ABSTRACT
Background: Substance use disorders (SUDs) have a serious adverse impact on the physical and mental well-being of people with HIV. Previously, using a 39-site dual-randomized type 2 hybrid trial design, findings from the Substance Abuse Treatment to HIV Care Project supported the Implementation and Sustainment Facilitation (ISF) strategy to improve implementation and effectiveness of a motivational interviewing brief intervention (MIBI) for SUD within HIV service settings across the United States (US). Building on this trial, this parallel cluster-randomized type 3 hybrid trial aimed to test the incremental effectiveness of a pay-for-performance (P4P), a form of the "alter incentive/allowance structures" strategy. Methods: Twenty-six HIV service organizations, their staff participants (N=87), and their client participants (N=341) were cluster-randomized to one of two implementation conditions. The control condition included staff-focused training, feedback, and consultation (TFC) and team-focused implementation and sustainment (ISF). The experimental condition included TFC+ISF as well as P4P (TFC+ISF+P4P). P4P used financial incentives to reward MIBI implementation (US$10 per MIBI delivered) and MIBI implementation at or above a pre-defined level of quality (US$10 per demonstration). In addition to these outcomes, past 4-week changes/reductions in client participant's days of primary substance use and anxiety symptoms were examined. Results: The addition of P4P had a large and significant effect on the number of MIBIs implemented ( d =1.30, p<.05) and reduction in anxiety ( d= -1.54), but there was no impact on days of substance use. P4P had large effects on MIBI quality ( d =1.24) and MIBI implementation effectiveness ( d =1.28), but these were not significant ( p <.10). Conclusions: P4P is a form of the "alter incentive/allowance structures" strategy. Its function is to reward the implementation of a clinical innovation. Rewarding implementation is consistent with the theory of implementation effectiveness, which suggests implementation climate (i.e., the extent to which implementation is expected, supported, and rewarded) is a key antecedent of implementation effectiveness (i.e., the consistency and quality of implementation). We found that P4P had a significant, positive impact on MIBI implementation in HIV service settings, but client-level outcomes were mixed. Future research should examine the effectiveness of the P4P strategy to improve implementation and sustainment of other evidence-based innovations. Trial registration: ClinicalTrials.gov: NCT04687917. Registered 12/18/2020.
ABSTRACT
BACKGROUND: Scaling up overdose education and naloxone distribution (OEND) and medications for opioid use disorder (MOUD) is needed to reduce opioid overdose deaths, but barriers are pervasive. This study examines whether the Communities That HEAL (CTH) intervention reduced perceived barriers to expanding OEND and MOUD in healthcare/behavioral health, criminal-legal, and other/non-traditional venues. METHODS: The HEALing (Helping End Addiction Long-Term®) Communities Study is a parallel, wait-list, cluster randomized trial testing the CTH intervention in 67 communities in the United States. Surveys administered to coalition members and key stakeholders measured the magnitude of perceived barriers to scaling up OEND and MOUD in November 2019-January 2020, May-June 2021, and May-June 2022. Multilevel linear mixed models compared Wave 1 (intervention) and Wave 2 (wait-list control) respondents. Interactions by rural/urban status and research site were tested. RESULTS: Wave 1 respondents reported significantly greater reductions in mean scores for three outcomes: perceived barriers to scaling up OEND in Healthcare/Behavioral Health Venues (-0.26, 95% confidence interval, CI: -0.48, -0.05, p = 0.015), OEND in Other/Non-traditional Venues (-0.53, 95% CI: - 0.84, -0.22, p = 0.001) and MOUD in Other/Non-traditional Venues (-0.34, 95% CI: -0.62, -0.05, p = 0.020). There were significant interactions by research site for perceived barriers to scaling up OEND and MOUD in Criminal-Legal Venues. There were no significant interactions by rural/urban status. DISCUSSION: The CTH Intervention reduced perceived barriers to scaling up OEND and MOUD in certain venues, with no difference in effectiveness between rural and urban communities. More research is needed to understand facilitators and barriers in different venues.
