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Table 3 Effectiveness and implementation outcomes

From: Assessing effectiveness and implementation of a perioperative enhanced recovery protocol for children undergoing surgery: study protocol for a prospective, stepped-wedge, cluster, randomized, controlled clinical trial

 

Aim 1 - clinical effectiveness

Aim 2 - implementation

Test

ENRICH-US Intervention

Implementation strategy

Analysis

Patient- and hospital-level assessment

Surgeon- and hospital-level assessments

Theoretical outcomes

Health outcomes; process/quality measures are considered intermediate steps

Adoption/uptake of the clinical intervention; process/quality measures

Primary outcomes

Length of stay (LOS) for Aim1a

Implementation metrics including adoption, fidelity, and sustainability for Aim2a

Secondary outcomes

Decreased intra-operative fluid usea, decreased intra-operative and post-operative opioid usea, shorter time to regular dieta, health care utilization, surgical complicationsb, HRQoL assessment for Aim 2b.

Contextual factors associated with implementation including modifications and adaptations to materials, implementation barriers, implementation outcomes, and feedback on challenging ERP elements at site level for Aim2b

  1. aThese outcomes are specifically addressed by ERP elements and interventions
  2. bComplications are defined as per ACS NSQIP Pediatric definitions