David H. Gustafson, Ph.D. - US grants

Young adolescents (ages 10-14) comprise an age group considerably at risk for drug abuse, including alcohol and tobacco. Prevention programs, are seldom targeted for high risk young teens. This research seeks to answer two critical questions in the field of drug abuse prevention. First, how can an individual adolescent's relative risk for either initiating drug use or becoming a drug user be assessed? Second, can a computer-based drug prevention system that relies on risk assessment to channel adolescents to the most appropriate information, skills training and decision supports, be effective in preventing drug abuse in high risk young adolescents? In developing a risk assessment tool, a mathematical model based on Bayes Theorem will be developed. The items in the Substance Abuse Risk Assessment (SARA) will be strongly influenced by the Jessor and Jessor Problem Behavior Model. Panels of experts (using a methodology we have employed in developing other risk indices) will refine the items in the Jessor's model in light of their experience and current empirical knowledge. The SARA will be programmed on a microcomputer which allows for speedy and accurate risk calculations and has proven to be an attractive medium for the target population. In earlier research, the investigators designed a computer-based health promotion system (The Body Awareness Resource Network BARN) for adolescents and their families. The system includes information on drugs, including alcohol and tobacco as well as related issues such as: stress, family communications, human sexuality, etc.. BARN has been successful in attracting high risk teens and in delaying onset of risk behavior, particularly among young adolescents. This research proposes to build on the BARN system by adding the SARA. The SARA would direct users, based on their scores, to appropriate sections of the BARN system. The predictive power of the SARA and the impact of the SARA/BARN system will be evaluated in several ways including an experiment with young adolescents from 120 high risk families. Families will be randomly assigned to control or experimental groups. The experimental group will have the SARA/BARN system in their homes for 3 months. All family members will be tested prior to and following the installation, and again 1 year and 2 years later.

When cancer strikes, patients desperately need help. But pressures to reduce costs of care are reducing provider time to help patients cope with these crises. Computers hold the potential to help providers improve patient support. This is a proposal to compare the cost and effectiveness of four combinations of Internet-based and stand-alone computer systems, CHESS (the Comprehensive Health Enhancement Support System). Both pilot tests and randomized clinical trials have found that CHESS: is widely accepted and used, improves quality of life and leads to more efficient use of health services. Three fundamental ways in which CHESS and Internet differ are: 1) Content: CHESS content is carefully filtered-and focused on meeting needs identified in studies of women with breast cancer. Internet content is vast but unfocused. 2) Social Support: internet chat groups involve large numbers of people, are facilitated and occur off-line through a bulletin board format. 3) Platform: CHESS uses an interface that is convenient and very easy to use. The Internet's platform can operate on virtually any computer but is subject to delays and is less easy to use. The question is: does any of this make a difference and if so, what changes are need to make these systems more effective for patients facing a health crisis? To examine these issues we propose to construct and evaluate four systems: combinations of CHESS and Internet platforms, content and support. Women with breast cancer, 200 Caucasian and 100 African-American will be randomly assigned to one of the four computer systems. Patients will have computers placed in their homes (unless they own an appropriate computer) and will have access to that system for five months. They will complete a pre-test survey and post tests at 2 and 4 months. Primary Outcome measures will compare the impact on: quality of life, and decision satisfaction. Secondary outcomes explore the impact of platform, content and support on: decision choices and criteria, system acceptance and use, knowledge of breast cancer, satisfaction of needs, operational costs, as well as demographic effects on use and outcome. Implications for systems design will result.

DESCRIPTION: (Applicant's Description) Research nas not yet uncovered a treatment that effectively reduces the risk of relapse; i.e., no efficacious relapse prevention treatments exist. This research is designed to produce information on the nature of smoking relapse and to develop and evaluate a treatment intended to reduce an abstinent smoker's risk of relapse. Subjects in this research (N=480; 160 subjects per group) will all be abstinent following a brief smoking cessation treatment. For Brief Therapy subjects this will constitute their only treatment. For Brief Therapy + Net subjects, the brief cessation treatment will be followed by access to Internet sites that provide smoking cessation resources. Brief Therapy + CHESS subjects will be given access to the Comprehensive Health Enhancement Support System (CHESS) following the brief treatment. CHESS is a computer-based guided universe of information, emotional support, and problem-solving assistance. Exposure to the Internet or CHESS will continue for 4 months following a subject's quit date. For this grant, a version of CHESS will be created that specifically targets smoking relapse. This Relapse Prevention CHESS will be based upon the following notions: (1) either episodic events, or worsening trends in affective/withdrawal symptoms, or both can trigger a smoking lapse. (2) efficacious treatments exist that address these threats to abstinence, but these treatments are efficacious only while on-going. Therefore, the key to efficacious relapse prevention is to sustain consistent treatment involvement over the period of significant relapse risk. And, (3) because trends in affective/withdrawal symptoms presage smoking lapses, through daily tracking of a subject's symptoms, CHESS can accurately anticipate lapses and intervene prior to a lapse. This research project will therefore, develop and evaluate a novel, research-based strategy of relapse prevention. This strategy is designed to use computer-integrated treatments in a cost-effective manner, and is designed to be widely disseminated in concert with a variety of cessation programs. Other goals of this research are to assess smokers' acceptance and use of the relapse interventions, and to identify mechanisms through which the interventions produce their effects.

DESCRIPTION (provided by applicant): Informal caregivers need information, skills and emotional support to address physical, spiritual, and emotional needs associated with chronic illnesses including late stage cancer. Unfortunately, current conditions force clinicians to reduce interaction time with patients and informal caregivers. Complimentary methods must be developed to provide needed information and support to caregivers. The proposed research will measure and explain the impact of two computer-based support systems that meet caregiver needs and facilitate information exchange with clinicians. The system, CHESS (Comprehensive Health Enhancement Support System), is a non- commercial computer system that provides patients with disease specific information, emotional support and skills building tools. In the expanded form to be tested here, CHESS with Caregiver Support (CGCHESS) will also provide the caregiver with more information, support and skills training related to palliative care. CGCHESS will be further enhanced to communicate essential patient and caregiver information to clinicians prior to a scheduled clinic visit and when patient symptoms exceed a threshold. Using as recruitment sites the University of Wisconsin Comprehensive Cancer Centers in Madison and Milwaukee, 300 caregivers (33% minorities) of advanced breast and prostate cancer patients will be randomly assigned to: 1) Control group given usual care, 2) Caregiver CHESS (CGCHESS) designed to support both patients and caregivers and 3) Caregiver CHESS with Clinician Report (CGCHESS+CR). Inclusion of breast and prostate cancer patients will provide caregivers of both genders. Our primary hypothesis is that CGCHESS will significantly improve caregiver burden, affect, coping self-efficacy and information competence because of the information, skills building and emotional support CHESS offers to caregivers. We also hypothesize that CGCHESS+CR will improve the outcomes more and that minority caregivers will benefit more than Caucasians. Our process analyses will study the mechanisms of CHESS effect.

Revised Abstract: The goal of the University of Wisconsin (UW) Center of Excellence in Cancer Communication is to advance interactive cancer communication systems (ICCSs) to improve the quality of life of patients and families facing cancer across the disease spectrum--with special emphasis on underserved populations. CHESS (Comprehensive Health Enhancement Support Systems), developed at UW is an ICCS that pioneered the use of interactive computer technology for cancer patients. In the five years of this proposal we will: 1) Extend the reach of interactive health communication systems to include new skills in managing distress, relating as couples, help for caregivers and patients facing the end of life and bereavement, and sophisticated tailoring of systems to individual needs. 2) Understand the mechanisms of effect of a successful interactive cancer communication system. 3) Measure the cost and outcomes of integrating interactive computer technology with CIS telephone information service, creating a cancer mentor. 4) Learn the impact on patient and caregiver quality of life when clinicians are informed electronically about patient's health status and patient and caregiver levels of distress 5) Determine how partner/caregivers are affected by interactive cancer communication systems 6) Develop cost-effective ICCS for the underserved. 7) Build an inter-disciplinary structure that supports creative discourse, understanding and modeling of pioneering cancer communication technologies 8)Improve our interdisciplinary career development path in cancer communication and create new paths for underserved populations 9) Expand our multi-institutional partnerships to speed translation of technologies and findings into practice.

DESCRIPTION (provided by applicant): Addiction treatment is often characterized by long delays between first contact and treatment as well as high no-show and drop out rates leading to unused capacity in apparently full agencies. Patients do not get needed care and agency financial stability is threatened. The Network for Improvement of Addiction Treatment (NIATx) is a high-intensity improvement collaborative of 39 addiction treatment agencies distributed across 25 states. Over the past three years, NIATx has substantially improved time to treatment, no-show rates, admission to, and continuation in treatment by making improvements to organizational processes (such as first contact, intake and assessment, engagement, level of care transitions, paperwork, social support, outreach, and scheduling). While the results are very encouraging, they have, by intent, been obtained from a select group of agencies using a high-cost combination of services. A more practical diffusion model is needed to spread process improvements across the spectrum of treatment agencies. This is a resubmission of an application to conduct a randomized trial to test the effectiveness and cost of less expensive combinations of the services that make up the NIATx collaborative (Web site, interest circles, coach calls, coach visits and learning sessions). This RCT will randomly assign 240 treatment agencies in 5 states to six experimental arms, including a control group. It will have two primary aims: 1) Determine whether a state-based strategy can (with NIATx support) lead mainstream treatment agencies to implement and sustain process changes that improve the study's Primary Outcomes: time to treatment, no-show rates, admissions to, and continuation in treatment;and 2) Evaluate the effectiveness and cost of five combinations of the services making up NIATx. Secondary outcomes include impact of the study arms on treatment completion, status of innovations attempted, impact of study arms on particular innovations, employee turnover, contribution to margin, organization-wide readiness to implement and sustain process innovations. This study should create a practical model for improving efficiency and effectiveness of addiction treatment.

