Is there a role for physician involvement in introducing research to surrogate decision makers in the intensive care unit? (The Approach trial: a pilot mixed methods study)

Burns, Karen E. A.; Rizvi, Leena; Smith, Orla M.; Lee, Y.; Lee, J.; Wang, M.; Brown, Maedean; Parker, Melissa; Premji, Azra; Leung, Doris; Mobilio, Melanie Hammond; Gotlib-Conn, Lesley; Nisenbaum, Rosane; Santos, Marlene; Li, Y.; Mehta, Sangeeta

doi:10.1007/s00134-014-3558-3

Cited by 14 publications

(20 citation statements)

References 35 publications

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“…One ethics board did raise concerns about the person obtaining consent, and recommended a deviation from common ethical guidelines stating that treating physicians should not be involved in the process of consent,10 instead arguing that the physician's close relationship with the family would make the consent process more acceptable in this unique situation. This is in contrast to literature suggesting that families do not feel that physician involvement in the informed consent process is useful11 or that physician approach for informed consent may be perceived as coercion 12…”

Section: Discussioncontrasting

confidence: 83%

Feasibility of conducting prospective observational research on critically ill, dying patients in the intensive care unit

et al. 2016

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Studying patients during the end of life is important, as it has the potential to lead to improvements in care for the dying. For patients who die after a controlled withdrawal of life-sustaining therapies in the intensive care unit, information about the natural history of death and the process of removing life support has additionally led to advances in practice for deceased organ donation. However, this unique population of severely critically ill and imminently dying patients has been difficult to study, largely due to assumptions made by research teams and ethics boards alike about the logistical difficulties of obtaining consent and completing research procedures before or during the process of withdrawal of life-sustaining therapies. In this paper, we describe the ethics substudy of the first prospective observational research study in Canada to obtain consent and collect clinical data on patients during the process of withdrawal of life-sustaining therapies in the intensive care unit. We describe in detail the process of protocol development, review by five institutional research ethics boards and bedside staff satisfaction with the study. We conclude that prospective research on a critically ill and imminently dying population is feasible and can be conducted in an ethical manner. Further information is needed about the experiences and motivations of families and substitute decision makers who provide consent for research on critically ill intensive care unit patients at the end of life.

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Section: Discussioncontrasting

confidence: 83%

Feasibility of conducting prospective observational research on critically ill, dying patients in the intensive care unit

et al. 2016

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“…[48] Although none of the study team members recruiting family members were physicians, all were trained to approach family members professionally and to allow families sufficient information, time, and space to make an informed decision about participation. [49] Recent qualitative research on the experiences of ICU families asked to participate in critical care research suggests that family members ultimately weigh the risk of participation against the potential benefit to the patient. [50,51] One of the “risks” associated with participation in our study was leaving the patient’s room and missing an update from a physician.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of a strategy for enrolling the families of critically ill patients in research using limited human resources

et al. 2017

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RationaleClinical trials of interventions aimed at the families of intensive care unit (ICU) patients have proliferated but recruitment for these trials can be challenging.ObjectivesTo evaluate a strategy for recruiting families of patients currently being treated in an ICU using limited human resources and time-varying daily screening over 7 consecutive daysMethodsWe screened the Johns Hopkins Hospital medical ICU census 7 days per week to identify eligible family members. We then made daily, in-person attempts to enroll eligible families during a time-varying 2-hour enrollment period until families declined participation, consented, or were no longer eligible.Measurements and main resultsThe primary outcome was the proportion of eligible patients for whom ≥1 family member was enrolled. Secondary outcomes included enrollment of legal healthcare proxies, the consent rate among families approached for enrollment, and success rates for recruiting at different times during the day and week. Among 284 eligible patients, 108 (38%, 95% CI 32%-44%) had ≥1 family member enrolled, and 75 (26%, 95% CI 21%-32%) had their legal healthcare proxy enrolled. Among 117 family members asked to participate, 108 (92%, 95% CI 86%-96%) were enrolled. Patients with versus without an enrolled proxy were more likely to be white (44% vs. 30%, P = .02), live in a zip code with a median income of ≥$100,000 (15% vs. 5%, P = .01), be mechanically ventilated (63% vs. 47%, P = .01), die in the ICU (19% vs. 9%, P = .03), and to have longer ICU stays (median 5.0 vs. 1.8 days, P<.001). Day of the week and time of day were not associated with family presence in the ICU or consent rate.ConclusionsFamily members were recruited for more than one third of eligible patients, and >90% of approached consented to participate. There are important demographic differences between patients with vs without an enrolled family member.

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“…4 SDM rationale for providing or declining consent in the ICU has been previously described. 8 Frequent reasons that SDMs provide consent include 1) belief that the patient will benefit from participation; 2) a strong desire to help others; 3) wanting to advance medical knowledge; and 4) the belief that their loved one would want to participate. The most common SDM reasons for declining consent were 1) uncertainty about their loved one’s wishes regarding research participation and 2) the concern that the risk may be greater than the benefits for their loved one.…”

Section: Discussionmentioning

confidence: 99%

Improving Research Enrollment of Severe Burn Patients

Lachiewicz

Williams²,

Carson

et al. 2017

Journal of Burn Care & Research

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Objective Enrolling severely burn injured patients into prospective research studies poses specific challenges to investigators. Methods We describe our experience of recruiting adults with ≥20% total body surface area burns or inhalation injury admitted to a single academic burn unit into observational research with minimally invasive specimen collection. We outline iterative changes that we made to our recruitment processes in response to perceived weaknesses leading to delays in enrollment. Our primary outcome was the change in days to consent for enrolled patients or cessation of recruitment for non-enrolled patients before and after the interventional modifications. We assessed change in overall enrollment as a secondary outcome. Results Study enrollment was ~70% in both 4-month study periods before and after the intervention. Following the intervention, time to consent by surrogate decision maker decreased from a median of 26.5 days (IQR 14–41) to 3 days (IRQ 3–6) (p=0.004). Time to initial consent by patient changed from a median of 15 days (IQR 2–30) to 3 days (IQR 2–6) (p=0.27). Time to decline for non-enrolled patients decreased from a median of 12 days (IQR 6.5–27) to 1.5 days (IQR 1–3.5) (p=0.026). Conclusions Both the findings of our study and our brief literature review suggest that careful design of the recruitment protocol, increased experience of the study team, and broad time windows for both approach and enrollment improve the efficiency of recruiting critically ill burn patients into research.

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Is there a role for physician involvement in introducing research to surrogate decision makers in the intensive care unit? (The Approach trial: a pilot mixed methods study)

Abstract: NCT01232621.

Cited by 14 publications

References 35 publications

Feasibility of conducting prospective observational research on critically ill, dying patients in the intensive care unit

Feasibility of conducting prospective observational research on critically ill, dying patients in the intensive care unit

Evaluation of a strategy for enrolling the families of critically ill patients in research using limited human resources

Improving Research Enrollment of Severe Burn Patients

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