Article

Consent for emergency treatment: Emergency department patient recall and understanding

Correspondence / American Journal of Emergency Medicine 37 (2019) 13621393 1387

Table 1

Patient demographic and stress tests information.

Patient demographics

Frequency (n = 57) Percent

Gender

Male

20

35%

Female

37

65%

Lorenz MW, Von Kegler S, Steinmetz H, Markus HS, Sitzer M. Carotid intima- media thickening indicates a higher vascular risk across a wide age range: pro- spective data from the carotid atherosclerosis progression study (CAPS). Stroke 2006;37:87-92.
  • Lorenz MW, Markus HS, Bots ML, Rosvall M, Sitzer M. Prediction of clinical cardio-
  • vascular events with carotid-intima media thickness: a systematic review and meta-analysis. Circulation 2007;115:459-67.

    Coskun U, Jildiz A, Esen OB, Baskurt M, Cakar MA, Kilikesmez KO, et al. Relationships between carotid intima-media thickness and coronary angiographic findings: a pro-

    Ethnicity

    spective study. Cardiovasc Ultrasound 2009;7:59.

    White

    24

    42.1%

    Black

    21

    36.8%

    Hispanic

    10

    17.5%

    American Indian

    1

    1.8%

    Asian

    1

    1.8%

    Age

    Consent for emergency treatment: Emergency

    Mean Age

    53

    department patient recall and understanding

    Min Age

    33

    Max Age

    Stress test

    79

    Frequency (n = 57)

    Percent

    Exercise stress ECHO

    33

    57.9%

    Pharmacologic stress ECHO

    22

    38.6%

    Pharmacologic nuclear stress

    2

    3.5%

    Table 2

    2 x 2 table for positive CIMT on either side.

    Stress Pos

    Stress Neg

    CIMT Pos

    4

    26

    30

    CIMT Neg

    1

    26

    27

    5

    52

    57

    Table 3

    2 x 2 table for positive composite average CIMT.

    Stress Pos

    Stress Neg

    CIMT Pos

    4

    16

    20

    CIMT Neg

    1

    36

    37

    5

    52

    57

    References

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    2. Amsterdam EA, et al. AHA/ACC guideline for the management of patients with non-

      ST-elevation acute coronary syndromes. Circulation 2014;2014(130):2354-95.

      Yes, I read part of the document

      31 (11%)

      [3] Howard G, Sharrett AR, Heiss G, Evans GW, Chambless LE, Riley WA, et al. Carotid

      No, I did not read the document

      101 (36%)

      artery intimal-medial thickness distribution in general populations as evaluated by

      No, I did not read the document but I received a verbal explanation

      126 (45%)

      B-mode ultrasound. ARIC investigators. Stroke 1993;24:1297-304.

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      trasound to identify subclinical vascular disease and evaluate cardiovascular disease

      Table 2

      risk: a consensus statement from the American Society of Echocardiography Carotid

      Intima-Media Thickness Task Force endorsed by the Society for Vascular Medicine. J Am Soc Echocardiogr 2008;21:93-111.

      What did you consent to?a

      Don’t know

      107 (39%)

      [6] Eleid MF, Lester SJ, Wiedenbeck TL, Patel SD, Appleton CP, Nelson MR, et al. Carotid

      Treatment

      144 (52%)

      ultrasound identifies high risk subclinical atherosclerosis in adults with low Fra-

      Attending physician

      0 (0%)

      mingham risk scores. J Am Soc Echocardiogr 2010;23:802-8.

      Privacy/HIPAA

      12 (4%)

      [7] Chambless LE, Heiss G, Folsom AR, Rosamond W, Szklo M, Sharrett AR, et al. Associ-

      Photography

      0 (0%)

      ation of Coronary Heart Disease incidence with carotid arterial wall thickness and

      Finances, billing

      36 (13%)

      major risk factors: the Atherosclerosis Risk in Communities (ARIC) study,

      Personal property

      0 (0%)

      1987-1993. Am J Epidemiol 1997;146:483-94.

      [8] O’Leary DH, Polak JF, Kronmal RA, Manolio TA, Burke GL, Wolfson Jr SI. Carotid-

      patient rights

      9 (3%)

      Informed consent is a crucial component of patient autonomy and shared decision-making. Previous studies have shown that comprehen- sion of a variety of types of informed consent by patients is poor [1-3]. This study was undertaken to identify patient recall and understanding of the emergency department (ED) Consent for Treatment document.

