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Trial record 7 of 27 for:    Heyland

Improving Partnerships With Family Members of ICU Patients (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02920086
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : September 9, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Griffith University
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital

Tracking Information
First Submitted Date  ICMJE September 19, 2016
First Posted Date  ICMJE September 30, 2016
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE May 9, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2016)
  • Nutritional adequacy during the ICU stay [ Time Frame: Up to 30 days in ICU ]
  • Consumption of Oral Nutritional Supplements [ Time Frame: First four weeks once on ward ]
  • Intake on hospital wards (3 day calorie count) [ Time Frame: First four weeks once on ward ]
  • Hand grip strength [ Time Frame: At or before hospital discharge or up to 90 days ]
    Hydraulic hand dynamometer
  • Use of shared-decision making (OPTION tool) [ Time Frame: Within first week in ICU ]
  • Change in decisional conflict [ Time Frame: 1 week ]
    10-item Decisional Conflict Scale
  • Family satisfaction with decision-making [ Time Frame: 1 week ]
  • Overall family satisfaction with ICU [ Time Frame: At ICU discharge, an average of 12 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Partnerships With Family Members of ICU Patients
Official Title  ICMJE Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
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.
Detailed Description

There is a pressing need to improve the care of critically ill older patients. For critically ill patients who are frequently unable to participate in their own care and decision-making, partnering with their family members is particularly important for improving experiences and outcomes of care for both patients and families. However, the optimal means by which families engage in the role they play, and how best to capacitate them as advocates and partners in care while helping them maintain their own wellbeing, is not known.

The IMPACT trial will evaluate two interventions, each with a separate context, but similar in that they empower and support families; one focused on involvement in care, and the other focused on involvement in decision-making. The first is a nutrition intervention The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICs) intervention, a multi-faceted strategy to engage and empower family members to advocate for and audit best nutrition practices in their family members. The second is a decision support intervention. The REALISTIC-80 Decision Support Intervention, is a web-based tool (www.myicuguide.com) to support families in shared decision-making about goals of medical treatments.

The investigators propose to conduct a mixed methods multi-centre, open-label, randomized, clinical trial involving 3 groups (2 active interventions and a usual care group). The overall goal of this study is to demonstrate that the multi-faceted nutritional strategies that engage families in care of their family member tested in this trial will increase nutritional intake and optimize physical recovery in older critically ill patients at high nutrition risk.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Critical Illness
Intervention  ICMJE
  • Behavioral: Nutrition Education Program
    • 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)
    Other Name: OPTICS
  • Other: Decision Support Program
    • 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
    Other Names:
    • The REALISTIC-80 Decision Support Intervention
    • My ICU Guide
Study Arms  ICMJE
  • Experimental: Nutrition Education Program
    Nutrition education for family members of an elderly critically ill patient
    Intervention: Behavioral: Nutrition Education Program
  • Experimental: Decision Support Program
    Decision support education for family members of an elderly critically ill patient
    Intervention: Other: Decision Support Program
  • No Intervention: Usual Care
    No intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for Patients:

1a) > 60 years of age OR

1b) 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

Exclusion Criteria for Patients:

  • 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

Inclusion Criteria for Family Member:

  • 18 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daren Heyland, MD 613-549-6666 ext 3339 dkh2@queensu.ca
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02920086
Other Study ID Numbers  ICMJE IMPACT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
Study Sponsor  ICMJE Clinical Evaluation Research Unit at Kingston General Hospital
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Griffith University
Investigators  ICMJE
Principal Investigator: Daren Heyland, MD Clinical Evaluation Research Unit
PRS Account Clinical Evaluation Research Unit at Kingston General Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP