REDOXS© Trial Pilot

REDOXS© Trial Pilot

Consent Training Module Version 4: August 7th, 2013 Obtaining Informed Consent Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans Free and informed consent refers to the dialogue, information sharing and general process through

which prospective subjects choose to participate in research involving themselves Timing : When? Consent must be obtained within 72 hrs of admission to ICU Who obtains consent?

Site Investigator or delegate i.e. sub investigator or research nurse must be specified on the Delegation of Authority Log Whom to get consent from? Patients are often incapable given acuity of illness

Substitute decision maker (SDM) or patients legally acceptable representative Pre-Consent Check to see if patient has refused participation in research in general. Ensure patient meets the inclusion & no exclusion criteria

Familiarize yourself with the patients history Discuss the eligibility criteria and appropriateness of enrolment with Site Investigator. Involve nursing staff Approach bedside nursing staff/medical staff for and update on the familys involvement and their degree of knowledge of the patients condition.

Inform the appropriate nurse you are considering this patient for the TOP-UP Study. Ask RN when family member is expected. At the time of Consent Arrange for a quiet, private location for discussion with family member(s) with the Site Investigator/delegate. The Site Investigator will provide an overview of the study to

the family members and inform them that their family member is appropriate for participation in the TOP-UP study. The Site investigator will then introduce the Research coordinator to the family. State that you are seeking permission for the patient to participate in a research study Highlight that your hospital promotes improving patient care through research

Language Use simple and clear language Avoid medical jargon Do NOT coerce family member Personalize the discussions i.e. Patients like your family member, may benefit from participating in this study....

Explain Study Procedures Feeding via EN is standard of care Feeding via PN is standard of care, if patient unable to take enough EN SF-36 follow up at 3 and 6 months to check on patients status

Olimel Critically ill patients can become malnourished quickly and this may lead to an increased rate of infections and death. Intensive care units are not being fed well and on average they receive only 40-60% of the calories and protein that they should be receiving. Signals from studies show that giving more calories and protein to overweight and underweight patients may improve survival.

The purpose of this study is to find out if giving more calories and protein to underweight and overweight critically ill patients (BMI <25 or 35) will improve their chances of survival. Risks and benefits Risks: No known risks but there maybe others that we do not know about. If the MD in charge of your family member feels that your family member is deteriorating because of the

supplement, he can stop the study supplement. Your family member will be monitored daily Benefits: your family member may have a better chance of survival but we do not know for sure. Other elements of ICF Voluntary participation If refuse participation, will still receive the same medical

care. Consent may be withdrawn at any time No compensation, no cost Contact person for their rights and questions Data will be accessed but kept confidential Provide ICF to SDM Provide a copy of the REB approved ICF to family for their review

Give them sufficient time to ask questions and encourage them to speak to the Site Investigator. Ensure that they have understood that they are signing on behalf of their family member Provide contact numbers for questions or concerns After consent obtained When the SDM has given consent, ensure that they

have dated and signed the ICF. Provide them with one copy. Place a copy of the signed ICF in the medical chart and copies in your site files Follow up with SDM Thank the SDM for the opportunity to include the patient in TOP-UP

Provide the SDM with informal updates when you see them during future ICU visits, whether things are uneventful or not Ongoing contact with the SDM will help to make their exposure to medical research a positive experience Resources online

www.criticalcarenutrition.com

Recently Viewed Presentations

  • Leadership Styles - Loudoun County Public Schools

    Leadership Styles - Loudoun County Public Schools

    Activity: CARE Leadership Styles. This activity associates leadership qualities with an easy-to-remember acronym of the word CARE: C=CONGENIALITY. Enjoy interaction. Want to know how they can get others involved. Want everyone to feel good and have a good time.
  • The Principles of Design Balance Equalizing visual forces,

    The Principles of Design Balance Equalizing visual forces,

    The skirts the women are wearing are large, and some of the men are wearing top hats. A man is sitting on the front left side wearing a baseball hat and a sleeveless shirt. There is a woman and a...
  • Extended Essays - West High School

    Extended Essays - West High School

    Huan tran. An exploration of the effects of perceived stigma on individuals seeking treatment for depression. Christine huang. How king louis XIV used ballet to rule his kingdom. ... Anna penner. The history of the relationship between gun control and...
  • WHAT IS THE MEDICARE PAYMENT PLAN? ARE THERE

    WHAT IS THE MEDICARE PAYMENT PLAN? ARE THERE

    CodoniX will configure the system and recommend the items you will need to enforce and be compliant with. This package includes: Enrollment in E-Prescribing. The fee for E-Prescribing is $650 annually per 1 Full Time Equivalent. Facility will be billed...
  • Nefes Darliği İle Baş Edebi̇lme Yöntemleri̇

    Nefes Darliği İle Baş Edebi̇lme Yöntemleri̇

    Breathing rate Anxiety Dyspnea Yu, J Psychosom Res, 2007 * Progressive muscle relaxation * Forward leaning * Forward Leaning Barach, 1974 Sharp, 1980 Druz, 1982 Delgato, 1982 O'Neil, 1983 Reduces scalen and sternomastoid muscles activities Increases transdiaphragmatic pressure Regulatesthoracoabdominal motions...
  • 3 rd Harmonic Cavity Processing Status Chart Preliminary

    3 rd Harmonic Cavity Processing Status Chart Preliminary

    Mount Cavity to V. Coupler & Leak Chk. Install Cavity/Coupler on VTD Vertical Test Remove Cavity/Coupler from VTD Store Cavity in Class 10 Clean Room Receive Titanium Vessel from Fab. Degrease Ti Vessel and Weld Fixtures Etch Ti Vessel Weld...
  • Zapatista Movement Impact & Political Outcomes in Mexico

    Zapatista Movement Impact & Political Outcomes in Mexico

    Why Wear Masks. Conceal Individual Identity- so that no one person can stand out & gender is concealed. Seen as a GROUP, not as individuals\ See no gender, race, or religion… "Delegate Zero" is their spokesperson & does not wear...
  • Conservation of 2 endangered species in Hong Kong

    Conservation of 2 endangered species in Hong Kong

    Conservation of 2 endangered species in Hong Kong Chinese White Dolphin Black-faced spoonbill