National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis

Abstract

Background and Purpose

No standard approach to obtaining informed consent for stroke thrombolysis with tissue plasminogen activator (tPA) currently exists. We aimed to assess current nationwide practice patterns of obtaining informed consent for tPA.

Methods

An online survey was developed and distributed by email to clinicians involved in acute stroke care. Multivariable logistic regression analyses were performed to determine independent factors contributing to always obtaining informed consent for tPA.

Results

Among 268 respondents, 36.7% reported always obtaining informed consent and 51.8% reported the informed consent process caused treatment delays. Being an emergency medicine physician (OR 5.8, 95% CI 2.9–11.5) and practicing at a non-academic medical center (OR 2.1, 95% CI 1.0–4.3) were independently associated with always requiring informed consent. The most commonly cited cause of delay was waiting for a patient’s family to reach consensus about treatment.

Conclusions

Most clinicians always or often require informed consent for stroke thrombolysis. Future research should focus on standardizing content and delivery of tPA information in order to reduce delays.

Introduction

The benefits of tissue plasminogen activator (tPA) for acute ischemic stroke are extremely time dependent.¹ Efforts such as the American Heart Association’s Get With the Guidelines-Stroke focusing on systems-based improvements have reduced thrombolytic treatment times nationally.² Despite this and similar initiatives, substantial proportions of tPA-eligible patients still have delayed treatment² while some refuse tPA treatment altogether.³

Current professional guidelines recommend that physicians obtain informed consent prior to the administration of tPA.^{4, 5} Improvement in the informed consent process has been a suggested target to further reduce delays.^{3, 6} However, no standardized approach exists to obtain informed consent for tPA. The objective of this national survey was to determine current practice patterns of informed consent for stroke thrombolysis.

Methods

All data, analytic methods, and study materials are available upon request. See Supplemental Methods for complete details.

Survey Content

We developed a 27-question survey assessing practice patterns of obtaining informed consent for tPA. Informed consent was defined as “either written or verbal” informed consent. Respondents were asked but not required to add free-text responses describing the causes of delay in obtaining informed consent.

Survey Administration and Participant Selection

Invitations to participate in the online survey were emailed to clinicians (e.g., neurologists, emergency physicians, interventional radiologists, and internists). The survey was self-administered and remained open from November 1, 2015 until February 29, 2016. We used a modified Dillman recruitment method to increase participation.⁷ Consent was provided upon initiation of the survey. The local Institutional Review Board approved the study.

Data Analysis

Descriptive statistics entailed Chi-squared tests for categorical comparisons and non-parametric tests for continuous variables. Multivariable logistic regression analyses were performed to determine independent factors contributing to consent practices.

Qualitative analysis involved thematic analysis⁸ of free-text comments that were independently coded by two authors (SM and LT). Coding continued until reaching thematic saturation.⁸

Results

Response Rate and Demographics

Of 809 invited clinicians, 268 (33.1%) completed the survey among whom 199 clinicians reported routinely evaluating acute stroke patients’ eligibility for tPA (Table 1).

Table 1.

Survey Respondents.

	Study Cohort
Characteristics	N = 199	%
Medical Specialty
Neurology	113	56.8
Emergency medicine	73	36.7
Interventional radiology/neurology	9	4.5
Internal medicine	4	2.0
Professional status
Attending physician	130	65.3
Resident or fellow in training	7	3.5
Nurse/nurse practitioner	20	10.1
Other/not specified	42	21.1
Practice environment
Academic medical center	146	73.4
Employed by community hospital/medical group	40	20.1
Private practice affiliation	9	4.5
Other/not specified	4	2.0
Years in practice, mean (SD)	13.1	(9.5)

Practices of Informed Consent for tPA

Neurology attending physicians (64.8%), neurology residents (57.8%), and emergency medicine attending physicians (54.8%) were identified most often involved in obtaining informed consent (Supplementary Table I). Most respondents (90.5%) identified the risk of intracranial hemorrhage as necessary content to disclose and 87.4% reported a verbal description of risk and benefits as the preferred means of communication.

In the 3-hour treatment window, 36.7% of respondents reported always requiring informed consent (Table 2), being highest among emergency medicine physicians. Another 21.1% of clinicians reported never requiring informed consent for tPA in the 3-hour window, being highest among those who practiced neurology (69.0%).

Table 2.

