Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. METHODS: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. DISCUSSION: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. TRIAL REGISTRATION: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.

Reduction of Long-Term Opioid Prescribing for Back Pain in Community Health Centers After a Medicaid Policy Change.

INTRODUCTION: Beginning around 2011, innumerable policies have aimed to improve pain treatment while minimizing harms from excessive use of opioids. It is not known whether changing insurance coverage for specific conditions is an effective strategy. We describe and assess the effect of an innovative Oregon Medicaid back/neck pain coverage policy on opioid prescribing patterns. METHODS: This retrospective cohort study uses electronic health record data from a network of community health centers (CHCs) in Oregon to analyze prescription opioid dose changes among patients on long-term opioid treatment (LOT) affected by the policy. RESULTS: Of the 1,789 patients on LOT at baseline, 41.6% had an average daily dose of <20 morphine milligram equivalents (MME), 32.3% had ≥20 to <50 MME, 14.5% had ≥50 to <90 MME, and 11.6% ≥90 MME. Around half of each group discontinued opioids within the 18-month policy period. Those who discontinued did so gradually (average of 11 months) regardless of starting dosage. Predictors of discontinuation included: diagnosis of opioid use disorder, older, non-Hispanic white, and less medical complexity. CONCLUSIONS: Regardless of starting opioid dose, nearly half of patients affected by the 2016 Oregon Medicaid back/neck pain treatment policy no longer received opioid prescriptions by the end of the 18-month study period; another 30% decreased their dose. Gradual dose reduction was typical. These outcomes suggest that the policy impacted opioid prescribing. Understanding patient experiences resulting from such policies could help clinicians and policy makers navigate the complex balance between potential harms and benefits of LOT.

Development and Assessment of a Crosswalk Between ICD-9-CM and ICD-10-CM to Identify Patients with Common Pain Conditions.

Effective management of patients with pain requires accurate information about the prevalence, outcomes, and co-occurrence of common pain conditions. However, the transition from ICD-9-CM to ICD-10-CM diagnostic coding in 2015 left researchers without methods for comparing the prevalence of pain conditions before and after the transition. In this study, we developed and assessed a diagnostic framework to serve as a crosswalk between ICD-9-CM and ICD-10-CM diagnosis codes for common pain-related health conditions. We refined existing ICD-9-CM definitions for diagnostic clusters of common pain conditions consistent with the US National Pain Strategy and developed corresponding ICD-10-CM definitions. We then assessed the stability of prevalence estimates and associated patient socio-demographic features of each diagnostic cluster during 1-year periods before and after the transition to ICD-10-CM in 3 US health care systems using electronic health records data for in-person encounters. Prevalence estimates and socio-demographic characteristics were similar before and after the transition. The Pain Condition ICD-9-CM to ICD-10-CM Crosswalk includes a full spectrum of common pain conditions to enable prevalence estimates of multiple and chronic overlapping pain conditions. This allows the tool to serve as a foundation for a broad array of pain-related health services research utilizing electronic databases. PERSPECTIVE: This article details the development and assessment of the Pain Condition ICD-9-CM to ICD-10-CM Crosswalk, a diagnostic framework for assessing pain condition prevalence across the ICD-9-CM to ICD-10-CM transition. This framework can serve as a standardized tool for research on pain conditions, including health services and epidemiologic research.

Cost-Effectiveness of Preventing Depression Among At-Risk Youths: Postintervention and 2-Year Follow-Up.

OBJECTIVE: Youth depression can be prevented, yet few programs are offered. Decision makers lack cost information. This study evaluated the cost-effectiveness of a cognitive-behavioral prevention program (CBP) versus usual care. METHODS: A cost-effectiveness analysis was conducted with data from a randomized controlled trial of 316 youths, ages 13-17, randomly assigned to CBP or usual care. Youths were at risk of depression because of a prior depressive disorder or subthreshold depressive symptoms, or both, and had parents with a prior or current depressive disorder. Outcomes included depression-free days (DFDs), quality-adjusted life years (QALYs), and costs. RESULTS: Nine months after baseline assessment, youths in CBP experienced 12 more DFDs (p=.020) and .018 more QALYs (p=.007), compared with youths in usual care, with an incremental cost-effectiveness ratio (ICER) of $24,558 per QALY. For youths whose parents were not depressed at baseline, CBP youths had 26 more DFDs (p=.001), compared with those in usual care (ICER=$10,498 per QALY). At 33 months postbaseline, youths in CBP had 40 more DFDs (p=.05) (ICER=$12,787 per QALY). At 33 months, CBP youths whose parents were not depressed at baseline had 91 more DFDs (p=.001) (ICER=$13,620 per QALY). For youths with a currently depressed parent at baseline, CBP was not significantly more effective than usual care at either 9 or 33 months, and costs were higher. CONCLUSIONS: CBP produced significantly better outcomes than usual care and was particularly cost-effective for youths whose parents were not depressed at baseline. Depression prevention programs could improve youths' health at a reasonable cost; services to treat depressed parents may also be warranted.