      In this prospective survey study design, eligible participants in- cluded ED patients age 18 and older, who were able to communicate, not in distress, and consented to participate. After signing informed con- sent document per ED registration protocol, a convenience sample of patients meeting the inclusion criteria were invited to participate.

      A total of 293 patients consented to participate (95% participation rate). The mean age was 52 and the majority of participants were female (58%) and White (62%). The majority of participants stated that they had signed a consent document (N = 272; 93%). A minority of patients read the entire document (7%) or read part of the document (11%). Most patients did not read the document (36%) or received only a verbal ex- planation (45%) (Table 1). Many patients did not recall anything about what they signed (N = 107; 39%). The most frequently recalled ele- ments of consent included consent for treatment (N = 144; 52%), infor- mation regarding finances and billing (N = 36; 13%), and privacy rights (N = 12; 4%) (Table 2).

      Reading the document prior to signing was associated with African American ethnicity (p = 0.01). Age, gender, mode of arrival, and triage level were not associated with reading the document (Table 3). Respon- dents who indicated they didn’t know what they had consented to were significantly older (median 56 years) than respondents who remem- bered something from the consent form (median 47; p = 0.01). A

      Table 1

      Did you read the document prior to signing?

      Yes, I read the entire document 20 (7%)

      artery intima and media thickness as a risk factor for myocardial infarction and stroke in older patients. N Engl J Med 1999;340:14-22.

      a More than 1 response possible. Percentages are calculated based on n = 276.

      1388 Correspondence / American Journal of Emergency Medicine 37 (2019) 13621393

      Table 3

      Associations with reading the document prior to signing.

      References

      verbally explained

      Age (years,

      median [IQR]

      278

      44 [34-55]

      53 [34-60]

      55 [40-68]

      49 [32-64]

      0.13

      Male

      117

      9 (7.7%)

      12 (10.3%)

      50 (42.7%)

      46 (39%)

      0.25

      Female

      161

      11 (6.8%)

      19 (11.8%)

      51 (31.7%)

      80 (50%)

      African

      95

      9 (9.5%)

      14 (14.7%)

      22 (23.2%)

      50 (53%)

      0.01

      American White

      170

      11 (6.5%)

      15 (8.8%)

      74 (43.5%)

      70 (41%)

      Walk-in

      201

      18 (9.0%)

      24 (11.9%)

      73 (36.3%)

      86 (43%)

      0.22

      Ambulance

      Triage level

      74

      2 (2.7%)

      7 (9.5%)

      26 (35.1%)

      39 (53%)

      2

      74

      4 (5.4%)

      8 (10.8%)

      29 (39.2%)

      33 (45%)

      0.16

      3

      175

      16 (9.1%)

      18 (10.3%)

      66 (37.7%)

      75 (43%)

      4

      27

      0 (0%)

      5 (18.5%)

      5 (18.5%)

      17 (63%)

      higher percentage of walk-in respondents (56%) recalled consenting to treatment compared to ambulance arrivals (41.1%; p = 0.02). Respon- dents with higher triage levels more frequently recalled consenting to treatment (p = 0.02).

      When asked for comments about the consent for treatment process, the majority had no problems with the process or no specific comments (237 (81%)).

      Informed consent is an important ethical and legal component of medical care. In this study, we demonstrated that the majority of ED pa- tients in this study recalled signing a consent document, but most were not aware of elements of the consent document they had signed. De- spite this lack of awareness, the majority of participants indicated they were satisfied with the current process. These data speak favorably of patient trust in ED providers.

      health literacy is an important component of communication with patients. Poor health literacy is common among ED patients [4]. The In- stitute of Medicine (IOM) reports that over 90 million people, nearly half the adult population lack proper health literacy skills to understand their health [5]. Improving understanding of one’s health is crucial to maintaining patient’s autonomy and decision-making capacity. Some studies have reported a variety of approaches to improving patient health literacy [6-8].

      In conclusion, the majority of ED patients in this study recalled signing a consent document. Most were not aware of elements of the Consent for Treatment document they had signed. Walk in patients were more likely to recall the document than patients who arrived by ambulance. Patients high lower triage acuity recalled consenting to treatment compared to higher acuity.

      Catherine A. Marco Department of Emergency Medicine, Wright State University Boonshoft School of Medicine, Dayton, OH, United States of America

      Corresponding author.

      E-mail address: [email protected].

