Supplemental Information and Table

Supplemental Information and Table

Methods

Research personnel complete their questionnaires in advance of receiving SDM responses or as soon as possible after the encounter. We pilot tested the screening log, study forms, and study procedures in 18 patients (not included in the study results) prior to study initiation.

Participating Centres

In a 24 bed medical-surgical unit, photos of staff physicians were posted outside of the ICU without accompanying names. In a 19 bed trauma and neurosurgical unit, in the same hospital, the names of attending physicians, fellows, and junior residents were similarly displayed (paper and whiteboard) within the ICU without photos. In both ICUs, there were no specific policies regarding the timing of initial family updates which were typically conducted by the attending physician or the fellow. The third ICU (16 beds), located in a separate hospital, admitspredominantly medical-surgical patients and is connected to a regional cancer centre. In this ICU, a notice board displayed the names of team members (attending physicians, dieticians, social workers) outside the family lounge. By policy, a patient status update was provided by available staff (attending physician, fellow, or residents) and a multidisciplinary (chaplain, social work, charge and bedside nurse, resident or fellow, staff physician) meeting were held within 24 and 48 hours of admission to this ICU.

Statistical Analysis

We report time intervals using mean and standard deviation (alternatively, median and interquartile range for skewed data). We anticipated collecting data on one initial encounter per site per week or every other week in participating ICUs over an approximate 6 to 8 month period [1].

Results

Secondary Outcomes

Questionnaire Response Rates

Questionnaires regarding both the initial approach and the consent decision were returned by 97/102 (95.1%) of SDMs that explicitly provided or declined consent.

Consent Outcomes Based on Eligibility Events

Based on the investigative team’s assignment of study risk (low vs. high) by study (including the 2 events for which consent was provided and declined), we found that rates of providing (3/48 vs 1/52; p=0.3) and declining (2/13 vs 1/13; p=1.0) consent were similar for high risk studies in the MD and non-MD arms, respectively. Similarly, using SDM-assigned risk, we found no between- group differences in the rates of providing (3/45 vs 3/51; p=1.0) or declining (6/8 vs 4/9; p=0.3) in the MD vs. non-MD arms, respectively.

While RC’s impressions of SDMs rationale for providing consent were similar to those expressed by SDMs, their impressions of why SDMs declined consent were qualitatively different with research personnel highlighting that SDMs were overwhelmed [8/32 (25.0%)] and did not want to change current treatment [7/32 (21.9%)].

We also found a significantly higher rate of declined consents when an update was provided when we combined explicit and implicit declines (no response received from SDM) in a sensitivity analysis.

Table E1: ICU Characteristics

ICU / ICU # 1 / ICU # 2 / ICU # 3
Physical Beds and Admissions
Total no. of physical beds / 24 / 19 / 16
Average no. of beds (weekday) / 24 / 19 / 15.5
Average no. of beds (weekend) / 22 / 19 / 15.5
Total no of admissions during
the study period / 797 / 690 / 256
Research Personnel
Full Time Equivalent RCs / 1 / 2 / 1
Part Time Equivalent RCs / 2 / 0 / 0
Average Experience RCs (years) / 3.06 / 8.0 / 2.91
RC's availability on weeknights / No / No / No
RC's availability on weekends / No / No / No
Research Culture
Posters in Family Waiting Room
Critical Care research, in general
Specific studies / Yes
Yes / No
No / No
No
Pamphlets in Family Waiting Room
Critical Care research, in general
Specific studies / Yes
No /
No
No /
Yes
No
Poster elsewhere* to inform ICU personnel regarding
Critical Care research, in general
Specific studies / Yes
Yes / No
Yes / Yes
Yes
Access to interpreters / No / No / Yes
Letter of Information in other languages** / No / No / No
Facsimile consent permitted / Yes / Yes / Yes
Telephone consent permitted / Yes / Yes / Yes
Co-enrollment permitted / Yes / Yes / Yes
Research Ethics Board Membership and Representation
No. of regular members / 35 / 35 / 23†
Critical care representation / Yes / Yes / Yes
No. of members from Critical Care / 2 / 2 / 1

Table E2: Study Characteristics at Participating ICUs

ICU # 1 / ICU # 2 / ICU # 3
Number of studies / 10 / 4 / 8
Study Design
Full RCT
Pilot RCT
Observational (no intervention)
Observational (with intervention)
Biological Specimen Collection
Observational (no intervention) and Physiological
Observational (no intervention) and Biological specimen
Observational (with intervention) and Biological specimens
Other / 2
1
1
1
1
1
2
1
0 / 1
0
2
1
0
-
0
0
0 / 2
1
-
1
0
1
1
0
2

