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Whitlock EP, Green CA, Polen MR, et al. Behavioral Counseling Interventions in Primary Care to Reduce Risky/Harmful Alcohol Use [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2004 Mar. (Systematic Evidence Reviews, No. 30.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Behavioral Counseling Interventions in Primary Care to Reduce Risky/Harmful Alcohol Use [Internet].

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3Results

Key Question 1: Is there direct evidence that behavioral counseling interventions to reduce risky or harmful alcohol use reduce morbidity and/or mortality?

We identified four reports of health outcomes associated with long-term followup of adult interventions. 107 110 Fleming et al. reported outcomes at 48 months among 282 male and 292 female adults drinking more than 14 drinks/week (men) or 11 drinks/week (women). 108 Drinkers were randomized as part of a trial in 17 community-based primary care practices to receive either usual care or 2 brief (15-minute) physician intervention visits about one month apart, each followed by 2 brief (5-minute) telephone calls by a nurse. 111 The intervention visits used a workbook protocol that focused the interaction on drinking cues, a drinking agreement written as a prescription, and self-monitoring through drinking diary cards. Long-term (48 month) outcomes included self-reported alcohol use, self-reported health care utilization, self-reported accidents and injuries, and legal events and deaths ascertained from state agencies. Compared to the control group, the intervention group maintained statistically significant reductions in drinking outcomes (weekly alcohol use, number of binge episodes) seen at earlier time points. The intervention group self-reported fewer emergency department visits, fewer days in the hospital, and fewer motor vehicle accidents or moving violations, although only self-reported hospital days were statistically significant (429 vs. 664 days, p<.05). Intervention group participants incurred 32% fewer legal arrests (28 vs. 41), but only the subgroup of arrests for controlled substance/liquor violations were significantly different between intervention and control (2 vs. 11, p<0.05). Seven deaths were reported in the control group and 3 in the treatment group at 48-months follow-up (p>0.10).

Berglund 109 reported on the long-term follow up of the Malmo Screening and Intervention Study (MSIS), a controlled study that conducted screenings for cardiovascular risk factors and high alcohol intake between 1974-1992. All middle-aged males and females in the community were identified by birth year, and cohorts in alternating birth years were invited to health screenings at the outpatient Department of Preventive Medicine, with about 70% of invited cohorts attending. Nurses performed examinations that involved physical measures, functional tests, risk factor identification, and laboratory tests. Those in the invited group who screened positive for increased serum gamma-glutamyl transpeptidase levels (GGT) and history of excessive alcohol consumption (about 11% of all those screened) were offered repeat MD office visits (1/2 hour) as often as every 3 months over at least 18 months, preceded by repeat lab and consumption measures. MDs gave feedback concerning lab results and consumption measures, advised patients to drink moderately, and encouraged self-monitoring for situations/cues to heavy use. A treatment goal of moderation rather than abstinence was agreed upon. 112 Participants were also contacted monthly by an RN during active treatment. Over a 5-year period, active treatment was offered until lab tests and/or consumption normalized, and was then reduced to maintenance (2 MD visits and 2 RN contacts per year). Those in control cohorts received usual care. Subjects in both invited and non-invited cohorts were followed through 1995, beginning at the same age for individuals in both cohorts and using local registers to examine death rates and causes. Although there have been various followup reports over the years for this study, 109, 113 115 earlier reports are not included in the rest of this review by virtue of not collecting intermediate alcohol consumption measures on all participants, by high attrition rates, or by reporting results for subgroups. The 2000 report covers mortality measures on all individuals in both invited and non-invited cohorts, after individual followup periods from 3–21 years that were comparable between intervention and control cohorts. Using intention-to-treat analysis, total and cause-specific mortality rates did not differ between intervention and control groups among men. However, significantly fewer male intervention cohort members (18/10,000 person-years) than male control cohort members (23/10,000 person-years) had “other death mortality” (p<.02). “Other deaths” were those attributable to causes other than ischemic heart disease, stroke, other cardiovascular disease (CVD), total CVD, or cancer. Younger men at baseline (aged 32–37) had both lower total mortality rates (24/10,000 person-years compared to 30/10,000 person-years) (p<.02) and lower “other death” cause-specific mortality rates (p<.03) in intervention versus control cohorts, respectively. Mortality rates did not differ between cohorts for female participants, however the average length of followup was shorter than that for males.