[unreadable] DESCRIPTION (provided by applicant): This is a resubmission of Mobile CHESS Research on Emergency Medical Services for Children by the University of Wisconsin's Center for Health Enhancement Systems Studies in collaboration with the University of Wisconsin Pediatric Asthma Clinical Research Program and five managed care organizations (MCO's) in Milwaukee County. This randomized control trial's primary aims are to test whether an interactive PDA supporting low income teenagers (ages 12-18) with significant asthma and MCO nurse case managers can improve: asthma control and reduce asthma-related emergency, urgent care visits, and hospitalizations. Secondary aims include testing whether this system increases adherence to asthma control medication and reduces school absenteeism. We will also examine a mediational model to help explain mechanisms by which this system has its effects. Four hundred Medicaid recipients (ages 12-18) with an asthma related urgent care or emergency visit in the last 12-months will be recruited into this study. All will receive their care (and be identified through electronic claims data) from the five participating MCO's serving Medicaid recipients in Milwaukee County. We anticipate a 20% dropout rate during the 12 month intervention. Subjects will be randomly assigned to one of two study arms and will participate in a 12-month intervention plus a 12-month follow-up period. All subjects will receive PDAs. Control group PDAs will offer limited asthma information, and collect and transmit posttest data. The experimental group's PDA will also: 1-access the internet, 2-deliver extensive text, audio and video asthma-related educational material, 3-deliver automated reminders and 4-allow communication with support groups and case manager. [unreadable] [unreadable] [unreadable]

ADMINSTRATIVE CORE A. SPECIFIC AIMS The University of Wisconsin Center of Excellence in Cancer Communication Research II (our Center) will include an Administrative Core supporting the activities of scientific and administrative staff who will oversee our Center, and provide our researchers with the resources necessary for the successful conduct of the interdisciplinary research, training, development projects and dissemination proposed. The main activities of the Administrative Core will be to: [unreadable] Provide an organizational infrastructure and coordinate shared resources to ensure that the research, career training, development projects and dissemination activities described in this application are conducted efficiently and in a manner consistent with the program goals of our Center and the National Cancer Institute (NCI). [unreadable] Work with NCI to ensure compliance with all administrative and programmatic mandates of the grant and comply with federal, state and University of Wisconsin (UW) policies and procedures regarding ethical conduct of research with human subjects. [unreadable] Oversee all center activities to ensure that they are performed and reported in a manner that is timely and consistent with the overall theme of the Center. [unreadable] Support the activities and ensure communication of the recommendations of the Patient/Caregiver and National Advisory Boards. [unreadable] Work closely with the University of Wisconsin Institute for Clinical and Translational Research to translate the research findings coming out of our Center into evidence based policies and real-life practice. [unreadable] Collaborate and exchange information with investigators at other CECCR's and beyond. [unreadable] Support and implement directions of PI and the Management Team. [unreadable] Provide budget oversight, subcontracts, record keeping and monitor all Center activities. [unreadable] Assist with hiring, evaluation, and other personnel activities. [unreadable] Coordinate with and communicate research efforts to the UWCCC Cancer Control Program.

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Research Project 3: ICCS DIRECTED PHYSICAL ACTIVITY ENHANCEMENT FOR COLON CANCER SURVIVORS Project Summary: In the U.S., colon cancer survivors are the third largest group of cancer survivors (only breast and prostate cancer survivors surpass them). Strong evidence indicates that a sedentary lifestyle contributes not only to the incidence of colon cancer but also an increased risk of recurrence and mortality after diagnosis. To date, physical activity programs for cancer survivors have been delivered via face-to-face or telephone counseling, interventions which are costly and have limited reach. Interactive cancer communication systems (ICCS) can deliver more precisely tailored physical activity interventions to broader populations of survivors. This approach may be more effective than other delivery methods because of the dynamic interaction with the user and its' ability to continuously adapt the programs and services offered based on users' needs in real time. We propose to develop and test a new ICCS, Mobile Comprehensive Health Enhancement Support System (mCHESS) in a randomized controlled trial at three National Cancer Institute-designated cancer centers (University of Wisconsin, University of North Carolina at Chapel Hill, and MD Anderson Cancer Center) for men and women with stage l-lll colon cancer. mCHESS will provide information, tools, and a support system based on our previous work with FRESH START and CHESS, two highly successful interventions that have promoted lifestyle change among cancer survivors. mCHESS will be designed to help survivors develop 1) competence in information gathering, decision-making, and behaviors they are trying to change, 2) social support systems to help deal with the cancer experience, and 3) autonomy that comes with regaining a sense of control over their lives; this in turn, will help them adopt or maintain healthy lifestyle behaviors and improve their quality of life. We anticipate that several factors may moderate the effects of mCHESS including age, gender, education, and income as well as stage of cancer, cancer treatment, and co-morbidity. We hypothesize that autonomy, competence, and relatedness will mediate the effects that mCHESS has on physical activity (primary outcome) leading to weight change, decreased levels of distress, and increased overall quality of life (secondary outcomes), and that mCHESS use will mediate these constructs. If effective, these changes may decrease survivors' risk for recurrence and co-morbid illnesses leading to decreased morbidity and mortality from colon cancer. Data that emanate from this trial will be instrumental in guiding future interventions that bank on this emerging technology. Relevance: The survivorship project addresses both reach and efficacy components of the RE-AIM model. Extended reach is accomplished with the use of mobile technology and by addressing low literacy issues in its' design and delivery. We will test the efficacy of our program of information and support to help newly diagnosed colon cancer survivors increase their physical activity, decrease distress, and improve quality of life.

