Open Access Study protocol

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

Andrew R Quanbeck1*, David H Gustafson1, James H Ford1, Alice Pulvermacher1, Michael T French2, K John McConnell3 and Dennis McCarty4

Author Affiliations

1 Center for Health Enhancement Systems Studies, Industrial and Systems Engineering Department, University of Wisconsin-Madison, Madison, WI 53706, USA

2 Departments of Sociology, Epidemiology and Public Health, and Economics, University of Miami, Coral Gables, FL 33124, USA

3 Department of Emergency Medicine, Oregon Health and Science University, Portland, OR 97239, USA

4 Department of Public Health and Preventive Medicine, Oregon Health and Science University, Portland, OR 97239, USA

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Implementation Science 2011, 6:44  doi:10.1186/1748-5908-6-44

Published: 27 April 2011

Abstract

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