      Ashley LaFountain Ashwatha Thenappan

      Daniel E. Ross

      Wright State University Boonshoft School of Medicine, Dayton, OH, United

      States of America

      12 January 2019

      https://doi.org/10.1016/j.ajem.2019.01.019

      completing the informed consent process. Clin Trials 2014 Feb;11(1):70-6.

      Rose D, Russo J, Wykes T. Taking part in a pharmacogenetic clinical trial: assessment of trial participants understanding of information disclosed during the informed con- sent process. BMC Med Ethics 2013 Sep 11;14:34.

      N

      1. Read all

      2. Read

      3. Did

      4. Did not

      p-Value

      [1] Mexas F, Efron A, Luiz RR, Cailleaux-Cezar M, Chaisson RE, Conde MB. Understanding

      parts

      not read

      read but

      and retention of trial-related information among participants in a clinical trial after

      Sanchini V, Reni M, Calori G, Riva E, Reichlin M. Informed consent as an ethical re- quirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient’s informed consent comprehension. J Med Ethics 2014 Apr;40 (4):269-75.

    3. Balakrishnan MP, Herndon JB, Zhang J, Payton T, Shuster J, Carden DL. The association

      of health literacy with preventable emergency department visits: a cross-sectional study. Acad Emerg Med 2017 Sep;24(9):1042-50.

      Institute of Medicine. In: Nielsen-Bohlman L, Panzer A, Kindig DA, editors. Health lit- eracy: a prescription to end confusion. Washington, D.C.: National Academy Press; 2004

    4. Tait AR, Voepel-Lewis T, Chetcuti SJ, Brennan-Martinez C, Levine R. Enhancing patient understanding of medical procedures: evaluation of an interactive multimedia pro- gram with in-line exercises. Int J Med Inform 2014 May;83(5):376-84.
    5. Perrenoud B, Velonaki VS, Bodenmann P, Ramelet AS. The effectiveness of health lit- eracy interventions on the informed consent process of Health care users: a system- atic review protocol. JBI Database System Rev Implement Rep 2015 Oct;13(10): 82-94.
    6. Ryan RE, Prictor MJ, McLaughlin KJ, Hill SJ. Audio-visual presentation of information

      for informed consent for participation in clinical trials. Cochrane Database Syst Rev 2008 Jan 23;1:CD003717.

      Comparison of Quick Track(TM) and Melker(TM) for emergent invasive airway management in Simulated Obese Model

      To the Editor,

      emergent cricothyrotomy is the final step in managing difficult air- ways [1,2]. The Quick Trach II(TM) (QT; VBM Medizintechnik GmbH, Sulz am Neckar, Germany) was developed for direct placement in the tra- chea using the catheter-over-needle technique. In contrast, the Melker Set(TM) (Melker; Cook Group Incorporated, Bloomington, IN) uses a guide-wire for placing the cannula with the Seldinger method. It re- mains controversial which of direct placement or the Seldinger method is optimal for invasive airway management.

      While invasive airway management is known to be difficult in obese patients, no comparison of efficacy of QT and Melker devices have been performed in this patient population. Against this backdrop, the present study aimed to compare the performance of QT and Melker devices in terms of efficacy of cricothyrotomy on an obese manikin.

      Ethical approval was deemed unnecessary by the institutional re- view board of Osaka Medical College, and written consent was obtained from each participant. Participants were 15 doctors specialized in criti- cal care such as emergency medicine or anesthesiology who were re- cruited from a difficult airway training course at Osaka Medical College. Participants had 7.5 +- 4.9 years of Clinical training, and had used the QT 4.8 +- 3.9 times and the Melker 6.6 +- 3.2 times for cricothyrotomy in clinical or simulated situations.

      The SimMan(R) 3G (Laerdal, Sentrum, Stavenger, Norway) mani- kin was used in this study. The obese model was constructed by attaching 1 cm of simulated subdermal tissue (CVC training pad, Kyotokagaku, Japan) to the Cricothyroid membrane (Fig. 1a, b). In the Melker trial, participants used the Melker set, which consisted of a needle, a syringe, a guide-wire, a scalpel, a dilator, a 5-mm can- nula with an Inflatable cuff, and a syringe for blocking the cuff. In the QT trial, participants used the QT set, which consisted of a syringe, a conical-shaped needle, a plastic 4-mm cannula with an inflatable cuff, and a stopper [3]. Participants were given 30 min to practice these techniques, with the instructor available for advice. A trial started when the participant picked up the QT or Melker and ended

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