Effects of Bundling Medication for Opioid Use Disorder With an mHealth Intervention Targeting Addiction: A Randomized Clinical Trial.

OBJECTIVE: Medication for opioid use disorder (MOUD) improves treatment retention and reduces illicit opioid use. A-CHESS is an evidence-based smartphone intervention shown to improve addiction-related behaviors. The authors tested the efficacy of MOUD alone versus MOUD plus A-CHESS to determine whether the combination further improved outcomes. METHODS: In an unblinded parallel-group randomized controlled trial, 414 participants recruited from outpatient programs were assigned in a 1:1 ratio to receive either MOUD alone or MOUD+A-CHESS for 16 months and were followed for an additional 8 months. All participants were on methadone, buprenorphine, or injectable naltrexone. The primary outcome was abstinence from illicit opioid use; secondary outcomes were treatment retention, health services use, other substance use, and quality of life; moderators were MOUD type, gender, withdrawal symptom severity, pain severity, and loneliness. Data sources were surveys comprising multiple validated scales, as well as urine screens, every 4 months. RESULTS: There was no difference in abstinence between participants in the MOUD+A-CHESS and MOUD-alone arms across time (odds ratio=1.10, 95% CI=0.90-1.33). However, abstinence was moderated by withdrawal symptom severity (odds ratio=0.95, 95% CI=0.91-1.00) and MOUD type (odds ratio=0.57, 95% CI=0.34-0.97). Among participants without withdrawal symptoms, abstinence rates were higher over time for those in the MOUD+A-CHESS arm than for those in the MOUD-alone arm (odds ratio=1.30, 95% CI=1.01-1.67). Among participants taking methadone, those in the MOUD+A-CHESS arm were more likely to be abstinent over time (b=0.28, SE=0.09) than those in the MOUD-alone arm (b=0.06, SE=0.08), although the two groups did not differ significantly from each other (∆b=0.22, SE=0.11). MOUD+A-CHESS was also associated with greater meeting attendance (odds ratio=1.25, 95% CI=1.05-1.49) and decreased emergency department and urgent care use (odds ratio=0.88, 95% CI=0.78-0.99). CONCLUSIONS: Overall, MOUD+A-CHESS did not improve abstinence relative to MOUD alone. However, MOUD+A-CHESS may provide benefits for subsets of patients and may impact treatment utilization.

Using Smart Displays to Implement an eHealth System for Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial.

BACKGROUND: Voice-controlled smart speakers and displays have a unique but unproven potential for delivering eHealth interventions. Many laptop- and smartphone-based interventions have been shown to improve multiple outcomes, but voice-controlled platforms have not been tested in large-scale rigorous trials. Older adults with multiple chronic health conditions, who need tools to help with their daily management, may be especially good candidates for interventions on voice-controlled devices because these patients often have physical limitations, such as tremors or vision problems, that make the use of laptops and smartphones challenging. OBJECTIVE: The aim of this study is to assess whether participants using an evidence-based intervention (ElderTree) on a smart display will experience decreased pain interference and improved quality of life and related measures in comparison with participants using ElderTree on a laptop and control participants who are given no device or access to ElderTree. METHODS: A total of 291 adults aged ≥60 years with chronic pain and ≥3 additional chronic conditions will be recruited from primary care clinics and community organizations and randomized 1:1:1 to ElderTree access on a smart display along with their usual care, ElderTree access on a touch screen laptop along with usual care, or usual care alone. All patients will be followed for 8 months. The primary outcomes are differences between groups in measures of pain interference and psychosocial quality of life. The secondary outcomes are between-group differences in system use at 8 months, physical quality of life, pain intensity, hospital readmissions, communication with medical providers, health distress, well-being, loneliness, and irritability. We will also examine mediators and moderators of the effects of ElderTree on both platforms. At baseline, 4 months, and 8 months, patients will complete written surveys comprising validated scales selected for good psychometric properties with similar populations. ElderTree use data will be collected continuously in system logs. We will use linear mixed-effects models to evaluate outcomes over time, with treatment condition and time acting as between-participant factors. Separate analyses will be conducted for each outcome. RESULTS: Recruitment began in August 2021 and will run through April 2023. The intervention period will end in December 2023. The findings will be disseminated via peer-reviewed publications. CONCLUSIONS: To our knowledge, this is the first study with a large sample and long time frame to examine whether a voice-controlled smart device can perform as well as or better than a laptop in implementing a health intervention for older patients with multiple chronic health conditions. As patients with multiple conditions are such a large cohort, the implications for cost as well as patient well-being are significant. Making the best use of current and developing technologies is a critical part of this effort. TRIAL REGISTRATION: ClinicalTrials.gov NCT04798196; https://clinicaltrials.gov/ct2/show/NCT04798196. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37522.

