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Abstract: Study objective(s): To evaluate the cost-effectiveness of implementation facilitation compared with a standard educational strategy to promote emergency department (ED)-initiated buprenorphine with linkage to ongoing opioid use disorder care in the community, from a health care-sector perspective. Methods: A prospective cost-effectiveness analysis was conducted alongside “Project ED Health” (CTN-0069), a hybrid type 3 implementation-effectiveness study conducted at 4 academic EDs. Resources were gathered and valued according to the health care-sector perspective. Three effectiveness measures were evaluated: quality-adjusted life-years, opioid-free years, and patient engagement in community-based opioid use disorder care on the 30th day following the index ED visit. An incremental cost-effectiveness ratio was calculated for each measure of effectiveness. Likelihood of cost-effectiveness was evaluated across a wide range of “value” thresholds through cost-effectiveness acceptability curves. Results: The mean, per-person, health care-sector cost associated with ED-administered buprenorphine following implementation facilitation did not differ significantly from that of standard education ($3,239 versus $4,904), whereas the mean effectiveness for all 3 measures significantly favored the implementation facilitation strategy. Implementation facilitation has a 74% to 75% probability of being considered cost-effective from a health care-sector perspective at the recommended value range of $100,000 to $200,000 per quality-adjusted life-year. Incremental cost-effectiveness ratios estimated using secondary effectiveness measures had a 75% probability of being considered cost-effective at $25,000 per opioid-free year and $38,000 per engagement. Conclusion: Implementation facilitation, relative to a standard educational strategy, has a moderate-to-high likelihood of being considered cost-effective from a health care-sector perspective, depending on decisionmakers’ willingness to pay for units of effectiveness. Related protocols: CTN-0069

Abstract:

This paper reports on a cost-effectiveness study of protocol CTN-0007, designed to determine if prize-based contingency management (CM), which has been shown to improve treatment outcomes over usual care (UC) alone, is worth the additional cost to treatment agencies. Six methadone maintenance community-based treatment programs (CTPs) in the CTN participated, with a study sample of 388 participants, 190 in the UC condition and 198 in the CM condition (which combined usual care with contingency management).

The authors found that prize-based contingency management provided better patient outcomes than usual care, but required additional costs. Compared to usual care, the incremental cost of using prize-based contingency management to lengthen the longest duration of abstinence (LDA) by one week was $141. The incremental cost to obtain an additional stimulant-negative urine sample was $70. Whether this extra expenditure is worthwhile depends upon the value placed on these outcomes. Using only the benefit of averted crime, an acceptability curve developed by the authors demonstrates a cost-effectiveness benefit of 90%. However, this estimate is quite conservative because averted crime is only one of the many potential benefits of a reduction in substance abuse. By comparing this study to a companion study, the authors also found that adding prize-based contingency management to usual care may be more cost-effective in methadone maintenance clinics than in counseling-based drug-free clinics. Further empirical analyses are needed to help policy makers decide whether CM is worth the extra expense; this paper helps to build an empirical basis for these important decisions.

Related protocols: CTN-0007-A-2

Abstract:

Using data from a randomized trial (CTN-0064, “Linkage to Hepatitis C Virus (HCV) Care Among HIV/HCV Co-Infected Substance Users”), researchers evaluated the cost of HCV care facilitation that supports moving along the continuum of care for HIV/HCV co-infected individuals with substance use disorder.

Participants were HIV patients residing in the community, initially recruited from eight US hospital sites. They received HCV care facilitation (n = 51) or treatment as usual (n = 62) for up to six months. Researchers used micro-costing methods to evaluate costs from the healthcare sector and patient perspectives in 2017 USD, conducted sensitivity analyses varying care facilitator caseloads, and examined offsetting savings using participant self-reported healthcare utilization.

