ETHICS/BRIEF RESEARCH REPORT
Including Frequent Emergency Department Users With Severe Alcohol Use Disorders in Research: Assessing Capacity Ryan P. McCormack, MD*; Timothy Gallagher, MD; Lewis R. Goldfrank, MD; Arthur L. Caplan, PhD *Corresponding Author. E-mail: [email protected].
Study objective: Frequent emergency department (ED) users with severe alcohol use disorders are often excluded from research, in part because assessing capacity to provide consent is challenging. We aim to assess the feasibility of using the University of California, San Diego Brief Assessment of Capacity to Consent, a 5-minute, easy-to-use, validated instrument, to screen for capacity to consent for research in frequent ED users with severe alcohol use disorders. Methods: We prospectively enrolled a convenience sample of 20 adults to assess their capacity to provide consent for participation in 30-minute mixed-methods interviews using the 10-question University of California, San Diego Brief Assessment of Capacity to Consent. Participants were identified through an administrative database, had greater than 4 annual ED visits for 2 years, and had severe alcohol use disorders. The study was conducted with institutional review board approval from March to July 2013 in an urban, public, university ED receiving approximately 120,000 visits per year. Blood alcohol concentration and demographic data were extracted from the medical record. Results: We completed assessments for 19 of 20 participants. One was removed because of agitation. Sixteen of 19 participants passed each question and were deemed capable of providing informed consent. Interventions to improve understanding (prompting and material review) were required for 15 of 19 participants. The mean duration to describe the study and perform the assessment was 10.4 minutes (SD 3 minutes). The mean blood alcohol concentration was 211.5 mg/dL (SD 137.4 mg/dL). The 3 patients unable to demonstrate capacity had blood alcohol concentrations of 226 and 348 mg/dL, with 1 not obtained. Conclusion: This pilot study supports the feasibility of using the University of California, San Diego Brief Assessment of Capacity to Consent to assess capacity of frequent ED users with severe alcohol use disorders to participate in research. Blood alcohol concentration was not correlated with capacity. [Ann Emerg Med. 2015;65:172-177.] Please see page 173 for the Editor’s Capsule Summary of this article. A podcast for this article is available at www.annemergmed.com. 0196-0644/$-see front matter Copyright © 2014 by the American College of Emergency Physicians. http://dx.doi.org/10.1016/j.annemergmed.2014.09.027
INTRODUCTION Despite the considerable prevalence of alcohol use disorders, the majority of individuals with them do not access specialty treatment.1,2 Patients with alcohol-related frequent emergency department (ED) use often have numerous comorbidities, psychosocial instability, and a severe form of alcohol use disorder.3,4 These individuals often receive care exclusively in EDs, where treatment or referrals for alcohol use disorders are rarely initiated.2 Research to develop and implement effective interventions is even less common in this setting, particularly for individuals with severe alcohol use disorders for whom attrition or failure is expected. The challenges of properly obtaining informed consent in this population, particularly capacity to provide valid consent, further diminish the likelihood of participation in studies.5 Many existing measures of capacity may not be practical or reliable in this population in ED settings. 172 Annals of Emergency Medicine
It is critical to first define capacity and differentiate it from the process of informed consent. To have capacity, subjects must be able to (1) understand the facts involved in the decision; (2) appreciate the nature and significance of the decision; (3) weigh risks and benefits and potential alternatives; and (4) express their choice.6 When these basic elements of capacity are intact, the subject is capable of participating in the informed consent process, during which the potential participant may freely choose whether to participate in research (in this scenario) according to a clear understanding of what it involves. Objective measures of decisional capacity and interventions to enhance subjects’ understanding would help ensure inclusion of this vulnerable population in appropriate studies. Instruments and methods that are feasible in this population and in the ED setting are necessary to provide adequate subject protection without placing undo restrictions on potentially beneficial Volume 65, no. 2 : February 2015
McCormack et al
Including Frequent ED Users With Alcohol Disorders in Research
Editor’s Capsule Summary
What is already known on this topic Enrollment of subjects for studies on the emergency care of long-term alcoholics is challenging because of issues about the capacity of such patients to provide informed consent. What question this study addressed This observational, mixed-methods study investigated whether a 10-question instrument could identify longterm alcoholics who, despite having recently ingested substantial quantities of alcohol, had capacity to provide informed consent. What this study adds to our knowledge Seventeen of the 20 patients enrolled had blood alcohol levels greater than 100 mg/dL. Sixteen of the 20 participants (80%) answered all 10 items correctly and were deemed to have capacity. How this is relevant to clinical practice This instrument appears to successfully identify longterm alcoholics who have capacity to provide informed consent.