Effect of an mHealth Intervention on Hepatitis C Testing Uptake Among People With Opioid Use Disorder: Randomized Controlled Trial.

BACKGROUND: The 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. OBJECTIVE: We 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. METHODS: HCV 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. RESULTS: Overall, 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). CONCLUSIONS: Incorporating 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 REGISTRATION: ClinicalTrials.gov NCT02712034; https://clinicaltrials.gov/ct2/show/NCT02712034. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/12620.

A Web-Based eHealth Intervention to Improve the Quality of Life of Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial.

BACKGROUND: Multiple chronic conditions (MCCs) are common among older adults and expensive to manage. Two-thirds of Medicare beneficiaries have multiple conditions (eg, diabetes and osteoarthritis) and account for more than 90% of Medicare spending. Patients with MCCs also experience lower quality of life and worse medical and psychiatric outcomes than patients without MCCs. In primary care settings, where MCCs are generally treated, care often focuses on laboratory results and medication management, and not quality of life, due in part to time constraints. eHealth systems, which have been shown to improve multiple outcomes, may be able to fill the gap, supplementing primary care and improving these patients' lives. OBJECTIVE: This study aims to assess the effects of ElderTree (ET), an eHealth intervention for older adults with MCCs, on quality of life and related measures. METHODS: In this unblinded study, 346 adults aged 65 years and older with at least 3 of 5 targeted high-risk chronic conditions (hypertension, hyperlipidemia, diabetes, osteoarthritis, and BMI ≥30 kg/m2) were recruited from primary care clinics and randomized in a ratio of 1:1 to one of 2 conditions: usual care (UC) plus laptop computer, internet service, and ET or a control consisting of UC plus laptop and internet but no ET. Patients with ET have access for 12 months and will be followed up for an additional 6 months, for a total of 18 months. The primary outcomes of this study are the differences between the 2 groups with regard to measures of quality of life, psychological well-being, and loneliness. The secondary outcomes are between-group differences in laboratory scores, falls, symptom distress, medication adherence, and crisis and long-term health care use. We will also examine the mediators and moderators of the effects of ET. At baseline and months 6, 12, and 18, patients complete written surveys comprising validated scales selected for good psychometric properties with similar populations; laboratory data are collected from eHealth records; health care use and chronic conditions are collected from health records and patient surveys; and ET use data are collected continuously in system logs. We will use general linear models and linear mixed models to evaluate primary and secondary outcomes over time, with treatment condition as a between-subjects factor. Separate analyses will be conducted for outcomes that are noncontinuous or not correlated with other outcomes. RESULTS: Recruitment was conducted from January 2018 to December 2019, and 346 participants were recruited. The intervention period will end in June 2021. CONCLUSIONS: With self-management and motivational strategies, health tracking, educational tools, and peer community and support, ET may help improve outcomes for patients coping with ongoing, complex MCCs. In addition, it may relieve some stress on the primary care system, with potential cost implications. TRIAL REGISTRATION: ClinicalTrials.gov NCT03387735; https://www.clinicaltrials.gov/ct2/show/NCT03387735. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25175.

A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial.

BACKGROUND: People who inject drugs are at a disproportionate risk for contracting hepatitis C virus (HCV). However, use of HCV prevention and treatment services remains suboptimal among people with substance use disorders due to various health system, societal, and individual barriers. Mobile health applications offer promising strategies to support people in recovery from substance use disorders. We sought to determine whether the Addiction-Comprehensive Health Enhancement Support System (A-CHESS), an existing mobile health application for opioid use disorder, could be adapted to improve HCV screening and treatment. OBJECTIVE: The goals of this paper are to describe: (1) the components and functionality of an HCV intervention incorporated into the existing A-CHESS system; and (2) how data are collected and will be used to evaluate HCV testing, linkage to care, and treatment. METHODS: People with recent opioid use were enrolled in a randomized controlled trial to test whether A-CHESS reduced relapse. We developed and implemented HCV intervention content within the A-CHESS platform to simultaneously evaluate whether A-CHESS improved secondary outcomes related to HCV care. All A-CHESS users received the HCV intervention content, which includes educational information, private messages tailored to an individual's stage of HCV care, and a public discussion forum. Data on patients' HCV risk behaviors and stage of care were collected through quarterly telephone interviews and weekly surveys delivered through A-CHESS. The proportion of people with opioid use disorder who are HCV untested, HCV-negative, HCV antibody-positive, or HCV RNA-positive, as well as linked to care, treated and cured at baseline is described here. The 24-month follow-up is ongoing and will be completed in April 2020. Survey data will then be used to assess whether individuals who received the HCV-enhanced A-CHESS intervention were more likely to reduce risky injection behaviors, receive HCV testing, link to medical care, initiate treatment, and be cured of HCV compared to the control group. RESULTS: Between April 2016 and April 2018, 416 individuals were enrolled and completed the baseline interview. Of these individuals, 207 were then randomly assigned to the control arm and 209 were assigned to the intervention arm. At baseline, 202 individuals (49%) self-reported ever testing HCV antibody-positive. Of those, 179 (89%) reported receiving HCV RNA confirmatory testing, 134 (66%) tested HCV RNA-positive, 125 (62%) were linked to medical care and 27 (13%) were treated and cured of HCV. Of the remaining 214 individuals who had never tested HCV antibody-positive, 129 (31%) had tested HCV antibody-negative within the past year and 85 (20%) had not been tested within the past year. CONCLUSIONS: The A-CHESS mobile health system allows for the implementation of a bundle of services as well as the collection of longitudinal data related to drug use and HCV care among people with opioid use disorders. This study will provide preliminary evidence to determine whether HCV-specific services embedded into the A-CHESS program can improve HCV outcomes for people engaged in addiction treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT02712034; https://clinicaltrials.gov/ct2/show/NCT02712034. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12620.

Detecting Recovery Problems Just in Time: Application of Automated Linguistic Analysis and Supervised Machine Learning to an Online Substance Abuse Forum.

BACKGROUND: Online discussion forums allow those in addiction recovery to seek help through text-based messages, including when facing triggers to drink or use drugs. Trained staff (or "moderators") may participate within these forums to offer guidance and support when participants are struggling but must expend considerable effort to continually review new content. Demands on moderators limit the scalability of evidence-based digital health interventions. OBJECTIVE: Automated identification of recovery problems could allow moderators to engage in more timely and efficient ways with participants who are struggling. This paper aimed to investigate whether computational linguistics and supervised machine learning can be applied to successfully flag, in real time, those discussion forum messages that moderators find most concerning. METHODS: Training data came from a trial of a mobile phone-based health intervention for individuals in recovery from alcohol use disorder, with human coders labeling discussion forum messages according to whether or not authors mentioned problems in their recovery process. Linguistic features of these messages were extracted via several computational techniques: (1) a Bag-of-Words approach, (2) the dictionary-based Linguistic Inquiry and Word Count program, and (3) a hybrid approach combining the most important features from both Bag-of-Words and Linguistic Inquiry and Word Count. These features were applied within binary classifiers leveraging several methods of supervised machine learning: support vector machines, decision trees, and boosted decision trees. Classifiers were evaluated in data from a later deployment of the recovery support intervention. RESULTS: To distinguish recovery problem disclosures, the Bag-of-Words approach relied on domain-specific language, including words explicitly linked to substance use and mental health ("drink," "relapse," "depression," and so on), whereas the Linguistic Inquiry and Word Count approach relied on language characteristics such as tone, affect, insight, and presence of quantifiers and time references, as well as pronouns. A boosted decision tree classifier, utilizing features from both Bag-of-Words and Linguistic Inquiry and Word Count performed best in identifying problems disclosed within the discussion forum, achieving 88% sensitivity and 82% specificity in a separate cohort of patients in recovery. CONCLUSIONS: Differences in language use can distinguish messages disclosing recovery problems from other message types. Incorporating machine learning models based on language use allows real-time flagging of concerning content such that trained staff may engage more efficiently and focus their attention on time-sensitive issues.

SurvivorCHESS to increase physical activity in colon cancer survivors: can we get them moving?

