title: Disseminating quality improvement: study protocol for a large cluster-randomized trial.
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.
  
  
  RESULTS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials. govNCT00934141.
authors.affiliation: Center for Health Enhancement Systems Studies, Industrial and Systems Engineering Department, University of Wisconsin-Madison, Madison, WI 53706, USA. andrew.quanbeck@chess.wisc.edu
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Quanbeck
authors.forename: David H
authors.initials: DH
authors.lastname: Gustafson
authors.forename: James H
authors.initials: JH
authors.lastname: Ford
authors.forename: Alice
authors.initials: A
authors.lastname: Pulvermacher
authors.forename: Michael T
authors.initials: MT
authors.lastname: French
authors.forename: K John
authors.initials: KJ
authors.lastname: McConnell
authors.forename: Dennis
authors.initials: D
authors.lastname: McCarty
mesh_terms: D016000:Cluster Analysis; D003362:Cost-Benefit Analysis; D003376:Counseling; D006801:Humans; D057194:Intention to Treat Analysis; D020407:Internet; D009936:Organizational Innovation; D010043:Outcome and Process Assessment, Health Care; D058996:Quality Improvement / Q000191:economics; D016032:Randomized Controlled Trials as Topic / Q000191:economics; D012044:Regression Analysis; D012107:Research Design; D012944:Social Support; D019966:Substance-Related Disorders / Q000191:economics / Q000453:epidemiology / Q000628:therapy*; D013689:Telephone; D014481:United States / Q000453:epidemiology