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The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial.

ABSTRACT: BACKGROUND:Opioid dependence has devastating and increasingly widespread consequences and costs, and the most common outcome of treatment is early relapse. People who inject opioids are also at disproportionate risk for contracting the human immunodeficiency virus (HIV) and hepatitis C virus (HCV). This study tests an approach that has been shown to improve recovery rates: medication along with other supportive services (medication-assisted treatment, or MAT) against MAT combined with a smartphone innovation called A-CHESS (MAT?+?A-CHESS). METHODS/DESIGN:This unblinded study will randomly assign 440 patients to receive MAT?+?A-CHESS or MAT alone. Eligible patients will meet criteria for having an opioid use disorder of at least moderate severity and will be taking methadone, injectable naltrexone, or buprenorphine. Patients with A-CHESS will have smartphones for 16 months; all patients will be followed for 24 months. The primary outcome is the difference between patients in the two arms in percentage of days using illicit opioids during the 24-month intervention. Secondary outcomes are differences between patients receiving MAT?+?A-CHESS versus MAT in other substance use, quality of life, retention in treatment, health service use, and, related to HIV and HCV, screening and testing rates, medication adherence, risk behaviors, and links to care. We will also examine mediators and moderators of the effects of MAT?+?A-CHESS. We will measure variables at baseline and months 4, 8, 12, 16, 20, and 24. At each point, patients will respond to a 20- to 30-min phone survey; urine screens will be collected at baseline and up to twice a month thereafter. We will use mixed-effects to evaluate the primary and secondary outcomes, with baseline scores functioning as covariates, treatment condition as a between-subject factor, and the outcomes reflecting scores for a given assessment at the six time points. Separate analyses will be conducted for each outcome. DISCUSSION:A-CHESS has been shown to improve recovery for people with alcohol dependence. It offers an adaptive and extensive menu of services and can attend to patients nearly as constantly as addiction does. This suggests the possibility of increasing both the effectiveness of, and access to, treatment for opioid dependence. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02712034 . Registered on 14 March 2016.

SUBMITTER: Gustafson DH

PROVIDER: S-EPMC5153683 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial.

Gustafson David H DH Landucci Gina G McTavish Fiona F Kornfield Rachel R Johnson Roberta A RA Mares Marie-Louise ML Westergaard Ryan P RP Quanbeck Andrew A Alagoz Esra E Pe-Romashko Klaren K Thomas Chantelle C Shah Dhavan D

Trials 20161212 1

<h4>Background</h4>Opioid dependence has devastating and increasingly widespread consequences and costs, and the most common outcome of treatment is early relapse. People who inject opioids are also at disproportionate risk for contracting the human immunodeficiency virus (HIV) and hepatitis C virus (HCV). This study tests an approach that has been shown to improve recovery rates: medication along with other supportive services (medication-assisted treatment, or MAT) against MAT combined with a ...[more]

PMID: 27955689

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Project description:Background: Opioids accounted for 75% of drug overdoses in the United States in 2020, with rural states particularly impacted by the opioid crisis. While medication assisted treatment (MAT) with Suboxone remains one of the more efficacious treatments for opioid use disorder (OUD), approximately 40% of people receiving Suboxone for outpatient MAT for OUD (MOUD) relapse within the first 6 months of treatment. We developed the smartphone app-based intervention OptiMAT as an adjunctive intervention to improve MOUD outcomes. The aims of this study are to (1) evaluate the efficacy of adjunctive OptiMAT use in reducing opioid misuse among people receiving MOUD; and (2) evaluate the role of specific OpitMAT features in reducing opioid misuse, including the use of GPS-driven just-in-time intervention. Methods: We will conduct a two-arm, single-blind, randomized controlled trial of adults receiving outpatient MOUD in the greater Little Rock AR area. Participants are English-speaking adults ages 18 or older recently enrolled in outpatient MOUD at one of our participating study clinics. Participants will be allocated via 1:1 randomized block design to (1) MOUD with adjunctive use of OptiMAT (MOUD+OptiMAT) or (2) MOUD without OptiMAT (MOUD-only). Our blinded research statistician will evaluate differences between the two groups in opioid misuse (as determined by quantitative urinalysis conducted by clinical lab staff blinded to group membership) during the 6-months following study enrolment. Secondary analyses will evaluate if OptiMAT-usage patterns within the MOUD+OptiMAT group predict opioid misuse or continued abstinence. Discussion: This study will test if adjunctive use of OptiMAT improve MOUD outcomes. Study findings could lead to expansion of OptiMAT into rural clinical settings, and the identification of OptiMAT features which best predict positive clinical outcome could lead to refinement of this and similar smartphone appbased interventions. Trial registration: ClinicalTrials.gov identifier: NCT05336188, registered March 21, 2022, https://clinicaltrials.gov/ct2/show/NCT05336188.

