0145-6008/04/2807-1060$03.00/0 ALCOHOLISM: CLINICAL AND EXPERIMENTAL RESEARCH
Vol. 28, No. 7 July 2004
Using Daily Interactive Voice Response Technology to Measure Drinking and Related Behaviors in a Pharmacotherapy Study Henry R. Kranzler, Khamis Abu-Hasaballah, Howard Tennen, Richard Feinn, and Kevin Young
Background: Interactive voice response technology (IVR) allows investigators to collect daily measures of drinking, medication adherence, mood, and other treatment-relevant variables that may change day to day during a clinical trial. Despite these advantages, no published studies have used IVR in alcohol pharmacotherapy trials. Methods: Subjects provided daily data via IVR during the 12-week treatment period. Seven subjects completed the trial. Results: We found a high level of participant adherence to the IVR protocol, higher levels of drinking reported by IVR than by a commonly used recall method, and distinct within-day associations between daily mood and alcohol consumption: these could not be obtained through traditional assessment methods. Conclusions: IVR seems to be feasible for the collection of daily indicators of treatment outcomes and processes in pharmacotherapy studies among problem drinkers. Key Words: Interactive Voice Response, Outcomes Assessment, Problem Drinkers, Pharmacotherapy, Alcoholism.
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VARIETY OF METHODS have been developed to measure drinking behavior in alcohol-treatment trials. The most widely used approach is the timeline follow-back method (TLFB; Sobell and Sobell, 1992), in which an interviewer uses a calendar of events identified by the respondent to facilitate the respondent’s retrospective estimates of alcohol consumption on a day-to-day basis. Although aggregate levels of alcohol consumption obtained with the TLFB compare favorably with reports obtained daily, the TLFB cannot accurately identify day-to-day variation in drinking behavior (Carney et al., 1998). Daily reports represent a novel and uniquely informative approach to data collection in alcohol-treatment studies, because they provide an opportunity to study the moderating effect of treatment on relations between drinking and subjective states such as mood (Collins et al., 1998; Kranzler et al., 2004). Furthermore, daily variation in mood or desire to From the Lowell P. Weicker, Jr. General Clinical Research Center (HRK, KA-H), the Department of Community Medicine and Healthcare (HT), and the Alcohol Research Center, Department of Psychiatry (HRK, HT, RF, KY), University of Connecticut Health Center, Farmington, Connecticut. Received for publication December 24, 2003; accepted April 20, 2004. Supported by NIH Grants P50 AA03510, K24 AA13736, and M01 RR06192 (University of Connecticut General Clinical Research Center). Reprint requests: Henry R. Kranzler, MD, Department of Psychiatry, University of Connecticut Health Center, 263 Farmington Ave., Farmington, CT 06030-2103; Fax: 860-679-1316; E-mail:
[email protected]. Copyright © 2004 by the Research Society on Alcoholism. DOI: 10.1097/01.ALC.0000130806.12066.9C 1060
drink may help to elucidate the mechanism of treatment effects on drinking behavior (Kranzler et al., 2004; Tennen et al., 2000). Interactive voice response technology (IVR) is a relatively new and increasingly popular technology that uses the telephone to administer survey questions. The respondent answers each question by pressing the keys on the telephone keypad, and responses are entered automatically in a database. IVR has a number of advantages over traditional face-to-face interviews, including interview consistency, access to difficult-to-reach populations such as recovering drug users and alcoholics (Alemi et al., 1994), immediate data availability and accessibility, and convenience both for respondents and investigators. In view of these advantages, IVR has been used in a wide variety of studies ranging from symptom and alcohol consumption monitoring to psychological assessment and treatment (Corkrey and Parkinson, 2002). Bardone et al. (2000), Helzer et al. (2002), and Searles et al. (2000, 2002) have demonstrated the feasibility, reliability, and validity of daily IVR drinking reports in community and student samples. This pilot study examined the feasibility of daily IVR to evaluate both outcomes and treatment processes in an open-label study of daily versus targeted naltrexone to reduce drinking among problem drinkers. To our knowledge, this represents the first use of IVR for evaluating outcomes in an alcohol-treatment study. Alcohol Clin Exp Res, Vol 28, No 7, 2004: pp 1060–1064