A more recent report from a nested randomized controlled trial within Malmo Screening and Intervention Study 107 examined cause-specific mortality rates among a subgroup of men aged 45–49 with elevated serum gamma-glutamyl transferase levels (GGTs) at the initial screening examination who were followed a median of 13 years. Those with 2 elevated GGTs within 3 weeks were randomized to receive the active intervention (as described above) (n=365) versus letter notification and follow up at 2 years (n=302). A second control group was formed from those with a single elevated GGT who did not meet study inclusion criteria (n=311). Deaths were determined from a centralized registry, and a high proportion (88–100%) of deaths were autopsied during the followup time period. Overall death rates were 12.7% (38/365 in IG, 42/302 in CG1, and 44/311 in CG2), and were not reported as differing statistically between groups. Deaths were divided into four discrete causes: 1) alcohol-related deaths (ARD)—including accidents in an alcohol-intoxicated state, cause unknown in known alcoholics, death in known alcoholics with tissue evidence of alcoholic intoxication and no other specific demonstrable cause of death, deaths from organic complications of alcoholism, or suicide/pneumonia in known alcoholics; 2) coronary heart disease (CHD); 3) cancer; and 4) miscellaneous. Alcohol-related death rates were higher (52%) in both control groups than in the intervention group (37%) [risk ratio=2.0 (1.1–3.6), p=.026] and were higher than CHD death rates in control groups. CHD deaths exceeded alcohol-related deaths only in the intervention group. Among those with ARD in all groups, most had received treatment for alcoholism at some point.

Among risky/harmful non-dependent drinkers in the Australian arm of the WHO trial (n=554), 9-month reductions in average drinking consumption and unsafe drinking patterns in intervention vs. control subjects did not result in long-term differences in alcohol consumption (median alcohol consumption, mean reduction in consumption from baseline), in morbidity, problem drinking, or mortality rates, or in diagnoses of abuse/dependence at 10 year follow-up. 110 Younger drinkers (mean age 35 years vs. 41.6 years at baseline) were differentially lost to followup. The authors note that there is no evidence that brief advice and counseling without regular followup and reinforcement can sustain long-term reductions in drinking behavior, and therefore any associations with improved health outcomes.

Few fair-to-good quality intervention studies included in this review reported morbidity outcomes such as problem scores, 116 119 psychological scores, 116, 118 and other beneficial outcomes, such as improvements in lifestyle, and reduced accidents or injuries 111, 116, 120, 121 in the original time frame of the study. In 2 of 4 studies examining problem scores, both groups generally improved over the duration of the trials, but no differences were seen at followup between interventions and controls. 116, 117 The other 2 (male and female arms of the same study design) showed no changes from baseline to followup within or between groups. 118, 119 The 5 studies 111, 116, 118, 120, 121 measuring changes in outcomes such as general health, smoking depression, and accidents or injuries found no changes over the trials or differences between intervention and control groups.

Another adult intervention study 122 has reported a post hoc analysis of the association between changes in drinking and quality of life and alcohol-related problems. 123 A self-selected, statistically comparable subgroup (213/301) of those randomized to receive either usual care, brief, or extended brief intervention completed quality of life (SF-36, reported as the physical component summary, PCS, and the mental health component summary, MCS) and alcohol-related problem (Short Inventory of Problems, SIP) measures at baseline and 12 months. Since all groups equally improved their drinking from baseline to 12-month followup, all drinkers were combined and stratified by whether or not they had reduced their drinking by 30% or more over that time period. Seventy-seven (36%) of subjects sustained a 30% or more decrease in their drinking; these subjects averaged 85.5 drinks/month (SD 77.3) at baseline and 22.5 drinks/month (SD 29.0) at 12-month followup, while those that didn't decrease 30% or more had steady alcohol intakes of 66.0 (SD 61.2) and 65.3 (SD 59.1) drinks/months at baseline and 12 months respectively. Over 12 months, PCS, MCS, and SIP scores were relatively unchanged in those whose drinking was not reduced by at least 30%; compared to these, drinkers who reduced their average intake by 30% or more showed significantly improved MCS and SIP scores (p<.002) even after removing those with definite abuse/dependence. When the cut points were changed to include those with a 20% or greater reduction of alcohol consumption (n=98), MCS and SIP improvements remained statistically significant. Requiring a 40% or greater reduction of alcohol consumption (n=65) to define “improvers” retained the statistically significant comparative improvement in SIP scores, but eliminated the improvement in MCS scores. PCS scores appeared to improve primarily in those with definite abuse/dependence who reduced their drinking. These findings should be considered preliminary as they are limited by the post hoc nature of the analyses that addressed “responders” regardless of intervention condition and by virtue of including only two-thirds of the original participants who agreed to complete the additional outcome assessments analyzed in this study.

