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Use of a Brief Negotiation Interview in the emergency department to reduce high‐risk alcohol use among older adults: A randomized trial

Abstract Objective To determine whether a Brief Negotiation Interview (BNI) performed in the emergency department (ED) can reduce future rates of alcohol use among older adults who are high‐risk drinkers. Methods Adults aged 65 years and older in a single academic ED were screened for high‐risk alcohol use based on the National Institute for Alcohol Abuse and Alcoholism definition of >7 drinks per week or >3 drinks per occasion. Eligible individuals who were high‐risk drinkers who passed a cognitive impairment screener and who consented to enrollment were randomly assigned to receive the BNI versus usual care. Outcomes were assessed at 3, 6, and 12 months. The primary outcome was the rate of high‐risk alcohol use at 6 months. Results Of 2250 ED patients who were screened, 183 (8%) met the criteria for high‐risk alcohol use. Of those, 98 (53%) patients met full criteria and consented to participation. Of the participants, 67% were men and 83% were non‐Hispanic White. There was no significant difference in the primary outcome of high‐risk alcohol use at 6 months between the BNI at 59.1% (95% confidence interval [CI], 45.5%–76.8%) and the control at 49.1% (95% CI, 36.9%–65.2%). However, there was a significant time‐effect reduction in alcohol consumption and rates of high‐risk alcohol use for both groups. Conclusion Among older adults who met the criteria for high‐risk alcohol use, the BNI in the ED did not result in a reduction in high‐risk alcohol use at 6 months, although both groups showed significant reductions after their ED visit. Further work is needed to determine the optimal setting and time to use the BNI to impact high‐risk alcohol use in this population.


Background
Alcohol abuse and misuse are important, preventable causes of morbidity and mortality. The best ways to intervene and reduce high-risk alcohol use in older adults (aged ≥65 years) have not yet been established. Prior studies of a Brief Negotiation Interview (BNI) performed with high-risk alcohol users in the emergency department (ED) have had mixed results, although some have successfully shown reductions in future alcohol consumption and improved health outcomes. [1][2][3][4] However, no prior work has focused specifically on the older adult population, and results from the general adult population may not be generalizable to older patients.
ED visits represent an opportunity to identify and intervene in potentially harmful alcohol use, especially for older adults. The ED is an important site of care for older adults, who make upwards of 23 million visits annually. 5,6 EDs are an important point of healthcare contact, particularly for individuals with limited access to primary healthcare, low socioeconomic status, or limited means of transportation who may not have regular primary care visits where their alcohol use could be identified. 7,8 Older adults will make up a growing percentage of ED patients in the coming decades. They are often systematically excluded or underrepresented in clinical trials 9 because of their greater medical and pharmacological complexity as well as the added need of screening for the cognitive capability to allow consent and enrollment. It is important to understand how interventions function in this population.

Importance
Alcohol is the fourth leading cause of preventable death in the United States. 1 Excess alcohol use also contributes to liver disease, cancer, and ischemic heart disease as well as accidental injury and death, accounting for 31% of motor vehicle collision (MVC) fatalities. 1,10 Alcohol use poses a significant risk to older adults. Lower blood volume leads to higher alcohol concentration per given intake, putting older drinkers at high risk for additional impairment and injury. 11,12 Older adults tend to have more chronic conditions and are at higher risk for falls, both of which are exacerbated by alcohol use. An additional risk comes from combining alcohol with medications, and 90% of older adults take at least 1 prescription medication, many of which interact negatively with alcohol. 13 For all these reasons, identifying and preventing high-risk alcohol use is an important healthcare initiative in this population.
Receiving a BNI in the ED can potentially improve future outcomes.
Results have been mixed, but a 2017 systematic review found moderate evidence for a small reduction in alcohol use, a decrease in negative consequences (eg, injury), and a lower number of future ED visits among children and adults reporting excessive alcohol use who received a BNI in the ED. 1

Goals of this investigation
The National Institute for Alcohol Abuse and Alcoholism (NIAAA) guidelines define high-risk alcohol use as >7 drinks per week or 3 drinks per occasion for both men and women aged ≥65 years. 15 We conducted a randomized trial to determine the efficacy of a 1time, ED-based BNI on rates of high-risk alcohol use, quantity of alcohol consumed, and on health outcomes at 6 and 12 months among highrisk drinkers aged ≥65 years.
The goal of this investigation was to assess the effectiveness of a BNI to reduce future rates of high-risk alcohol use. If effective, the BNI could provide a relatively cheap, easily implementable method to reduce the negative health consequences of high-risk alcohol use and could be used in many EDs.