The average site start-up cost was $6320 (site range: $4320-$7000), primarily consisting of training. The mean weekly cost per participant was $20 (site range: $4-$30) for care facilitation visits and contacts, $360 (site range: $130- $700) for supervision and client outreach, and $70 (site range: $20-$180) for overhead. In sensitivity analyses applying a weekly caseload of 10 participants per care facilitator (versus 1–6 observed in the trial), the total mean weekly care facilitation cost from the healthcare sector perspective decreased to $110. Weekly participant time and travel costs averaged $7. There were no significant differences in other healthcare service costs between participants in the intervention and control arms.

Conclusions: Weekly HCV care facilitation costs were approximately $450 per participant, but approximately $110 at a real-world setting maximum caseload of 10 participants per week. No healthcare cost offsets were identified during the trial period, although future savings might result from successful HCV treatment.

Related protocols: CTN-0064

Abstract:

Investigators and colleagues associated with the Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV (CHERISH) conducted primary and secondary economic analyses using data collected from the X:BOT trial (CTN-0051). They measured the cost, quality of life impact, and cost-effectiveness of initiating extended-release naltrexone (XR-NTX) and buprenorphine naloxone (BUP-NX) in inpatient and residential treatment programs.

This two-page factsheet provides an overview of the study and its findings and makes these recommendations:

1. Policymakers interested in maximizing economic value should consider supporting policies that promote BUP-NX as the preferred treatment over XR-NTX when both medications are shown to be equally effective and clinically appropriate for patients.
2. Providers should direct patients to services that address their socioeconomic and psychosocial needs in addition to efforts to improve medication adherence. Customizing care to a patient’s needs can improve HRQoL benefits of treatment for OUD.
3. Healthcare systems should invest in models of care that increase the likelihood of successful initiation of medication treatment for OUD, especially for XR-NTX, and decrease the duration of detoxification and residential days.

Funding: NIDA supported the health economic analyses (R01DA035808) and dissemination activities (P30DA040500). The X:BOT trial was supported by the NIDA CTN (UG1DA013034; UG1DA013035; UG1DA013714; HHSN271201200017C; HHSN271201500065C; U10DA013045; U10DA013046; U10DA013714; U10DA015833).

Related protocols: CTN-0051

Abstract:

In a United States randomized-effectiveness trial comparing extended release naltrexone (XR-NTX) with buprenorphine-naloxone (BUP-NX) for the prevention of opioid relapse among participants recruited during inpatient detoxification (CTN-0051), the requirement to complete opioid detoxification prior to initiating XR-NTX resulted in lower rates of initiation XR-NTX (72% XR-NTX vs 94% BUP-NX). This led to higher relapse rates and average healthcare costs among XR-NTX participants. This study, a secondary analysis of data from CTN-0051, estimated the extent to which a more efficient model of XR-NTX induction would improve the economic value of XR-NTX relative to BUP-NX.

The analysis looked at 283 participants randomized to receive XR-NTX and included follow-up data over 24-36 weeks. Efficiency was estimated using a multivariable generalized-structural-equation model to explore simultaneous determinants of XR-NTX induction and induction duration (detoxification + residential days). Cost-effectiveness was estimated from the healthcare sector perspective and included expected costs and quality-adjusted life-years (QALYs).

The study revealed that treatment site was the only modifiable factor that simultaneously increased the likelihood of XR-NTX induction and decreased induction duration. Incorporating the higher predicted probability of XR-NTX induction and fewer predicted days of detoxification and subsequent residential treatment into the cost-effectiveness framework reduced the incremental average 24-week total cost of XR-NTX treatment from $5,317 more than that of BUP-NX to a non-statistically significant difference of $1,016. QALYs gained remained similar across arms.

Conclusions: Adopting an efficient model of extended-release naltrexone initiation could result in XR-NTX and BUP-NX being of comparable economic value from the healthcare sector perspective over 24-26 weeks for patients seeking treatment for opioid use disorder at an inpatient detoxification facility.

