COMParative Early Treatment Effectiveness between physical therapy and usual care for XXXX (COMPETE): study protocol for a randomized controlled trial.

@entity2319 @entity1 @entity1643 @entity717
BACKGROUND: @entity1643 is among the leading causes of medical visits and lost duty days among members of the United States Armed Forces and represents the highest 5-year risk of @entity2319 in the US Army. For certain elements of care, the timing may be just as important as the type of care. The purpose of this study is to assess the impact of the timing of access to a physical therapist by @entity1 with @entity1643 , by looking at outcomes and @entity1643 -related healthcare utilization over a 1-year period. METHODS/DESIGN: This trial will be a two-arm pragmatic randomized clinical trial occurring at two different clinical sites in the Military Health System. We will assess outcomes and related downstream costs for @entity1 who access physical therapy at the primary care level compared to those that receive usual care only. There will be 220 consecutive @entity1 randomized to receive care in either group (early physical therapy or usual care only) for the first 4  weeks, and these @entity1 will then be allowed to receive any additional care dictated by their primary care provider for the following year. The primary outcome measure is the @entity717 Index. Secondary outcome measures are the Global Rating of Change, @entity1 Satisfaction and 1-year healthcare utilization. Follow-ups will occur at 4  weeks, 3  months and 1  year. DISCUSSION: This trial takes a pragmatic approach to delivering care by enabling a usual care environment for managing @entity1643 , while also allowing immediate access to physical therapy. After the initial intervention, the @entity1 's primary provider can continue to manage the @entity1 as he/she normally would in practice. The Military Health System Data Repository will capture all @entity1643 -related healthcare utilization that occurs in order to allow for a comparison between groups. Analysis from retrospective cohorts has shown improved outcomes and decreased costs for @entity1 that received early versus late physical therapy, but this has yet to be shown in prospective trials. TRIAL REGISTRATION: ClinicalTrials.Gov NCT01556581 initially on 14 March 2012.
