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Table 3 Additional outcomes for the IMPACT trial

From: Improving partnerships with family members of ICU patients: study protocol for a randomized controlled trial

Parameter

Defined as…

Enrollment and consent rate

We will judge the current study protocol feasible if > 75% of eligible families of eligible patients are approached and > 60% of these consent.

Compliance with the components of the OPTICs intervention.

The dietitian will keep a log of all FMs with whom the OPTICs intervention materials were reviewed, the time the intervention was delivered, and whether a nutrition plan was presented at the end of the ICU stay (survivors only) and ward stay. At baseline, the review of these materials should occur in > 90% of enrolled FMs and the nutrition plan should be presented in > 75% of eligible cases for this to be considered feasible.

Compliance with the components of the family directed decision-support intervention

Review of the website should occur in 100% of the FMs enrolled in this group, and the family meeting (including the enrolled FM) should occur within 72 h in > 75% of cases for this intervention to be considered feasible. In addition, the RC will perform a chart review after ICU death or discharge for all enrolled patients and document evidence that the components of the decision-support intervention were included in the medical record. We will consider the protocol successful if > 75% of charts contained such evidence.

Physician Awareness Assessment

One week after enrollment, the RC will administer the Physician’s Awareness Assessment to the attending physician and/or fellow responsible for the care of the patient during the period of enrollment to assess the extent to which they were aware of study materials, the variables captured in the study intervention output (nutritional history, patient pre-morbid functional state, values, preferences, etc.) and the degree to which this knowledge influenced their decision-making. If > 75% of them acknowledge exposure to study tools and rate their impact as substantial, in the respective interventional groups, the intervention will be considered feasible.

Contamination

We will ask all FMs whether they have had a facilitated review of the myicuguide website and OPTICs tools. If < 10% of the families of patients in the usual care group acknowledge that they have seen the study tools and if < 10% of the intervention groups acknowledge they have been exposed to the other intervention, we will consider this acceptable.

  1. FM family member, RC research coordinator, ICU intensive care unit