Encouraging the scale-up of proven interventions: Infrastructure development for the "Evidence-to-Implementation" award.

BACKGROUND/OBJECTIVE: Although most research universities offer investigators help in obtaining patents for inventions, investigators generally have few resources for scaling up non-patentable innovations, such as health behavior change interventions. In 2017, the dissemination and implementation (D & I) team at the University of Wisconsin's Clinical and Translational Science Award (CTSA) created the Evidence-to-Implementation (E2I) award to encourage the scale-up of proven, non-patentable health interventions. The award was intended to give investigators financial support and business expertise to prepare evidence-based interventions for scale-up. METHODS: The D & I team adapted a set of criteria named Critical Factors Assessment, which has proven effective in predicting the success of entrepreneurial ventures outside the health care environment, to use as review criteria for the program. In March 2018 and February 2020, multidisciplinary panels assessed proposals using a review process loosely based on the one used by the NIH for grant proposals, replacing the traditional NIH scoring criteria with the eight predictive factors included in Critical Factors Assessment. RESULTS: two applications in 2018 and three applications in 2020 earned awards. Funding has ended for the first two awardees, and both innovations have advanced successfully. CONCLUSION: Late-stage translation, though often overlooked by the academic community, is essential to maximizing the overall impact of the science generated by CTSAs. The Evidence-to-implementation award provides a working model for supporting late-stage translation within a CTSA environment.

The Balanced Opioid Initiative: protocol for a clustered, sequential, multiple-assignment randomized trial to construct an adaptive implementation strategy to improve guideline-concordant opioid prescribing in primary care.

BACKGROUND: Rates of opioid prescribing tripled in the USA between 1999 and 2015 and were associated with significant increases in opioid misuse and overdose death. Roughly half of all opioids are prescribed in primary care. Although clinical guidelines describe recommended opioid prescribing practices, implementing these guidelines in a way that balances safety and effectiveness vs. risk remains a challenge. The literature offers little help about which implementation strategies work best in different clinical settings or how strategies could be tailored to optimize their effectiveness in different contexts. Systems consultation consists of (1) educational/engagement meetings with audit and feedback reports, (2) practice facilitation, and (3) prescriber peer consulting. The study is designed to discover the most cost-effective sequence and combination of strategies for improving opioid prescribing practices in diverse primary care clinics. METHODS/DESIGN: The study is a hybrid type 3 clustered, sequential, multiple-assignment randomized trial (SMART) that randomizes clinics from two health systems at two points, months 3 and 9, of a 21-month intervention. Clinics are provided one of four sequences of implementation strategies: a condition consisting of educational/engagement meetings and audit and feedback alone (EM/AF), EM/AF plus practice facilitation (PF), EM/AF + prescriber peer consulting (PPC), and EM/AF + PF + PPC. The study's primary outcome is morphine-milligram equivalent (MME) dose by prescribing clinicians within clinics. The study's primary aim is the comparison of EM/AF + PF + PPC versus EM/AF alone on change in MME from month 3 to month 21. The secondary aim is to derive cost estimates for each of the four sequences and compare them. The exploratory aim is to examine four tailoring variables that can be used to construct an adaptive implementation strategy to meet the needs of different primary care clinics. DISCUSSION: Systems consultation is a practical blend of implementation strategies used in this case to improve opioid prescribing practices in primary care. The blend offers a range of strategies in sequences from minimally to substantially intensive. The results of this study promise to help us understand how to cost effectively improve the implementation of evidence-based practices. TRIAL REGISTRATION: NCT04044521 (ClinicalTrials.gov). Registered 05 August 2019.

A randomized matched-pairs study of feasibility, acceptability, and effectiveness of systems consultation: a novel implementation strategy for adopting clinical guidelines for Opioid prescribing in primary care.

BACKGROUND: This paper reports on the feasibility, acceptability, and effectiveness of an innovative implementation strategy named "systems consultation" aimed at improving adherence to clinical guidelines for opioid prescribing in primary care. While clinical guidelines for opioid prescribing have been developed, they have not been widely implemented, even as opioid abuse reaches epidemic levels. METHODS: We tested a blended implementation strategy consisting of several discrete implementation strategies, including audit and feedback, academic detailing, and external facilitation. The study compares four intervention clinics to four control clinics in a randomized matched-pairs design. Each systems consultant aided clinics on implementing the guidelines during a 6-month intervention consisting of monthly site visits and teleconferences/videoconferences. The mixed-methods evaluation employs the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Quantitative outcomes are compared using time series analysis. Qualitative methods included focus groups, structured interviews, and ethnographic field techniques. RESULTS: Seven clinics were randomly approached to recruit four intervention clinics. Each clinic designated a project team consisting of six to eight staff members, each with at least one prescriber. Attendance at intervention meetings was 83%. More than 80% of staff respondents agreed or strongly agreed with the statements: "I am more familiar with guidelines for safe opioid prescribing" and "My clinic's workflow for opioid prescribing is easier." At 6 months, statistically significant improvements were noted in intervention clinics in the percentage of patients with mental health screens, treatment agreements, urine drug tests, and opioid-benzodiazepine co-prescribing. At 12 months, morphine-equivalent daily dose was significantly reduced in intervention clinics compared to controls. The cost to deliver the strategy was $7345 per clinic. Adaptations were required to make the strategy more acceptable for primary care. Qualitatively, intervention clinics reported that chronic pain was now treated using approaches similar to those employed for other chronic conditions, such as hypertension and diabetes. CONCLUSIONS: The systems consultation implementation strategy demonstrated feasibility, acceptability, and effectiveness in a study involving eight primary care clinics. This multi-disciplinary strategy holds potential to mitigate the prevalence of opioid addiction and ultimately may help to improve implementation of clinical guidelines across healthcare. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02433496). https://clinicaltrials.gov/ct2/show/NCT02433496 Registered May 5, 2015.