research. Previously cited objective measures, such as blood alcohol concentration, and subjective measures, such as clinical gestalt, have significant limitations.5,6 For subjects who are alcohol tolerant and require an elevated blood alcohol concentration to function at baseline because of their brittle dependence or who may have cognitive impairment and mental illness, these metrics are neither sensitive nor specific. Mandates to assess capacity when enrolling individuals with psychiatric illness in human subjects research led to the development of instruments to perform this task. However, existing instruments have yet to be adequately studied in patients with substance use disorders. Among these, the MacArthur Competence Assessment Tool for Clinical Research is the most studied and has demonstrated validity and reliability.7 This structured interview requires extensive training to administer and interpret, and the assessment requires 20 minutes, which limit its use in some settings. The University of California, San Diego Brief Assessment of Capacity to Consent, a 5-minute, easy-to-use, validated tool, may be a more feasible alternative.8 Similar to the MacArthur tool, the assessment occurs after potential participants are informed about the study. Both rate the basic elements of capacity (understanding, appreciation, reasoning, and ability to express a choice) to identify subjects with questionable capacity to consent to a specified research project. Volume 65, no. 2 : February 2015
Our study aims to examine whether the University of California, San Diego Brief Assessment of Capacity to Consent can be used to evaluate the capacity to consent to ED research of patients with severe alcohol use disorders and frequent ED use.
MATERIALS AND METHODS In this pilot study, we prospectively assessed the feasibility of using the University of California, San Diego Brief Assessment of Capacity to Consent to screen for capacity to consent for minimalrisk research with adults with frequent ED use related to severe alcohol use disorders. Participants were informed that a capacity screen would occur when they were initially recruited to participate in 30-minute, mixed-method interviews involving sensitive topics related to their alcohol use and social milieu. The university institutional review board approved the study with a waiver of consent to review medical records and written consent to conduct interviews. Participants received a $10 gift card. The study was conducted at an urban, public, university, tertiary care hospital receiving approximately 120,000 ED patient visits per year. We recruited a convenience sample during various hours and days of the week from March to July 2013. Potential participants were identified through an administrative database and approached for study participation when they presented to the ED. Participants were older than 18 years, spoke English, and met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for alcohol dependence with at least 2 days of heavy drinking per week, and had greater than 4 alcohol-related annual ED visits for 2 consecutive years. Patients were excluded if they received a diagnosis of moderate or severe dementia, had not consumed alcohol within 12 hours, or were unwilling to participate, or if the treating physician thought that the patient was not medically or psychologically stable to qualify for research participation. The interviewer provided and read to each participant the written informed consent document. Because our institution’s informed consent template, a 12-page document with 12th-grade reading level, exceeds comprehension recommendations, we summarized each section in simple language. We also provided a 1-page study overview that emphasized key points. Participants were permitted to refer to the documents when their capacity was assessed and were directed to sections when intervention to enhance their comprehension was necessary. The interviewer administered the 10-question University of California, San Diego Brief Assessment of Capacity to Consent questionnaire, which was adapted to our study (Figure). The questions include a mixture of yes/no and short-answer queries designed to test the understanding, reasoning, and appreciation of the information given. Predesignated closed-ended prompts and questions were used to facilitate answers when necessary. For example, if participants were unable to describe the purpose of the study (question 1), they would be asked the 2 related yes/no questions. If those questions were answered properly, they would then be asked to restate that information in their own words in response to the original question. Other prompts provided Annals of Emergency Medicine 173
Including Frequent ED Users With Alcohol Disorders in Research
McCormack et al
Figure. University of California, San Diego Brief Assessment of Capacity to Consent questions and prompts modified to our study.
