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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Daren K. Heyland, Judy Davidson, Yoanna Skrobik, Amanda Roze des Ordons, Lauren J. Van Scoy, Andrew G. Day, Virginia Vandall-Walker, Andrea P. Marshall
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:https://​doi.​org/​10.​1186/​s13063-017-2379-4) contains supplementary material, which is available to authorized users.

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.
Zusatzmaterial
Additional file 1: Description of background rationale for the OPTICs and decision-support intervention. (DOCX 47 kb)
13063_2017_2379_MOESM1_ESM.docx
Additional file 2: SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOCX 74 kb)
13063_2017_2379_MOESM2_ESM.docx
Additional file 3: Eligibility criteria. (DOCX 45 kb)
13063_2017_2379_MOESM3_ESM.docx
Additional file 4: Baseline data collection. (DOCX 45 kb)
13063_2017_2379_MOESM4_ESM.docx
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