Subject(s)
Naloxone , Narcotic Antagonists , Opioid-Related Disorders , Humans , Naloxone/therapeutic use , United States , Opioid-Related Disorders/drug therapy , Narcotic Antagonists/therapeutic use , Male , Female , Drug Overdose/prevention & control , Drug Overdose/drug therapy , Adult , Surveys and Questionnaires , Middle Aged , Health Services Accessibility , Health Education/methodsABSTRACT
BACKGROUND: The United States (US) continues to face decades-long increases in opioid overdose fatalities. As an opioid overdose reversal medication, naloxone can dramatically reduce opioid overdose mortality rates when distributed to people likely to experience or witness an opioid overdose and packaged with education on its use, known as overdose education and naloxone distribution (OEND). Syringe services programs (SSPs) are ideal venues for OEND with staff who are culturally competent in providing services for people who are at risk of experiencing or observing an opioid overdose. We carried out a randomized controlled trial of SSPs to understand the effectiveness of the organize and mobilize for implementation effectiveness (OMIE) approach at improving OEND implementation effectiveness within SSPs. METHODS: Using simple randomization, 105 SSPs were enrolled into the trial and assigned to one of two study arms - (1) dissemination of OEND best practice recommendations (Control SSPs) or the OMIE approach along with dissemination of the OEND best practice recommendations (i.e., OMIE SSPs). OMIE SSPs could participate in 60-min OMIE sessions once a month for up to 12 months. At 12-month post-baseline, 102 of 105 SSPs (97%) responded to the follow-up survey. RESULTS: The median number of sessions completed by OMIE SSPs was 10. Comparing OMIE SSPs to control SSPs, we observed significant increases in the number of participants receiving naloxone (incidence rate ratio: 2.15; 95% CI: 1.42, 3.25; p < 0.01) and the rate of naloxone doses distributed per SSP participant (adjusted incidence rate ratio: 1.97; 95% CI: 1.18, 3.30; p = 0.01). We observed no statistically significant difference in the number of adopted best practices between conditions (difference in means 0.2, 95% CI: - 0.7, 1.0; p = 0.68). We also observed a threshold effect where SSPs receiving a higher OMIE dose had greater effect sizes with regard to the number of people given naloxone and the number of naloxone doses distributed. CONCLUSIONS: In conclusion, the multifaceted OMIE approach was effective at increasing naloxone distribution from SSPs, despite substantial external shocks during the trial. These findings have major implications for addressing the overdose crisis, which has continued unabated for decades. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03924505 . Registered 19 April 2019.
Subject(s)
Drug Overdose , Opiate Overdose , Opioid-Related Disorders , Humans , United States , Naloxone/therapeutic use , Opiate Overdose/drug therapy , Drug Overdose/drug therapy , Drug Overdose/prevention & control , Health Education , United States Department of Veterans Affairs , Narcotic Antagonists/therapeutic use , Opioid-Related Disorders/drug therapyABSTRACT
BACKGROUND: Contingency management (CM) is an evidence-based intervention for stimulant use and is highly effective in combination with medication for opioid use disorder. Yet, uptake of CM in opioid treatment programs that provide medication for opioid use disorder remains low. This paradox in which CM is one of the most effective interventions, yet one of the least available, represents one of the greatest research-to-practice gaps in the addiction health services field. Multi-level implementation strategies are needed to address barriers to CM implementation at both the provider- and organization-level. This type III hybrid effectiveness-implementation trial was funded by the National Institute on Drug Abuse to evaluate whether a multi-level implementation strategy, the Science of Service Laboratory (SSL), can effectively promote CM implementation in opioid treatment programs. Specific aims will test the effectiveness of the SSL on implementation outcomes (primary aim) and patient outcomes (secondary aim), as well as test putative mediators of implementation outcomes (exploratory aim). METHODS: Utilizing a fully powered type III hybrid effectiveness-implementation trial with a stepped wedge design, we propose to randomize a cohort of 10 opioid treatment programs to receive the SSL across four steps. Each step, an additional 2-3 opioid treatment programs will receive the SSL implementation strategy, which has three core components: didactic training, performance feedback, and external facilitation. At six intervals, each of the 10 opioid treatment programs will provide de-identified electronic medical record data from all available patient charts on CM delivery and patient outcomes. Staff from each opioid treatment program will provide feedback on contextual determinants influencing implementation at three timepoints. DISCUSSION: Between planning of this protocol and receipt of funding, the landscape for CM in the USA changed dramatically, with multiple Departments of Health launching state-wide CM initiatives. We therefore accelerated the protocol timeline and offered some cursory training resources to all sites as a preparation activity. We also began partnering with multiple Departments of Health to evaluate their rollout of CM using the measures outlined in this protocol. TRIAL REGISTRATION: This study protocol is registered via ClinicalTrials.gov Identifier: NCT05702021. Date of registration: January 27, 2023.