Project description:BACKGROUND:Poor adherence to inhaled corticosteroid medications for children with high-risk asthma is both well documented and poorly understood. It has a disproportionate prevalence and impact on children of minority demographics in urban settings. Financial incentives have been shown to be a compelling method to engage those in a high-risk asthma population, but whether adherence can be maintained by offering financial incentives and how these incentives can be used to sustain high adherence are unknown. OBJECTIVE:The aim of this study is to determine the marginal effects of a financial incentive-based intervention on inhaled corticosteroid adherence, health care system use, and costs. METHODS:Participants include children aged 5 to 12 years who have had either at least two hospitalizations or one hospitalization and one emergency department visit for asthma in the year prior to their enrollment (and their caregivers). Participants are given an electronic inhaler sensor in order to track their medication use over a period of 7 months. After a 1-month period of observation, participants are randomized to 1 of 3 arms for a 3-month period. Participants in arm 1 receive daily text message reminders, feedback, and gain-framed, nominal financial incentives; participants in arm 2 receive daily text message reminders and feedback only, and participants in arm 3 receive no reminders, feedback, or incentives. All participants are subsequently observed for an additional 3-month period with no reminders, feedback, or incentives to assess whether any sustained effects are apparent. RESULTS:Study enrollment began in September 2019 with a target sample size of N=125 children. As of June 2020, 61 children have been enrolled. Data collection is estimated to be completed in June 2022, and analyses will be completed by June 2023. CONCLUSIONS:This study will provide data that will help to determine whether a financial incentive-based mobile health intervention for promoting inhaled corticosteroid use can be effective in patients with high-risk asthma over longer periods. TRIAL REGISTRATION:Clinicaltrial.gov NCT03907410; https://clinicaltrials.gov/ct2/show/NCT03907410. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16711.

Project description:BackgroundThe growing epidemic of opioid use disorder (OUD) and associated injection drug use has resulted in a surge of new hepatitis C virus (HCV) infections. Approximately half of the people with HCV infection are unaware of their HCV status. Improving HCV awareness and increasing screening among people with OUD are critical. Addiction-Comprehensive Health Enhancement Support System (A-CHESS) is an evidence-based, smartphone-delivered relapse prevention system that has been implemented among people with OUD who are receiving medications for addiction treatment (MAT) to improve long-term recovery.ObjectiveWe incorporated HCV-related content and functionality into A-CHESS to characterize the HCV care continuum among people in early remission and receiving MAT for OUD and to determine whether incorporating such content and functionality into A-CHESS increases HCV testing.MethodsHCV intervention content, including dissemination of educational information, private messages tailored to individuals' stage of HCV care, and a public discussion forum, was implemented into the A-CHESS platform. Between April 2016 and April 2020, 416 participants with OUD were enrolled in this study. Participants were randomly assigned to receive MAT alone (control arm) or MAT+A-CHESS (experimental arm). Quarterly telephone interviews were conducted from baseline to month 24 to assess risk behaviors and HCV testing history. Cox proportional hazards regression was used to assess whether participants who used A-CHESS were tested for HCV (either antibody [Ab] or RNA testing) at a higher rate than those in the control arm. To assess the effect of A-CHESS on subsets of participants at the highest risk for HCV, additional analyses were performed to examine the effect of the intervention among participants who injected drugs and shared injection equipment.ResultsOverall, 44.2% (184/416) of the study participants were HCV Ab positive, 30.3% (126/416) were HCV Ab negative, and 25.5% (106/416) were considered untested at baseline. At month 24, there was no overall difference in HCV testing uptake between the intervention and control participants. However, among the subset of 109 participants who engaged in injection drug use, there was a slight trend toward increased HCV testing uptake among those who used A-CHESS (89% vs 85%; hazard ratio: 1.34; 95% CI 0.87-2.05; P=.18), and a stronger trend was observed when focusing on the subset of 32 participants who reported sharing injection equipment (87% vs 56%; hazard ratio: 2.92; 95% CI 0.959-8.86; P=.06).ConclusionsIncorporating HCV prevention and care information into A-CHESS may increase the uptake of HCV testing while preventing opioid relapse when implemented among populations who engage in high-risk behaviors such as sharing contaminated injection equipment. However, more studies that are powered to detect differences in HCV testing among high-risk groups are needed.Trial registrationClinicalTrials.gov NCT02712034; https://clinicaltrials.gov/ct2/show/NCT02712034.International registered report identifier (irrid)RR2-10.2196/12620.