Related protocols: CTN-0051

Abstract:

Patients with opioid use disorder (OUD) frequently present to the emergency department (ED) after overdose, or seeking treatment for medical conditions, their addiction, withdrawal symptoms, or complications from injection drug use, such as soft tissue infections. ED-initiated buprenorphine has been shown to be effective in increasing patient engagement in treatment compared with brief intervention with a facilitated referral or referral alone. However, adoption into practice has lagged behind need. To address this implementation change, we are evaluating the impact of implementation facilitation (IF) on the adoption of ED-initiated buprenorphine for OUD into practice.

This article describes a study that is being conducted through the NIDA Clinical Trials Network (CTN-0099). A hybrid type III effectiveness-implementation study design is being used to evaluate the effectiveness of a standard educational dissemination strategy versus IF on implementation (primary) and effectiveness (secondary) outcomes in four urban, academic EDs. Sites start with a standard 60-minute “Grand Rounds” educational intervention describing the prevalence of ED patients with OUD, the evidence for opioid agonist treatment and for innovative interventions with ED-initiated buprenorphine, followed by a 1-year baseline evaluation period.

Using a modified stepped wedge design, sites are randomly assigned to the IF intervention, which is guided by the Promoting Action on Research Implementation in Health Services (PARiHS) framework to assess evidence, context, and facilitation-related factors impacting the adoption of ED-initiated buprenorphine.

During the 6 months of IF through the 1-year IF evaluation period, external facilitators will work with local stakeholders to tailor and refine a bundle of activities to meet the site’s needs. The primary analyses will compare the baseline evaluation period to the IF evaluation period (n=120 patients with untreated OUD enrolled during each period) on (1) rates of provision of ED-initiated buprenorphine by ED providers with referral for ongoing medication (implementation outcome) and (2) rates of patient engagement in addiction treatment on the 30th day after the ED visit (effectiveness outcome). Finally, researchers will perform a cost-effectiveness analysis (CEA) to determine if the effectiveness benefits are worth the additional costs.

Conclusions: The ED is rapidly being identified as a “24/7/365” site to combat the opioid crisis by offering access to medications for opioid use disorder treatment. Sustainable, evidence-based practice implementation is a complex and challenging process. This study has the potential to identify an implementation strategy that can be translated to other EDs, thereby increasing the adoption of ED-initiated buprenorphine into practice, narrowing the gap between OUD identification and treatment.

Related protocols: CTN-0099

Abstract:

Not enough evidence exists to compare buprenorphine-naloxone with extended-release naltrexone for treating opioid use disorder. This study evaluated the cost-effectiveness of these two medications using data from NIDA Clinical Trials Network protocol CTN-0051, which examined their effectiveness for opioid use disorder treatment in inpatient detoxification or short-term residential treatment programs.

Costs were evaluated from health care system and societal perspectives over the 24-week intervention and the 36-week observation period. Researchers estimated economic and clinical effectiveness outcomes (Quality-Adjusted Life-Years (QALYs) and abstinent years) and compared incremental costs to incremental effectiveness. Sensitivity analyses included assuming a higher cost of XR-NTX ($1,309/injection vs. $704), and excluding participants who were not successfully initiated on their randomized treatment (i.e., per protocol).

Results found that the mean cost, per participant, of XR-NTX exceeded that of BUP-NX, including $427 greater study-provided detoxification cost and $1,250 greater study-provided medication/therapy cost, but the only statistically significant difference was from the health care system perspective at 24 weeks. Differences in effectiveness were not significant. Considering costs and effectiveness together, BUP-NX was preferred.

Conclusions: Data from this clinical trial indicate that BUP-NX is less costly from the health care system perspective and has similar effectiveness compared to XR-NTX; higher detoxification and medication costs for XR-NTX were not offset by savings in other costs. The inclusion of additional society perspective costs (criminal justice, productivity, and patient time and travel) introduced more uncertainty. Per protocol results were similar, indicating that among those initiating treatment, XR-NTX detoxification and medication costs remain important economic concerns.