Key Question 2: What methods were used to identify the target populations for the behavioral counseling interventions?

We examined the recruitment, screening, and study participant identification methods used in the 12 studies included in our main evidence table for adults. Brief descriptions of these methods and procedures, inclusion and exclusion criteria related to alcohol consumption patterns and alcohol problems, and descriptive data on the numbers of participants included or excluded at various study stages are depicted in Table 11 of the Appendix.

Table 11. Screening and screening-related assessment procedures used in the brief intervention trials included in this review.

Table 11

Screening and screening-related assessment procedures used in the brief intervention trials included in this review.

In all except 3 studies, 116, 118, 124 alcohol use was assessed as part of a battery of other lifestyle behaviors in an effort to maintain participant and/or provider blinding as to the intent of the study or to diffuse initial patient resistance to addressing alcohol consumption. Almost all screening and screening-related assessments were done by research personnel, prior to the intervention visit, by self-assessment in the waiting room, 117, 124 by mail, 125 by telephone or face-to-face interview, 119, 126 or by a combination of these. 111, 116, 118, 120, 122, 127, 128 Studies used various instruments (AUDIT, CAGE, HSQ), and different subsets of questions to ascertain quantity, frequency, maximum use per occasion, and other alcohol-associated queries. In general, the types of patients identified for these intervention studies, particularly those conducted more recently in the United States, were less heavy, risky, or dependent drinkers than would be detected by use of validated screening tests, such as AUDIT, alone. Many studies also included patients if their quantity and frequency estimates exceeded recommended low-risk weekly thresholds for quantity (e.g., >12–14 drinks/week for men and > 7–9 drinks per week for women) or any indication of recent heavy episodic drinking (binge use).

Although the trials employed various recruitment and screening methods and procedures, several commonalities are apparent. First, several adapted the methods of Wallace et al. 128 This study used a two-stage screening and screening-related assessment procedure. The first stage involved a self-administered questionnaire, which embedded drinking questions among other health behavior items and which included both drinking quantity and frequency questions, the CAGE instrument, and an item allowing self-identification of having a drinking problem. The second stage, a longer, in-person interview, asked detailed questions about each day's drinking in the past week. Inclusion criteria for the first stage were based on usual consumption that exceeded gender-specific limits, on indications of alcohol-related symptoms or consequences (from the CAGE), or on self-description of having a drinking problem. Inclusion criteria at the second stage were based on total consumption in the past week, and those whose consumption exceeded gender-specific limits were included in the trial. Close variants of these two-step identification procedures were used by 5 subsequent studies. 111, 116, 118, 120, 127 The U.S. studies 111, 120, 127 often used a time-line followback (TLFB) procedure, considered by many to be the gold standard for assessing alcohol consumption. 129 This procedure is generally too time-consuming, however, for use in routine primary care.