[unreadable] DESCRIPTION (provided by applicant): A central characteristic of alcoholism and other addictive behaviors is the chronically relapsing nature. Despite continuing care's potential for reducing relapse, its implementation is not wide spread due in part to cost, geographic distance, lack of time and peer support. This proposal builds upon the premise that these barriers can be reduced with computer based support systems. We are the national program office for the Network for Improvement of Addiction Treatment (NIATx) and developers of the Comprehensive Health Enhancement Support System (CHESS), a non-commercial eHealth system shown to improve quality of life and produce behavior change. We propose to adapt CHESS for alcohol-dependency relapse prevention and test it in a randomized clinical trial. Addiction CHESS (ACHESS) will be delivered through a new modality (smart-phone) to broaden access, focus on new patients (alcohol dependent patients leaving residential care), offer optional audio delivery to provide access to the functionally illiterate and be enhanced with services tailored to relapse prevention: 1) communication with peer support groups and addiction experts; 2) monitoring of relapse risks, 3) alerts and reminders to encourage adherence to therapeutic goals; 4) addiction-related educational material and tools tailored to individual patients and 5) one-touch communication with a care manager. Research hypotheses include: Primary Outcome. ACHESS + standard care (vs standard care control group) will reduce days of risky drinking over a 12-month period. Secondary Outcomes. ACHESS will reduce proximal outcomes of cravings, negative affect, withdrawal symptoms and temptation events, and produce distal outcomes of increased total abstinence, days of abstinence and reduced negative consequences of substance use. Mechanism of effect. We hypothesize a mediational model where ACHESS improves competence, relatedness and autonomy, which will improve outcomes. We will recruit a final sample of 280 alcohol dependent patients (30% minorities) from two NIATx addiction treatment agencies. Data sources will be interviews at pretest, 3, 6, 9 and 12 months, chart reviews, lab tests and automatic collection of computer use data. This is a resubmission of 1R01 AA01792-01. [unreadable] [unreadable] [unreadable]

The Center for Health Enhancement Systems Studies at the University of Wisconsin - Madison submits this proposal, entitled "Building a Sustainable National Infrastructure for Research and Dissemination of Improved Behavioral Health Treatment Practices," in order to enhance the NIATx network of more than 2500 behavioral health care providers, heretofore focused on quality improvement practice projects, and to engage them in community-based participatory research. The goal is to create a national community of treatment and recovery support providers who have the capacity to inform the national research agenda, to engage in research related to the improvement of care and the identification, adoption, and dissemination of evidence-based practices using a community based participatory research model. This project will develop the human capacity for research and community development within the treatment network and create an electronic data collection, communication and information infrastructure to support and sustain the community in its research efforts. The project will use an integrative group process to consult experts in community organizing and IT/social networking development to design an electronic mechanism for identifying and training natural connectors, providers who are linked to many providers and their community, to support the human capital of the infrastructure. The project will also use a series of surveys and focus groups to solicit the needs and interests of network members;the results will inform the development of research projects and the electronic infrastructure's tools and content. Additionally, an electronic data collection, communication and information infrastructure will be built to support and sustain the national community of providers in research on quality improvement, evidence-based practice implementation, and dissemination activities. The development of provider connections, the enhancement of provider research knowledge and skills, and the creation of an electronic information and communication infrastructure will form the foundation for a national community of providers capable of participating in research to improve treatment systems.

DESCRIPTION (provided by applicant): This proposal is a collaboration of the University of Wisconsin, Dartmouth College, Forward Health Group, Arapahoe SUD treatment, Access, Salud and Partnership community health centers, and The National Council for Community Behavioral Health and led by multiple PIs David H. Gustafson PhD and Lisa Marsch PhD. Primary care providers are being asked to integrate substance use disorder (SUD) treatment and HIV care into their practices. That means adding a new, complex caseload to an already overburdened system. We propose to test a strategy to implement a wireless smart phone based delivery system, composed of proven treatment and recovery computer programs that will add SUD services and HIV care but relieve the burden. Two information and communication systems have demonstrated ability to improve the effectiveness of SUD treatment and HIV care (TES) and continuing care (ACHESS). While their potential is great, success relies not only on technology, but on a creating a welcoming environment and effective processes to implement and sustain. We propose to overcome key barriers to integrating substance abuse treatment and HIV care into primary care by using a blending of three proven strategies (informed by quality improvement) to implement a seamless combination of evidence-based computer assisted system called Seva (the Sanskrit word for selfless caring). Seva includes: TES addiction treatment, ACHESS relapse prevention, video counseling as well as registry PopulationManager. Seva integrates HIV risk behaviors, status, and services into both the patient interface and provider registry components. Each component of Seva has proven to be effective, but each has its own interface and operates independently making it difficult to easily take advantage of their synergistic potential. We hypothesize that our implementation strategy will create welcoming environment, and enhance implementation success and sustainability by removing barriers and building on facilitators, thus allowing Seva to flourish. We will use quantitative and qualitative methods to determine how much our implementation of SEVA will improve: Reach, Effectiveness, Adoption, Implementation and Maintenance. We will implement Seva in 3 FQHCs. One FQHC (ACCESS community health center in Madison) will be used to test and refine the implementation strategy and adapt SEVA to meet FQHC needs and ensure ease of use. Two other FQHCs will receive SEVA at six-month intervals in a stepped wedge (multiple baseline) design. A coach will be assigned to each FQHC (as is common in quality improvement) to help implement, operate and sustain SEVA. We will measure impact on the FQHC over a three year period.