concrete examples that might be more understandable to participants. For example, to help clarify the risk of breach of confidentiality (question 7), we described how a neighboring patient might overhear the interview. Participants who remained unable to answer the original question or the prompting questions were informed of the correct answer, referred to the corresponding section of the consent document, and later reassessed. Questions were scored as a “pass” only if participants were ultimately able to answer the original question (with or without facilitation through prompting or document review). Participants were deemed to have 174 Annals of Emergency Medicine
adequate capacity to provide capable informed consent if they passed all 10 questions. The interviewer noted participants’ responses, remediation required, and a summary of the encounter, including duration and participant-specific barriers and facilitating interventions required to process completion. Participants demonstrating adequate capacity were asked selected questions from the Alcohol Severity Index pertaining to medical history, psychiatric history, and alcohol and drug use. Participants also rated their degree of intoxication and withdrawal and ability to make important decisions. Volume 65, no. 2 : February 2015
McCormack et al The interviewer was blinded to the blood alcohol concentration and medications administered for treatment of alcohol withdrawal, which were extracted from the medical record. We used an ethanol elimination rate of 20 mg/dL per hour to estimate the blood alcohol concentration at the interview.9
RESULTS The University of California, San Diego Brief Assessment of Capacity to Consent questionnaire was administered and data were collected on 19 of the 21 patients who agreed to participate in the study; one withdrew consent and another was removed from the study at the beginning of the assessment because of acute agitation and delirium. The cohort had a mean age of 51.4 years (SD 9.4 years) and was predominantly composed of white men with precarious housing (Table 1). The participants consumed an average of 21 standard drinks per day and all but 1 drank daily. Twelve participants (63.2%) reported being brought to the ED involuntarily by ambulance or police for intoxication. At the interview, the participants’ mean blood alcohol concentration was 211.5 mg/dL (SD 137.4 mg/dL) (N¼18), 7 of 19 reported symptoms of alcohol withdrawal, and 5 participants had received benzodiazepines for withdrawal before our evaluation. The average duration to describe the study and perform the capacity assessment was 10.4 minutes (SD 3 minutes); approximately half this time was spent conducting the University of California, San Diego Brief Assessment of Capacity to Consent. Sixteen of 19 patients were deemed capable of providing informed consent by passing all 10 questions. Prompts were required for all but 4 participants, and 1 required review of the consent document for 3 questions. The 5 open-ended questions were more challenging for the cohort, each required prompting or remediation for more than half of the participants (Table 2). Three participants were deemed to lack capacity because they were unable to state the potential risks and benefits or differentiate clinical care and research. All 3 were unable to provide adequate responses to multiple questions and were among the 84% who felt capable of making an important decision. They had blood alcohol concentrations of 226 and 348 mg/dL (blood alcohol concentration not obtained for the third patient); 8 (50%) and 3 (19%) of the participants demonstrating capacity had higher blood alcohol concentrations (Figure E1). The capacity assessment outcome, remediation required, and blood alcohol concentration for each subject is shown in Figure E2.
LIMITATIONS Our study and conclusion that the University of California, San Diego Brief Assessment of Capacity to Consent is feasible for ED-based studies of patients with alcohol use disorders has several limitations. The primary one is that it was a small pilot study with convenience sampling of a specific population from a single institution. To minimize selection bias, we approached all potentially eligible patients (ie, those who, having >4 annual Volume 65, no. 2 : February 2015
Including Frequent ED Users With Alcohol Disorders in Research Table 1. Subject characteristics. Characteristics
Mean (SD)
Age, y Male sex Race White Black Hispanic Education
Including Frequent Emergency Department Users With Severe Alcohol Use Disorders in Research: Assessing Capacity Ryan P. McCormack, MD*; Timothy Gallagher, MD; Lewis R. Goldfrank, MD; Arthur L. Caplan, PhD *Corresponding Author. E-mail: [email protected].