Studies differed in the use of specific alcohol consumption measures (e.g., past week consumption vs. average consumption; or average consumption over different time frames), and in whether they specifically assessed for and included those with heavy episodic use (bingeing); when “bingers” were included, the definitions for these also varied. Studies also differed in whether or not they used established screening instruments (e.g., AUDIT, CAGE). The AUDIT was used as the primary identification tool in 2 studies, 122, 124 but even in these it was supplemented with additional items or criteria to more clearly identify heavy usual consumption or heavy episodic drinking. Most studies used established screening instruments as adjuncts to various quantity, frequency, and use-per-occasion measures. 120 122, 126 128

Two studies 124, 126 also used the AUDIT score to exclude patients and/or refer them for evaluation for specialty alcohol treatment. None of the studies relied primarily on the CAGE instrument to identify risky drinkers, using it instead as a supplement to quantity-frequency items.

Among more recent U.S. studies that identified those with risks due to heavy episodic drinking as well as recent heavy average use, the screening yields of potentially eligible patients were 11–18% for patients undergoing screening and screening-related assessment as part of a two-step process. 111, 120, 126, 127 Where data were available for the second step among these, about half of these patients were found to be eligible to receive primary-care based intervention after screening-related assessment. 111, 120, 127 This approximates the final screening yields reported (6.9–7.7%) for studies that recruited primary care patients from the waiting room, 119, 124 and suggests that about 7% of general primary care patients might be candidates for these brief interventions. Although many studies did not report active refusal rates among participants, those that did suggest only small proportions refused. 124, 127

Key Question 3: What are adverse effects associated with alcohol use screening and screening-related assessment?

No data are available on any false-positive or negative effects that occur from generalized screening for alcohol misuse among patients. Another concern about potential harms related to screening for alcohol consumption revolves around uncertainties about whether patients may be offended. Greater dropout among those receiving brief interventions for risky alcohol use compared with controls in some studies 124, 126, 128 provides indirect evidence that such concerns may be warranted for small proportions of individuals. Alternatively, those receiving interventions that did not change their drinking may have dropped out due to embarrassment. However, we were unable to find research directly addressing potential adverse effects for either screening or brief interventions for alcohol problems.

Key Question 4: Does behavioral counseling intervention in primary care reduce risky or harmful alcohol use in the targeted subgroup?

We located 5 meta-analyses or systematic evidence reviews published between 1994 and April 2002, that addressed very brief to extended interventions to reduce risky/harmful alcohol use. 96 99, 101 All of these were judged to meet the USPSTF criteria for good systematic reviews, although they differed in questions addressed, methodology used, or research base available at the time of the review (see Appendix: Detailed Review of Other Recent SERs/Meta-Analyses). Kahan 96 reviewed the results of 11 randomized controlled trials (RCTs) on the effect of brief physician intervention with problem drinkers in a health care facility. The 4 with the highest validity scores 116, 118, 128, 130 were all in primary care settings and showed decreases in weekly alcohol consumption (5–20 standard drinks per week) and higher assumption of moderate drinking levels (7–19%) for men. The results for women were mixed. Wilk 97 conducted a meta-analysis of 12 RCTs testing “brief” (less than 1 hour) alcohol interventions in heavy drinkers (heavy consumption, problem use, or those with mild alcohol abuse/dependence). Five of the 6 highest-quality trials 116 118, 128, 131 were all conducted in primary care settings; these 6 trials had a summary odds ratio for reduced or moderated drinking of 1.91 (95% 1.61–2.27) among heavy drinkers receiving “brief” intervention. In these trials, 44% of the intervention group achieved alcohol moderation compared to 28% of the controls. Poikolainen 98 conducted a meta-analysis of 7 RCTs to examine the effectiveness of “very brief” (5–20 minutes) versus “extended brief” (up to several visits) physician interventions on average alcohol intake or serum GGT changes in problem drinkers (excluding alcoholics) from primary care populations. Outcomes were analyzed by intervention intensity (“brief” versus “extended brief”) for treatment arms comparing men and women separately. Three groups of comparisons (for very brief interventions in men and women, and extended brief interventions in women) were statistically homogeneous, but only extended brief interventions in women showed a statistically significant decrease in alcohol intake (-51 grams/week or ½ drink/day). Dinh-Zarr, DiGuiseppi, and others 101 published a systematic review of 18 interventions for preventing injuries in problem drinkers (those with alcohol dependence, alcohol abuse, and hazardous use of alcohol) for the Cochrane Injuries Group. 132 None of the studies that met our inclusion criteria also reported injury outcomes. Moyer 99 completed a meta-analysis of 54 controlled clinical trials, 34 of which compared “brief” (4 or fewer sessions) interventions for alcohol use disorders with usual care controls or more extensive treatment. For studies with 6–12 months of followup, the average effect size for the composite of all drinking-related outcomes was .241 (95% C.I., .184, .299). The effect size for alcohol consumption in these same studies was .263 (95% C.I. .203, .323), but the results were statistically heterogeneous. As a convention, such effect sizes are generally interpreted as showing small-medium effects in favor of intervention. 133, 134 Very few studies (5/34) reported followup greater than 1 year.

