Testing support models for implementing an evidence-based digital intervention for alcohol use disorder: results of a pragmatic hybrid implementation-effectiveness trial.

This paper reports results of a hybrid effectiveness-implementation randomized trial that systematically varied levels of human oversight required to support implementation of a digital medicine intervention for persons with mild to moderate alcohol use disorder (AUD). Participants were randomly assigned to three groups representing possible digital health support models within a health system: self-monitored use (n = 185), peer-supported use (n = 186), or a clinically integrated model (n = 187). Across all three groups, percentage of risky drinking days dropped from 38.4% at baseline (95%CI [35.8%, 41%]) to 22.5% (19.5%, 25.5%) at 12 months. The clinically integrated group showed significant improvements in mental health quality of life compared to the self-monitoring group (p = 0.011). However, higher rates of attrition in the clinically integrated group warrants consideration in interpreting this result. Results suggest that making a self-guided digital intervention available to patients may be a viable option for health systems looking to promote alcohol risk reduction.

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.

Which elements of improvement collaboratives are most effective? A cluster-randomized trial.

AIMS: Improvement collaboratives consisting of various components are used throughout health care to improve quality, but no study has identified which components work best. This study tested the effectiveness of different components in addiction treatment services, hypothesizing that a combination of all components would be most effective. DESIGN: An unblinded cluster-randomized trial assigned clinics to one of four groups: interest circle calls (group teleconferences), clinic-level coaching, learning sessions (large face-to-face meetings) and a combination of all three. Interest circle calls functioned as a minimal intervention comparison group. SETTING: Out-patient addiction treatment clinics in the United States. PARTICIPANTS: Two hundred and one clinics in five states. MEASUREMENTS: Clinic data managers submitted data on three primary outcomes: waiting-time (mean days between first contact and first treatment), retention (percentage of patients retained from first to fourth treatment session) and annual number of new patients. State and group costs were collected for a cost-effectiveness analysis. FINDINGS: Waiting-time declined significantly for three groups: coaching (an average of 4.6 days/clinic, P = 0.001), learning sessions (3.5 days/clinic, P = 0.012) and the combination (4.7 days/clinic, P = 0.001). The coaching and combination groups increased significantly the number of new patients (19.5%, P = 0.028; 8.9%, P = 0.029; respectively). Interest circle calls showed no significant effect on outcomes. None of the groups improved retention significantly. The estimated cost per clinic was $2878 for coaching versus $7930 for the combination. Coaching and the combination of collaborative components were about equally effective in achieving study aims, but coaching was substantially more cost-effective. CONCLUSIONS: When trying to improve the effectiveness of addiction treatment services, clinic-level coaching appears to help improve waiting-time and number of new patients while other components of improvement collaboratives (interest circles calls and learning sessions) do not seem to add further value.

Examining access to addiction treatment: scheduling processes and barriers.

This paper reports on the phone scheduling systems that patients encounter when seeking addiction treatment. Researchers made a series of 28 monthly calls to 192 addiction treatment clinics to inquire about the clinics' first available appointment for an assessment. Each month, the date of each clinic's first available appointment and the date the appointment was made were recorded. During a 4-month baseline data collection period, the average waiting time from contact with the clinic to the first available appointment was 7.2 days. Clinics engaged in a 15-month quality improvement intervention in which average waiting time was reduced to 5.8 days. During the course of the study, researchers noted difficulty in contacting clinics and began recording the date of each additional attempt required to secure an appointment. On average, 0.47 callbacks were required to establish contact with clinics and schedule an appointment. Based on these findings, aspects of quality in phone scheduling processes are discussed. Most people with addiction seek help by calling a local addiction treatment clinic, and the reception they get matters. The results highlight variation in access to addiction treatment and suggest opportunities to improve phone scheduling processes.

The effects of combining Web-based eHealth with telephone nurse case management for pediatric asthma control: a randomized controlled trial.