Study objective: Frequent emergency department (ED) users with severe alcohol use disorders are often excluded from research, in part because assessing capacity to provide consent is challenging. We aim to assess the feasibility of using the University of California, San Diego Brief Assessment of Capacity to Consent, a 5-minute, easy-to-use, validated instrument, to screen for capacity to consent for research in frequent ED users with severe alcohol use disorders. Methods: We prospectively enrolled a convenience sample of 20 adults to assess their capacity to provide consent for participation in 30-minute mixed-methods interviews using the 10-question University of California, San Diego Brief Assessment of Capacity to Consent. Participants were identified through an administrative database, had greater than 4 annual ED visits for 2 years, and had severe alcohol use disorders. The study was conducted with institutional review board approval from March to July 2013 in an urban, public, university ED receiving approximately 120,000 visits per year. Blood alcohol concentration and demographic data were extracted from the medical record. Results: We completed assessments for 19 of 20 participants. One was removed because of agitation. Sixteen of 19 participants passed each question and were deemed capable of providing informed consent. Interventions to improve understanding (prompting and material review) were required for 15 of 19 participants. The mean duration to describe the study and perform the assessment was 10.4 minutes (SD 3 minutes). The mean blood alcohol concentration was 211.5 mg/dL (SD 137.4 mg/dL). The 3 patients unable to demonstrate capacity had blood alcohol concentrations of 226 and 348 mg/dL, with 1 not obtained. Conclusion: This pilot study supports the feasibility of using the University of California, San Diego Brief Assessment of Capacity to Consent to assess capacity of frequent ED users with severe alcohol use disorders to participate in research. Blood alcohol concentration was not correlated with capacity. [Ann Emerg Med. 2015;65:172-177.] Please see page 173 for the Editor’s Capsule Summary of this article. A podcast for this article is available at www.annemergmed.com. 0196-0644/$-see front matter Copyright © 2014 by the American College of Emergency Physicians. http://dx.doi.org/10.1016/j.annemergmed.2014.09.027
INTRODUCTION Despite the considerable prevalence of alcohol use disorders, the majority of individuals with them do not access specialty treatment.1,2 Patients with alcohol-related frequent emergency department (ED) use often have numerous comorbidities, psychosocial instability, and a severe form of alcohol use disorder.3,4 These individuals often receive care exclusively in EDs, where treatment or referrals for alcohol use disorders are rarely initiated.2 Research to develop and implement effective interventions is even less common in this setting, particularly for individuals with severe alcohol use disorders for whom attrition or failure is expected. The challenges of properly obtaining informed consent in this population, particularly capacity to provide valid consent, further diminish the likelihood of participation in studies.5 Many existing measures of capacity may not be practical or reliable in this population in ED settings. 172 Annals of Emergency Medicine
It is critical to first define capacity and differentiate it from the process of informed consent. To have capacity, subjects must be able to (1) understand the facts involved in the decision; (2) appreciate the nature and significance of the decision; (3) weigh risks and benefits and potential alternatives; and (4) express their choice.6 When these basic elements of capacity are intact, the subject is capable of participating in the informed consent process, during which the potential participant may freely choose whether to participate in research (in this scenario) according to a clear understanding of what it involves. Objective measures of decisional capacity and interventions to enhance subjects’ understanding would help ensure inclusion of this vulnerable population in appropriate studies. Instruments and methods that are feasible in this population and in the ED setting are necessary to provide adequate subject protection without placing undo restrictions on potentially beneficial Volume 65, no. 2 : February 2015
McCormack et al
Including Frequent ED Users With Alcohol Disorders in Research
Editor’s Capsule Summary
What is already known on this topic Enrollment of subjects for studies on the emergency care of long-term alcoholics is challenging because of issues about the capacity of such patients to provide informed consent. What question this study addressed This observational, mixed-methods study investigated whether a 10-question instrument could identify longterm alcoholics who, despite having recently ingested substantial quantities of alcohol, had capacity to provide informed consent. What this study adds to our knowledge Seventeen of the 20 patients enrolled had blood alcohol levels greater than 100 mg/dL. Sixteen of the 20 participants (80%) answered all 10 items correctly and were deemed to have capacity. How this is relevant to clinical practice This instrument appears to successfully identify longterm alcoholics who have capacity to provide informed consent.