For our review, we identified 44 potentially eligible trials. We eliminated 27 studies that were poor-quality (n=17) 115, 131, 135 149 or were conducted in a non-primary care setting (inpatient setting or emergency department) (n=10) 150 159 (see Appendix: Table 10). As a result, we included 16 trials (12 targeting adults; 3 targeting pregnant women; 1 targeting adolescents) that met all inclusion/exclusion criteria for review. One adult study 160 met criteria but could not be included because data were not published at the time of this report (see Appendix: Table 12). We report on study results for each population group separately.

Table 12. Studies Awaiting Assessment and Ongoing Studies.

Table 12

Studies Awaiting Assessment and Ongoing Studies.

Adults

The 12 fair- to good-quality trials of behavioral counseling interventions in adults are summarized in Table 8 of the Appendix. 111, 116 120, 122, 124 128 All of the studies were randomized controlled trials except for one population-based study from Norway. 125 All but one study 125 were conducted in multiple primary care practices (ranging from 3–47 practices per study). Eight were conducted in community-based primary care settings, one in an academic medical center, 127 2 in an HMO setting 124, 126 and 1 in a range of outpatient settings in 8 countries. 119 Most studies involved a large number of participants (n>500). All except 2 119, 125 clearly targeted participants who were seeking or had recently received routine primary care. Women represented a third or more of study participants in all US studies but were less well represented in international studies that did not target females specifically. 119, 125, 128 Rates of non-White participation were not reported in many older international studies, and were low where reported in more recent US studies (4–27% non-White participation). 111, 124, 126, 127

Table 8. Evidence for Adults.

Table 8

Evidence for Adults.

The trials generally targeted high-average and/or heavy occasional (binge) users. Alcohol consumption limits for risky/harmful use varied among studies but were lower for women in most studies. 111, 116 120, 122, 127, 128

Table 13 of the Appendix, shows the baseline consumption for participants across studies by gender when available. “Corrected” columns reflect consumption levels adjusted for whether a standard drink is defined as containing 12 grams or 14 grams of alcohol, the usual range of standard drink sizes in the US. Even after “correction” it is clear that earlier non-US studies 116 118, 128 tended to recruit heavier baseline alcohol users among both men and women (men 37–44 mean DR/week at baseline; women 25 mean DR/week at baseline) than later US studies; these earlier studies also included some drinkers with “less severe” but definite dependence symptoms compared with more recent US studies, which tended to exclude heavier or dependent drinkers.

Table 13. Baseline Consumption of Alcohol Among Risky/Harmful Drinkers Recruited for Interventions in Primary Care (Mean DR/week) *.

Table 13

Baseline Consumption of Alcohol Among Risky/Harmful Drinkers Recruited for Interventions in Primary Care (Mean DR/week) *.

Interventions

Studies primarily tested interventions delivered all or part by the patient's usual primary care physician. Exceptions to this were the use of research personnel, 122 “health advisors” (46% RNs, 18% MDs, 35% other), 119 or unspecified intervention personnel. 125 Among the interventions involving a patient's usual primary care physician, some used the physicians to deliver initial and any repeated intervention contacts 117, 118, 127 while others also used health educators/counselors, 124, 126 or clinic nurses. 111, 120, 128 However, most interventions also involved contact with a research person to determine study eligibility through screening and screening-related assessment prior to intervention.

