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 improvementReport as inadecuate




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Implementation Science

, 10:13

First Online: 22 January 2015Received: 09 December 2014Accepted: 05 January 2015DOI: 10.1186-s13012-015-0204-6

Cite this article as: Dorr, D.A., McConnell, K.J., Williams, M.PJ. et al. Implementation Sci 2015 10: 13. doi:10.1186-s13012-015-0204-6

Abstract

BackgroundHealth 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-DesignTo 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.

DiscussionThe 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.

Trial registrationClinicalTrials.gov registration: NCT02106221.

AbbreviationsACOaccountable care organizations

CG-CAHPSClinician and Group—Consumer Assessment of Healthcare Providers and Systems

CMPCare Management Plus

CMSCenters for Medicare and Medicaid Services

CPATCollaborative Practice Assessment Tool

CPCComprehensive Primary Care initiative

CSQclinician staff questionnaire

EDemergency department

EHRelectronic health record

HIThealth information technology

HVEhigh-value elements

ICCISIntegrated Care Coordination Information System

ITinformation technology

NDPnational demonstration project

PCMHpatient-centered medical homes

PIprincipal investigator

PRECISpragmatic-explanatory continuum indicator summary

QIquality improvement

RCTrandomized controlled trial

TDMTeam Development Measure

TOPMEDTransforming Outcomes for Patients through Medical home Evaluation and reDesign

Electronic supplementary materialThe online version of this article doi:10.1186-s13012-015-0204-6 contains supplementary material, which is available to authorized users.

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Author: David A Dorr - Kenneth John McConnell - Marsha Pierre-Jacques Williams - Kimberley A Gray - Jesse Wagner - Lyle J Fagna

Source: https://link.springer.com/







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