Subject(s)
Behavior, Addictive , Opioid-Related Disorders , Humans , Analgesics, Opioid/therapeutic use , Behavior Therapy , Opioid-Related Disorders/drug therapy , Electronic Health RecordsABSTRACT
BACKGROUND: Opioid overdoses have continued to increase since the start of the COVID-19 pandemic. The pathways through which the COVID-19 pandemic has affected trajectories of opioid use and opioid-related problems are largely unknown. Using the Epidemic-Pandemic Impacts Inventory (EPII), a novel instrument that assess pandemic-related impacts across multiple life domains, we tested the hypothesis that COVID-related impacts (on e.g., interpersonal conflict, employment, infection exposure, and emotional health) experienced in the early months of the pandemic would predict changes in opioid use and opioid-related problems at follow-up. METHODS: This analysis was embedded within a cluster randomized type 3 implementation-effectiveness hybrid trial that had enrolled 188 patients across eight opioid treatments prior to the start of the pandemic. Participants had all been recently inducted on medication for opioid use disorder and were actively receiving treatment. Participants reported on their opioid use and opioid-related problems at baseline and 3-, 6-, and 9-month post-baseline assessments. Between May and August 2020, participants were sent an optional invitation to complete the EPII. RESULTS: One hundred thirty-three respondents completed the EPII and 129 had sufficient data to analyze the EPII and at least one subsequent follow-up. In logistic and zero-inflated negative binomial analyses adjusting for covariates, each endorsed pandemic impact in the interpersonal conflict domain was associated with 67% increased odds of endorsement of any opioid use, and each impact in the employment and infection exposure-domains was associated with 25% and 75% increases in number of endorsed opioid-related problems, respectively. CONCLUSIONS: Mitigating the effect of the pandemic on patients' interpersonal relationships and employment, and promoting greater infection control in opioid treatment programs, could be protective against negative opioid-related outcomes. Trial registration The present study describes secondary data analysis on a previously registered clinical trial: clinicaltrials.gov/ct2/show/NCT03931174.
Subject(s)
COVID-19 , Opioid-Related Disorders , Humans , Analgesics, Opioid/adverse effects , Pandemics , Secondary Data Analysis , Opioid-Related Disorders/drug therapy , Opioid-Related Disorders/epidemiologyABSTRACT
Background: Early in the pandemic, the United States population experienced a sharp rise in the prevalence rates of opioid use, social isolation, and pain interference. Given the high rates of pain reported by patients on medication for opioid use disorder (MOUD), the pandemic presented a unique opportunity to disentangle the relationship between opioid use, pain, and social isolation in this high-risk population. We tested the hypothesis that pandemic-induced isolation would partially mediate change in pain interference levels experienced by patients on MOUD, even when controlling for baseline opioid use. Such work can inform the development of targeted interventions for a vulnerable, underserved population. Methods: Analyses used data from a cluster randomized trial (N = 188) of patients on MOUD across eight opioid treatment programs. As part of the parent trial, participants provided pre-pandemic data on pain interference, opioid use, and socio-demographic variables. Research staff re-contacted participants between May and June 2020 and 133 participants (71% response rate) consented to complete a supplemental survey that assessed pandemic-induced isolation. Participants then completed a follow-up interview during the pandemic that again assessed pain interference and opioid use. A path model assessed whether pre-pandemic pain interference had an indirect effect on pain interference during the pandemic via pandemic-induced isolation. Results: Consistent with hypotheses, we found evidence that pandemic-induced isolation partially mediated change in pain interference levels among MOUD patients during the pandemic. Higher levels of pre-pandemic pain interference and opioid use were both significantly associated with higher levels of pandemic-induced isolation. In addition, pre-pandemic pain interference was significantly related to levels of pain interference during the pandemic, and these pain levels were partially explained by the level of pandemic-induced isolation reported. Conclusions: Patients on MOUD with higher use of opioids and higher rates of pain pre-pandemic were more likely to report feeling isolated during COVID-related social distancing and this, in turn, partially explained changes in levels of pain interference. These results highlight social isolation as a key risk factor for patients on MOUD and suggest that interventions promoting social connection could be associated with reduced pain interference, which in turn could improve patient quality of life.
