Table 3.
Thematic summary with key concepts and supporting quotes
| Key Concepts | Supporting Quotes |
|---|---|
| Recruitment and consent process | |
| Communication of study purpose and processes by trusted team member • Health care team members understand patient's condition holistically • Health care team members as an information relay between patient and research team • Conveying the belief that trial participation is appropriate and low risk • Use of accessible language and terminology |
I think the more it [trial recruitment] can be someone who's got a relationship with the wife and the patient. I love the idea of the nurse…a clinical relationship, a trusted relationship—Participant 1, Group A The person that's doing it [trial recruitment] has to believe in it and be authentic about it—Participant 2, Group A If I had to make a decision for my husband, my biggest concern is when he wakes up is he going to say—“Why did you give that to [me]?” I would want to be assured that that decision I'm making is a good one for him—Participant 2, Group B I think as long as they have a good bedside manner, I've had some pretty bad ones in hospital. I think you need the right person to sit down and talk to you. Where they come from, it doesn't really matter, they just have to be good at it—Participant 1, Group C We talked about an easy way to explain it to the patient so they understand it and the side effects and the risk associated with the drug. It's that simplification of what the effects are and what the risks are going to be—Participant, Large-group discussion |
| Streamlined recruitment through access to electronic health records • Integration within clinical workflows • Consent to access health records implied as a requirement of inpatient care • Avoiding delays in potentially beneficial treatment for people with critical illness • Respect for privacy concerns by limiting the type/amount of health data accessible to research teams |
That's not an invasion of anyone's privacy. There is already invasion at your request, you came in the door of the hospital asking for help—Participant 2, Group A There should not be a middleman. It should be direct between the patient and the research team, and it should be the health care system flagging it to the researchers that there is a potential match and then going from there—Participant 2, Group C I share the hesitancy with the information being shared from specific groups in our community. If Black people would know that researchers could get a hold of them and talk to them and they might have hesitancy because of the history of research of being abusive toward specific groups, racialized groups and they would be like shocked that research has access to their medical information—Participant 2, Group C Everyone was in favor of technology enabled [recruitment] by the research team. They wanted the potential to participate to happen as quickly as possible. They didn't want people to having to comb through their medical record to see if they were on medications, they wanted it to happen quickly—Participant, Large-group discussion |
| Family and/or physician involvement in decisions about participation • Consent by family member when patient condition precludes active care participation • Family member assistance with information processing • Physician advocacy for optimal care extends to trial participation • Credibility of and trust in physician advice |
I was in a medically induced coma for 5 wk and all the decisions were made by my wife. I know for a fact the only question that she is going to ask is—what's best for my husband?—Participant 1, Group B Patients don't know the medical research behind [intervention]. We trust whatever our doctors are telling us is in our best interest—Participant 2, Group B I think the argument would be they [physicians] are already making life and death decisions for you, so if they already add on—well there's also this research study that might help a life-or-death situation—Participant 5, Group B It's very important to develop an approach for the recruitment and get the consent from a family member. Some people are not conscious when this is going on, so I think a family member is a key point—Participant, Large-group discussion |
| Intervention delivery | |
| Weighing risks associated with intervention components • Appreciating the risks of participation and nonparticipation • Acceptability of a placebo arm • Commitment to trial participation supersedes concerns about minor risks • Disclosure about possible indirect adverse events (e.g., IV site infection, hospital-acquired infection) |
There are even different opinions among the health care team about how long it's safe to leave a line [IV access] in each location. Some people say 48-hours, others would say a week—Participant 2, Group A I would make sure that they understand that we've been using this [cilastatin] for a long time in the system and it hasn't had any ill effects on anybody. I think that's very necessary—Participant 1, Group B I think the doctor should give you the heads up on the drug, give you the option of taking it or not taking it. I mean, at that point if you are sick and you've got kidney failure, what options do you have?—Participant 5, Group B If I knew that I could just get a placebo and that I'm going to actually have some kidney function decrease with this medication that I'll be getting for my cancer, I would be really concerned. I've taken part in medication trials… I found out when it was finished that I actually did [receive study drug], but I was so glad because getting the placebo would have put me in danger of losing my kidney after my kidney transplant—Participant 3, Group C They also wanted to know the safety risks. The safety profile of cilastatin would make them more or less likely to agree to a longer-term treatment or a second IV port—Facilitator, Large-group discussion |
| Intervention administration and monitoring tied to routine care activities • Complying with study processes to enable participation • Placement of new IV access only if care team deems necessary • Availability of close monitoring in inpatient setting • Convenience of intervention administration while hospitalized |