According to our intensity definition (see Appendix, Table 2), 2 studies evaluated very brief interventions, 117, 119 6 studies 116, 118, 119, 122, 124, 125 evaluated brief interventions, and 7 evaluated brief multi-contact interventions. 111, 120, 122, 125 128 Fifteen intervention arms were contributed by the 12 studies (i.e., since three studies adequately tested more than one arm of varying intervention intensities against controls). 119, 122, 125 Control conditions involved screening/assessment only, 116, 118, 119, 125, 126 screening/assessment followed by usual care, 124 provision of a general health pamphlet after screening/assessment, 111, 120, 127, 128 or screening/assessment results recorded on the chart 117 or forwarded to a physician. 122 We considered that very brief or brief interventions (n=8) were those that could more feasibly be incorporated into current routine primary care with relatively minimal changes, while brief multi-contact interventions (n=7) were those likely to need more substantial primary care reconfiguration and/or systems support in addition to provider behavior change for incorporation into routine care.

Rates of intervention delivery provide an estimate of whether the tested intervention was delivered adequately enough to fairly evaluate it. Most fair- to good-quality studies reported to what degree the intervention was delivered as intended, although several studies did not, 116, 118, 119, 125 and 1 study with multiple intervention arms reported intervention delivery only for the most intensive intervention. 117 For the extended brief intervention arm of this study, only 49% of patients got anything beyond the very brief initial intervention contact, diluting the possibility of adequately evaluating the more intensive approach. Some studies reported reasonable completion rates for the entire protocol 111, 122, 124, 127 varying from 60–76%, while others reported fewer participants completing the entire protocol. 126, 128 Interpreting the lower delivery rates for these 2 studies is complicated because their protocols involve “up to” a certain number of contacts at the discretion of the provider and/or patient. Completion rates for the first 2 contacts of these protocols were 60% or above. Some studies reported much higher completion rates (91–94%), 120, 122, 126, 127 but these rates usually reflected only the initial contact of an intervention.

Outcomes. All studies included estimates of intervention impact on average alcohol consumption at 6–12 months followup. One study 111 reported longer-term (48-month) followup in 2 separate reports. 108, 121 Intervention groups had significantly lower average alcohol consumption in six of the 12 studies, 111, 119, 120, 125, 127, 128 and the rest consistently reported minimal to modest decreases in average drinks/week in both interventions and controls that were not statistically significantly different. 116 118, 122, 124, 126

Among the very brief and brief single contact interventions, 116 119, 122, 124, 125 one study testing both very brief and brief interventions 119 (with optional followup at some centers) reported significantly reduced average alcohol consumption among those receiving either intervention compared to controls at 12-month followup. Another study testing both brief and brief multi-contact interventions 125 found that both types of interventions significantly reduced alcohol consumption compared to controls, although the potential for contamination between conditions wasn't clear. Most of the very brief or brief intervention studies did not report intervention delivery except 2 122, 124 with adequate to good intervention delivery for the single component intervention. Therefore lack of intervention delivery may confound the failure to find treatment effects for most brief or very brief interventions. Among seven adequately tested brief multi-contact interventions, 111, 120, 122, 125 128 five 111, 120, 125, 127, 128 reported that participants had significantly lower average alcohol consumption than controls at 12 months 111, 125, 128 120 or 6 127 months. The other 2 showed no difference in mean drinks (DR)/week among intervention and control participants. 122, 126

Long-term alcohol consumption was measured in 1 study 111 for the entire cohort 108 and for a subset of women of child-bearing age. 121 Men and women in the intervention group maintained the reduction in alcohol consumption (mean DR/week) achieved by 12-months through 48-month follow up. By 48 months, differences between intervention and control were no longer statistically significant because of late onset (between 36 and 48 months) reductions in control group usage primarily among men. The relatively delayed reduction in control consumption to levels achieved by the intervention group at 12 months could reflect (late) regression to the mean, the natural history of alcohol consumption, or the cumulative effect of yearly followups. 108 For a subset of women of childbearing age (18–40), 111 average alcohol consumption significantly decreased in interventions compared with controls by 12 months. Reduced levels were maintained among intervention patients over 48 months, but were no longer statistically significantly different at 48 months because of late onset (between 24–28) reductions among controls.