INTERACTIVE VOICE RESPONSE IN HEAVY DRINKERS
METHODS Overview Nine heavy-drinking subjects were recruited through newspaper advertisements. After a telephone screening interview, subjects were interviewed in person by a research nurse, gave informed consent to participate, and then underwent a clinical laboratory evaluation and physical examination. All subjects who were interviewed met study criteria and, consequently, were assigned to receive naltrexone, an orally available opioid antagonist approved for the treatment of alcohol dependence. The dose of naltrexone used was either daily (i.e., one 50-mg tablet) or targeted [i.e., one 50-mg tablet to be used 3–5 days per week in anticipation of (and to prevent) a heavy-drinking episode]. Heavy-drinking episodes were defined as four or more drinks in a day for women and five or more drinks in a day for men. By using the Inventory of Drinking Situations (Annis et al., 1987) as a guide, subjects provided a list of the five riskiest settings in terms of the likelihood of their drinking in excess of that amount. Subjects also received brief counseling every other week during the 12-week treatment period. Retrospective drinking assessments were conducted at the time of study enrollment, every two weeks at each treatment visit, and at the end of treatment. Subjects were asked to call a toll-free study telephone number to complete an IVR interview each day of the 84-day study. Subjects Inclusion criteria were age 18 to 60 years, stable residence, ability to read English, average weekly intake of ⱖ18 standard drinks for women and ⱖ24 standard drinks for men, and a desire to reduce their drinking. Women of childbearing potential were included in the study only if they were practicing reliable birth control and had a negative serum pregnancy test. Subjects were excluded if they showed clinical evidence of physical dependence on alcohol, were deemed to require more intensive clinical care than that provided in the study, met current criteria for a DSM-IV drug use disorder (other than nicotine), met lifetime criteria for opioid dependence, had used psychoactive drugs in the preceding month, or had a serious psychiatric or medical illness. Five of the nine subjects enrolled in this pilot study were men, and all were white. Mean age was 48.4 years (SD, 8.3 years), and mean education was 17.4 years (SD, 3.2 years). Seven individuals (78%) met DSM-IV criteria for current alcohol dependence. Comorbid psychiatric disorders were identified in four individuals, three of whom met criteria for a lifetime (but not current) diagnosis of major depressive disorder. Two individuals met criteria for a lifetime (but not current) diagnosis of cannabinoid use disorder (one of the individuals with major depressive disorder had cannabinoid dependence; another individual met cannabinoid abuse criteria). Three subjects were receiving antidepressant therapy at the time of their study participation. Subjects reported drinking on 93.2% of days (SD, 5.2%), of which 50.2% of these drinking days were heavy-drinking days (four or more drinks per day for women and five or more drinks per day for men). Four of the subjects received the targeted treatment, whereas the remaining five received the daily treatment. Assessments A demographic form and the Structured Clinical Interview for DSM-IV (First et al., 1996) were administered to determine study eligibility. The TLFB was administered to assess the subjects’ accuracy in reporting drinking and medication adherence both at 2-week intervals and also once at the completion of the study to cover the entire 12-week treatment period. IVR Technology The IVR system used SmartQuest and DialQuest (Telesage, Inc., Seattle, WA). Each question was answered numerically by using the telephone keypad. The system allowed participants to respond to ques-