ABSTRACT
Despite being one of the most effective adjunctive behavioral interventions in combination with medication for opioid use disorder, contingency management (CM) is one of the least available interventions in opioid treatment programs. This paradoxical state of affairs is perhaps the greatest example of the research-to-practice gap in the behavioral health field. Implementation science, a discipline that aims to identify replicable methods that can be used across settings and populations to bridge the gap between research and practice, can potentially help. Based on our team's experience implementing CM in opioid treatment programs, we detail five key lessons for researchers, clinicians, policy makers, and others seeking to implement and sustain CM in real-world settings. First, multiple barriers to CM implementation exist at both the counselor- and organization-levels, requiring multi-level solutions. Second, one-shot CM training alone is not sufficient for successful implementation: ongoing support is essential to achieve levels of intervention fidelity that will benefit patients. Third, assessing an organization's capacity for implementation prior to support provision can prevent costly mistakes. Fourth, implementors should plan for high staff turnover rates and expect the unexpected by developing detailed contingency plans. Finally, implementors should remember that the goal is to implement evidence-based CM and not simply incentives. We encourage colleagues to consider these lessons to increase the likelihood that CM can be implemented and sustained in a manner that improves the quality of care in opioid treatment programs.
Subject(s)
Analgesics, Opioid , Opioid-Related Disorders , Humans , United States , Opioid-Related Disorders/drug therapy , Opioid-Related Disorders/prevention & control , Behavior Therapy , MotivationABSTRACT
Background: Substance use disorders (SUDs) have a serious adverse impact on people living with HIV. Previously, using a 39-site dual-randomized type 2 hybrid trial design, findings from the Substance Abuse Treatment to HIV Care Project supported the Implementation and Sustainment Facilitation (ISF) strategy to improve implementation and effectiveness of a motivational interviewing brief intervention (MIBI) for SUD within HIV service settings across the United States (US). Building on this trial, this cluster-randomized type 3 hybrid trial aimed to test the incremental effectiveness of a pay-for-performance (P4P), a form of the "alter incentive/allowance structures" strategy. Methods: Twenty-six HIV service organizations, their staff participants (N=87), and their client participants (N=341) were cluster-randomized to one of two implementation conditions. The control condition included staff-focused training, feedback, and consultation (TFC) and team-focused implementation and sustainment (ISF). The experimental condition included TFC+ISF as well as P4P (TFC+ISF+P4P). P4P used financial incentives to reward MIBI implementation (US$10 per MIBI delivered) and MIBI implementation at or above a pre-defined level of quality (US$10 per demonstration). In addition to these outcomes, past 4-week changes/reductions in client participant's days of primary substance use and anxiety symptoms were examined. Results: The addition of P4P had a large and significant effect on the number of MIBIs implemented (d=1.30, p<.05) and reduction in anxiety (d=-1.54), but there was no impact on days of substance use. P4P had large effects on MIBI quality (d=1.24) and MIBI implementation effectiveness (d=1.28), but these were not significant (p<.10). Conclusions: P4P is a form of the "alter incentive/allowance structures" strategy Its function is to reward the implementation of a clinical innovation. Rewarding implementation is consistent with the theory of implementation effectiveness, which suggests implementation climate (i.e., the extent to which implementation is expected, supported, and rewarded) is a key antecedent of implementation effectiveness (i.e., the consistency and quality of implementation). We found that P4P had a significant, positive impact on MIBI implementation in HIV service settings, but client-level outcomes were mixed. Future research should examine the cost-effectiveness of this strategy, as well as to examine the effectiveness of P4P to improve the implementation of other evidence-based innovations. Trial registration: ClinicalTrials.gov: NCT04687917. Registered 12/18/2020.
ABSTRACT
Behavior therapy implementation relies in part on training to foster counselor skills in preparation for delivery with fidelity. Amidst Covid-19, the professional education arena witnessed a rapid shift from in-person to virtual training, yet these modalities' relative utility and expense is unknown. In the context of a cluster-randomized hybrid type 3 trial of contingency management (CM) implementation in opioid treatment programs (OTPs), a multi-cohort design presented rare opportunity to compare cost-effectiveness of virtual vs. in-person training. An initial counselor cohort (n = 26) from eight OTPs attended in-person training, and a subsequent cohort (n = 31) from ten OTPs attended virtual training. Common training elements were the facilitator, learning objectives, and educational strategies/activities. All clinicians submitted a post-training role-play, independently scored with a validated fidelity instrument for which performances were compared against benchmarks representing initial readiness and advanced proficiency. To examine the utility and expense of in-person and virtual trainings, cohort-specific rates for benchmark attainment were computed, and per-clinician expenses were estimated. Adjusted between-cohort differences were estimated via ordinary least squares, and an incremental cost effectiveness ratio (ICER) was calculated. Readiness and proficiency benchmarks were attained at rates 12-14% higher among clinicians attending virtual training, for which aggregated costs indicated a $399 per-clinician savings relative to in-person training. Accordingly, the ICER identified virtual training as the dominant strategy, reflecting greater cost-effectiveness across willingness-to-pay values. Study findings document greater utility, lesser expense, and cost-effectiveness of virtual training, which may inform post-pandemic dissemination of CM and other therapies.