Related protocols: CTN-0051

Abstract:

This study describes the approach and results of a comprehensive cost analysis of NIDA Clinical Trials Network protocol CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT), the first head-to-head randomized clinical trial in the U.S. of extended-release injectable naltrexone (XR-NTX) and buprenorphine-naloxone (BUP-NX) for preventing opioid relapse. The objective was to provide rigorous estimates of the costs of training, inpatient detoxification, and medication management visits, highlighting the variation in these costs across sites and settings. Results found that providing XR-NTX and BUP-NX to patients receiving inpatient detoxification generates relatively modest costs to the healthcare provider. The average costs per patient were $5,416 for XR-NTX and $4,148 for BUP-NX. Results of the X:BOT cost analysis study provide current practical information on the types of costs incurred by providers, payers, and patients for XR-NTX and BUP-NX, but continued research is needed to understand the costs of medication-assisted treatment as the system continues to evolve.

Abstract:

This study evaluated the cost-effectiveness of extended-release naltrexone (XR-NTX) versus buprenorphine-naloxone (BUP-NX) alongside the recently completed U.S. randomized clinical trial testing their effectiveness in the prevention of opioid relapse as outpatient continuation after initiating treatment in an inpatient detoxification setting (CTN-0051). Costs were evaluated from the health care system and societal perspectives over the 24-week intervention and the 36-week observation period. Researchers estimated economic and clinical effectiveness outcomes (Quality-Adjusted Lief-Years (QALYs) and abstinent years) and compared incremental costs to incremental effectiveness. Sensitivity analyses included assuming a higher cost of XR-NTX ($1,309/injection vs. $704), and excluding participants who were not successfully initiated on their randomized treatment (i.e., per protocol).

Results found that the mean cost, per participant, of XR-NTX exceeded that of BUP-NX, including $427 greater study-provided detoxification cost and $1,250 greater study-provided medication/therapy cost, but the only statistically significant difference was from the health care system perspective at 24 weeks. Differences in effectiveness were not significant. Considering costs and effectiveness together, BUP-NX was preferred.

Conclusions: Data from this clinical trial indicate that BUP-NX is less costly from the health care system perspective and similar effective compared to XR-NTX; higher detoxification and medication costs for XR-NTX were not offset by savings in other costs. The inclusion of additional society perspective costs (criminal justice, productivity, and patient time and travel) introduced more uncertainty. Per protocol results were similar, indicating that among those initiating treatment, XR-NTX detoxification and medication costs remain important economic concerns.

Related protocols: CTN-0051

Abstract:

Substance misuse and excessive alcohol consumption are major public health issues. Internet-based interventions for substance use disorders (SUDs) are a relatively new method for addressing barriers to access and supplementing existing care. This study examines cost-effectiveness in a multisite, randomized trial of an Internet-based version of the community reinforcement approach (CRA) with contingency management (CM) known as the Therapeutic Education System (TES) (CTN protocol 0044, “Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders”). The study involved an economic evaluation of the 12-week trial with follow-up at 24 and 36 weeks. 507 individuals who were seeking therapy for alcohol or other substance use disorders at 10 outpatient community-based treatment programs were recruited and randomized to either treatment as usual (TAU) or TES+TAU. Sub-analyses were completed on participants with a poorer prognosis (i.e., those not abstinent at study entry).

Results found that, from the provider’s perspective, TES+TAU as it was implemented in this study costs $278 (SE=87) more than TAU alone after 12 weeks. The quality-adjusted life years gained by TES+TAU and TAU were similar; however, TES+TAU participants remained in treatment longer and achieved more days of abstinence than TAU patients. Regarding clinical outcome of abstinent years, TES+TAU qualifies as cost-effective with a level of confidence exceeding 95% for willingness-to-pay values above $20,000. That is, if the stakeholder is willing to pay $20,000 per abstinent-year, it is 95% likely they will find TES+TAU to be a “good value.” In general, findings were more promising for participants who were not abstinent at study entry.