Practice of obtaining informed consent for tPA

Question	Answer*	N = 199	%
Is informed consent required within 3 hour time window	Never	42	21.1
	Rarely	21	10.6
	Sometimes	29	14.6
	Often	34	17.1
	Always	73	36.7
Practice of informed consent differs between 3 and extended 4.5 hour time-window	No	132	66.3
Time required to obtain informed consent	< 5 min	109	54.8
	5 – ≤ 10	64	32.2
	10 – ≤ 20	18	9.0
	> 20 min	3	1.5
Experienced tPA delay due to a problem in obtaining informed consent	Yes	103	51.8
Always attempts to find a proxy if patient cannot consent	Yes	102	51.3
Time spent on attempting to contact a proxy	No time	53	26.6
	< 15 min	115	57.8
	≥ 15 min	10	5.0
As long as it takes		17	8.5
Ever administer tPA without informed consent	Yes	153	76.9
Content of informed consent		N=199	%
Risk of intracranial hemorrhage		180	90.5
Time dependent benefit		152	76.4
Side effect (e.g angioedema)		140	70.4
Potential for no benefit		130	65.3
One-third of patients will show some improvement with therapy		122	61.3
Professional guidelines about tPA		73	36.7
No effect of tPA on stroke mortality		59	29.6
Level of evidence for therapy		58	29.1
Other (e.g. cost, FDA approval)		22	11.1

^*Most common answer shown for dichotomous (yes/no) variables

In the 3-to-4.5-hour treatment window, 50.3% of respondents indicated that they always obtain informed consent, including 8.0% who require signed written consent. Another 13.5% of clinicians reported never obtaining informed consent for tPA in the extended window.

Over half of clinicians (51.8%) reported a delay in administering tPA because of a problem in obtaining informed consent. The median frequency of consent-related delay was 15.0% (interquartile range 10.0 to 25.0%).

In univariable analysis, being an emergency medicine physician (p<0.01), practicing for more than 20 years (p=0.03), and not being affiliated with an academic medical center (p<0.01) were associated with always requiring informed consent for tPA within the 3-hour time window. In a multivariable model of predictors of always requiring consent, emergency medicine physicians (OR 5.8, 95% CI [2.9–11.5], p<0.01) and practicing at a non-academic medical center (OR 2.1, 95% CI [1.0–4.3], p=0.04) were significantly more likely to always require consent for tPA.

Causes for Delay

We identified three major themes from the 85 completed surveys (42.7%) that contained free-text comments about the causes for consent delay (Supplementary Table II). The most commonly cited theme (36.5%) was delay due to waiting for a patient’s family to reach consensus about treatment.

Discussion

In a national survey, a majority of clinicians always or often require informed consent for tPA and report treatment delays because of the informed consent process. Since informed consent is a barrier to stroke thrombolysis, future interventions to facilitate rapid treatment should target consent practices.

Current professional guidelines recommend obtaining informed consent for tPA “when feasible,”^{4, 5} such as when the patient possesses capacity or a proxy “can be found after reasonable effort.”⁴ Our finding that emergency medicine physicians are more likely to require informed consent may reflect different professional views about risks and benefits of tPA. The American Academy of Emergency Medicine states that “objective evidence regarding efficacy, safety, and applicability of tPA for acute ischemic stroke is insufficient to warrant its classification as standard of care.”⁹ This is in contrast to the American Academy of Neurology¹⁰ and American Heart Association/American Stroke Association’s⁵ strong endorsement.

While a variety of decision aids exist to assist clinicians in the informed consent process for tPA,^{11, 12} no standardized content, format, nor requirements have been developed. A generalizable decision aid will need to balance the informational needs of patients and proxies with the time-sensitive nature of stroke thrombolysis.

This study has limitations. The response rate, while low for an in-person survey, is consistent with online surveys administered to healthcare professionals.¹³ The findings may not generalize to all stroke providers. The results may over-represent the practices of neurologists and those practicing in academic medical centers who comprised the majority of respondents. However, we included clinicians from academic, non-academic, urban, and rural healthcare systems in 40 different states. Respondents’ reported behaviors may not reflect actual behavior. Lastly, thematic analyses were limited to those clinicians who provided free-text comments and, thus, may not reflect all clinicians’ experiences.

Summary

Most clinicians obtain informed consent prior to stroke thrombolysis and experience delays during the process. Emergency medicine physicians and those practicing at non-academic medical centers are more likely to require consent for tPA. Given the time-sensitive nature of stroke thrombolysis, future research should focus on standardizing the content, format, and delivery of information in a manner that respects patient autonomy while delivering timely treatment.