1. Vitamin D to Improve Outcomes by Leveraging Early Treatment
VIOLET STUDY
Vitamin D to Improve Outcomes by Leveraging Early Treatment

2. SUMMARY
Objective
To assess the efficacy and safety of early administration of vitamin D3 (cholecalciferol) in reducing mortality and morbidity for vitamin D deficient patients at high risk for ARDS and mortality.
Hypothesis
Early administration of vitamin D3 (cholecalciferol) will improve all-cause, all-location mortality to day 90 in vitamin D deficient patients at high risk for ARDS and mortality.

3. Flow diagram

4. Eligibility/Inclusion
Age >/= 18
Intent to admit to ICU
Must have at least 1 acute risk factor:
Pneumonia
Aspiration
Smoke inhalation
Lung contusion
Mechanical ventilation
Shock
Pancreatitis
Must have confirmed Vitamin D level < 20 ( per Qualigen Analyzer)

5. Exclusion criteria Unable to obtain informed consent
Unable to randomize within12 hours from decision to admit to ICU
Unable to take oral/enteral medication
Hypercalcemia
Current or history of multiple kidney stones
Decision to withhold life support
Expect < 48 hour survival
Mechanical ventilation exclusions (Mechanical ventilation exclusions: If no other risk factors present, a) mechanical ventilation primarily for airway protection, pain/agitation control, or procedure; or b) elective surgical patients with routine postoperative mechanical ventilation; or c) anticipated mechanical ventilation duration <24 hours; or d) chronic/home mechanical ventilation for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion).
Prisoner/Pregnancy
Mechanical ventilation exclusions: If no other risk factors present, a) mechanical ventilation primarily for airway protection, pain/agitation control, or procedure; or b) elective surgical patients with routine postoperative mechanical ventilation; or c) anticipated mechanical ventilation duration <24 hours; or d) chronic/home mechanical ventilation for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion).

6. Consenting process
Consent/guidance packets located in critical care room, above the portable x-ray machine
There are 2 main parts to ICF:
Main (required) and Genetics (optional)
Be sure to use most current version of consent (posted on emguidelines.org)
LAR (legally authorized representative) is permitted
Refer to institutional guidelines to identify appropriate LAR
Follow telephone script
Consent must be faxed or ed to LAR for review during call
Witness is required when using an LAR
LAR agrees to provide written consent as soon as possible
Once the patient is able, he or she will need to be re-consented
* Informed telephone consent approval in process

7. Consenting Cont.
Page research coordinator at ( ) after consent has been obtained and leave the following information: (call back number, who is calling, patient name, DOB and location of patient)
If re-consent is required, the original consenter (if available) or an investigator must obtain
A telephone consenting script has been created to help with the consenting process. It is available in the consent packets and on emguidelines.org
Important: “For Best Practice, an independent consent note should be documented as soon as possible. Research consent notes should not be embedded in clinical note”.
Smart phrases containing required elements are available for both written “.violetconsent” and telephone consent (pending)

8. VIOLET Informed Telephone Consent Guidelines
Principal Investigator: Michael R. Baumann, MD
Study Title: VIOLET: Vitamin D to Improve Outcomes by Leveraging Early Treatment
Hospital: Maine Medical Center
“Hello, my name is (research personnel). I am calling from Maine Medical Center about a research study. I am trying to reach (name of LAR)? I was given your phone number from (contact source), is this a good time to talk? I expect this call will take about (20 minutes)”.
If LAR is not available, arrange to leave a message, or ask for a good time to call back.
“I am calling because your friend/relative (name of patient) may be eligible to participate in a research study and I would like to get your permission for (name of patient) to participate in a vitamin D study. He or she is eligible because they are being admitted to the intensive care unit at Maine Medical Center and may benefit from participation in this clinical trial. Many patients with severe illness have low vitamin D levels. Patients who have low vitamin D levels may have a higher risk of dying from severe illness, however we do not know if giving vitamin D improves survival. We would test a blood sample with a rapid screening test. If the screening test suggests that (his/her) vitamin D levels are low, (name of patient) will receive either one high dose of vitamin D (orally or through a tube) or a placebo (inactive liquid that does not contain vitamin D). I would like to provide you with the consent form either by or fax for you to review with me over the phone, which will give you an opportunity to ask any questions you may have regarding the study. May I send you the consent form?
Please instruct the surrogate that the consent form needs to be signed and the ORIGINAL needs to be returned to the research team. The ICF can be faxed, brought back to the hospital or mailed only (NO RETURN BY ). Note: Signature from LAR should be witnessed in real time when returned if possible.
Once consent has been obtained, a consent process enrollment note needs to be documented in EPIC.
Subject will need to be re-consented once they are able to do so.

9. EXAMPLE CONSENT NOTE:
Study: VIOLET
Date and time of phone consent: 10/1/2017 at 1600.
Patient meets all inclusion and no exclusion criteria.
Informed consent was (faxed or ed) for LAR to review
Informed consent obtained via telephone from patient's (name and contact info)
Length of discussion with legally authorized representative: (40 minutes.)
I personally reviewed the VIOLET informed consent document with (the LAR) and they were encouraged to ask any clarifying questions. (The LAR’s) understanding of the study was assessed using a teach-back process. They were able to describe important aspects of study participation including describing in their own words the study purpose and procedures, follow-up, alternatives to participating in the study, the voluntary nature of their participation, and whom they should contact for any questions or concerns. Telephone consent discussion and verbal consent of LAR was witnessed by J. Smith (clinical nurse). LAR has agreed to provide written consent at their next visit. The subject will be approached for re-consent when/if they become able.
Signature/date/time: _____________________________________

10. Other tips
Violet study information (including staff meeting slides) and most recent ICF are located on emguidelines.org
Once subject has been consented, no further clinical action is necessary for consenter
There is a 12 hour window to randomize/administer study drug, once the decision has been made to admit to the ICU Note: due to prep time, phlebotomy and sample processing, subjects at
> 8hrs since decision to admit to ICU will not be recruited.
Citi training and protocol training are necessary in order to consent for research studies. If you have not completed these steps and wish to consent, please see Tania or Dr. Baumann

11. Questions??