To further summarize the effect sizes and consistency of the alcohol consumption results, Figure 4 of the Appendix shows the net change in mean drinks/week (DR/week) for brief interventions (listed first) and brief multi-contact interventions that reported intention-to-treat baseline and followup levels of consumption for intervention subjects compared with controls. 111, 116, 118, 120, 122, 126 128 Two studies were rated fair quality 116, 122 while the rest were rated good quality. The effects range from a net reduction of about 1 to 10 mean DR/week. Among brief multi-contact trials with statistically significant effects, 111, 120, 127, 128 patients receiving the intervention consumed 2.9 to 8.7 fewer drinks per week than those in the control conditions. Among effective trials that report results by gender, 2 111, 127 of 3 111, 127, 128 show similar or better effects among women.

Figure 5 of the Appendix shows the net percentage-point reduction in mean DR/week between interventions and controls at followup. The 3 brief intervention arms are listed first, followed by the brief multi-contact interventions. Drinkers receiving effective brief multi-contact interventions reduced their drinking between 13 and 34 percentage points compared with controls. The largest effect sizes (30–34%) were seen among women in the Fleming 1997 study and older adults (65+). 120

Figure 5. Net percentage point reduction in mean drinks per week .

Figure

Figure 5. Net percentage point reduction in mean drinks per week .

Binge/heavy episodic drinking was reported in a subset of good studies 111, 116, 120, 124, 126, 127 and 1 fair-rated study 118 (n=7) (see Appendix: Figure 6). Three good quality studies 111, 116, 120 that also reported reducing average alcohol consumption showed reduced numbers of binge users in intervention compared with control, while the rest showed no differences. Across studies, binge use remained fairly common. For example, in trials with at least 49% binge users at baseline, 111, 120, 127 binge drinkers remained fairly common (31–69%) among intervention participants.

Figure 6. Percent Not Binge Drinking at Follow-up.

Figure

Figure 6. Percent Not Binge Drinking at Follow-up.

Three fair-quality 117 119 and 7 good-quality studies 111, 116, 120, 124, 126 128 reported some measure of the proportion that benefited from the intervention compared to controls (see Appendix: Figures 7 & 8). These were defined differently across studies, but addressed the proportion drinking within safe/recommended limits, 116 120, 124 the proportion not drinking excessively, 111, 128 the proportion with safe weekly intake and no bingeing, 127 and the proportion not reporting any at-risk drinking pattern (including driving after drinking 3 or more drinks). 126 Among 6 111, 116, 120, 126 128 of the 7 good quality studies, significantly more intervention participants than controls achieved recommended drinking patterns. Across these studies, 10–19% more intervention participants than controls achieved recommended or safe drinking limits. Three studies that did not show a beneficial effect 117, 118, 124 were similarly ineffective as measured by average drinking consumption and bingeing outcomes where available. One study 119 showed significant results for males only.

Figure 7. Percent Achieving Recommended Drinking Levels/Patterns at Followup (Total).

Figure

Figure 7. Percent Achieving Recommended Drinking Levels/Patterns at Followup (Total).

Few fair- to good-quality studies in adults addressed intervention effects besides alcohol consumption and alcohol-related behaviors. These are addressed in Key Question 5.

Pregnant Women

We identified 3 fair- to good-quality behavioral counseling interventions in primary care settings that targeted women making prenatal visits. 161 163 One additional study 149 was excluded from the review because it failed to meet at least fair internal validity criteria. All 3 included studies were randomized controlled trials that assessed alcohol consumption during the perinatal period. Table 9 of the Appendix records the details of these studies, which are summarized in this section.