Study design and setting
This was a randomized, controlled trial comparing the effectiveness of a BNI versus usual care on rates of high-risk alcohol use. The study was approved by the institutional review board of the University of North Carolina at Chapel Hill and was registered with ClinicalTrials.gov (NCT02236494). Additional low-risk drinkers were enrolled, as reported on the registration, in a parallel study to compare the characteristics of high-risk and low-risk drinkers. 16 The study was conducted at a single, academic, level 1 trauma center in the southeast United States that serves a socioeconomically diverse population with 70,000 visits annually, of which 16% are patients aged >64 years. ing is defined as ≥1 binge-drinking episodes in the past 3 months or an average of ≥8 drinks per week. These 2 screening questions can rapidly and accurately identify high-risk alcohol use in the ED. 16 Patients were randomized in a 1:1 allocation using randomly permuted blocks with randomly selected block sizes of 8 or 12. Sequential group assignment papers were placed in sealed, numbered envelopes. Envelopes were opened, and participants were assigned to either the BNI or usual care at the time of enrollment. The treating physicians were blinded to the randomization arm.

Selection of participants
After consent was obtained, a trained RA conducted a structured interview using the timeline follow-back (TLFB) method to characterize drinking in the past 7 days and binge episodes in the past 28 days. 18 The TLFB is a commonly used method to assess alcohol consumption. Beginning with the previous day, the patient works backward and reports their alcohol consumption each day for the prior week. Then, using a calendar as a reference to remind the patient of special occasions, such as holidays or social events, the patient reviews and reports any dates with binge drinking episodes of >3 drinks per occasion. 19 The following 2 commonly used alcohol screening tools were also administered: the AUDIT 20 and CAGE 21 assessment. In addition to standard sociodemographic characteristics, we also assessed the number of falls, MVCs, episodes of driving after drinking, and the number of outpatient, ED, and inpatient healthcare encounters in the 6 months before the interview. Patients' ability to perform activities of daily living (ADLs) was assessed using the Katz Index of Independence in ADLs, 22 and depression was assessed using the Patient Health Questionnaire-2 (PHQ-2). 23 The initial interview also asked about patients' social support, past or current alcohol rehabilitation treatment, drug and substance use, mobility, and chronic pain.

Interventions
Patients in the intervention arm received the BNI. The BNI is a welldescribed 3-step, structured interview that (1) asks the patient to explore the connection between alcohol use and their ED visit, (2) reviews the patient's current alcohol use compared with NIAAA guidelines, (3) gauges readiness for change by identifying motivations for cutting back, and (4) asks the patient to develop and agree on a goal related to drinking. 24 The patient identifies his or her readiness to change on a scale of 1-10, and the individual performing the BNI asks the patient to identify why their readiness is not a lower number than they indicated to help the patient identify his or her motivations for cutting back. The BNI was performed by trained RAs, which is standard research practice in the field.
Patients randomly assigned to the control arm received the usual care, which generally consisted of education and discharge instructions from their treating physician related to their chief complaint or diagnosis, but no specific alcohol interventions. If patients expressed a desire to cut down on drinking or had a history of complicated withdrawal, the ED physician was notified and provided the appropriate care as needed.
RAs were trained in recruitment, enrollment, consent, cognitive screening of older adults, and performance of the BNI. Training in the BNI included training modules, videos, role-play exercises, and completion of 2 90-minute live practice sessions in which the RAs practiced the BNI to ensure mastery of the interview and BNI process.

Measurements
Alcohol consumption was assessed at enrollment and at 3, 6, and 12 months after enrollment. Follow-up interviews after the initial enrollment were conducted over the telephone by trained RAs. The rates of high-risk alcohol use based on NIAAA guidelines were determined at each time point. At the 6-month and 12-month interviews, assessments were repeated, including measures of (1) general physical and mental health; (2) self-reported healthcare use, including hospitalizations, primary care, and specialist visits; (3) negative consequences related to alcohol, including falls and MVC; and (4) drinking behavior and readiness to change drinking behavior.

Outcomes
The primary outcome was the rate of high-risk alcohol use at 6 months, as the primary goal was the reduction of rates of high-risk alcohol use and to compare values to prior ED-based studies. 4 Secondary outcomes included changes in weekly alcohol consumption, number of monthly binge episodes, AUDIT and CAGE scores, risk-taking behavior (driving after drinking), alcohol-related injury or trauma, healthcare use and encounters, and measures of general health including mobility, depression, and chronic pain. This study was powered at the 0.8 level with an α of 0.05 to detect an absolute difference in the proportion of patients meeting criteria for high-risk alcohol use of 20% between the 2 groups with enrollment of 98 participants. We estimated that there would be a reduction in the rates of high-risk alcohol use of 5% in the control group and 25% in the intervention group.

Analysis
Descriptive statistics were used to summarize the characteristics of the BNI and control populations. Standardized differences were computed to identify an imbalance (>0.10) in the baseline characteristics between the BNI and control groups. 25

Characteristics of study participants
During the enrollment period, 2250 ED patients aged ≥65 years were screened for high-risk alcohol use based on NIAAA guidelines. 16 A total of 183 (8%) met the criteria for high-risk alcohol use. All highrisk patients were screened using the further eligibility criteria, and 98 (53%) were enrolled. Of those who did not enroll, 13 failed the 6-item screener for cognitive impairment. The remainder declined to participate in the study for various reasons, including feeling too sick (17), concern it would take too much time (13), disinclination to take part in a study about alcohol (7), feeling too anxious (6), or other reasons (29).
The enrolled sample was 67% men and 83% non-Hispanic White with a mean age of 73 years (age range, 65-94 years). The intervention and control arms did not vary greatly in demographics or in baseline characteristics ( Table 1). The control group reported consuming a higher number of drinks in the prior week using the TLFB method (19.9 vs 14.6) and more withdrawal symptoms than did the BNI group.

Primary outcome: high-risk alcohol use at 6 months
The primary outcome was the rate of high-risk alcohol use at 6 months.
Using either the TLFB method or the patient's estimate of weekly consumption, there was no statistically significant difference in rates of high-risk alcohol use between the treatment and control groups (Table 2) at 3, 6, or 12 months after enrollment. Rates of high-risk alcohol use had declined at 6 months to 57.3% in the intervention group and to 54.1% in the control group (p = 0.579) as measured using the 2-question screener, and to 59.1% and 49.1% respectively measured using the TLFB method (p = 0.350). There was a statistically significant time effect in the reduction in alcohol use in both groups ( Figure 1).

Secondary outcomes
General measures of health, including mobility, depression, and pain, healthcare use, and negative consequences, were similar at baseline for the treatment and control groups, and there was no significant difference between the intervention and control groups at 6 months.
Mobility and pain scores changed minimally in both groups, whereas PHQ-2 scores decreased in both groups at 6 months. The percentage of patients who had been hospitalized increased at 6 months for both groups before decreasing at 12 months, although there were wide con-  (Table 3).

Time effects
There was a statistically significant time effect seen in both groups. The average drinks per week and the rate of high-risk alcohol use decreased in both the intervention and control groups from the initial enrollment to 6 months ( Figure 1). In the BNI group, the average number of drinks per week decreased from 17.4 to 12.4 at 6 months. For the control group, the mean number of drinks per week decreased more, from 20.4 to 8.4 drinks. Alcohol misuse, as measured by AUDIT and CAGE scores, decreased for both groups at 6 months ( Figure 2). Rates of driving after having ≥2 drinks fell from 27% to 6.3% at 12 months in the intervention group and 25% to 13.5% in the control group (Table 3).

