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Table 1 Preparation steps for trial design

From: 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

Aspect Results Changes made
PRECIS (pragmatic trial) review Initial high-value elements were too focused and prescriptive Broadened to allow flexibility and health professional judgment
Alignment with health reform via multistakeholder panel (N = 12) Incentives too complex; lack of alignment with other health reform efforts; team and clinic culture will drive results Generated alignment document; revised intervention metrics and approach to better align with initiatives; extensive team and clinic assessment
Chronic illness patient focus group (N = 9) Access to the clinic and the specific services need to be improved; information gaps about what is newly available (like care coordination) was common Look carefully for patient experience measures that examine access and information gathering; expect different experiences from patients than reported by clinics; improve education
Insurer focus group (N = 22) Each insurer had their own initiative or had a separate take on the current initiative set Aligned principles were agreed to by payers; encourage payer alignment
Pilot clinic interviews (N = 6) Expectations of the clinic too vague and time-consuming Generated a memorandum of understanding that clinics revised and implemented