Reducing Symptom Distress in Patients With Advanced Cancer Using an e-Alert System for Caregivers: Pooled Analysis of Two Randomized Clinical Trials.

BACKGROUND: Symptom distress in patients toward the end of life can change rapidly. Family caregivers have the potential to help patients manage those symptoms, as well as their own stress, if they are equipped with the proper resources. Electronic health (eHealth) systems may be able to provide those resources. Very sick patients may not be able to use such systems themselves to report their symptoms but family caregivers could. OBJECTIVE: The aim of this paper was to assess the effects on cancer patient symptom distress of an eHealth system that alerts clinicians to significant changes in the patient's symptoms, as reported by a family caregiver. METHODS: A pooled analysis from two randomized clinical trials (NCT00214162 and NCT00365963) compared outcomes at 12 months for two unblinded groups: a control group (Comprehensive Health Enhancement Support System [CHESS]-Only) that gave caregivers access to CHESS, an online support system, and an experimental group (CHESS+CR [Clinician Report]), which also had CHESS but with a CR that automatically alerted clinicians if symptoms exceeded a predetermined threshold of severity. Participants were dyads (n=235) of patients with advanced lung, breast, or prostate cancer and their respective family caregivers from 5 oncology clinics in the United States of America. The proportion of improved patient threshold symptoms was compared between groups using area-under-the-curve analysis and binomial proportion tests. The proportion of threshold symptoms out of all reported symptoms was also examined. RESULTS: When severe caregiver-reported symptoms were shared with clinicians, the symptoms were more likely to be subsequently reported as improved than when the symptoms were not shared with clinicians (P<.001). Fewer symptom reports were completed in the group of caregivers whose reports went to clinicians than in the CHESS-Only group (P<.001), perhaps because caregivers, knowing their reports might be sent to a doctor, feared they might be bothering the clinician. CONCLUSIONS: This study suggests that an eHealth system designed for caregivers that alerts clinicians to worrisome changes in patient health status may lead to reduced patient distress. TRIAL REGISTRATION: Clinicaltrials.gov NCT00214162; https://clinicaltrials.gov/ct2/show/NCT00214162 (Archived by WebCite at http://www.webcitation.org/6nmgdGfuD) and Clinicaltrials.gov NCT00365963; https://clinicaltrials.gov/ct2/show/NCT00365963 (Archived by WebCite at http://www.webcitation.org/6nmh0U8VP).

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.

The effect of an information and communication technology (ICT) on older adults' quality of life: study protocol for a randomized control trial.

BACKGROUND: This study investigates the use of an information and communication technology (Elder Tree) designed for older adults and their informal caregivers to improve older adult quality of life and address challenges older adults face in maintaining their independence (for example, loneliness and isolation, falling, managing medications, driving and transportation). METHODS/DESIGN: This study, an unblinded randomized controlled trial, will evaluate the effectiveness and cost of Elder Tree. Older adults who are at risk for losing their independence - along with their informal caregivers, if they name them - are randomized to two groups. The intervention group has access to their usual sources of information and communication as well as to Elder Tree for 18 months while the control group uses only their usual sources of information and communication. The primary outcome of the study is older adult quality of life. Secondary outcomes are cost per Quality-Adjusted Life Year and the impact of the technology on independence, loneliness, falls, medication management, driving and transportation, and caregiver appraisal and mastery. We will also examine the mediating effect of self-determination theory. We will evaluate the effectiveness of Elder Tree by comparing intervention- and control-group participants at baseline and months 6, 12, and 18. We will use mixed-effect models to evaluate the primary and secondary outcomes, where pretest score functions as a covariate, treatment condition is a between-subjects factor, and the multivariate outcome reflects scores for a given assessment at the three time points. Separate analyses will be conducted for each outcome. Cost per Quality-Adjusted Life Year will be compared between the intervention and control groups. Additional analyses will examine the mediating effect of self-determination theory on each outcome. DISCUSSION: Elder Tree is a multifaceted intervention, making it a challenge to assess which services or combinations of services account for outcomes in which subsets of older adults. If Elder Tree can improve quality of life and reduce healthcare costs among older adults, it could suggest a promising way to ease the burden that advancing age can place on older adults, their families, and the healthcare system. TRIAL REGISTRATION: ClinicalTrials.gov NCT02128789 . Registered on 26 March 2014.