BACKGROUND: Asthma is the most common pediatric illness in the United States, burdening low-income and minority families disproportionately and contributing to high health care costs. Clinic-based asthma education and telephone case management have had mixed results on asthma control, as have eHealth programs and online games. OBJECTIVES: To test the effects of (1) CHESS+CM, a system for parents and children ages 4-12 years with poorly controlled asthma, on asthma control and medication adherence, and (2) competence, self-efficacy, and social support as mediators. CHESS+CM included a fully automated eHealth component (Comprehensive Health Enhancement Support System [CHESS]) plus monthly nurse case management (CM) via phone. CHESS, based on self-determination theory, was designed to improve competence, social support, and intrinsic motivation of parents and children. METHODS: We identified eligible parent-child dyads from files of managed care organizations in Madison and Milwaukee, Wisconsin, USA, sent them recruitment letters, and randomly assigned them (unblinded) to a control group of treatment as usual plus asthma information or to CHESS+CM. Asthma control was measured by the Asthma Control Questionnaire (ACQ) and self-reported symptom-free days. Medication adherence was a composite of pharmacy refill data and medication taking. Social support, information competence, and self-efficacy were self-assessed in questionnaires. All data were collected at 0, 3, 6, 9, and 12 months. Asthma diaries kept during a 3-week run-in period before randomization provided baseline data. RESULTS: Of 305 parent-child dyads enrolled, 301 were randomly assigned, 153 to the control group and 148 to CHESS+CM. Most parents were female (283/301, 94%), African American (150/301, 49.8%), and had a low income as indicated by child's Medicaid status (154/301, 51.2%); 146 (48.5%) were single and 96 of 301 (31.9%) had a high school education or less. Completion rates were 127 of 153 control group dyads (83.0%) and 132 of 148 CHESS+CM group dyads (89.2%). CHESS+CM group children had significantly better asthma control on the ACQ (d = -0.31, 95% confidence limits [CL] -0.56, -0.06, P = .011), but not as measured by symptom-free days (d = 0.18, 95% CL -0.88, 1.60, P = 1.00). The composite adherence scores did not differ significantly between groups (d = 1.48%, 95% CL -8.15, 11.11, P = .76). Social support was a significant mediator for CHESS+CM's effect on asthma control (alpha = .200, P = .01; beta = .210, P = .03). Self-efficacy was not significant (alpha = .080, P = .14; beta = .476, P = .01); neither was information competence (alpha = .079, P = .09; beta = .063, P = .64). CONCLUSIONS: Integrating telephone case management with eHealth benefited pediatric asthma control, though not medication adherence. Improved methods of measuring medication adherence are needed. Social support appears to be more effective than information in improving pediatric asthma control. TRIAL REGISTRATION: Clinicaltrials.gov NCT00214383; http://clinicaltrials.gov/ct2/show/NCT00214383 (Archived by WebCite at http://www.webcitation.org/68OVwqMPz).

Disseminating quality improvement: study protocol for a large cluster-randomized trial.

BACKGROUND: Dissemination is a critical facet of implementing quality improvement in organizations. As a field, addiction treatment has produced effective interventions but disseminated them slowly and reached only a fraction of people needing treatment. This study investigates four methods of disseminating quality improvement (QI) to addiction treatment programs in the U.S. It is, to our knowledge, the largest study of organizational change ever conducted in healthcare. The trial seeks to determine the most cost-effective method of disseminating quality improvement in addiction treatment. METHODS: The study is evaluating the costs and effectiveness of different QI approaches by randomizing 201 addiction-treatment programs to four interventions. Each intervention used a web-based learning kit plus monthly phone calls, coaching, face-to-face meetings, or the combination of all three. Effectiveness is defined as reducing waiting time (days between first contact and treatment), increasing program admissions, and increasing continuation in treatment. Opportunity costs will be estimated for the resources associated with providing the services. OUTCOMES: The study has three primary outcomes: waiting time, annual program admissions, and continuation in treatment. Secondary outcomes include: voluntary employee turnover, treatment completion, and operating margin. We are also seeking to understand the role of mediators, moderators, and other factors related to an organization's success in making changes. ANALYSIS: We are fitting a mixed-effect regression model to each program's average monthly waiting time and continuation rates (based on aggregated client records), including terms to isolate state and intervention effects. Admissions to treatment are aggregated to a yearly level to compensate for seasonality. We will order the interventions by cost to compare them pair-wise to the lowest cost intervention (monthly phone calls). All randomized sites with outcome data will be included in the analysis, following the intent-to-treat principle. Organizational covariates in the analysis include program size, management score, and state. DISCUSSION: The study offers seven recommendations for conducting a large-scale cluster-randomized trial: provide valuable services, have aims that are clear and important, seek powerful allies, understand the recruiting challenge, cultivate commitment, address turnover, and encourage rigor and flexibility. TRIAL REGISTRATION: ClinicalTrials. govNCT00934141.

Using action research to implement an integrated pediatric asthma case management and eHealth intervention for low-income families.

Asthma case management and education programs improve pediatric asthma outcomes, but designing rigorous randomized controlled studies that accurately measure effects while encouraging parent participation is challenging. This is especially so for low-income African American families, who face significantly more severe asthma and social stress than their middle-class counterparts. Action research can help health education researchers negotiate between the elegant and complex designs favored by scientists with the real-life challenges of recruitment, implementation, and retention. This article discusses how a multidisciplinary team uses action research concepts to continuously adjust originally proposed protocols through the planning and implementation phases to encourage participation in a year-long randomized controlled trial of a program that combines telephone asthma case management and comprehensive online asthma education. As a result of these efforts, a higher proportion of low-income African American families are recruited into the study than originally proposed.