research. Previously cited objective measures, such as blood alcohol concentration, and subjective measures, such as clinical gestalt, have significant limitations.5,6 For subjects who are alcohol tolerant and require an elevated blood alcohol concentration to function at baseline because of their brittle dependence or who may have cognitive impairment and mental illness, these metrics are neither sensitive nor specific. Mandates to assess capacity when enrolling individuals with psychiatric illness in human subjects research led to the development of instruments to perform this task. However, existing instruments have yet to be adequately studied in patients with substance use disorders. Among these, the MacArthur Competence Assessment Tool for Clinical Research is the most studied and has demonstrated validity and reliability.7 This structured interview requires extensive training to administer and interpret, and the assessment requires 20 minutes, which limit its use in some settings. The University of California, San Diego Brief Assessment of Capacity to Consent, a 5-minute, easy-to-use, validated tool, may be a more feasible alternative.8 Similar to the MacArthur tool, the assessment occurs after potential participants are informed about the study. Both rate the basic elements of capacity (understanding, appreciation, reasoning, and ability to express a choice) to identify subjects with questionable capacity to consent to a specified research project. Volume 65, no. 2 : February 2015
Our study aims to examine whether the University of California, San Diego Brief Assessment of Capacity to Consent can be used to evaluate the capacity to consent to ED research of patients with severe alcohol use disorders and frequent ED use.
MATERIALS AND METHODS In this pilot study, we prospectively assessed the feasibility of using the University of California, San Diego Brief Assessment of Capacity to Consent to screen for capacity to consent for minimalrisk research with adults with frequent ED use related to severe alcohol use disorders. Participants were informed that a capacity screen would occur when they were initially recruited to participate in 30-minute, mixed-method interviews involving sensitive topics related to their alcohol use and social milieu. The university institutional review board approved the study with a waiver of consent to review medical records and written consent to conduct interviews. Participants received a $10 gift card. The study was conducted at an urban, public, university, tertiary care hospital receiving approximately 120,000 ED patient visits per year. We recruited a convenience sample during various hours and days of the week from March to July 2013. Potential participants were identified through an administrative database and approached for study participation when they presented to the ED. Participants were older than 18 years, spoke English, and met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for alcohol dependence with at least 2 days of heavy drinking per week, and had greater than 4 alcohol-related annual ED visits for 2 consecutive years. Patients were excluded if they received a diagnosis of moderate or severe dementia, had not consumed alcohol within 12 hours, or were unwilling to participate, or if the treating physician thought that the patient was not medically or psychologically stable to qualify for research participation. The interviewer provided and read to each participant the written informed consent document. Because our institution’s informed consent template, a 12-page document with 12th-grade reading level, exceeds comprehension recommendations, we summarized each section in simple language. We also provided a 1-page study overview that emphasized key points. Participants were permitted to refer to the documents when their capacity was assessed and were directed to sections when intervention to enhance their comprehension was necessary. The interviewer administered the 10-question University of California, San Diego Brief Assessment of Capacity to Consent questionnaire, which was adapted to our study (Figure). The questions include a mixture of yes/no and short-answer queries designed to test the understanding, reasoning, and appreciation of the information given. Predesignated closed-ended prompts and questions were used to facilitate answers when necessary. For example, if participants were unable to describe the purpose of the study (question 1), they would be asked the 2 related yes/no questions. If those questions were answered properly, they would then be asked to restate that information in their own words in response to the original question. Other prompts provided Annals of Emergency Medicine 173
Including Frequent ED Users With Alcohol Disorders in Research
McCormack et al
Figure. University of California, San Diego Brief Assessment of Capacity to Consent questions and prompts modified to our study.
