NCT02920086

Brief Summary

The purpose of this study is to improve the outcomes of critically ill older patients and the health outcomes of their families by capacitating and partnering with families in optimizing patient/family centered care.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
3 countries

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

May 9, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

3.6 years

First QC Date

September 19, 2016

Last Update Submit

September 5, 2019

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (8)

  • Nutritional adequacy during the ICU stay

    Up to 30 days in ICU

  • Consumption of Oral Nutritional Supplements

    First four weeks once on ward

  • Intake on hospital wards (3 day calorie count)

    First four weeks once on ward

  • Hand grip strength

    Hydraulic hand dynamometer

    At or before hospital discharge or up to 90 days

  • Use of shared-decision making (OPTION tool)

    Within first week in ICU

  • Change in decisional conflict

    10-item Decisional Conflict Scale

    1 week

  • Family satisfaction with decision-making

    1 week

  • Overall family satisfaction with ICU

    At ICU discharge, an average of 12 days

Study Arms (3)

Nutrition Education Program

EXPERIMENTAL

Nutrition education for family members of an elderly critically ill patient

Behavioral: Nutrition Education Program

Decision Support Program

EXPERIMENTAL

Decision support education for family members of an elderly critically ill patient

Other: Decision Support Program

Usual Care

NO INTERVENTION

No intervention

Interventions

Nutrition Education ProgramBEHAVIORAL

* The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICS) intervention * Nutritional education will be provided to ICU patents' families by a dietitian * Tracking of nutritional information by family * Encouragement for families to advocate for two or more Oral Nutritional Supplements per day for the patients (approximately 400 kcal/day)

Also known as: OPTICS
Nutrition Education Program
Decision Support ProgramOTHER

* Families will be provided with a web-based decision support tool (My ICU Guide) * Families will meet with the ICU medical team early in ICU stay to review goals of care

Also known as: The REALISTIC-80 Decision Support Intervention, My ICU Guide
Decision Support Program

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a) \> 60 years of age OR
  • b) 55 years to 59 years old with one or more of the following diagnoses:
  • Chronic obstructive lung disease - 2 of the 4 of: baseline PaCO2 of \> 45 torr, cor pulmonale; respiratory failure episode within the preceding year; forced expiratory volume in 1 sec \<0.5 L.
  • Congestive heart failure - New York Heart Association class IV symptoms and left ventricular ejection fraction \< 25%.
  • Cirrhosis - confirmed by imaging studies or documentation of esophageal varices and one of three conditions: a) hepatic coma, b) Child's class C liver disease, or c) Child's class B liver disease with gastrointestinal bleeding.
  • Cancer - metastatic cancer or stage IV lymphoma.
  • End-stage dementia (inability to perform all ADLs, mutism or minimal verbal output secondary to dementia, bed-bound state prior to acute illness) 2) Have a projected duration of ICU dependency of \>72 hours from time of final assessment. We define ICU dependency as the need for one or more of the following:
  • Mechanical ventilation
  • Non-invasive ventilation
  • Renal replacement therapy
  • Vasopressors or
  • Artificial nutrition because of their underlying illness

You may not qualify if:

  • Patients who are not expected to remain alive in ICU for 72 hours after initial screening (physician judgment) or for whom life-sustaining treatments are expected to be withdrawn in the subsequent 72 hours (as sufficient time will be required for implementation of the study interventions)
  • Uncomplicated elective surgical patients (regardless of age)
  • Patients who have received organ transplantation during this hospitalization
  • years of age or older,
  • present and expected to visit regularly (minimum about 3 times a week) while the patient is in hospital
  • the nominated or legally appointed substitute decision-maker
  • able to communicate in English (verbally and in writing).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Phoenix VA Medical Center

Phoenix, Arizona, 85012, United States

RECRUITING

Barnes Jewish Hospital/Washington University

St Louis, Missouri, 63110-1093, United States

RECRUITING

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Legacy Salmon Creek Medical Center

Vancouver, Washington, 98686, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Gold Coast Health

Gold Coast, Queensland, Australia

RECRUITING

University of Calgary

Calgary, Alberta, Canada

WITHDRAWN

University of Ottawa

Ottawa, Ontario, Canada

RECRUITING

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

RECRUITING

University Health Network

Toronto, Ontario, Canada

TERMINATED

Related Publications (2)

  • Marshall AP, Van Scoy LJ, Chaboyer W, Chew M, Davidson J, Day AG, Martinez A, Patel J, Roberts S, Skrobik Y, Taylor B, Tobiano G, Heyland DK. A randomised controlled trial of a nutrition and a decision support intervention to enable partnerships with families of critically ill patients. J Clin Nurs. 2023 Sep;32(17-18):6723-6742. doi: 10.1111/jocn.16752. Epub 2023 May 9.

    PMID: 37161555DERIVED

  • Heyland DK, Davidson J, Skrobik Y, des Ordons AR, Van Scoy LJ, Day AG, Vandall-Walker V, Marshall AP. Improving partnerships with family members of ICU patients: study protocol for a randomized controlled trial. Trials. 2018 Jan 4;19(1):3. doi: 10.1186/s13063-017-2379-4.

    PMID: 29301555DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Optics and Photonics

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EngineeringTechnology, Industry, and Agriculture

Study Officials

  • Daren Heyland, MD

    Clinical Evaluation Research Unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daren Heyland, MD

CONTACT

613-549-6666dkh2@queensu.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2016

First Posted

September 30, 2016

Study Start

May 9, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

September 9, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)US(5)AU(1)