Table 1 HATRICC-US outcome measures
Outcome (type) | Rationale | Unit of analysis and approach to measurement | Frequency and timing of measurement |
|---|---|---|---|
Co-primary outcomes | |||
Fidelity (Imp) | Fidelity is a necessary precursor to effectiveness | Handoff-level; observations by site-based staff, count on a 10-point scale (quant), field notes (qual) | Monthly, Years 2-5 |
New-onset organ failure (Eff) | Per-protocol handoffs enable clinicians to follow expected care practices and to anticipate and avoid postoperative deterioration | ICU-level; composite measure of AHRQ Patient Safety Indicators (PSIs) [53] that reflect organ failure (quant) | Monthly, Years 2-5 |
Secondary outcomes | |||
Feasibility (Imp) Acceptability (Imp) Appropriateness (Imp) | These “early” implementation outcomes will influence subsequent fidelity and will help in the interpretation of fidelity findings | Clinician- and ICU-level; AIM [54], FIM [54], IAM [54] (quant); site visit findings (qual) | 3 times: Year 1; within 2 months of implementation (Years 2-3); within 2 months of sustainment start (Years 4–5) |
Sustainment (Imp) | Sustainment is the ultimate goal of the implementation effort | Handoff-level; characterized as fidelity over time (quant) | Monthly, Years 4–5 |
Affordability (Cost; Imp) | Implementation cost is an important consideration for transferability of study findings | ICU-level; accounting-based cost analysis as described by Hoeft et al. [55] (quant) | Within 2 months of implementation; within 2 months of sustainment start |
Teamwork (Eff) Professionalism (Eff) | Strong teamwork and professionalism are expected to result from protocol use | Handoff-level; field notes from trained site-based staff (qual) | Quarterly, Years 2–5 |
Clinician satisfaction (Eff) | Clinician satisfaction is an early indicator of effectiveness | Clinician-level; surveys (quant); site visit findings (qual) | Annually, Years 1–5 |
Clinician workload (Eff) | Workload influences clinicians’ EBP use; fidelity is likelier if workload is unchanged or lower | Clinician-level; NASA Task Load Index [45] (quant); field notes, site visit findings (qual) | Quarterly, Years 2–5 |
Information omissions (Eff) | Per-protocol handoffs will show fewer information omissions | Handoff-level; direct observations* by trained site-based staff (quant) | Monthly, Years 2–5 |
Adverse events (Eff) | Per-protocol handoffs include enable the prevention of adverse events by promoting shared team understanding of patients’ care | ICU-level; composite measure based on 10 routinely collected measures of care (AHRQ PSI 90 [56]) | Quarterly, Years 2–5 |