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tions before the question was completed, thus creating a shorter interview as the participant became familiar with the system. This IVR system offers the best combination of verifiable daily electronic data entry, easy participant access to a data-entry portal, and automated transfer to a Microsoft Access database (Redmond, WA), yet without requiring that participants be comfortable in a personal computer or handheld computer environment. This system also eliminates the inevitable data-transcription and coding errors associated with paper-andpencil assessment. The IVR system was configured to process up to six calls simultaneously. During their baseline visit, subjects met with a research assistant for a brief (10 –15 min) IVR training session, at which time they were provided with a toll-free number that directed them to six available lines. Each subject was provided with an anonymous study identification number (to ensure the confidentiality of all study assessments) and a personalized alternate number (i.e., based on birth date) to use in the event that he or she forgot the study number. Subjects were asked to call the system from a touch-tone phone (which could be a cell phone) between the hours of 5:00 and 9:00 PM. This time frame offered sufficient flexibility to allow the individual to respond on the basis of the day’s experience before the time of day when individuals typically drink most heavily. We selected a 4-hr reporting window to provide consistent timing of reports across days and to promote adherence to the IVR regimen. Data were not obtained on days that subjects failed to call in during the 4-hr window. This feature reflects our interest in the temporal relations among events and the overall high levels of response that we anticipated would occur on the basis of our prior experience with daily paper booklets (Kranzler et al., 2003). Each subject was provided with a wallet-sized interview guide with key terms for each interview question in the order in which it was presented by the system. The system was programmed so that a subject who wished to change a response after it was entered could do so by pressing the star (*) key to re-enter the response. Subjects who did not call the toll-free number by 8:00 PM were called by the system at a preferred phone number and reminded to complete the interview. The reminder prompt was brief and provided no details of the study or its purpose. When the final IVR interview question was answered, the subject’s data for that day were stored in a data file that was automatically associated with her or his identification number. The IVR interview assessed mood, desire for alcohol, confidence to resist drinking, medication use and side effects, and alcohol consumption since the last day’s call. The main focus of this report is on medication adherence and alcohol consumption—two key measures in the conduct of medication trials to treat alcohol dependence. We also contrast daily mood reports with mood assessment based on aggregate (between-person) reports. Medication Adherence. Using IVR, subjects reported whether they consumed a naltrexone tablet since the previous call. In TLFB interviews conducted by a research nurse biweekly, subjects recalled the days on which they took medication. Daily Drinking. Each day, subjects recorded their alcohol consumption for the previous night (i.e., after the last IVR survey) and for that day. They reported the number and quantity (in standard drinks) of each of three categories of alcoholic beverages—beer, wine, and liquor—separately for “last night” (the time elapsed between the preceding day’s call and the end of the day) and “today” (the time elapsed since the beginning of the day and the time of the call). Daily Mood. Subjects were asked to rate their mood for that day by using nine mood descriptors (active, angry, bored, enthusiastic, happy, nervous, relaxed, sad, and tranquil) derived from the mood circumplex (Larsen and Diener, 1992) and our previous research. Each mood was rated on a five-point scale (0 ⫽ “not at all” to 4 ⫽ “extremely”). The moods were combined into two groups: (1) positive mood, consisting of the items active, happy, enthusiastic, tranquil, and relaxed (␣ ⫽ 0.90 based on aggregated responses), and (2) negative mood, consisting of the items sad, angry, nervous, and bored (␣ ⫽ 0.86 based on aggregated responses).
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Consistent with the circumplex model, positive and negative moods were not significantly related ( ⫽ ⫺0.48; p ⫽ 0.19; n ⫽ 9). Statistical Analysis Cohen’s and the Pearson coefficient (r) or Spearman coefficient () were used to measure concordance and association among measures, respectively. Multilevel modeling with hierarchical linear modeling (Raudenbush et al., 2001) was used to determine change over time in the duration of phone calls and the number of daily drinks.
