging for facilities with the smallest change in SUD-16. CONCLUSIONS: Early impacts of a multi-faceted implementation approach demonstrated a strong signal for positively impacting M-OUD prescribing in low-adopting VHA facilities. This signal indicates that external facilitation can influence adoption of M-OUD at the facility level in the early implementation phase. These short-term wins experienced by stakeholders may encourage continued adoption and long-term sustainability M-OUD.

Evaluation of an Implementation Intervention to Increase Reach of Evidence-Based Psychotherapies for PTSD in US Veterans Health Administration PTSD Clinics.

To evaluate an implementation intervention to increase the uptake, referred to as reach, of two evidence-based psychotherapies (EBP) for posttraumatic stress disorder (PTSD) in Veterans Health Administration (VHA) PTSD specialty clinics. The implementation intervention was external facilitation guided by a toolkit that bundled strategies associated with high EBP reach in prior research. We used a prospective quasi-experimental design. The facilitator worked with local champions at two low-reach PTSD clinics. Each intervention PTSD clinic was matched to three control clinics. We compared the change in EBP reach from 6-months pre- to post-intervention using Difference-in-Difference (DID) effect estimation. To incorporate possible clustering effects and adjust for imbalanced covariates, we used mixed effects logistic regression to model the probability of EBP receipt. Analyses were conducted separately for PTSD and other mental health clinics. 29,446 veterans diagnosed with PTSD received psychotherapy in the two intervention and six control sites in the two 6-month evaluation periods. The proportion of therapy patients with PTSD receiving an EBP increased by 16.98 percentage points in the intervention PTSD clinics compared with .45 percentage points in the control PTSD clinics (DID = 16.53%; SE = 2.26%). The adjusted odd ratio of a patient receiving an EBP from pre to post intervention was almost three times larger in the intervention than in the control PTSD clinics (RoR 2.90; 95% CI 2.22-3.80). EBP reach was largely unchanged in other (not PTSD specialty) mental health clinics within the same medical centers. Toolkit-guided external facilitation is a promising intervention to improve uptake of EBPs in VHA. Toolkits that pre-specify targets for clinic change based on prior research may enhance the efficiency and effectiveness of external facilitation. Trial registration ISRCTN registry identifier: ISRCTN65119065. Available at https://www.isrctn.com/search?q=ISRCTN65119065 .

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.

Does need for cognitive closure explain individual differences in lung cancer screening? A brief report.

The need for cognitive closure describes the extent to which a person, faced with a decision, prefers any answer in lieu of continued uncertainty. This construct may be relevant in lung cancer screening, which can both reduce and increase uncertainty. We examined whether individual differences in need for cognitive closure are associated with Veterans' completion of lung cancer screening using a self-administered survey (N = 361). We also assessed whether need for cognitive closure moderates an association between screening completion and lung cancer risk perception. Contrary to our main hypothesis, high need for cognitive closure Veterans were not more likely to complete lung cancer screening and need for cognitive closure did not have a moderating role.

Association of invitation to lung cancer screening and tobacco use outcomes in a VA demonstration project.

A potential unintended consequence of lung cancer screening (LCS) is an adverse effect on smoking behaviors. This has been difficult to assess in previous randomized clinical trials. Our goal was to determine whether cessation and relapse behaviors differ between Veterans directly invited (DI) to participate in LCS compared to usual care (UC). We conducted a longitudinal survey of tobacco use outcomes among Veterans (Minneapolis VA) from 2014 to 2015, randomized (2:1) to DI versus UC and stratified by baseline smoking status (current/former). Within the DI group, we explored differences between those who did and did not choose to undergo LCS. A total of 979 patients (n = 660 DI, n = 319 UC) returned the survey at a median of 484 days. Among current smokers (n = 488), smoking abstinence rates and cessation attempts did not differ between DI and UC groups. More baseline smokers in DI were non-daily smokers at follow-up compared to those in UC (25.3% vs 15.6%, OR 1.97 95%CI 1.15-3.36). A significant proportion of former smokers at baseline relapsed, with 17% overall indicating past 30-day smoking. This did not differ between arms. Of those invited to LCS, smoking outcomes did not significantly differ between those who chose to be screened (161/660) versus not. This randomized program evaluation of smoking behaviors in the context of invitation to LCS observed no adverse or beneficial effects on tobacco cessation or relapse among participants invited to LCS, or among those who completed screening. As LCS programs scale and spread nationally, effective cessation programs will be essential.

Cost-effectiveness of population-level proactive tobacco cessation outreach among socio-economically disadvantaged smokers: evaluation of a randomized control trial.