Cost-effectiveness of Cognitive Behavioral Therapy for Depressed Youth Declining Antidepressants.

BACKGROUND AND OBJECTIVES: Adolescents with depression identified in primary care settings often have limited treatment options beyond antidepressant (AD) therapy. We assessed the cost-effectiveness of a brief cognitive behavioral therapy (CBT) program among depressed adolescents who declined or quickly stopped using ADs. METHODS: A total of 212 youth with depression were randomly assigned to treatment as usual (TAU) or TAU plus brief individual CBT. Clinical outcomes included depression-free days (DFDs) and estimated quality-adjusted life-years (QALYs). Costs were adjusted to 2008 US dollars. Incremental cost-effectiveness ratios (ICERs) comparing CBT to TAU were calculated over 12- and 24-month follow-up periods. RESULTS: Youth randomly assigned to CBT had 26.8 more DFDs (P = .044) and 0.067 more QALYs (P = .044) on average compared with TAU over 12 months. Total costs were $4976 less (P = .025) by the end of the 24-month follow-up among youth randomly assigned to CBT. Total costs per DFD were -$51 (ICER = -$51; 95% confidence interval [CI]: -$394 to $9) at 12 months and -$115 (ICER = -$115; 95% CI: -$1090 to -$6) at 24 months. Total costs per QALY were -$20 282 (ICER = -$20 282; 95% CI: -$156 741 to $3617) at 12 months and -$45 792 (ICER = -$45 792; 95% CI: -$440 991 to -$2731) at 24 months. CONCLUSIONS: Brief primary care CBT among youth declining AD therapy is cost-effective by widely accepted standards in depression treatment. CBT becomes dominant over TAU over time, as revealed by a statistically significant cost offset at the end of the 2-year follow-up.

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.

BACKGROUND: The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped. METHODS: To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design. RESULTS: In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs. CONCLUSION: A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

Health Care Systems Support to Enhance Patient-Centered Care: Lessons from a Primary Care-Based Chronic Pain Management Initiative.

BACKGROUND: Supporting day-to-day self-care activities has emerged as a best practice when caring for patients with chronic pain, yet providing this support may introduce challenges for both patients and primary care physicians. It is essential to develop tools that help patients identify the issues and outcomes that are most important to them and to communicate this information to primary care physicians at the point of care. OBJECTIVE: We describe our process to engage patients, primary care physicians, and other stakeholders in the context of a pilot randomized controlled trial of a patient-centered assessment process implemented in an everyday practice setting. We identify lessons on how to engage stakeholders and improve patient-centered care for those with chronic conditions within the primary care setting. METHODS: A qualitative analysis of project minutes, interviews, and focus groups was conducted to evaluate stakeholder experiences. Stakeholders included patients, caregivers, clinicians, medical office support staff, health plan administrators, an information technology consultant, and a patient advocate. RESULTS: Our stakeholders included many patients with no prior experience with research. This approach enriched the applicability of feedback but necessitated extra time for stakeholder training and meeting preparation. Types of stakeholders varied over the course of the project, and more involvement of medical assistants and Information Technology staff was required than originally anticipated. CONCLUSION: Meaningful engagement of patient and physician stakeholders must be solicited in a well-coordinated manner with broad health care system supports in place to ensure full execution of patient-centered processes.

A primary care-based, multicomponent lifestyle intervention for overweight adolescent females.

BACKGROUND AND OBJECTIVE: Most clinic-based weight control treatments for youth have been designed for preadolescent children by using family-based care. However, as adolescents become more autonomous and less motivated by parental influence, this strategy may be less appropriate. This study evaluated a primary care-based, multicomponent lifestyle intervention specifically tailored for overweight adolescent females. METHODS: Adolescent girls (N = 208) 12 to 17 years of age (mean ± SD: 14.1 ± 1.4 years), with a mean ± SD BMI percentile of 97.09 ± 2.27, were assigned randomly to the intervention or usual care control group. The gender and developmentally tailored intervention included a focus on adoptable healthy lifestyle behaviors and was reinforced by ongoing feedback from the teen's primary care physician. Of those randomized, 195 (94%) completed the 6-month posttreatment assessment, and 173 (83%) completed the 12-month follow-up. The primary outcome was reduction in BMI z score. RESULTS: The decrease in BMI z score over time was significantly greater for intervention participants compared with usual care participants (-0.15 in BMI z score among intervention participants compared with -0.08 among usual care participants; P = .012). The 2 groups did not differ in secondary metabolic or psychosocial outcomes. Compared with usual care, intervention participants reported less reduction in frequency of family meals and less fast-food intake. CONCLUSIONS: A 5-month, medium-intensity, primary care-based, multicomponent behavioral intervention was associated with significant and sustained decreases in BMI z scores among obese adolescent girls compared with those receiving usual care.