DESCRIPTION (provided by applicant): Continuing care is important in the management of patients with substance use disorders. New SMART Phone communication technology provides a novel way to provide personalized continuing care support following alcohol treatment. Dr. Gustafson and colleagues at the University of Wisconsin have recently developed an addiction version of the Comprehensive Health Enhancement Support System (CHESS), a smart phone system that provides a range of functions that directly support patients. In randomized trials CHESS significantly improved: (a) quality of life and self-efficacy for women with breast cancer, (b) quality of life and costs of care in people with HIV, (c) asthma control for young children, and (d) quality of dying and survival length for lung cancer patients. Most important, findings from a recently completed NIAAA-funded study of an addiction version of CHESS (ACHESS) indicated that it produces better drinking outcomes than standard continuing care when provided to patients leaving inpatient treatment. The system's features include: Access to family, friends, and others in recovery access to discussion groups, other recovery supports, and web links tailored information on coping with stressors. Global Positioning System (GPS) alerts when patients approach risky geographic areas~ alerts/reminders of appointments~ ongoing mini assessments and check-ins (monitoring)~ and a panic button (patient or GPS activated). McKay and colleagues have also developed a telephone- based approach to continuing care, Telephone Monitoring and Counseling (TMC), which has demonstrated efficacy in two randomized trials with alcohol dependent patients. Although the ACHESS and TMC interventions use telephone technology, they have complementary strengths. ACHESS provides automated 24/7 re- co very support services and frequent assessment of symptoms and status, but does not involve regular con- tact with a counselor. TMC, on the other hand, provides regular and sustained contact with the same counselor, but does not provide ongoing support between calls. The future of continuing care for alcohol use disorders is likely to involve both automated mobile technology and counselor contact, but little is known about how best to integrate these services. To address this question, the study will feature a 2 x 2 design [ACHESS for 12 months (yes/no) x TMC for 12 months (yes/no)], in which 280 alcohol dependent patients in an intensive outpatient program (IOP) will be randomized to one of the four conditions and followed for 18 months. We will determine whether adding TMC to ACHESS produces fewer heavy drinking days than TMC or ACHESS alone, and test for TMC and ACHESS main effects. We will also conduct economic analyses, to determine the cost and cost-effectiveness of each intervention and their combination. Additional analyses will examine secondary outcomes, including a biological measure of alcohol use, and hypothesized moderation and mediation effects. The results of the study will yield important information on improving patient alcohol use outcomes by integrating mobile automated recovery support and counselor contact.

? DESCRIPTION (provided by applicant): This R01 proposal seeks to pair medication-assisted treatment (MAT) with an evidence-based, smartphone- delivered relapse prevention system (A-CHESS) to improve long-term recovery from opioid use disorders. Although MAT has been shown to be effective for opioid dependence, the high rate of relapse suggests that MAT is not enough. Long-term recovery remains a challenge. Our hope is that A-CHESS will help patients transfer the skills they learn in treatment into their daily lives after treatment and as a result, have greater success in sustained recovery. A-CHESS also will include tools for improving outcomes related the hepatitis C virus and HIV-infections that disproportionately affect opioid-dependent people. The project also seeks to understand which elements of treatment work for whom and why so that interventions, especially mobile health interventions, can be made more effective. The proposal builds upon evidence that A-CHESS improves outcomes among those suffering from alcohol and opioid use disorders. In one randomized trial, patients leaving residential treatment for alcohol use disorders who had A-CHESS had 57% fewer risky drinking days than those without it, an effect that was even greater among patients who had been opioid- as well as alcohol- dependent. In a pilot test, A-CHESS was bundled with MAT to treat transient veterans with documented alcohol use disorders and, anecdotally, high rates of other drug use. This test found that readmissions to residential detox decreased 71% for those with A-CHESS compared to those without it. This study proposes a randomized clinical trial of 24 months, with patients from 3 treatment agencies assigned either to MAT + A- CHESS or MAT alone. The primary aim of the project is to determine the difference between the two groups in opioid use days. Secondarily, we want to detect differences in quality of life; retention in treatment; unscheduled use of health services; and, for HCV and HIV, screening rates, risk behaviors, testing, and among those infected, treatment initiation. We will also test the 4 factors that we hypothesize mediate the relationship between the interventions and outcomes: the 3 constructs of self-determination theory-competence, relatedness, and intrinsic motivation-plus negative affect. We also seek to understand factors that affect the strength of the relationship between intervention and outcome, which we hypothesize are gender and-among those who have A-CHESS-communication style in discussion groups. Through qualitative research, we will explore (1) the differences between people who respond better to MAT + A-CHESS vs. those who do not, (2) the struggles in implementing and sustaining the interventions, and (3) the relationship between outcomes and using A-CHESS. The proposed project offers an innovative approach to a nearly intractable and increasingly common problem. The project is significant both for its potential to improve long-term treatment outcomes and to create and share new knowledge and understanding about factors that can be used to tailor future treatments for greater effectiveness and reach.