AIMS: To estimate the cost-effectiveness at population-level of the OPT-IN proactive tobacco cessation outreach program for adult smokers enrolled in publicly funded health insurance plans for low-income persons (e.g. Medicaid). DESIGN: Cost-effectiveness analysis using a state transition model based on data from the Offering Proactive Treatment Intervention (OPT-IN) randomized control trial. SETTING: The trial was conducted in Minnesota, USA, and the economic analysis was conducted from the Medicaid program perspective. PARTICIPANTS: Data were used from 2406 smokers who were randomized into the intervention or comparator groups. INTERVENTION AND COMPARATOR: The intervention was comprised of proactive outreach (mailed invitation and telephone calls) and free cessation treatment (nicotine replacement therapy and intensive telephone counseling). The comparator was usual care, which comprised access to a primary care physician, insurance coverage of Food and Drug Administration (FDA)-approved smoking cessation medications and the state's telephone quitline. MEASUREMENTS: Smoking status, quality of life and health-care use at varying times, including at baseline and 1 year. FINDINGS: The OPT-IN program cost an average of $84 per participant greater than the comparator. One year after randomization, the population-level, 6-month prolonged smoking abstinence rate was 16.5% in the proactive outreach intervention group and 12.1% in the usual care group (P < 0.05). The model projected that the proactive outreach intervention added $78 in life-time cost and generated 0.005 additional quality-adjusted life-years (QALYs), with an expected incremental cost-effectiveness ratio of $4231 per QALY. Probabilistic sensitivity analysis found that the proactive outreach intervention would be cost-effective against a willingness-to-pay threshold of $50 000/QALY approximately 68% of the time. CONCLUSIONS: Population-level proactive tobacco treatment with personal telephone outreach was effective in achieving higher population-level quit rates and was cost-effective at various willingness-to-pay thresholds, compared with usual care (i.e. reactive treatment). Taken together with prior research, population-level proactive tobacco cessation outreach programs are judged to be highly cost-effective over the long term.

Smoking Cessation among Female and Male Veterans before and after a Randomized Trial of Proactive Outreach.

INTRODUCTION: Female veterans smoke cigarettes at high rates compared with both male veterans and nonveteran women. Proactive outreach to smokers may reduce gender disparities in cessation care. The objectives of this study were to compare baseline experiences with VA smoking cessation care for men and women and to assess for gender differences in response to a proactive outreach intervention. METHODS: We conducted a post hoc subgroup analysis of a pragmatic, multisite randomized, controlled trial comparing proactive outreach with usual care (UC). Baseline experiences included physician advice to quit, satisfaction with care, and past-year treatment use. At the 1-year follow-up, treatment use, quit attempts, and 6-month prolonged abstinence for women and men randomized to proactive outreach versus UC were compared using logistic regression. RESULTS: Baseline and follow-up surveys were returned by 138 women and 2,516 men. At baseline, women were less likely than men to report being very or somewhat satisfied with the process of obtaining smoking cessation medications in the VA (47% of women vs. 62% of men), but no less likely to report having used cessation medications from the VA in the past year (39% of women vs. 34% of men). After the intervention, phone counseling and combined therapy increased among both women and men in proactive outreach as compared with UC. At the 1-year follow-up, men in proactive outreach were significantly more likely to report prolonged abstinence than those in UC (odds ratio, 1.65; 95% CI, 1.28-2.14); results for women were in the same direction but not statistically significant (odds ratio, 1.39; 95% CI, 0.48-3.99). CONCLUSIONS: Satisfaction with cessation care in VA remains low. Proactive outreach to smokers was associated with an increased use of cessation therapies, and increased odds of achieving prolonged abstinence. A subgroup analysis by gender did not reveal significant differences in the treatment effect.

A cross-sectional study of the relationship of proximal smoking environments and cessation history, plans, and self-efficacy among low-income smokers.

INTRODUCTION: Proximal environments could facilitate smoking cessation among low-income smokers by making cessation appealing to strive for and tenable. AIMS: We sought to examine how home smoking rules and proximal environmental factors such as other household members' and peers' smoking behaviors and attitudes related to low-income smokers' past quit attempts, readiness, and self-efficacy to quit. METHODS: This analysis used data from Offering Proactive Treatment Intervention (OPT-IN) (randomized control trial of proactive tobacco cessation outreach) baseline survey, which was completed by 2,406 participants in 2011/12. We tested the associations between predictors (home smoking rules and proximal environmental factors) and outcomes (past-year quit attempts, readiness to quit, and quitting self-efficacy). RESULTS: Smokers who lived in homes with more restrictive household smoking rules, and/or reported having 'important others' who would be supportive of their quitting, were more likely to report having made a quit attempt in the past year, had greater readiness to quit, and greater self-efficacy related to quitting. CONCLUSIONS: Adjustments to proximal environments, including strengthening household smoking rules, might encourage cessation even if other household members are smokers.

The relationship between smoking cessation and binge drinking, depression, and anxiety symptoms among smokers with serious mental illness.

INTRODUCTION: Concerns about the adverse effects of smoking cessation on alcohol use and mental health are a barrier to cessation for smokers with serious mental illness (SMI). The purpose of this study is to examine how incident smoking cessation affects binge drinking and symptoms of depression and anxiety among smokers with SMI. METHODS: The present study is a secondary analysis of the OPTIN trial, which demonstrated the effectiveness of proactive outreach for smoking cessation among Minnesota Health Care Programs enrollees. Participants with ICD-9 codes indicating schizophrenia spectrum disorders, psychotic disorders, bipolar disorders, or severe/recurrent major depressive disorder were categorized as having SMI (n = 939); remaining smokers were categorized as non-SMI (n = 1382). Multivariable regressions modeled the association between incident smoking cessation and binge drinking, PHQ-2 depression scores, and PROMIS anxiety scores in the two groups. RESULTS: Quitting smoking was not associated with binge drinking among those with SMI, but was associated with less binge drinking among those without SMI (p = 0.033). Quitting smoking was not associated with PHQ-2 depression scores among those with or without SMI. However, quitting smoking was associated with lower mean PROMIS anxiety scores for those with SMI (p = 0.031), but not those without SMI. CONCLUSION: Quitting smoking was not associated with heightened binge drinking or symptoms of depression and anxiety among smokers with SMI. These findings suggest that quitting smoking is not detrimental for these patients, and provide evidential support for facilitating access to cessation resources for patients with serious mental illness who smoke.