PURPOSE: This randomized controlled trial evaluated the impact of SurvivorCHESS, an eHealth intervention, on physical activity in colon cancer survivors and to explore the impact of SurvivorCHESS on quality of life and distress. METHODS: This was a two-arm single-blinded multi-site randomized controlled trial comparing a control group to an intervention group receiving a smartphone with the SurvivorCHESS program. RESULTS: Participants using SurvivorCHESS (n = 144) increased their moderate to vigorous physical activities from 19.4 min at baseline to 50 min compared to the control group (n = 140) increasing from 15.5 to 40.3 min at 6 months (p = .083) but was not sustained 3 months after the study ended. No significant differences were found between groups over time for quality of life or distress items. Reports of physical symptoms were greater than other categories for distress items. Patients who had a higher body mass index and number of comorbid conditions were less likely to increase their physical activity. Self-determination theory including autonomous motivation and relatedness was not associated with the outcomes. CONCLUSIONS: Physical activity did increase over time in both groups and was not significantly different with the use of the eHealth intervention, SurvivorCHESS, compared to the control group. The amount of SurvivorCHESS use was not associated with physical activity. IMPLICATIONS FOR CANCER SURVIVORS: Increasing physical activity in colon cancer survivors has the potential to improve quality of life and reduce recurrences. Using smartphone-tracking devices may be useful in helping to change this health behavior.

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

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.

Using the NIATx Model to Implement User-Centered Design of Technology for Older Adults.

What models can effectively guide the creation of eHealth and mHealth technologies? This paper describes the use of the NIATx model as a framework for the user-centered design of a new technology for older adults. The NIATx model is a simple framework of process improvement based on the following principles derived from an analysis of decades of research from various industries about why some projects fail and others succeed: (1) Understand and involve the customer; (2) fix key problems; (3) pick an influential change leader; (4) get ideas from outside the field; (5) use rapid-cycle testing. This paper describes the use of these principles in technology development, the strengths and challenges of using this approach in this context, and lessons learned from the process. Overall, the NIATx model enabled us to produce a user-focused technology that the anecdotal evidence available so far suggests is engaging and useful to older adults. The first and fourth principles were especially important in developing the technology; the fourth proved the most challenging to use.

Reducing the digital divide for low-income women with breast cancer: a feasibility study of a population-based intervention.

A fundamental challenge to helping underserved women and their families cope with breast cancer is providing them with easily accessible, reliable health care information and support. This is especially true for low-income families living in rural areas where resources are few and frequently distant as well as low-income families in urban areas where access to information and support can be complex and overwhelming. The Internet is one mechanism that has tremendous potential to help these families cope with breast cancer. This article describes a feasibility test of the potential for the National Cancer Institute's (NCI's) Cancer Information Service (CIS) to provide access to an Internet-based system that has been shown to improve quality of life for underserved breast cancer patients. The test was conducted in rural Wisconsin (low socioeconomic status [SES] Caucasian women) and in Detroit, Michigan (low SES African American women), and compares the effectiveness of several different dissemination strategies. Using these results we propose a model for how CIS telephone and partnership program services could efficiently disseminate such information and support systems. In doing so we believe that important steps can be taken to close the digital divide that separates low-income families from the resources they need to effectively face cancer. This is the first of two articles coming from this study. A companion article reports on an evaluation of the use and impact of this system on the women who were given access to it.

Use and Impact of eHealth System by Low-income Women With Breast Cancer.

This article is the second of a two-part series reporting on a population-based study intended to use an eHealth system to examine the feasibility of reaching underserved women with breast cancer (Gustafson, McTavish et al., Reducing the digital divide for low-income women with breast cancer, 2004; Madison Center for Health Systems Research and Analysis, University of Wisconsin; Comprehensive Health Enhancement Support System [CHESS]) and determine how they use the system and what impact it had on them. Participants included women recently diagnosed with breast cancer whose income was at or below 250% of poverty level and were living in rural Wisconsin (n = 144; all Caucasian) or Detroit (n = 85; all African American). Because this was a population-based study all 229 participants received CHESS. A comparison group of patients (n = 51) with similar demographics was drawn from a separate recently completed randomized clinical trial. Use rates (e.g., frequency and length of use as well as type of use) as well as impact on several dimensions of quality of life and participation in health care are reported. Low-income subjects in this study logged on and spent more time on CHESS than more affluent women in a previous study. Urban African Americans used information and analysis services more and communication services less than rural Caucasians. When all low-income women from this study are combined and compared with a low-income control group from another study, the CHESS group was superior to that control group in 4 of 8 outcome variables at both statistically and practically significant levels (social support, negative emotions, participation in health care, and information competence). When African Americans and Caucasians are separated the control group's sample size becomes 30 and 21 thus reducing power. Statistical significance is retained, however, in all four outcomes for Caucasians and in two of four for African Americans. Practical significance is retained for all four outcomes. We conclude that an eHealth system like CHESS will be used extensively and have a positive impact on low-income women with breast cancer.