PROJECT SUMMARY/ABSTRACT This R01 proposal seeks to test a computer technology (C-CHESS) that offers a common approach to multiple chronic conditions (MCCs). Among Medicare beneficiaries, 65% have 3 or more MCCs and 23% have 5 or more. People with MCCs account for 90% of Medicare spending. MCCs are usually addressed in primary care. Increasing workloads in primary care often prevent clinicians from addressing self-management skills with patients, though such skills as goal-setting and tracking are important for managing chronic conditions. Behavioral interventions such as cognitive behavioral therapy, self-monitoring, and social support can improve both self-management skills and health outcomes, and technology can effectively deliver such interventions. C-CHESS (Chronic Condition Health Enhancement Support System) provides tools, motivation, and social support to help patients with MCCs better manage their conditions, including interactions that arise among the combination of conditions. C-CHESS is built on elements of success behavioral interventions: long duration, ongoing outreach, monitoring, prompts, action planning, problem solving, self-tailoring, and peer support. C-CHESS addresses clinician burden by promptly communicating important changes in patient status and?by improving patient-self-management?reducing primary care visits. C-CHESS will be tested in a randomized clinical trial in 5 primary care clinics in southern Wisconsin. The trial will involve 330 patients age 65 and older with 3 or all 4 of these conditions: hypertension, hyperlipidemia, diabetes, and osteoarthritis. Patients will be assigned to treatment as usual + C-CHESS or treatment as usual + access to the Internet. The trial will last 12 months with a 6-month follow up. The goal of the trial is to detect differences between the 2 groups in quality of life and use of primary care. Secondarily, the trial aims to detect differences between the 2 groups in (1) measures for each condition (blood pressure, LDL, blood sugar, and pain); (2) a composite score that combines the individual measures; and (3) number of symptoms patients have from a list of 8. The trial will also examine factors that may mediate the relationship between the interventions and outcomes: adherence to medications and appointment attendance, as well as the 3 components of self-determination theory (patient competence, relatedness to others, and motivation). Finally, the trial will examine factors that may affect the strength of the relationship between C-CHESS and outcomes: gender, age, and number of chronic conditions. If successful, C-CHESS will improve the health and reduce the burden on primary care of a large, growing, expensive group of patients whose conditions are not now well addressed. Successful implementation may point to a shift from care that is place-based, focused on medical management, and periodic to care focused on helping patients manage their own conditions through a system built on the proven principles of effective behavioral interventions made easy for both patients and clinicians to use.

Project Summary/Abstract A team of researchers from the Center for Health Enhancement Systems Studies (the Center) at University of Wisconsin?Madison College of Engineering and the Iowa Department of Public Health will test the effectiveness of the Network for the Improvement of Addiction Treatment-Technology Implementation (NIATx- TI) framework in implementing the ACHESS substance use disorder (SUD) treatment and recovery app. ACHESS uses smartphone technology to provide continual access to SUD care and has improved treatment outcomes in a randomized trial as well as in real-world SUD treatment settings with patients with opioid and alcohol use disorders. Despite its evidence base and 74% of SUD treatment patients possessing a smartphone, ACHESS is currently used in <1% of settings that provide SUD treatment. ACHESS is not unique in this regard; health care, in general, has low patient-centered technology adoption rates. This low adoption highlights yet another implementation gap and the need for the dissemination and implementation field to develop approaches to facilitate adoption of the growing list of evidence-based e-health technologies. The two strategies to be tested in increasing ACHESS use are the NIATx-TI framework and product training, followed by ongoing technical support. The NIATx-TI framework developed by our Center builds on our experience in applying the NIATx organizational change model in more than 3,300 organizations. NIATx-TI combines the systems engineering principles embedded in the NIATx organizational model with validated technology adoption techniques. NIATx-TI was piloted successfully in our Center's 7-state project, ?Promoting the Use of Technology to Improve Treatment and Recovery Learning Collaborative,? and led to a 2-fold increase in clients receiving distance treatment during the pilot study. The RE-AIM framework will be used to measure the impact of the 2 interventions in n=16 SUD organizations in Iowa (with n=8 organizations per each arm). A qualitative and cost analysis will be used to develop a better understanding of the implementation process. Iowa was selected as a research setting because of its diverse population of service providers, high participation rates in other national projects, strong data reporting systems, and because the Iowa Consortium for Substance Abuse Research & Evaluation will provide strong local support for the study. SUD treatment providers in Iowa and across the country need the effective treatment supports that evidence-based mobile technologies can provide when successfully implemented. ACHESS and other promising evidence-based patient-centered technologies are positioned to alter SUD treatment and its outcomes. Through testing the NIATx-TI framework and typical product training, this trial will yield a deeper understanding of how to successfully implement ACHESS and other promising evidence-based technologies.

PROJECT SUMMARY Alcohol use disorder (AUD) is the most common substance use disorder. Yet only a small fraction of people who need treatment receive it, and most of them get only short-term support even though continuing care has been shown to be much more effective. More consistent and available continuing care could greatly improve patient recovery. Partner support can also be critical to recovery, but many partners do not know how to support their partners' recovery or manage their own responses to it. Clinicians also lack evidence of the efforts patients are making toward recovery. Treating couples in which one member is recovering from AUD has been shown to be efficacious; in particular, Alcohol Behavioral Couples Therapy (ABCT) has shown positive outcomes. Still, ABCT has not been widely adopted, in part because of practical problems. A-CHESS is a smartphone-based system proven to substantially reduce relapse, but A-CHESS serves only the patient. Relapse prevention and recovery support for both patient and partner could be built into smartphones, which could make these services available almost anywhere and anytime. A majority of adults own a smartphone, regardless of race, education, and financial status. This project would develop and pilot test a new smartphone-based system for AUD patients, their partners, and clinicians called PartnerCHESS. PartnerCHESS would integrate key features of ABCT and A-CHESS. This R34 planning grant would pilot test PartnerCHESS and prepare for a large randomized trial to test the new system. PartnerCHESS will also include a Clinician Report that will automatically alert clinicians of patients at risk of relapse, along with other information on how recovery is proceeding. The project has three specific aims: 1. Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians. 2. Conduct a pilot test (a small randomized clinical trial) of PartnerCHESS to estimate effect size and refine the protocol, procedures, recruitment strategy, measurements, and operations we would use in a large RCT. 3a. Decide whether to pursue an R01 application. 3b. Possibly plan for the R01. The project would develop PartnerCHESS with 6 recruited couples who test the system and give feedback. Once ready, the system would be tested by 34 other couples randomized to receive either PartnerCHESS + treatment as usual (TAU) or A-CHESS + TAU for a 6-month trial. Data will be collected at baseline and 2, 4, and 6 months and analyzed to see if a large clinical trial holds promise and, if so, lead to an application for support of a full-scale trial based on the elements developed and results obtained in this pilot test. The study is important to public health because of the scope of the alcohol abuse and the potential of technology to improve the lives of both patients and partners. If successful, such technology could greatly broaden the reach and impact of AUD treatment in general and couples therapy in particular.