RESULTS
IVR Adherence Seven subjects (78%) completed the 12-week treatment trial; one subject was lost to follow-up, and one discontinued treatment because he found the medication not to be therapeutic. There was substantial variation in the proportion of daily IVR reports subjects provided, ranging from 12 to 84, with a total of 562 valid responses (mean, 74.3% of the maximum possible responses; SD, 29.0%). When we included only IVR reports from the first call to the day of the last call (to account for the two subjects who discontinued treatment prematurely), the average response rate was 83.0% (SD, 20.7%). The IVR system made 178 reminder calls to participants who had not made an IVR report by 8:00 PM. Subjects received an average of 19.8 calls (SD, 12.5). Reminder calls resulted in 54 calls to the system (i.e., a 30.3% rate of response to the reminder calls, which represents 9.3% of all calls received). The average duration of a phone call was 3.9 min (SD, 0.98 min). Eighty-seven percent of the calls were less than 5 min long, and as subjects became familiar with the IVR protocol over the first 10 weeks of the study, the duration of each call decreased [F(1,467) ⫽ 420.78; p ⬍ 0.001], with each successive call taking 0.02 min less than the previous call. After the 10th week, the length of the calls remained stable, taking on average 2.81 min. Medication Adherence When interviewed at 2-week intervals by using the TLFB, subjects reported taking medication on 434 days, compared with 423 days reported via IVR. The overall concordance rate between TLFB and IVR was 78.2% ( ⫽ 0.69; p ⬍ 0.001). Alcohol Consumption: IVR Versus TLFB Drinking Days. On the basis of IVR, subjects reported drinking on 479 days, compared with 470 days by using the biweekly TLFB. The correlation between IVR and TLFB for total number of drinking days by subject was ⫽ 0.95 (n ⫽ 9; p ⬍ 0.001). The number of drinking days did not differ by method at either the within-person level (t554 ⫽ 1.52; p ⫽ 0.13) or the between-persons level (t8 ⫽ 0.83; p ⫽ 0.43). The two methods agreed for 457 drinking days (i.e., 95%)
and 63 abstinent days (i.e., 83%), resulting in excellent concordance ( ⫽ 0.75; p ⬍ 0.001). Drinks per Day. The correlation between the number of daily drinks recorded with IVR and the biweekly TLFB was r ⫽ 0.69 (p ⬍ 0.001), ranging from r ⫽ ⫺0.12 to r ⫽ 0.90 for individual subjects. The correlation between IVR and the 12-week TLFB was r ⫽ 0.52 (p ⬍ 0.001), ranging from r ⫽ 0.10 to r ⫽ 0.60. When examined between persons, there was no difference in the number of drinks per day reported with daily IVR and biweekly TLFB (IVR: mean, 3.15; SD, 1.22; biweekly TLFB: mean, 2.75; SD, 1.40; t8 ⫽ 1.25; p ⫽ 0.25). However, subjects reported consuming more drinks on the daily IVR than when they reported their alcohol use on the 12-week TLFB (IVR: mean, 3.22; SD, 1.32; 12-week TLFB: mean, 2.44; SD, 0.81; t6 ⫽ 3.11; p ⫽ 0.021). By using multilevel modeling, with days nested within subject, the mean number of drinks within persons was higher for IVR (mean, 3.21; SD, 2.29) compared with both the biweekly TLFB (mean, 2.54; SD, 11.69; t8 ⫽ 2.69; p ⫽ 0.028) and the 12-week TLFB (mean, 2.50; SD, 1.40; t6 ⫽ 3.29; p ⫽ 0.017).* Within-Person Versus Between-Person Associations of Daily Drinking and Mood Daily reports allow a comparison of within-person and between-person associations among study variables. We compared within- and between-person associations of the number of drinks consumed with positive and negative mood. Participants reported consuming fewer drinks on days during which they experienced a more positive mood (r ⫽ ⫺0.13; p ⫽ 0.003), but the number of drinks on a given day was not related to that day’s negative mood (r ⫽ 0.05; p ⫽ 0.22). When the observations were aggregated across subjects (n ⫽ 9), producing between-persons drinking data comparable to what is reported in most clinical trials, there was no association between positive mood and the number of drinks per day ( ⫽ ⫺0.02; p ⫽ 0.97) or between negative mood and the number of drinks per day ( ⫽ 0.42; p ⫽ 0.26). DISCUSSION
This pilot study, conducted in preparation for a placebocontrolled trial investigating the effects of targeted naltrexone in problem drinkers, demonstrated the feasibility of using daily automated telephone interviews to evaluate outcomes in alcohol pharmacotherapy studies. IVR was well received by study participants, who demonstrated a * The correlation using within-subjects data violates the assumption of independent observations and may result in an erroneous conclusion regarding the relationship between the two variables of interest, whereas using the aggregate between-subjects data reduces the sample size and removes the variation that occurs within individuals. This is the main impetus for the popularity of multilevel modeling, in which both the within-person and between-person variation are modeled.
