title: Study protocol: transforming outcomes for patients through medical home evaluation and redesign: a cluster randomized controlled trial to test high value elements for patient-centered medical homes versus quality improvement.
abstract: BACKGROUND
  Health care in the United States is in the midst of a near perfect storm: strong cost pressures, dramatic redesign efforts like patient-centered medical homes and accountable care organizations, and a broad series of payment and eligibility reforms. To date, alternative models of care intended to reduce costs and improve outcomes have shown mixed effects in the U.S., in part due to the difficulty of performing rigorous evaluation studies that control for the broader transformation while avoiding other biases, such as organizational or clinic effect on individual patient outcomes. Our objective is to test whether clinics assigned to achieve high value elements (HVEs) of practice redesign are more likely than controls to achieve improvements in patient health and satisfaction with care and reduction in costs.
  
  
  METHODS
  To prepare, we interview stakeholders, align with health reform, and propose a pilot. Participants are primary care clinics engaged in reform. Study protocol requires that both arms receive monthly practice facilitation, IT-based milestone reporting, and small financial incentives based on self-determined quality improvement (QI) goals; intervention receives additional prompting to choose HVEs. Design is a cluster randomized controlled trial over 1 year with pre- and post-washout periods. Outcomes are unplanned utilization and costs, patient experience of care, quality, and team performance. Analysis is a multivariate difference-in-difference with adjustments for patient risk, intraclinic correlation, and other confounders.
  
  
  CONCLUSIONS
  The TOPMED study is a cluster randomized controlled trial focused on learning how primary care practices can transform within health reform guidelines to achieve outcomes related to the Triple Aim.
  
  
  BACKGROUND
  ClinicalTrials.gov registration: NCT02106221.
authors.affiliation: Oregon Health and Science University, SW Sam Jackson Park Rd, Portland, OR, USA. dorrd@ohsu.edu.
authors.forename: David A
authors.initials: DA
authors.lastname: Dorr
authors.affiliation: Oregon Health and Science University, SW Sam Jackson Park Rd, Portland, OR, USA. mcconnjo@ohsu.edu.
authors.forename: Kenneth John
authors.initials: KJ
authors.lastname: McConnell
authors.affiliation: Oregon Health and Science University, SW Sam Jackson Park Rd, Portland, OR, USA. pierreja@ohsu.edu.
authors.forename: Marsha Pierre-Jacques
authors.initials: MP
authors.lastname: Williams
authors.affiliation: Oregon Health and Science University, SW Sam Jackson Park Rd, Portland, OR, USA. followkim@gmail.com.
authors.forename: Kimberley A
authors.initials: KA
authors.lastname: Gray
authors.affiliation: Oregon Health and Science University, SW Sam Jackson Park Rd, Portland, OR, USA. wagnerje@ohsu.edu.
authors.forename: Jesse
authors.initials: J
authors.lastname: Wagner
authors.affiliation: Oregon Health and Science University, SW Sam Jackson Park Rd, Portland, OR, USA. fagnanl@ohsu.edu.
authors.forename: Lyle J
authors.initials: LJ
authors.lastname: Fagnan
authors.affiliation: Stanford University, Serra Mall, Stanford, CA, USA. malcolm1@stanford.edu.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Malcolm
mesh_terms: D006801:Humans; D017060:Patient Satisfaction; D018802:Patient-Centered Care / Q000458:organization & administration / Q000592:standards*; D015397:Program Evaluation; D058996:Quality Improvement / Q000592:standards; D011787:Quality of Health Care / Q000458:organization & administration / Q000592:standards