LIMITATIONS
This study was conducted at a single academic ED in the southeast United States. Cultural and regional factors as well as access to community resources (eg, Alcoholics Anonymous meetings) may influence the impact of the BNI. The number of individuals enrolled also limits its power to detect smaller effects of the intervention on alcohol use F I G U R E 1 Rates of high-risk alcohol use at 0, 3, 6, and 12 months by self-estimate (2-question screener) and TLFB method to estimate alcohol consumption. Mean drinks per week by self-estimate and last 7-day consumption by TLFB method. BNI, Brief Negotiation Interview; TLFB, timeline follow-back patterns. In addition, because this study required disclosure of alcohol use, patients who opted to participate may have been more motivated to change drinking behavior than other older adults engaging in hazardous drinking. Higher baseline motivation to change in both groups could mean that these patients were likely to decrease drinking behavior regardless of the intervention or follow-up.
The observed time effect in this study may reflect regression to the mean or an effect of the enrollment and interview process itself, as the effect of enrollment and discussion of alcohol use itself may have motivated the control group to reduce their consumption.
In this study, RAs administered the BNI, which is common practice.
However, administration by a physician or nurse may have a stronger effect on patient behavior. It is also possible that the BNI may have a greater effect if used when a patient is in the ED for an alcoholrelated illness or injury. Although we did assess whether the ED visit was directly or indirectly alcohol related, the number of enrollees was not large enough to gather statistically significant data related to this variable.

DISCUSSION
This study found that the BNI performed in the ED among patients aged ≥65 years who were high-risk alcohol users did not lead to lower rates of high-risk alcohol use at 6 months. Both the intervention and control groups reported >25% lower weekly alcohol consumption and had lower rates of high-risk use. However, it was the time effect, not the treatment effect, that was significant. These results were not expected, as our methods were very similar to prior studies that did show a greater reduction in alcohol use with the BNI compared with in the TA B L E 3 Secondary outcomes measured among the treatment (BNI) and control groups at baseline and 6 and 12 months There are several possible reasons why this study did not demonstrate an effect of the BNI compared with the control. One explanation is that older adults may not respond as robustly to the BNI as younger individuals. It is possible that other interventions would be more effective in this age group, such as discussions with a physician, longitudinal therapy, or medications. In addition, this study was powered to find an absolute difference of 20% in the rate of high-risk drinking, so would be underpowered to find a smaller effect.
There are also number of challenges inherent in the research of alcohol and substance use disorders that could confound results and that could be more pronounced in the older adult population, including stigma, avoidance bias, recall bias, and social acceptability bias. 27 It is also possible that the interview and enrollment itself served as a more significant inducement to reduce consumption in this age group.
The questioning about alcohol use itself may lead to reductions in consumption that overshadow the effect of the BNI. 1 Other studies have found no contribution of the assessment effect in an ED-based study of injured patients undergoing a 10-15 minute alcohol assessment. 28 However, the control group assessment in this study was of a different population and lasted 30-40 minutes. Other prior studies have also shown a reduction in alcohol consumption after an ED visit not attributable to any targeted ED-based intervention. 3,28,29 In this study, the follow-up interviews also included assessments of drinking behavior, legal side effects, and readiness to change. These interviews in and of themselves may have motivated participants in both groups to renew their efforts to cut back. Future work could further assess the role that questioning about alcohol in a control group can affect the drinking habits of older adult patients. Intervention studies may be clearer if the control group receives fewer questions related to alcohol. Finally, studies that include collaboration with a patient's PCP or referral to a substance use program could prove more effective in this population.
The reduction in alcohol use over time seen here could also represent a reversion to the mean. Prior studies have found that, particularly when the threshold for entry into a study increases, that regression to the mean can account for some of the time-related decrease in future consumption. 30 In this study, the threshold for enrollment was low, but the average number of drinks consumed was high and comparable with levels for younger adults enrolled in other similar ED-based studies. 4 In summary, among older ED patients who are high-risk alcohol users, a single BNI during an ED visit did not produce a statistically significant treatment effect, but both groups reduced their consumption up to a year after their index visit. Of note, this study preceded the COVID-19 pandemic, and alcohol consumption has escalated significantly since the pandemic onset. 31 Future work should study other interventions that may be more effective in serving this patient population, enroll a larger sample size, or reduce the assessment effect by minimizing the control group's alcohol-related questioning.