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high degree of adherence with the call requirements. The use of reminder calls demonstrably enhanced adherence, an important element in the application of IVR technology to clinical trials. The duration of the calls was generally less than 5 min, with a significant reduction over time through the first 10 weeks of the trial. Consistent with prior reports, daily IVR seems to provide a more accurate estimate of drinking behavior than does a commonly used retrospective recall method, whether the recall method is applied over a 2-week or a 12-week interval. When compared across subjects, we found convergence on both the number of drinking days and mean daily consumption between daily IVR and TLFB, which is in agreement with findings reported by Bardone et al. (2000). However, when compared by using within-person observations and multilevel modeling, there was evidence that subjects underreported alcohol use on the TLFB. On average, subjects reported drinking a mean of 0.58 more drinks per day when this was assessed with daily IVR compared with the biweekly TLFB and 0.78 drinks more drinks per day compared with the 12-week TLFB. These differences are consistent with the findings of Searles et al. (1995, 2000), who found that traditional quantity/frequency indicators of alcohol use yielded lower levels of alcohol use compared with daily IVR. In concluding that subjects underreported their alcohol use on the TLFB, we assume that close-to-real-time drinking reports (i.e., daily IVR) are more accurate than recalled drinking and that recall methods introduce memory decay and memory bias (Tennen and Affleck, 1996). The extreme variation in the correlation for individual subjects between daily IVR and TLFB also indicates that for some individuals, TLFB-derived drinking reports bear little resemblance to drinking reports captured close to their real-time occurrence through daily IVR. There was substantial variation in the proportion of daily IVR reports, with the number of daily reports ranging from 12 to 84. That data were missing from some individuals is potentially problematic, but no more so than in studies in which the TLFB is used retrospectively to measure drinking behavior. Another potential limitation of this study is that some individuals may have been intoxicated at the time they provided daily reports. Using blood alcohol concentration and collateral reports, Perrine et al. (1995) demonstrated the reliability of daily IVR reports. Furthermore, we found no evidence of outlying reporting days during which it took more time than usual to complete the daily protocol, which would suggest intoxication in the respondent. Because subjects had a relatively low level of alcoholdependence severity, research on the feasibility of using IVR in more severely dependent subjects is needed. In view of the small sample size and the subjects’ low level of dependence severity, caution should be exercised in generalizing the findings to the universe of alcohol-dependent subjects participating in treatment trials. Despite these limitations, as demonstrated in this study, IVR has potential utility in the conduct of alcohol-
treatment trials. A common problem in alcohol-treatment studies is subjects’ failure to return to the treatment site and to comply with efforts to collect TLFB information via the telephone. An advantage of daily data collection via IVR is that multilevel modeling, which is made possible by daily reports, is robust with regard to missing data and that it weights each participant’s data on the basis of the amount of data supplied by that individual. A distinct advantage of obtaining daily drinking reports in clinical trials is that they allow investigators to examine within-person associations as well as between-persons associations among study variables. Indeed, we found that although participants consumed fewer drinks on days during which they experienced a more positive mood, there was no association between positive mood and drinks per day when this was evaluated with traditional betweenperson (aggregated) data. Many theories of alcohol use describe inherently within-person processes. For example, the self-medication hypothesis asserts that problem drinkers use alcohol to alleviate negative affective states (Swendsen et al., 2000). Alcohol pharmacotherapy studies can begin to determine whether