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BACKGROUND: To determine whether Positive Health Check, a highly tailored video doctor intervention, can improve viral suppression and retention in care. SETTING: Four clinics that deliver HIV primary care. METHODS: A hybrid type 1 effectiveness-implementation randomized trial design was used to test study hypotheses. Participants (N = 799) who were not virally suppressed, were new to care, or had fallen out of care were randomly assigned to receive Positive Health Check or the standard of care alone. The primary endpoint was viral load suppression, and the secondary endpoint was retention in care, both assessed at 12 months, using an intention-to-treat approach. A priori subgroup analyses based on sex assigned at birth and race were examined as well. RESULTS: There were no statistically significant differences between Positive Health Check (N = 397) and standard of care (N = 402) for either endpoint. However, statistically significant group differences were identified from a priori subgroup analyses. Male participants receiving Positive Health Check were more likely to achieve suppression at 12 months than male participants receiving standard of care adjusted risk ratio [aRR] [95% confidence interval (CI)] = 1.14 (1.00 to 1.29), P = 0.046}. For retention in care, there was a statistically significant lower risk for a 6-month visit gap in the Positive Health Check arm for the youngest participants, 18-29 years old [aRR (95% CI) = 0.55 (0.33 to 0.92), P = 0.024] and the oldest participants, 60-81 years old [aRR (95% CI) = 0.49 (0.30 to 0.81), P = 0.006]. CONCLUSIONS: Positive Health Check may help male participants with HIV achieve viral suppression, and younger and older patients consistently attend HIV care. REGISTRY NAME: Positive Health Check Evaluation Trial. Trial ID: 1U18PS004967-01. URL: https://clinicaltrials.gov/ct2/show/NCT03292913.
Subject(s)
Anti-HIV Agents , HIV Infections , Adolescent , Adult , Aged , Aged, 80 and over , Anti-HIV Agents/therapeutic use , HIV Infections/drug therapy , Humans , Infant, Newborn , Male , Middle Aged , Serologic Tests , Viral Load , Young AdultABSTRACT
BACKGROUND: Given substance use disorders (SUDs) among people with HIV are highly prevalent, integrating SUD services within HIV service settings is needed to help end the HIV epidemic. In this study, we assessed the setting-intervention fit (SIF) of 9 evidence-based SUD interventions: acamprosate, disulfiram, oral naltrexone, injectable naltrexone, oral buprenorphine, injectable buprenorphine, contingency management, motivational interviewing, and cognitive behavioral therapy (CBT). SETTING: Clinical and nonclinical HIV service organizations (HSOs) in the United States. METHODS: In May 2020, a stakeholder-engaged real-time Delphi was completed with 202 HSOs. HSO respondents rated the extent to which each SUD intervention was fundable, implementable, retainable, sustainable, scalable, and timely for their HSO, and these 6 items were summed into an SIF score (possible range of 0-18). RESULTS: Motivational interviewing had the highest average SIF score (11.42), with SIF scores above the midpoint (9.5) for clinical (11.51) and nonclinical HSOs (11.36). For nonclinical HSOs, none of the other interventions were above the midpoint. For clinical HSOs, the average SIF scores were above the midpoint for CBT (10.97) and oral buprenorphine (9.51). Multivariate regression analyses, which controlled for characteristics of the HSO respondent, revealed geographic region of the United States and whether the HSO currently offered any substance use services as 2 of the best predictors of SIF scores. CONCLUSIONS: Notwithstanding the need to improve the SIF for the other evidence-based SUD interventions, motivational interviewing, CBT, and oral buprenorphine are currently the evidence-based SUD interventions with greatest perceived fit for integration within HSOs in the United States.