Table E3: Study Participation

Classifications / Never Approached / Approached, Consent Obtained / Approached, Consent Declined / Approached, Consent Obtained and Declined / Approached, No Decision
Study Arm
(n= number of SDMs) / MD
(n=15) / non-MD
(n=5) / MD
(n=35) / non-MD
(n=45) / MD
(n=9) / non-MD
(n=12) / MD
(n=2) / non-MD
(n=0) / MD
(n=6) / non-MD
(n=8)
Eligibility Events ( n)
Able
Dynamics
Enpoly
NGAL
Oscillate
PUN
Towards Recover
Starrt AKI
Oscillate Biomarker / n = 16
2
6
0
3
1
3
1
0
0 / n=5
0
0
1
0
0
4
0
0
0 / n=46
5
10
0
14
1
6
7
2
1 / n=52
4
10
0
15
0
7
15
1
0 / n=11
0
1
0
2
1
7
0
0
0 / n=13
0
5
0
1
1
6
0
0
0 / n=4
01
0
0
2
0
0
0
1 / - / n=7
0
0
0
1
0
2
4
0
0 / n=8
0
1
0
0
0
0
7
0
0

Table E4: Reasons Why Substitute Decision Makers Were Not Approached

Reasons / MD Introduction / Non-MD Introduction / Total
Patient now able to provide first party consent and SDM consent no longer required / 1∞ / 3§ / 4
Unable to contact SDM by telephone or in person (with functional contact information) / 3 / 1 / 4
Before RC is able to contact SDM, patient became ineligible for study or time ran out / 8 / 1 / 9
Unable to clarify who is the SDM despite efforts / 1* / 0 / 1
SDM has language barrier; translator not available / 1 / 0 / 1
Other / 1 / 0 / 1

Table E5: Reasons Why Substitute Decision Makers Did Not Provide a Decision

Reasons / MD Introduction / Non-MD Introduction / Total
SDM did not return a response regarding research participation to the team while the patient was still eligible / 1 / 0 / 1
SDM did not return a response regarding research participation to the team and concurrently the patient became ineligible / 2 / 0 / 2
SDM unwilling to make a decision on behalf of their loved one / 1 / 1 / 2
Patient died after SDM was approached / 0 / 1 / 1
Post SDM approach, patient now able to provide first party consent and SDM consent no longer required / 2∞ / 5§ / 7
Other / 0 / 1 / 1

Table E6:The Role of Physicians in the Consent Encounter (Supporting Quotes)

Favorable Views
Of Physician
Involvement
Unfavorable Views of Physician Involvement
Ambivalent Views of Physician Involvement: / “I would have been comfortable with physician involvement to give more insight on what was happening within the research. Having the physician explain the medical implications of what was taking part would have been better” (Interview #4; NonMD approach)
“It was classier … It made it easier for her (the research coordinator) because he is introducing her. She is not coming as a cold call.” (Interview #3; MD approach)
“Let them look after my husband and I’ll speak to the person about the survey” (Interview #2; MD approach)
“I know they are very busy. I don’t want them taking time away from other patients… their time should be spent …taking care of the patient or other patients…because it is a very busy place” (Interview #12; MD approach)
“A person may think they have to participate …if they don’t they might compromise the treatment the patient is getting….but I did not feel that way. You may think that there is some benefit that the physician may be gaining. Just a thought.” (Interview #13; MD approach)
“I don’t think that it is necessary to waste the time of the physician” (Interview 5; MD approach)
“I would rather him look after my son” (Interview 11; MD approach)
“I don’t have to have the person that is working on my mom introduce me to the person that is going to study a whole bunch of people….I can be approached by just that person” (Interview #9; NonMD approach)
“Nothing against being approached by a physician. I wouldn’t expect that as a requirement. I wouldn’t expect a doctor to approach me when he has a very capable person to handle that.” (Interview #1; NonMD approach)
“Even if the doctor or a nurse is explaining, it doesn’t really matter. I don’t really need a physician” (Interview #6; NonMD approach)
“As long as she could prove who she was, it would be more important to me” (Interview 5; MD approach)
“I don’t think it would have made any difference to my decision because I trust everybody that is in here…it didn’t make a difference whether it was a doctor or a nurse that approached me” (Interview 12; MD approach)
‘It would not have made any difference because it was voluntary and I could have withdrawn at any time” (Interview 13; MD approach)
“It was more comforting because I know that she (the physician) is looking after the needs of my father at the same time … it was just reassuring.” (Interview #13; MD approach)