Project description:IntroductionOpioid assisted treatment (OAT) with buprenorphine (BUP) is front-line medical maintenance intervention for illicit and prescription opioid use disorder (OUD). In many clinics, opioid medication is dispensed for several days for self-administration. This provides flexibility to the patient but may compromise the effectiveness of OAT because of nonadherence or medication diversion. OAT can be delivered as an entirely supervised intervention, but many patients discontinue treatment under this arrangement and dispensing costs may be prohibitive. An alternative is to enable patients to receive take-home doses contingent on OAT adherence guided by a medication management framework using Therapeutic Drug Monitoring (TDM) alongside negative urine drug screens (UDS) to provide evidence of abstinence. TDM is recommended to monitor adherence with BUP but it has not been applied in OAT programs and evaluation research to date.MethodsThe Suboxone Treatment and Recovery Trial (STAR-T) is a single site, 16-week, parallel-group, randomised controlled trial. The aim of the study is to determine the effectiveness of a medication management framework including TDM and UDS to enable patients enrolled on outpatient OAT (with buprenorphine/naloxone [sublingual film formulation; BUP/NX-F; Suboxone™]) to receive stepped take-home doses. Following stabilisation during inpatient care, adult participants with illicit or prescription OUD were allocated (1:1) to receive (1) BUP/NX-F plus medication management for take-home doses based on TDM, UDS, and contingency management protocol (the experimental group) or (2) BUP/NX-F plus UDS only (treatment-as-usual, the control group). The primary outcome is the mean percentage of negative UDS over 16 weeks. The secondary outcome is treatment retention defined as completion of 16 weeks of OAT without interruption. There will be an exploratory analysis of the association between participant characteristics, clinical data, and outcomes.ConclusionsProviding BUP/NX-F take-home doses contingent on adherence and opioid abstinence may enable OAT to be delivered flexibly and effectively.Trial registrationISRCTN41645723 is retrospectively registered on 15/11/2015.

Project description:IntroductionIllicit opioid use has become a national crisis in Canada, with over 65?000 people seeking treatment for opioid use disorder (OUD) in Ontario and British Columbia alone. Medication-assisted treatment (MAT) is a common treatment for OUD. There is substantial variability in treatment outcomes used to evaluate effectiveness of MAT, making it difficult to establish clinically and scientifically relevant treatment effect. Furthermore, patients are often excluded from the process of determining these outcomes. The primary objective of this review is to examine outcomes currently used to measure MAT effectiveness and to identify patient-relevant outcomes to enhance effectiveness of treatment options. This review refers to patient-important outcomes as those outcomes patients consider important to or markers of treatment success.Methods and analysisMEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Web of Science, Cochrane Library, Cochrane Clinical Trials Registry, National Institutes for Health Clinical Trials Registry and WHO International Clinical Trials Registry Platform databases will be searched. We will search databases from inception to the date the search is ran. Studies of interest include those evaluating the effectiveness of MAT for patients with OUD, with or without consultation with patients regarding what they consider to be important as an indicator of treatment success. Results will be analysed using thematic analysis and qualitative analysis where possible. This will result in comprehensive synthesis of all outcomes and measures found related to OUD treatment effectiveness.Ethics and disseminationWe are collaborating with Canadian Addiction Treatment Centres which provide MAT to patients with OUD who will participate in disseminating study results. Dissemination strategies will involve sharing study results through workshops, presentations, peer-reviewed publications, study reports, community presentations and resources in primary care settings.Prospero registration numberCRD42018095553.

Project description:OBJECTIVES:Community pharmacy continues to play a crucial role in the national response to the opioid epidemic. The purpose of this article is to describe the protocol for a pilot study that is examining the feasibility and acceptability of the Motivational Intervention-Medication Therapy Management (MI-MTM) model. This study also examines the preliminary clinical effect of MI-MTM for improving opioid medication misuse and patient activation in self-management of health conditions that increase risk for misuse. DESIGN:MI-MTM is a pharmacy-based integrated care model made up of 4 evidence-based practices: medication therapy management; brief motivational intervention; patient navigation; and naloxone training and referral. To test MI-MTM compared with Standard Medication Counseling (SMC), we are conducting a 2-group randomized single-blinded controlled trial with assessments at 3 time points. SETTING AND PARTICIPANTS:The study is being conducted within a western Pennsylvania university-based community pharmacy with 46 patients with opioid misuse (MI-MTM = 23; SMC = 23). MAIN OUTCOME MEASURES:Feasibility will be measured by capturing patient completion rate of MI-MTM sessions. Acceptability will be measured by administering satisfaction surveys regarding pharmacist and patient navigator services. Acceptability will also be captured by conducting intensive qualitative interviews. Preliminary effect of the intervention on misuse will be measured with the use of the Prescription Opioid Misuse Index and the Opioid Compliance Checklist. Activation in self-management will be measured with the use of the Patient Activation Measure. RESULTS:This project is currently recruiting, and results are to come. CONCLUSION:This study is the first in the United States to implement an evidence-based integrated behavioral intervention into the community pharmacy setting to address opioid medication misuse among pharmacy patients. The results of this study will provide necessary foundational data that allow further testing of this intervention model in a larger trial.

Project description:BackgroundNon-adherence to Tuberculosis (TB) medication is a serious threat to TB prevention and control programs, especially in resource-limited settings. The growth of the popularity of mobile phones provides opportunities to address non-adherence, by facilitating direct communication more frequently between healthcare providers and patients through SMS texts and voice phone calls. However, the existing evidence is inconsistent about the effect of SMS interventions on TB treatment adherence. Such interventions are also seldom developed based on appropriate theoretical foundations. Therefore, there is a reason to approach this problem more rigorously, by developing the intervention systematically with evidence-based theory and conducting the trial with strong measurement methods.MethodsThis study is a single-blind parallel-group design individual randomized control trial. A total of 186 participants (93 per group) will be individually randomized into one of the two groups with a 1:1 allocation ratio by a computer-generated algorithm. Group one (intervention) participants will receive daily SMS texts and weekly phone calls concerning their daily medication intake and medication refill clinic visit reminder and group two (control) participants will receive the same routine standard treatment care as the intervention group, but no SMS text and phone calls. All participants will be followed for two months of home-based self-administered medication during the continuation phases of the standard treatment period. Urine test for the presence of isoniazid (INH) drug metabolites in urine will be undertaken at the random point at the fourth and eighth weeks of intervention to measure medication adherence. Medication adherence will also be assessed by self-report measurements using the AIDS Clinical Trial Group adherence (ACTG) and Visual Analogue Scales (VAS) questionnaires, and clinic appointment attendance registration. Multivariable regression model analysis will be employed to assess the effect of the Ma-MAS intervention at a significance level of P-value < 0.05 with a 95% confidence interval.DiscussionFor this trial, a mobile-assisted medication adherence intervention will first be developed systematically based on the Medical Research Council framework using appropriate behavioural theory and evidence. The trial will then evaluate the effect of SMS texts and phone calls on TB medication adherence. Evidence generated from this trial will be highly valuable for policymakers, program managers, and healthcare providers working in Ethiopia and beyond.Trial registrationThe trial is registered in the Pan-Africa Clinical Trials Registry with trial number PACTR202002831201865.

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The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial.

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The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial.

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