Subject(s)
Buprenorphine , HIV Infections , Substance-Related Disorders , Delphi Technique , Evidence-Based Medicine , HIV Infections/complications , HIV Infections/drug therapy , Humans , Naltrexone , Substance-Related Disorders/drug therapy , Substance-Related Disorders/therapy , United States/epidemiologyABSTRACT
BACKGROUND: Positive Health Check is an evidence-based video doctor intervention developed for improving the medication adherence, retention in care, and viral load suppression of people with HIV receiving clinical care. SETTING: Four HIV primary care clinics within the United States. METHODS: As part of a type 1 hybrid trial, a mixed-methods approach was used to longitudinally assess the following 3 key implementation constructs over a 23-month period: innovation-values fit (ie, the extent to which staff perceive innovation use will foster the fulfillment of their values), organizational readiness for change (ie, the extent to which organizational members are psychologically and behaviorally prepared to implement organizational change), and implementation climate (ie, the extent to which implementation is expected, supported, and rewarded). Quantitative mixed-effects regression analyses were conducted to assess changes over time in these constructs. Qualitative analyses were integrated to help provide validation and understanding. RESULTS: Innovation-values fit and organizational readiness for change were found to be high and relatively stable. However, significant curvilinear change over time was found for implementation climate. Based on the qualitative data, implementation climate declined toward the end of implementation because of decreased engagement from clinic champions and differences in priorities between research and clinic staff. CONCLUSIONS: The Positive Health Check intervention was found to fit within HIV primary care service settings, but there were some logistical challenges that needed to be addressed. Additionally, even within the context of an effectiveness trial, significant and nonlinear change in implementation climate should be expected over time.
Subject(s)
HIV Infections , HIV Infections/diagnosis , HIV Infections/drug therapy , Humans , Organizational Innovation , United StatesABSTRACT
Although HIV and substance use disorders (SUDs) constitute a health syndemic, no research to date has examined the perceived negative impacts of different SUDs for people with HIV (PWH). In May 2019, 643 stakeholders in the U.S., representing clients of AIDS service organizations (ASOs), ASO staff, and HIV/AIDS Planning Council members, participated in an innovative Stakeholder-Engaged Real-Time Delphi (SE-RTD) survey focused on the prevalence and individual-level negative impact of five SUDs for PWH. The SE-RTD method has advantages over conventional survey methods by efficiently sharing information, thereby reducing the likelihood that between-group differences are simply due to lack of information, knowledge, and/or understanding. The population-level negative impacts were calculated by weighting each SUD's individual-level negative impact on indicators of the HIV Care Continuum and other important areas of life by the perceived prevalence of each SUD. Overall, we found these SUDs to have the greatest population-level negative impact scores (possible range 0-24): alcohol use disorder (population-level negative impact = 6.9; perceived prevalence = 41.9%), methamphetamine use disorder (population-level negative impact = 6.5; perceived prevalence = 3.2%), and opioid use disorder (population-level negative impact = 6.4; perceived prevalence = 34.6%). Beyond further demonstration of the need to better integrate SUD services within HIV settings, our findings may help inform how finite funding is allocated for addressing the HIV-SUD syndemic within the U.S. Based on our findings, such future efforts should prioritize the integration of evidence-based treatments that help address use disorders for alcohol, methamphetamine, and opioids.
Subject(s)
Alcoholism , HIV Infections , Methamphetamine , Opioid-Related Disorders , Substance-Related Disorders , Alcoholism/epidemiology , HIV Infections/complications , HIV Infections/epidemiology , Humans , Opioid-Related Disorders/epidemiology , Prevalence , Substance-Related Disorders/complications , Substance-Related Disorders/epidemiology , Substance-Related Disorders/therapy , United States/epidemiologyABSTRACT
To address the enduring gap between research and practice, there is a need to improve the speed and efficiency of research across the translational research spectrum. In 2012, the effectiveness-implementation hybrid trial design (HTD) was codified as a design with the potential to improve the speed and efficiency of translation, especially as part of T2 (clinical research) translational research. Building on this and other recent efforts to stimulate greater use of this novel HTD, the current article highlights an innovative application of each effectiveness-implementation HTD type. The completed application of the Type 1 effectiveness-implementation HTD tested the effectiveness of a clinical intervention for reducing HIV viral load and retaining people with HIV in care, as well as conducted a longitudinal mixed-methods examination to test for significant changes over time in three key measures of context, and economic evaluation of the clinical intervention. The completed application of the Type 2 effectiveness-implementation HTD used a dual-randomized design to simultaneously test the effectiveness of a clinical intervention for addressing substance use disorder among people with HIV and effectiveness of a blended strategy called the Implementation and Sustainment Facilitation (ISF) Strategy. This Type 2 hybrid trial was also innovative due to its focus on both sustainment and economic outcomes. The innovative Type 3 application (funded in 2008 and completed in 2012) tested the effectiveness and cost-effectiveness of using pay-for-performance to improve both implementation outcomes and client outcomes. This article also codifies a HTD called the Dissemination, Implementation, effectiveness, Sustainment, Economics, and Level-of-scaling (DIeSEL) HTD.