What Influences Participation in QI? A Randomized Trial of Addiction Treatment Organizations.

Healthcare providers have increased the use of quality improvement (QI) techniques, but organizational variables that affect QI uptake and implementation warrant further exploration. This study investigates organizational characteristics associated with clinics that enroll and participate over time in QI. The Network for the Improvement of Addiction Treatment (NIATx) conducted a large cluster-randomized trial of outpatient addiction treatment clinics, called NIATx 200, which randomized clinics to one of four QI implementation strategies: (1) interest circle calls, (2) coaching, (3) learning sessions, and (4) the combination of all three components. Data on organizational culture and structure were collected before, after randomization, and during the 18-month intervention. Using univariate descriptive analyses and regression techniques, the study identified two significant differences between clinics that enrolled in the QI study (n = 201) versus those that did not (n = 447). Larger programs were more likely to enroll and clinics serving more African Americans were less likely to enroll. Once enrolled, higher rates of QI participation were associated with clinics' not having a hospital affiliation, being privately owned, and having staff who perceived management support for QI. The study discusses lessons for the field and future research needs.

A smartphone application to support recovery from alcoholism: a randomized clinical trial.

IMPORTANCE: Patients leaving residential treatment for alcohol use disorders are not typically offered evidence-based continuing care, although research suggests that continuing care is associated with better outcomes. A smartphone-based application could provide effective continuing care. OBJECTIVE: To determine whether patients leaving residential treatment for alcohol use disorders with a smartphone application to support recovery have fewer risky drinking days than control patients. DESIGN, SETTING, AND PARTICIPANTS: An unmasked randomized clinical trial involving 3 residential programs operated by 1 nonprofit treatment organization in the Midwestern United States and 2 residential programs operated by 1 nonprofit organization in the Northeastern United States. In total, 349 patients who met the criteria for DSM-IV alcohol dependence when they entered residential treatment were randomized to treatment as usual (n = 179) or treatment as usual plus a smartphone (n = 170) with the Addiction-Comprehensive Health Enhancement Support System (A-CHESS), an application designed to improve continuing care for alcohol use disorders. INTERVENTIONS: Treatment as usual varied across programs; none offered patients coordinated continuing care after discharge. A-CHESS provides monitoring, information, communication, and support services to patients, including ways for patients and counselors to stay in contact. The intervention and follow-up period lasted 8 and 4 months, respectively. MAIN OUTCOMES AND MEASURES: Risky drinking days--the number of days during which a patient's drinking in a 2-hour period exceeded 4 standard drinks for men and 3 standard drinks for women, with standard drink defined as one that contains roughly 14 g of pure alcohol (12 oz of regular beer, 5 oz of wine, or 1.5 oz of distilled spirits). Patients were asked to report their risky drinking days in the previous 30 days on surveys taken 4, 8, and 12 months after discharge from residential treatment. RESULTS: For the 8 months of the intervention and 4 months of follow-up, patients in the A-CHESS group reported significantly fewer risky drinking days than did patients in the control group, with a mean of 1.39 vs 2.75 days (mean difference, 1.37; 95% CI, 0.46-2.27; P = .003). CONCLUSIONS AND RELEVANCE: The findings suggest that a multifeatured smartphone application may have significant benefit to patients in continuing care for alcohol use disorders. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01003119.

The effect of a computer-based intervention on adult children of alcoholics.

OBJECTIVES: People who grow up with a family member who has a substance use disorder (SUD) are at risk for serious problems, and yet support for family members focuses mainly on the individual with the SUD. Technology may offer a way to make support widely available to family members of those with SUDs. This small randomized trial examined an online system of resources called CHESS (Comprehensive Health Enhancement Support System) for adult children of alcoholics (ACOAs), a population at greater risk for SUDs, depression, and other difficulties than adults whose parents were not alcoholics. METHODS: The study randomized 23 self-identified ACOAs to 3 interventions for 8 weeks. The goal was to increase participants' treatment compliance and psychological health. The interventions were therapy only, CHESS only, and CHESS plus therapy. We used 2 measures: compliance with treatment, gauged by attendance in group therapy for the 2 groups assigned to therapy, and aspects of psychological health or distress, measured by a survey with items from 7 scales. RESULTS: The CHESS-plus-therapy group had an attendance rate in group therapy of 81.5% compared to 42.8% for the therapy-only group. The CHESS-only intervention had the largest effect size on 5 of the 7 measures of psychological health or distress. In 4 of the 5 cases, the effect size was large; in 1 case, it was moderate. CONCLUSIONS: The findings of this pilot study are based on a small sample, but they suggest the need for more research and the potentially important role of technology in behavioral health treatment.