I would think the conditions that are being treated, you would probably already have an IV. I think most of them would be very small percentage that you would be admitted without an IV in—Participant 2, Group B When I was in hospital, I didn't feel sick at all. I'm sitting there on an IV and looking for something to do—Participant 3, Group B Wouldn't that be the best time to do it [while in hospital]? You are continually monitored. You are hooked up to an IV—Participant 5, Group B I would get it done [receive intervention dose] as many times as required—Participant 4, Group C |
| Logistical considerations to enable follow-up • Reimbursement and support for travel, parking, childcare, lost wages, etc. • Minimizing unnecessary facility-based visits • Discontinuation of trial drug before discharge |
You have to pay for parking here [in hospital] which is outrageous and you have to maybe pay for a babysitter or a person sitter or you might have to give up hours at work—Participant 2, Group A Even if you lived in [town] and you are a patient here. If you are going to come back two and three times a day, I mean—Participant 4, Group A I would be nervous going home with it [IV access], to be honest—Participant 2, Group B Especially if you live alone, you are not feeling well and you don't have a lot of money for taxis, it's an issue—Participant 1, Group C I would do anything not to go into a hospital… Another clinic though, I mean at least it would be controlled, it would be smaller. I would feel more comfortable with that. I could mask up and they would be masked—Participant 3, Group C Their preference was if they were to get it [cilastatin] after would be not to come back to the hospital itself. That it would be better to be in a clinic somewhere, somewhere removed from the hospital itself—Participant, Large-group discussion |
| Trial outcomes | |
| Emphasis on kidney-related outcomes • Prioritization of averting adverse renal outcomes, such as AKI or need for dialysis • Availability of routinely collected electronic health data to measure short-term and long-term renal outcomes (e.g., serum creatinine, dialysis dependence) • Capture of both adverse (e.g., AKI) and favorable (e.g., AKI recovery) renal outcomes |
It should be emphasized how important kidney function is because they are really not taught to do that in medical school and we don't pay enough attention to it—Participant 2, Group A The clinical stuff is number one, I would say, to make sure his [patient from vignette] kidney function hasn't decreased—Participant 3, Group B They couldn't believe my recovery, and you probably remember how my kidneys went from this [low] to this [high] again, and you said, “Holy Dinah”—Participant 5, Group B The one thing that comes into my mind would be the long-term, probably clinical [outcomes]. That you are going to be left with a nonfunctioning or low functioning kidney leading to dialysis or loss of kidney function—Participant 1, Group C If you are in some sort of acute scenario keeping you alive, keeping your organs working for a long period of time and not having negative side effects are kind of the most important—Participant 4, Group C |
| Return to an acceptable quality of life and functional status • Re-establishing previous level of physical and mental wel-lbeing • Quality of life is affected by renal and other clinical outcomes • Not overlooking caregiver outcomes, such as caregiving burden and mental health • Objectively measuring of quality of life with validated tools (e.g., patient-reported outcome measures) |
I just think, for me [as caregiver], it's overwhelming, the world of ICU… It's a real challenge for family members—Participant 1, Group A I can tell you the kidney damage to quality of life is a lot more profound than patients will normally tell you. I mean people look at me and say, well you are ok because I play tennis four times a week and I'm doing almost everything I did before, but it's not the same. I'm not my normal self and I can't live a normal life.—Participant 2, Group A I would want to see my husband heal, get better… We want to see him get out of that bed and walk—Participant 3, Group A If they were working before they got sick, when they get better they could go back to work. You just want to be able to do the things you did before you got sick—Participant 2, Group B Taking care of me is taking care of my physical health and my mental health also. Both work hand in hand with each other. If somebody goes into hospital and they come out and have a mental [health] issue after because of what was done to them in the hospital—that's not right. We've got to protect that with those patients going in and out of the hospital—Participant 1, Group B I would think, you know, hoping that he would be able to work and be part of the family would be a big, big thing… I'm thinking long term consequences that would be the most important and that would be one of them—Participant 1, Group C |
| Expectations for monitoring outcomes and ensuring safety • Trends over time (e.g., kidney function, functional status) as important as dichotomous outcomes • Frequency, timing, and specific testing at the discretion of care team • Delegating responsibility for follow-up (e.g., nephrologist versus primary care) • Monitoring for long-term safety of intervention |
Whatever they [care team] need to do for a test to determine whether the medication is working or not—Participant 1, Group A It would be nice to know who should be in charge of that [monitoring outcomes], the family doctor or a nephrologist?—Participant 2, Group A We need to trend those stats… Where they are at, where they are going. Is it better? Is it worse?—Participant 4, Group A I think when you are dealing with the spouse, safety first has got to be the key with that—Participant 1, Group B When something happens to somebody, I think it's very necessary to measure and say, this is what our expectations are going forward—Participant 1, Group B |
ICU, intensive care unit.