PROJECT SUMMARY Individuals with substance use disorders are disproportionately experiencing homelessness, poverty, and chronic medical conditions (diabetes and hypertension), which are emerging risk factors for contracting SARS-CoV-2 (official name for the virus that causes COVID-19). Different types of substance use have been associated with development of respiratory infections and progression to severe respiratory failure, also known as Acute Respiratory Distress Syndrome (ARDS). However, complex syndromes like ARDS and behavioral conditions like substance misuse are difficult to identify from the electronic health record. Clinical notes and radiology reports provide a rich source of information that may be used to identify cases of substance misuse and ARDS. This information is routinely recorded during hospital care, and automated, data-driven solutions with natural language processing (NLP) can extract semantics and important risk factors from the unstructured data of clinical notes. The computational methods of NLP derive meaning from clinical notes, from which machine learning can predict risk factors for patients leaving AMA or progressing to respiratory failure. Our team developed tools with >80% sensitivity/specificity to identify individual types of substance misuse using NLP with machine learning (ML). Our single-center models delineated risk factors embedded in the notes (e.g., mental health conditions, socioeconomic indicators). Further, we have developed and externally validated a machine learning tool to identify cases of ARDS with high accuracy for early treatment. We aim to expand this work by pooling data across health systems and build a generalizable and comprehensive classifier that captures multiple types of substance misuse for use in risk stratification and prognostication during the COVID pandemic. We hypothesize that a single-model NLP substance misuse classifier will provide a standardized, interoperable, and accurate approach for universal analysis of hospitalized patients, and that such information can be used to identify those at risk for disrupted care and those at risk for respiratory failure. We aim to train and test our substance misuse classifiers at Rush in a retrospective dataset of over 60,000 hospitalizations that have been manually screened with the universal screen, AUDIT, and DAST. This Administrative Supplement will allow us to examine the correlations between substances of misuse and risk for COVID-19 as well as development of Acute Respiratory Distress Syndrome (ARDS) in the context of these phenomena.

Project Summary/Abstract Coronavirus (COVID-19) has disrupted the substance use disorder (SUD) treatment system, demanding an abrupt shift from in-person care to telehealth services. The transition to virtual care could permanently change SUD treatment delivery. This shift is coinciding with COVID-19-induced social isolation and anxiety, which could increase substance use and mental health disorder severity. A common refrain in the treatment and recovery field is that addiction is a disease of isolation; the cure is connection. To provide virtual treatment and the connection so essential to recovery, many SUD treatment centers are launching virtual services without a method for assessing how, where, and why virtual services are affecting their patients' quality of life and SUD recovery. The ACHESS smartphone app is currently being used at 40 Iowa treatment sites in the parent study, ?Test of a patient-centered e-health intervention in addiction treatment settings.? ACHESS offers a guide and a method for assessing use of virtual services and an unprecedented research opportunity. From 3/3/20 to 3/20/20, sign-ups for ACHESS in the parent study increased by 67% compared to the two prior weeks. Activity on the ACHESS app has nearly doubled in the same period! This supplement will address patient and organizational factors because of their integral roles in providing virtual care and adopting patient-centered technologies. The supplement will enhance ACHESS with new COVID-19 related features designed to help patients comply with social distancing guidelines, cope with unprecedented social isolation, and access virtual services and supports. The research will study how patients use ACHESS features, how organizations refer patients to the ACHESS, how they interact with patients in ACHESS, and the overall impact of the ACHESS features. The supplement's research aims are: Aim 1a: Refine ACHESS to provide information, support, and data on COVID-19, social distancing, adjusting to social isolation, and how to use virtual SUD services. Then, study how patients use existing ACHESS features before (for existing ACHESS services only), during, and after the announcement of social distancing guidelines. Aim 1b: Assess how the enhanced ACHESS APP affects anxiety, loneliness, and reported COVID-19 infections. Aim 2: Create ten case studies describing how agencies implemented and used COVID-19 enhanced ACHESS and how their patients used COVID-19 enhanced ACHESS. This supplement's projected outcomes will help us understand how to design virtual recovery systems to mitigate the effects of a pandemic and the resulting social isolation. The results will help design a virtual recovery system that can be used in future emergencies and to address the on-going challenges of social isolation in society post-COVID-19.