Table E7: Perceived Beneficial Roles of Physician Involvement in Introducing Research (Supporting Quotes)

Enhancing the credibility of research / “I think it just legitimizes the research” (Interview #10; MD approach)
It would be a good idea to have more members for clarification. There is a stamp of approval.” (Interview #7; NonMD approach)
“Better in terms of my respect” (participant 4; NonMD approach)
“I just wanted to hear it from a physician” (participant 8; NonMD approach)
“Invasive kind of ….study….I would have preferred it if an ICU physician had approached me” (participant 14; NonMD approach)
“I would still participate even if the physician wasn’t there. Having the physician there would have been better though” (participant 4; NonMD approach)
Providing reassurance and increasing comfort and confidence in decision-making / “The more that’s explained, the more comfortable I would feel. Coming from him (the MD) would give more confidence” (Interview #8; NonMD approach)
“I would have to say that it just adds……some re-assurance to what the social worker/nurse might be saying as well” (Interview 1; NonMD approach)
‘I probably would have wanted to ask him more questions about my husband’s condition” (Interview 2; MD approach)
“You would realize that they don’t consider the risk factors to be….potentially what they could be…It probably takes away from me wanting to make sure that it is safe” (Interview 10; MD approach)
“To give you a second opinion…..confirm what was going on” (Interview 12; MD approach)
Ensuring broad awareness of patient participation by the clinical team / “Just to have more members [know]…..there was a research study and I signed something” (Interview #7; NonMD approach)
“It adds some re-assurance. Obviously if you hear from two people, it reinforces. I don’t expect him to come to me and ask me. If he did, wonderful” (Interview #1; NonMD approach)
“By all means the physician should at least be informed…yes indeed this person has been interviewed and yes indeed they have agreed to participate, ….…and I think that’s good for the physician to know that” (participant 1; NonMD approach)
“Just to have more members [know]…..there was a research study and I signed something” (participant 7; NonMD approach)

Table E8: Secondary Themes (Supporting Quotes)