concrete examples that might be more understandable to participants. For example, to help clarify the risk of breach of confidentiality (question 7), we described how a neighboring patient might overhear the interview. Participants who remained unable to answer the original question or the prompting questions were informed of the correct answer, referred to the corresponding section of the consent document, and later reassessed. Questions were scored as a “pass” only if participants were ultimately able to answer the original question (with or without facilitation through prompting or document review). Participants were deemed to have 174 Annals of Emergency Medicine
adequate capacity to provide capable informed consent if they passed all 10 questions. The interviewer noted participants’ responses, remediation required, and a summary of the encounter, including duration and participant-specific barriers and facilitating interventions required to process completion. Participants demonstrating adequate capacity were asked selected questions from the Alcohol Severity Index pertaining to medical history, psychiatric history, and alcohol and drug use. Participants also rated their degree of intoxication and withdrawal and ability to make important decisions. Volume 65, no. 2 : February 2015
McCormack et al The interviewer was blinded to the blood alcohol concentration and medications administered for treatment of alcohol withdrawal, which were extracted from the medical record. We used an ethanol elimination rate of 20 mg/dL per hour to estimate the blood alcohol concentration at the interview.9
RESULTS The University of California, San Diego Brief Assessment of Capacity to Consent questionnaire was administered and data were collected on 19 of the 21 patients who agreed to participate in the study; one withdrew consent and another was removed from the study at the beginning of the assessment because of acute agitation and delirium. The cohort had a mean age of 51.4 years (SD 9.4 years) and was predominantly composed of white men with precarious housing (Table 1). The participants consumed an average of 21 standard drinks per day and all but 1 drank daily. Twelve participants (63.2%) reported being brought to the ED involuntarily by ambulance or police for intoxication. At the interview, the participants’ mean blood alcohol concentration was 211.5 mg/dL (SD 137.4 mg/dL) (N¼18), 7 of 19 reported symptoms of alcohol withdrawal, and 5 participants had received benzodiazepines for withdrawal before our evaluation. The average duration to describe the study and perform the capacity assessment was 10.4 minutes (SD 3 minutes); approximately half this time was spent conducting the University of California, San Diego Brief Assessment of Capacity to Consent. Sixteen of 19 patients were deemed capable of providing informed consent by passing all 10 questions. Prompts were required for all but 4 participants, and 1 required review of the consent document for 3 questions. The 5 open-ended questions were more challenging for the cohort, each required prompting or remediation for more than half of the participants (Table 2). Three participants were deemed to lack capacity because they were unable to state the potential risks and benefits or differentiate clinical care and research. All 3 were unable to provide adequate responses to multiple questions and were among the 84% who felt capable of making an important decision. They had blood alcohol concentrations of 226 and 348 mg/dL (blood alcohol concentration not obtained for the third patient); 8 (50%) and 3 (19%) of the participants demonstrating capacity had higher blood alcohol concentrations (Figure E1). The capacity assessment outcome, remediation required, and blood alcohol concentration for each subject is shown in Figure E2.
LIMITATIONS Our study and conclusion that the University of California, San Diego Brief Assessment of Capacity to Consent is feasible for ED-based studies of patients with alcohol use disorders has several limitations. The primary one is that it was a small pilot study with convenience sampling of a specific population from a single institution. To minimize selection bias, we approached all potentially eligible patients (ie, those who, having >4 annual Volume 65, no. 2 : February 2015
Including Frequent ED Users With Alcohol Disorders in Research Table 1. Subject characteristics. Characteristics
Mean (SD)
Age, y Male sex Race White Black Hispanic Education