ABSTRACT
Background: As part of the Substance Abuse Treatment to HIV Care Project, the Implementation & Sustainment Facilitation (ISF) strategy was found to be an effective adjunct to the Addiction Technology Transfer Center (ATTC) strategy for integrating a motivational interviewing-based brief intervention (MIBI) for substance use disorders. This study presents the cost and cost-effectiveness results. Methods: Thirty-nine HIV service organizations were randomized to receive the ATTC-only condition or the ATTC + ISF condition. Two staff from each organization received the ATTC-training. In ATTC + ISF organizations, the same two staff and additional support staff participated in facilitation sessions to support MIBI implementation. We estimated costs using primary data on the time spent in each strategy and the time spent delivering 409 MIBIs to clients. We estimated staff-level cost-effectiveness for the number of MIBIs delivered, average MIBI quality scores, and total client days abstinent per staff. We used sensitivity analyses to test how changes to key variables affect the results. Results: Adjusted per-staff costs were $2,915 for the ATTC strategy and $5,371 for ATTC + ISF, resulting in an incremental cost of $2,457. ATTC + ISF significantly increased the number of MIBIs delivered (3.73) and the average MIBI quality score (61.45), yielding incremental cost effectiveness ratios (ICERs) of $659 and $40. Client days abstinent increased by 59 days per staff with a quality-adjusted life-year ICER of $40,578 (95% confidence interval $29,795-$61,031). Conclusions: From the perspective of federal policymakers, ISF as an adjunct to the ATTC strategy may be cost-effective for improving the integration of MIBIs within HIV service organizations, especially if scaled up to reach more clients. Travel accounted for nearly half of costs, and virtual implementation may further increase value. We also highlight two considerations for cost-effectiveness analysis with hybrid trials: study protocols kept recruitment low and modeling choices affect how we interpret the effects on client-level outcomes.
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INTRODUCTION: The COVID-19 pandemic collided with the opioid epidemic and longstanding health inequities to exacerbate the disproportionate harms experienced by persons with opioid use disorder (OUD) who self-identify as from racial and ethnic minority groups. Disrupted access to harm reduction services (e.g., naloxone, sterile syringes, recovery support) is one pathway whereby COVID-19 might exacerbate health disparities. We tested the hypothesis that persons receiving medication for opioid use disorder (MOUD) who self-identify as from racial/ethnic minority groups would experience more disruptions in access to harm reduction services than persons identifying as non-Hispanic White, even when controlling for severity of opioid use and sociodemographics (e.g., education, income, biological sex, age). METHODS: Analyses used data from a cluster randomized trial that had enrolled 188 patients, all of whom had provided baseline data on sociodemographics and severity of opioid use, across eight opioid treatment programs. Data collectors re-contacted participants between May and June 2020 and 133 (71% response rate) agreed to complete a survey about access to harm reduction services. RESULTS: Twenty-six respondents (20%) identified as from racial/ethnic minority groups (predominantly Black, Hispanic, and/or biracial). Between 7% and 27% of respondents reported disrupted access to harm reduction services. Logistic regressions indicated that persons identifying as from racial/ethnic minority groups were 8-10 times more likely than persons identifying as non-Hispanic White to report reduced access to naloxone and sterile syringes (p < .01), even when accounting for potential confounding variables. CONCLUSIONS: This report concludes with a discussion of potential outreach strategies and policies to advance more equitable access to essential harm reduction services.
Subject(s)
COVID-19 , Opioid-Related Disorders , Ethnic and Racial Minorities , Ethnicity , Harm Reduction , Health Inequities , Humans , Minority Groups , Pandemics , SARS-CoV-2 , United StatesABSTRACT
BACKGROUND: The Grasha-Riechmann teaching styles, which includes three didactic and two prescriptive styles, have been shown to help enhance learning within educational settings. Although an adaption of the Grasha-Riechmann style classification has enabled coaching styles to be identified for use as part of quality improvement (QI) initiatives, research has not examined the styles actually utilized by coaches within a QI initiative or how the styles change overtime when the coach is guiding an organization through change implementation. Interactions between coaches and HIV service organization (HSO) staff participating in a large implementation research experiment called the Substance Abuse Treatment to HIV care (SAT2HIV) Project were evaluated to begin building an evidence base to address this gap in implementation research. METHODS: Implementation & Sustainment Facilitation (ISF) Strategy meetings (n = 137) between coaches and HSO staff were recorded and professionally transcribed. Thematic coding classifications were developed from the Grasha-Riechmann framework and applied to a purposively selected sample of transcripts (n = 66). Four coders independently coded transcripts using NVivo to facilitate text identification, organization, and retrieval for analysis. Coaching style use and changes across the three ISF phases were explored. RESULTS: Facilitator and formal authority were the two coaching styles predominately used. Facilitator sub-themes shifted from asking questions and providing support to supporting independent action over time. Coaches' use of formal authority sub-styles shifted notably across time from setting expectations or ensuring preparation to offering affirmation or feedback about changes that the HSO's were implementing. The use of the delegator or personal model coaching styles occurred infrequently. CONCLUSIONS: The current research extends implementation research's understanding of coaching. More specifically, findings indicate it is feasible to use the Grasha-Riechmann framework to qualitatively identify coaching styles utilized in a facilitation-based implementation strategy. More importantly, results provide insights into how different coaching styles were utilized to implement an evidence-based practice. Further research is needed to examine how coaching styles differ by organization, impact implementation fidelity, and influence both implementation outcomes and client outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02495402 . Registered on July 6, 2015.