The characteristics of the individual approaching / “I was 100% on that person’s side from the get-go and it was because of her personality … I wanted to listen to this person … The right person in the right position” (Interview #1; NonMD approach)
“She asked if I was comfortable first and was not pushy at all. She wasn’t trying to rush me and was very knowledgeable” (Interview #12; MD approach)
“It was very, very professional and done with a lot of thought and consideration. There was empathy” (Interview #4; NonMD approach)
“She made me feel comfortable with it … made me feel at ease. Very professional” (Interview #8; NonMD approach)
“She was polite, she was kind…..she was deferential” (Interview #9; NonMD approach).
The importance of timing in the approach and having space to make decisions / “My whole world was crashing. I was scared out of my brain and frightened for everything. It probably would have been better if we knew he was stabilized even before I was approached. It was probably just a wrong time. I think it would be totally different if it was maybe the next day when I had sleep and was able to think properly” (Interview #7; NonMD approach).
“I felt like I couldn’t make any decisions about anything….[they just need to] see the mental state of the person they are approaching whether they are up to listening and taking in information or not” (Interview #7; NonMD approach).
“I didn’t have time. I requested some information that I could look at after. She didn’t need an answer right then and I was good with that because I needed to review the information.” (Interview #11; MD approach)
“I don’t know if there was ever a real opportune time” (Interview #12; MD approach)
“I understood that we needed to be approached right away if you wanted to do this” (Interview #12; MD approach)
“Make sure nobody else is around. Consider privacy” (Interview #12; MD approach)
“You don’t want anybody to come and tell you about any research. ..all I want is you to come and tell me what is going on with my husband. Don’t tell me anything about research, please….it is not a priority for me. My priority is my husband” (Interview #6; NonMD approach)
“I mean they should assess the situation first and say are you up to date….I wanted to say please go and leave me alone. I was very upset so it was the wrong place at the wrong time” (Interview #6; NonMD approach)
“You may have to be careful with different people that may have had an acute situation or crisis develop and how hard it must be to be faced with stuff that they might find irrelevant” (Interview #10; MD approach)
“ I’m sure they do take into consideration when someone’s in crisis…..it must be awfully exhausting to have somebody come at you for research” (Interview #10; MD approach)
“I think you need to check with the nursing staff to see if the patient has somewhat stabilized because, if they are not, it maybe isn’t the best time to approach a family member. My son had stabilized so I could concentrate. It wasn’t a bad time. Other times might have been a bad time” (Interview #11; MD approach)
“It was handled very well but I guess just [consider] the emotional stability of the person making that decision.”(Interview #12; MD approach)
“I took my time. That’s why I told her, can you come back?” (Interview #6; NonMD approach)
“I would love to …but because I am so sad and I don’t know if he’s going to get better or pull through…..can you give me time to think? (Interview #6; NonMD approach)
“So much was happening. There were a lot of people around him and I was upset and worried sick. I was worried he wasn’t going to make it through. It took my mind off it when she spoke to me” (Interview #2; MD approach)
If the crisis develops further… I might have been more distracted…At this point, it is a bit of a diversion so I don’t mind being included” (Interview #10; MD approach)
“I didn’t really like it to tell you the truth. If you’re in this kind of situation, you don’t want anybody to come to tell you about any research. Don’t tell me anything about research, please.” (Interview #6; NonMD approach)
“To have been approached about the study would have maybe not been appropriate in front of other people” (Interview #11; MD approach)
Personal responsibility in their role as decision-maker / “It wasn’t up to them, it was up to me. I think they did it right and I made a decision and that’s all” (Interview #8; NonMD approach)
“Because she was unconscious at the time…I was the person to make the call” (Interview #9; NonMD approach)
“I felt very important and needed” (Interview 1;NonMD approach)
“Do you think you should have been approached for consent to participate in research studies?“Of course” (Interview #1; NonMD approach)
“ Because they wanted the research and I was the one that would give them permission” (Interview #2; MD approach)
“I am her husband, I am number one on the list” (Interview #3: MD approach)
Appraising risks and benefits to patient and others / “The possibility that my son, at any point throughout the study, might be able to benefit somehow was the goal for me.” (Interview #11; MD approach)
“Research is important and any research that can help somebody else further down the road, my husband probably wouldn’t be where he is today if there hadn’t been research” (Interview #2; MD approach)
“I wanted to be 100% sure that there would be no risks because she’s already in a bad enough situation. That was my main concern. As long as it didn’t do any harm, to my wife, I was fine with it” (Interview #8; NonMD approach)
“Well the benefit would be to the general population of ill people in furthering medicine and the risks to taking blood….I didn’t see that as much of a risk” (Interview #9: NonMD approach)
“Because I’m sitting there, basically not able to help medically with anything, this is an area where I can help my sister and the staff, so that’s why I certainly wanted to do it. It was a win-win and why wouldn’t I want to help them when they have been so wonderful to my sister (Interview #1; NonMD approach)
“I was thinking it…would give him more extra attention” (Interview #7; NonMD approach)
“Just to help the research and then from there …either benefit her or other patients in the future (Interview #8; NonMD approach)
“You know like this research is being done just to benefit the patients here.” (Interview #8; NonMD approach)
“Just help somebody or her” Interview #8; NonMD approach)
“ benefits, of course …would be to the general population of ill people in furthering medicine and risks to taking blood..I didn’t see that as much of a risk (Interview #9; NonMD approach)
“I thought if it can help other people understand what happens … the benefit it could bring to other people.” (Interview #9; NonMD approach)
“The only way to make progress is through research...find new ways of treating diseases and so on and eventually cures for some of the disease (Interview #14; NonMD approach)
“I don’t mind doing research if it benefits other people, I’m fine with that (Interview #7; NonMD approach”
“I knew it was for a good benefit….a good cause” (Interview #13; MD approach)
“I am helping out other patients and families” (Interview #13; MD approach)
“I think the overall main thing was that……it’s for a good cause, its helping other patients, whatever data that you collect from my father its going benefit” (Interview #13; MD approach)
“In the long run, helping other people….. getting ideas about how two different groups fare out in the end…..Is there any benefit or were they both the same……just for the research and you know progress” (Interview #14; NonMD approach),
“I believe in this……what you’re doing. I thank you for of thinking of us to put us in this study …because I think it can help a lot of people (Interview #12; MD approach)
“It helps others” (Interview #13; MD approach)
“Well other than the very slight amount of blood being taken….I didn’t see that as a risk” (Interview #9; NonMD approach)