Conclusions: With regard to the clinical outcome of abstinence, our cost-effectiveness findings of TES+TAU compare favorably to those found elsewhere in the CM literature. Moreover, depending on providers’ and payers’ thresholds for defining value with regard to abstinence, TES+TAU has a high likelihood of being considered a wise investment. The analyses performed here serve as an initial economic framework for future studies integrating technology into SUD therapy.

Related protocols: CTN-0044

Abstract:

There are an estimated 3.2 million individuals in the United States who are chronically infected with hepatitis C virus (HCV), of whom only have had an HCV antibody test and less than a quarter have had a confirmatory HCV RNA test. The US Centers for Disease Control and Prevention (CDC) has set a goal to reduce the proportion of HCV-infected individuals unaware of their status from 55% to 33%. This analysis of data from the National Drug Abuse Treatment Clinical Trials Network, study CTN-0032 (HIV Rapid Testing and Counseling), aimed to evaluate the cost-effectiveness of rapid HCV and simultaneous HCV/HIV antibody testing in substance abuse treatment programs. Researcher used a decision analytic model to compare the cost-effectiveness of no HCV testing referral or offer, off-site HCV testing referral, on-site rapid HCV testing offer, and on-site rapid HCV and HIV testing offer. Base case inputs included 11% undetected chronic HCV, 0.4% undetected HIV, 35% HCV co-infection among HIV-infected, 53% linked to HCV care after testing antibody positive, and 67% linked to HIV care. Disease outcomes were estimated from established computer simulation models of HCV (HEP-CE) and HIV (CEPAC). Measurements included lifetime costs (2011 US dollars) and quality-adjusted life years (QALYs) discounted at 3% annually and incremental cost-effective ratios (ICERs).

On-site rapid HCV testing had an ICER of $18,300/QALY compared with no testing, and was more efficient than (dominated) off-site HCV testing referral. On-site rapid HCV and HIV testing had an ICER of $64,500/QALY compared with on-site rapid HCV testing alone. In one and two-way sensitivity analyses, the ICER of on-site rapid HCV and HIV testing remained <$100,000/QALY, except when undetected HIV prevalence was <0.1% or when we assumed frequent HIV testing elsewhere. The ICER remained <$100,000/QALY in approximately 90% of probabilistic sensitivity analyses.

Conclusions: On-site rapid hepatitis C and HIV testing in substance abuse treatment programs is cost-effective at a <$100,000/quality-adjusted life years threshold. On-site rapid HCV and HIV testing in substance abuse treatment programs represents good value as a public health investment. Policymakers should identify ways to improve the capacity of substance abuse treatment programs to implement on-site HCV and HIV testing, bill for these services, and ensure that individuals testing positive for either virus receive further evaluation and treatment.

Related protocols: CTN-0032, CTN-0032-A-1

Abstract:

This is the Results Article for CTN-0032-A-1.

The President’s National HIV/AIDS Strategy calls for coupling HIV screening and prevention services with substance abuse treatment programs. Fewer than half of US community-based substance abuse treatment programs make HIV testing available on-site or through referral.

This article reports on outcomes from ancillary investigation CTN-0032-A-1 (“Economic Analysis of HIV Rapid Testing in Drug Abuse Treatment Programs”) in which the cost-effectiveness of three HIV testing strategies used in 12 community-based substance abuse treatment programs was evaluated: off-site testing referral, on-site rapid testing with information only, and on-site rapid testing with risk-reduction counseling. Data from the trial included patient demographics, prior testing history, test acceptance and receipt of results, undiagnosed HIV prevalence (0.4%), and program costs. The Cost-Effectiveness of Preventing AIDS Complications (CEPAC) computer simulation model was used to project life expectancy, lifetime costs, and quality-adjusted life years (QALYs) for HIV-infected individuals. Incremental cost-effectiveness ratios (2009 US $/QALY) were calculated after adding costs of testing HIV-uninfected individuals; costs and QALYs were discounted at 3% annually. Referral for off-site testing was found to be less efficient (dominated) compared to offering on-site testing with information only. The cost-effectiveness ratio for on-site testing with information is $60,400/QALY in the base case, or $76,300/QALY with 0.1% undiagnosed HIV prevalence. HIV risk-reduction counseling costs $36 per person more without additional benefit.

