Clinical Research Directory

The Family-ICU Trial

Family inclusion in adult intensive care unit (ICU) rounds is recommended by critical care professional societies, yet widespread uptake of this practice is limited. A key barrier cited by ICU clinicians is insufficient evidence to support this practice. There is a need for robust evidence to support family participation in adult ICU rounds and influence change to routine clinical care. The primary purpose of this study is to assess whether family participation in adult ICU rounds improves family engagement in care. The secondary objectives are to assess family satisfaction, and anxiety and depression, to explore user experiences of family participation in ICU rounds, and to evaluate strategies to improve family member recruitment and retention rates. This is a stepped-wedge cluster randomized trial (n=194) at 6 Canadian ICUs. The stepped wedge cluster randomized trial is a pragmatic study design that overcomes methodological limitations in evaluating a healthcare service delivery intervention. In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The stepped-wedge design also allows each site to function as its own control. The stepped-wedge design is more powerful than a parallel design when substantial cluster level effects are present.

Timing of Physician Rounds for Antepartum Patients

This study will include patients admitted to the Antepartum service at Duke University Hospital, many of whom are managing high-risk pregnancies that require extended hospital stays and frequent physician interactions. Currently, two rounding methods are used interchangeably for patients who do not have pregnancy or delivery complications that would preclude participation in delayed daytime rounding. This randomized controlled trial will compare two rounding models: the standard model, in which patients receive two rounds (an early morning bedside encounter and a later team discussion), and the intervention model, which consolidates both rounds into a single, later-morning bedside encounter following the team's review of clinical data. The primary objective is to assess whether consolidating physician rounds into a single, later-morning encounter-referred to as discovery rounding-improves patient satisfaction with communication.