treatment affects this withinperson process and other hypothesized drinking dynamics by incorporating daily reports as outcome indicators (Kranzler et al., 2004). Our findings indicate that daily IVR is a feasible and efficient way to measure outcomes and daily drinking processes in clinical trials and that the range of its application in such trials warrants further study. ACKNOWLEDGMENT We thank the staff of the Clinical Research and Evaluation Unit of the University of Connecticut Alcohol Research Center (particularly Lynn McLaughlin, RN, and Kristen Tremblay, BA) for their assistance in the conduct of this study. REFERENCES Alemi F, Stephens R, Parran T, Llorens S, Bhatt P, Ghadiri A, Eisenstein E (1994) Automated monitoring of outcomes: application to treatment of drug abuse. Med Decis Making 14:180 –187. Annis HM, Graham JM, Davis CS (1987) Inventory of Drinking Situations (IDS) User’s Guide. Alcoholism and Drug Addiction Research Foundation, Toronto. Bardone AM, Krahn DD, Goodman BM, Searles JS (2000) Using interactive voice response technology and timeline follow-back methodology in studying binge eating and drinking behavior: different answers to different forms of the same question? Addict Behav 25:1–11. Carney MA, Tennen H, Affleck G, Del Boca FK, Kranzler HR (1998) Levels and patterns of alcohol consumption using timeline follow-back, daily diaries and real-time electronic interviews. J Stud Alcohol 59:447– 454. Collins RL, Morsheimer ET, Shiffman S, Paty JA, Gnys M, Papandonatos GD (1998) Ecological momentary assessment in a behavioral drinking moderation training program. Exp Clin Psychopharmacol 6:306 –315. Corkrey R, Parkinson L (2002) Interactive voice response: review of studies 1989 –2000. Behav Res Methods Instrum Comput 34:342–353. First MB, Spitzer RL, Gibbon M, Williams JBW (1996) Structured Clinical Interview for DSM-IV Axis I Disorders—Patient Edition (SCID-I/P, Version 2.0). Biometrics Research Department, New York State Psychiatric Institute, New York.
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Helzer JE, Badger GJ, Rose GL, Mongeon JA, Searles JS (2002) Decline in alcohol consumption during two years of daily reporting. J Stud Alcohol 63:551–558. Kranzler HR, Armeli S, Feinn R, Tennen H (2004) Targeted naltrexone treatment moderates the relations between mood and drinking behavior among problem drinkers. J Consult Clin Psychol, 72:317–327. Kranzler HR, Armeli S, Tennen H, Blomqvist O, Oncken C, Petry N, Feinn R (2003) Targeted naltrexone for early problem drinkers. J Clin Psychopharmacol 23:294 –304. Larsen RJ, Diener E (1992) Promises and problems with the circumplex model of emotion, in Review of Personality and Social Psychology (Clark MS ed), pp 25–59. Sage, Newbury Park, CA. Perrine MW, Mundt JC, Searles JS, Lester L (1995) Validation of daily self-reported alcohol consumption using interactive voice response (IVR). J Stud Alcohol 56:487– 490. Raudenbush SW, Bryk AS, Cheong YF, Congdon R (2001) HLM 5: Hierarchical Linear and Nonlinear Modeling. Scientific Software International, Lincolnwood, IL. Searles JS, Helzer JE, Rose GL, Badger GJ (2002) Concurrent and retrospective reports of alcohol consumption across 30, 90 and 366 days:
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interactive voice response compared with the timeline follow back. J Stud Alcohol 63:352–362. Searles JS, Helzer JE, Walter DE (2000) Comparison of drinking patterns measured by daily reports and timeline follow back. Psychol Addict Behav 14:277–286. Searles JS, Perrine MW, Mundt JC, Helzer JE (1995) Self-report of drinking using touch-tone telephone: extending the limits of reliable daily contact. J Stud Alcohol 56:375–382. Sobell L, Sobell M (1992) Timeline follow-back: a technique for assessing self-reported alcohol consumption, in Measuring Alcohol Consumption (Litten R, Allen J eds). Human Press, Clifton, NJ. Swendsen J, Tennen H, Carney MA, Affleck G, Willard A, Hromi A (2000) Mood and alcohol consumption: an experience sampling test of the self-medication hypothesis. J Abnorm Psychol 109:198 –204. Tennen H, Affleck G (1996) Daily processes in coping with chronic pain: methods and analytic strategies, in Handbook of Coping (Zeidner M, Endler NS eds), pp 151–180. Wiley, New York. Tennen H, Affleck G, Armeli S, Carney MA (2000) A daily process approach to coping: linking theory, research and practice. Am Psychol 55:626 – 636.