Conclusions: A strategy of on-site rapid HIV testing offered with information only in substance abuse treatment programs increases life expectancy at a cost-effectiveness ratio < $100,000/QALY. Policy makers and substance abuse treatment leaders should seek funding to implement on-site rapid HIV testing in substance abuse treatment programs for those not recently tested.

Related protocols: CTN-0032-A-1

Abstract:

There has been a recent focus on providing adequate clinical oversight in a shrinking economic support environment. Concepts of remote monitoring to descrease travel costs and time, on-site monitoring that is structure to review specific information and developed with a frequency based on the risk level of the intervention, and streamlined safety reporting all combine to allow comprehensive clinical trial oversight. The use of robust web-based data systems allows for daily updates of clinical trial progress, automated notification of specific events, data quality checks at the time of data entry, built-in logic checks, remote monitoring capabilities, and real-time review of safety events.

The NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) experience serves as a model to transition to real-time reporting of trial progress, to risk-based clinical site monitoring and strategic risk-based safety reporting. A comprehensive clinical trial progress assessment has been created with site and safety monitoring plans that can improve the efficiency of monitoring programs. This poster describes examples and tools from the CTN that offer alternatives to standard clinical trial oversight and to 100% data auditing while maintaining data and ultimately study integrity.

Abstract:

Patients with untreated substance use disorders (SUDs) are at risk for frequent emergency department visits and repeated hospitalization. In partnership with the Delaware Valley Node of the National Drug Abuse Treatment Clinical Trials Network (CTN), Project Engage, a US pilot program at Wilmington Hospital in Delaware, was conducted to facilitate entry of these patients to SUD treatment after discharge. Patients identified as having hazardous or harmful alcohol consumption based on results of the Alcohol Use Disorders Identification Test-Primary Care (AUDIT-PC), administered to all patients on admission, received bedside assessment with motivational interviewing and facilitated referral to treatment by a patient engagement specialist (PES). This program evaluation provides descriptive information on self-reported rates of SUD treatment initiation of all patients and health-care utilization and costs for a subset of patients. Program-level data on treatment entry after discharge were examined retrospectively, providing descriptive information on health-care utilization and costs.

Between September 1, 2008 and December 30, 2010, 415 patients participated in Project Engage and 180 (43%) were admitted for SUD treatment. For a small cohort who participated between June 1, 2009 and November 30, 2009 (n=18), insurance claims demonstrated a 33% decrease in inpatient medical admissions, a 38% decrease in emergency department visits, a 42% increase in behavioral health/substance abuse (BH/SA) inpatient admissions, and a 33% increase in outpatient BH/SA admissions for an overall decrease of $37,760. For a small cohort who participated between June 1, 2010 and November 30, 2010 (n=25), claims demonstrated a 58% decrease in inpatient medical admissions; a 13% decrease in emergency department visits; a 32% decrease in BH/SA inpatient admissions, and a 32% increase in outpatient BH/SA admissions, for an overall decrease of $88,886.

Conclusions: These findings demonstrate that a large percentage of patients entered SUD treatment after participating in Project Engage, a novel intervention with facilitated referral to treatment. Although the findings are limited by the retrospective nature of the data and the small sample sizes, they do suggest a potentially cost-effective addition to existing hospital services if replicated in prospective studies with larger samples and controls.

Abstract:

Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse’s (NIDA’s) National Drug Abuse Treatment Clinical Trials Network (protocol CTN-0044). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings.

Related protocols: CTN-0044