ABSTRACT
BACKGROUND: Opioid-related overdoses and harms have been declared a public health emergency in the United States, highlighting an urgent need to implement evidence-based treatments. Contingency management (CM) is one of the most effective behavioral interventions when delivered in combination with medication for opioid use disorder, but its implementation in opioid treatment programs is woefully limited. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics) was funded by the National Institute on Drug Abuse to identify effective strategies for helping opioid treatment programs improve CM implementation as an adjunct to medication. Specific aims will test the impact of two different strategies on implementation outcomes (primary aim) and patient outcomes (secondary aims), as well as test putative mediators of implementation effectiveness (exploratory aim). METHODS: A 3-cohort, cluster-randomized, type 3 hybrid design is used with the opioid treatment programs as the unit of randomization. Thirty programs are randomized to one of two conditions. The control condition is the Addiction Technology Transfer Center (ATTC) Network implementation strategy, which consists of three core approaches: didactic training, performance feedback, and on-going consultation. The experimental condition is an enhanced ATTC strategy, with the same core ATTC elements plus two additional theory-driven elements. The two additional elements are Pay-for-Performance, which aims to increase implementing staff's extrinsic motivations, and Implementation & Sustainment Facilitation, which targets staff's intrinsic motivations. Data will be collected using a novel, CM Tracker tool to document CM session delivery, session audio recordings, provider surveys, and patient surveys. Implementation outcomes include CM Exposure (number of CM sessions delivered per patient), CM Skill (ratings of CM fidelity), and CM Sustainment (number of patients receiving CM after removal of support). Patient outcomes include self-reported opioid abstinence and opioid-related problems (both assessed at 3- and 6-months post-baseline). DISCUSSION: There is urgent public health need to improve the implementation of CM as an adjunct to medication for opioid use disorder. Consistent with its hybrid type 3 design, Project MIMIC is advancing implementation science by comparing impacts of these two multifaceted strategies on both implementation and patient outcomes, and by examining the extent to which the impacts of those strategies can be explained by putative mediators. TRIAL REGISTRATION: This clinical trial has been registered with clinicaltrials.gov (NCT03931174). Registered April 30, 2019. https://clinicaltrials.gov/ct2/show/NCT03931174?term=project+mimic&draw=2&rank=1.
Subject(s)
Motivation , Opioid-Related Disorders , Analgesics, Opioid/therapeutic use , Humans , Opioid-Related Disorders/drug therapy , Reimbursement, Incentive , Research Design , United StatesABSTRACT
The COVID-19 pandemic has adversely affected people with HIV due to disruptions in prevention and care services, economic impacts, and social isolation. These stressors have contributed to worse physical health, HIV treatment outcomes, and psychological wellness. Psychological sequelae associated with COVID-19 threaten the overall well-being of people with HIV and efforts to end the HIV epidemic. Resilience is a known mediator of health disparities and can improve psychological wellness and behavioral health outcomes along the HIV Continuum of Care. Though resilience is often organically developed in individuals as a result of overcoming adversity, it may be fostered through multi-level internal and external resourcing (at psychological, interpersonal, spiritual, and community/neighborhood levels). In this Perspective, resilience-focused HIV care is defined as a model of care in which providers promote optimum health for people with HIV by facilitating multi-level resourcing to buffer the effects of adversity and foster well-being. Adoption of resilience-focused HIV care may help providers better promote well-being among people living with HIV during this time of increased psychological stress and help prepare systems of care for future catastrophes. Informed by the literature, we constructed a set of core principles and considerations for successful adoption and sustainability of resilience-focused HIV care. Our definition of resilience-focused HIV care marks a novel contribution to the knowledge base and responds to the call for a multidimensional definition of resilience as part of HIV research.