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

Abstract

Background: Over the last decade, health care delivery has shifted to partnering with patients and their families to improve health and quality of care, and to lower costs. Partnering with family members (FMs) of critically ill patients who lack capacity is particularly important for improving experiences and outcomes for both patients and FMs. How best to apply such partnering strategies, however, is yet unknown. The IMPACT trial will evaluate two interventions that enable partnerships with families of critically ill patients, each in a distinct content area, but similar in that they empower and support FMs.

Methods: This multi-center, open-label, randomized, phase II clinical trial aims to randomize 150 older, long-stay ICU patients and their families into one of three groups (50 in each group): (1) The OPTimal nutrition by Informing and Capacitating FMs of best practices (OPTICs) group, a multi-faceted intervention to engage and empower FMs to advocate for, and audit, best nutritional practices for their critically ill FMs, (2) A web-based decision-support intervention called the ICU Workbook (The Canadian Researchers at the End of Life Network (CARENET) ICU Workbook; https://www.myicuguide.ca/ . Accessed 3 Feb 2017.) to support families in shared decision-making process regarding goals of medical treatments, and (3) Usual care. The main outcomes for this trial include nutritional adequacy in hospital and hand-grip strength prior to hospital discharge; satisfaction with decision-making; decision conflict; and degree of shared decision-making.

Discussion: With the goal of improving the functional recovery of nutritionally high-risk older patients and the quality of care at the end of life for these patients and their FMs in the ICU, we have proposed two novel family capacitation strategies. We hope that the nutrition and decision-support interventions implemented and evaluated in our study will contribute to the evidentiary basis for best family partnered care pathways focused on optimizing the quality of ICU care for patients with life-threatening illness and their families.

Trial registration: Clinical trials.gov, ID: NCT02920086 . Registered on 30 September 2016. Protocol version dated 11 October 2016.

Keywords: Critical care; End of life decision-making; Nutrition; Patient and family engagement; Randomized trial; Supportive care.

Conflict of interest statement

Ethics approval and consent to participate

This protocol will be reviewed at all participating centers and approved by local Ethics Boards prior to starting the study at each site. Currently, it has been approved at all US, Canadian and Australian sites. We will obtain written informed consent from all participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1

Conceptual model of family engagement in the intensive care unit (ICU). Many factors impact medical decisions for a patient. Patient factors include the patient as a person and their medical condition. Patient as a person represents the person’s prior experiences, values, preferences and goals. Environmental factors include the health care environment situated within a larger societal context. Family members may engage in care or decision-making. The family’s role in care gives purpose in crisis and may help family members cope with the exposure to critical illness. Their direct participation may also improve patient adherence to treatment plan and attainment of treatment goals. In shared decision-making the family is engaged as a member of the health care team. The family is typically most familiar with the patient as a person and the patient’s past health status. The clinicians are typically most knowledgeable of the patient’s critical illness. The decision-support intervention is designed to facilitate communication between the family and clinicians about the patient as a person and their medical condition. Family engagement in this manner facilitates a shared medical decision that is consistent with the patient’s values and goals in the context of their illness experience and medical condition, and is congruent with what the patient would choose if they were competent to make such a decision. Thus, we hypothesize that family engagement can influence family response to critical illness, and also the treatment plan. Ultimately, both patient and family outcomes are optimized

Fig. 2

Post-intensive care syndrome among families of intensive care unit (ICU) survivors. Reprinted with permission from Springer [20]

Fig. 3

Study overview

Fig. 4

Timeline of the interventions