Beliefs about eating and eating disorders.

Beliefs about foods and binge eating may influence the development and maintenance of eating disorders and the likelihood that people will seek treatment. We found that the majority of a random sample of members of a large health maintenance organization considered binge eating a problem for which there are effective treatments. Self-reported binge eaters, however, were significantly less likely to agree that there are effective treatments. Two thirds of the sample reported that certain foods are addictive and also believed that strict dieting is an effective means of reducing binge eating. Therapeutic implications of these attitudes are discussed.

Healthcare use by children with attention deficit/hyperactivity disorder with and without psychiatric comorbidities.

This study examined healthcare services used by children with attention-deficit/hyperactivity disorder (ADHD), with and without psychiatric comorbidities. The study was conducted in a large health maintenance organization in the Pacific Northwest on all continuously enrolled children aged 5 to 12 from January 1997 through July 1998. The study measured all outpatient medical care, specialty mental health care services, and prescription drug dispensings from computer records. Children with ADHD, with and without other psychiatric comorbidities, use more general medical services than do other groups of children, including outpatient visits, acute care (emergency room [ER] urgent care) visits. ADHD and other psychiatric comorbidities lead to higher use of specialty mental health services and greater use of psychotropic medications.

Use of psychotropic agents in preschool children: associated symptoms, diagnoses, and health care services in a health maintenance organization.

BACKGROUND: Recent pharmacoepidemiological reports have contributed to concerns about frequent and perhaps indiscriminate psychopharmacotherapy for very young children. OBJECTIVE: To examine the diagnoses, symptoms, and health care services associated with preschool children receiving psychotropic medication. DESIGN: Population-based pharmacoepidemiological analysis of electronic medical records, paper medical and mental health charts, and pharmacy records from 1997 and 1998. SETTING: A large Pacific Northwest health maintenance organization. PARTICIPANTS: Preschool children receiving psychotropic medication (psychostimulants, antidepressants, neuroleptics, or alpha(2)-adrenergic agonists). MEASURES: Physician-reported mental health diagnoses and related symptoms, functional impairment, family and participant characteristics, and the types and level of associated medical and mental health services. RESULTS: Of 743 preschool children who clinicians identified as having behavioral or emotional problems, 120 (16%) received psychotropic medication; 57 children (48%) were prescribed a stimulant medication only, and 60 (50%) received a diagnosis of attention-deficit/hyperactivity disorder. Most children had substantial psychosocial risk factors, including parents with psychiatric or substance abuse problems (71%; n = 85), documented histories of abuse (29%; n = 35), and out-of-home placement (31%; n = 37). Four of 5 children or families (83%; n = 99) received psychosocial services in addition to pharmacotherapy. On average, children received psychotropic medication at least 6 months after initial identification of a behavioral or mental health problem. CONCLUSIONS: Despite commentary by the popular media about widespread psychopharmacotherapy for very young children, such treatment was only infrequently received in this health plan. Most children receiving psychopharmacotherapy had substantial additional risk factors and were receiving psychosocial services for mental health or behavioral management.

Overcoming depression on the Internet (ODIN): a randomized controlled trial of an Internet depression skills intervention program.

BACKGROUND: Psychoeducational programs are increasingly being delivered over the Internet. We created an Internet-based, cognitive therapy, self-help program to be used as a stand-alone intervention for mild-to-moderate depression, or as an adjunct to traditional services for more severe depression. OBJECTIVE: To evaluate the effectiveness of a web-based intervention program to reduce depression in a randomized, controlled trial. METHODS: In a private, nonprofit health maintenance organization, we mailed recruitment brochures to two populations: depressed adults (n = 6994) who received traditional medical services for depression, and an age/gender matched sample of nondepressed adults (n = 6996). Participants consenting to the study were randomized to either the experimental Web site (n = 144), or a no-access control group (n = 155). Participants in both groups were free to obtain nonexperimental, usual care services for their depression. All participants completed an on-line version of the Center for Epidemiological Studies Depression Scale (CES-D) at enrollment and at 4-, 8-, 16- and 32-weeks after enrollment. Mean intake scores were in the severely depressed range. 74% of participants completed at least one follow-up assessment. Unfortunately, most intervention participants accessed the Internet site infrequently. RESULTS: We failed to find an effect for the Internet program across the entire sample. However, post-hoc, exploratory analyses revealed a modest effect among persons reporting low levels of depression at intake. CONCLUSIONS: The negative results might have resulted from infrequent patient use of the Internet site, or a more seriously depressed sample than the intervention was intended to help. Future studies should focus on recruiting persons with mild to moderate levels of depression, and on increasing participant use of the Internet site.