PROJECT SUMMARY AHRQ previously funded the development of Elder Tree (ET), a laptop-based eHealth system shown in a randomized trial to improve quality of life and health factors among older adults with multiple chronic conditions (MCCs) such as diabetes and hypertension. MCCs are pervasive and costly among older adults, reducing quality of life and accounting for 90% of Medicare spending. Self-management can help patients control their conditions, but these skills are rarely taught in primary care. ET provides tools and support for such self- management and addresses the frustration, discouragement, and loneliness shared by all patients with MCCs, regardless of specific disease. Despite positive results, though, many study participants did not use ET extensively, a problem for all health apps. In a separate survey, we learned that more than 60% of non-users abandoned ET because the computer was too hard to use. Voice-controlled smart technology may solve this problem. Smart speakers, used by speaking and listening rather than typing and reading, avoid barriers to use such as poor vision, tremors, and interface complexity; they have been adopted at a rate faster than the Internet or TV, especially among older adults. Smart displays enhance the system with a visual element, helping users remember content and creating access to media meant to be viewed. This application proposes to test the ability of voice-activated technology to expand the implementation and sustain the use of a proven electronic health system. Specifically, we propose to test whether older adults with MCCs will use and benefit more from ET delivered by a smart system (speaker plus display), due to ease of use, than from a laptop version of ET. The proposal has 2 aims: 1) develop the smart system platform (ET-SS) and 2) test it against laptop ET (ET-LT) in a 2-arm RCT. The trial will randomize 220 patients age 65+ with 4 or more chronic conditions to receive for 8 months either ET-LT or ET-SS. We hypothesize that: · patients with ET-SS (vs. ET-LT) will have greater ET use and better quality of life in month 8. · these clinical outcomes will improve: a) 30-day hospital readmissions), b) medication adherence, and c) composite score of HbA1c, mg/dL, mmHg, FEV-1, BMI, PHQ-8, FAS-GFR, and Brief Pain Inventory. · the amount of ET use at 4 months will mediate the effects of ET at 8 months (i.e. greater use at 4 months=greater effects at 8 months), and negative affect and Self-Determination Theory constructs of competence, social relatedness, and intrinsic motivation will mediate the effects of ET use. · ET-SS will have better outcomes for women and for patients with 6+ (vs. 4-5) chronic conditions. We, the investigators who developed ET, have conducted numerous RCTs of eHealth systems and published extensively. To our knowledge, this will be the first large RCT of a smart system as a platform to implement and disseminate a health intervention. The result could make ET more accessible and effective for older patients, improve their quality of life, and point the way to more impactful delivery of future eHealth innovations.

PROJECT SUMMARY / ABSTRACT In addition to their debilitating impact on health and well-being, multiple chronic conditions (MCCs) account for 90% of Medicare spending. Among beneficiaries, 65% have 3 or more conditions such as diabetes and hypertension, and 23% have 5 or more. MCCs are often addressed in primary care, where time pressures prevent focusing on self-management?although such skills are crucial for living successfully with MCCs. Our long-term goal is to improve health and self-management for these patients, while reducing healthcare costs. An AHRQ-funded P50 supported our development of Elder Tree (ET). That eHealth system was shown in a randomized trial to improve quality of life and health factors among older adults with MCCs who were high users of primary care. ET provides tools, motivation, and support to help patients manage their health. Despite positive results, many did not use ET extensively, a very common problem with health apps. Our central question is whether adapting and delivering ET with voice-controlled technology can increase ET use, thereby improving quality of life and health outcomes even more than ET on a laptop. Smart speakers, used by talking and listening rather than typing and reading, offer the tantalizing but unproven promise of being easy to use, which may in part explain why the technology is being adopted faster than the internet or TV. Smart displays raise expectations even higher by adding a visual element that enables the system to show as well as tell. We propose an R61/R33 project including a randomized clinical trial involving 282 (after attrition) patients age 65+ with 5 or more chronic conditions, 3 of which must be hypertension, hyperlipidemia, obesity, diabetes, or pre-diabetes. In the proposed 12-month trial plus 6-month follow-up, patients will be randomly assigned to receive ET via a laptop (ET-Text) or a smart display (ET-Voice). The project has the following specific aims: Aim 1: During the R61 phase, continue and complete development of the platform and operational procedures for delivering ET to the smart display group. Aim 2: During the R33 phase, conduct a balanced randomized clinical trial to test these hypotheses: Primary outcome: ET-Voice (vs. ET-Text) patients will have better functional health (a measure including physical function, pain, fatigue, sleep disturbance, anxiety, and depression) over time. Secondary outcomes: ET-Voice (vs. ET-Text) patients will have better outcomes for loneliness, number of symptoms, and healthcare use over time. In addition, amount of ET use, ease of use, and usefulness will be higher for the ET-Voice (vs. ET-Text) group. Mediators: Effects of study arm on outcomes will be mediated by ET use at 6 months and by Self-Determination Theory constructs of competence, social relatedness, and intrinsic motivation. Moderators: ET-Voice (vs. ET-Text) will show greater improvements in the primary outcome for: those age 65-74 vs. 75+ years old, women vs. men, those with 8+ vs. 5-7 chronic conditions, and those with more physical barriers to technology use (e.g. tremors). We will explore whether these moderation effects are also observed for the secondary outcomes.