Setting and Participants. All 3 studies were conducted in the United States among women making routine prenatal visits. Two 161, 162 were in university health center settings, while 1 163 was in a public health maternity clinic. Two of the studies were small (<100 participants) 161, 163 and 1 was medium-sized (n=250). 162 All clearly targeted women making prenatal visits. Ethnic diversity was greater in these studies than in the general adult brief intervention studies reviewed above, with the 2 smaller studies including over 60% ethnic minority participants (the other included 20% minority). Participants in the 2 smaller studies were also similar in terms of average age of participant (early to mid-20s), two-thirds single or divorced, and unemployment or low-income status. Participants in the larger study by Chang et al. 162 were older (approximately 30 years), and only 16% were single or divorced. The studies varied in extensiveness of alcohol assessment, ranging from 2 hours, 162 to 1 hour, 161 to a brief screening questionnaire. 163 The 2 smaller studies included women who reported any alcohol consumption in the previous month, while the larger study included women who were positive on the T-ACE screening instrument. A standard drink was defined in the Handmaker study 161 as approximately 0.5 ounces of alcohol; neither of the other 2 studies defined a standard drink. At baseline, reported average number of drinks in the past week (calculated from monthly figures when necessary) ranged from 2.25 in the Handmaker study 161 to 7–11 in Reynolds 163 (for intervention and control groups, respectively). Mean drinks per drinking day were reported in the Chang study 162 as ranging from 0.6 to 0.9 in the intervention and control groups, respectively. Handmaker et al. 161 presented evidence of underreporting of alcohol consumption to medical providers, compared to reports in research interviews. These authors also suggest that peak blood alcohol concentration (BAC) is the best indicator of potentially harmful fetal exposure to alcohol, and recommend the addition of this measure rather than solely relying on reported average consumption. The estimate of BAC in their study was based on self-reported drinks, however, not on breath or blood analysis.

Interventions. Two of the studies included face-to-face counseling interventions, while the other 163 combined a 10-minute educational session with a self-help manual. In the Handmaker et al. study, 161 women in the intervention group were given a 1-hour motivational interview at a visit subsequent to study enrollment. The primary intervention goal was to heighten the women's perceptions of fetal risks from alcohol consumption while simultaneously supporting their self-efficacy to reduce or quit drinking. The interview followed principles of brief motivational interventions as described in Miller and Rollnick. 164 Chang et al 162 delivered a 45-minute structured counseling intervention immediately following the 2-hour comprehensive assessment interview. The intervention focused on identifying the women's drinking goals, motivation, drinking risk situations, and alternatives to alcohol. Non-clinical personnel delivered the interventions in both the Handmaker and Chang studies. 161, 162 The Reynolds study was innovative in using clinic-based health educators to orient participants to a 9-step self-help manual, which was given to the participants to complete over a 9-day duration. All of these interventions would be considered “extended” interventions under our intensity definition (see Appendix, Table 2), although the Reynolds et al 163 intervention used only 10 minutes of clinic staff time. All used an intention-to-treat design. Usual care control conditions were used except in the Handmaker study, 161 in which controls were sent an informational letter about alcohol risks during pregnancy that also encouraged them to see their health care providers.

Outcomes. Followup intervals were relatively short in all 3 studies (1–2 months postpartum), and follow-up rates were excellent (92–99% in Reynolds 163 and Chang, 162 respectively) or acceptable (81% in Handmaker 161 ). Two of the studies were consistent in failing to show significant intervention impacts on indicators of average alcohol consumption. 161, 162 The Reynolds study 163 reported marginally statistically significant differences favoring the intervention group on mean total drinks in the previous month (0.36 versus 1.14 in intervention and control groups, respectively, p<.06), and on percent abstinent (88% versus 69% in intervention and control groups, respectively, p<0.058). Subgroup analyses in the Handmaker 161 study revealed an interaction between peak BAC level at baseline and treatment group, with women who had the highest BACs being more likely to respond to the intervention.

Adolescents

For adolescents in a health care setting, we identified only 1 intervention study that met inclusion criteria. Werch et al., 165 rated “fair” based on our quality criteria, conducted an RCT of a brief preventive intervention among students attending school sports physical examinations. Study participants were 178 7th to 9th grade students—60 from an urban school, 74 from a suburban school, and 44 from a rural school. Participants were fairly evenly divided on gender (51.7% male); nearly 75% were White and 13.5% were African American. At baseline, 55.1% had tried alcohol in their lives; 28.1% had consumed alcohol during the year prior to the study. Screening consisted of a “dip-stick” saliva bogus pipeline procedure to improve validity of self-reported alcohol use, and the 10-minute “Youth Alcohol and Drug Survey,” assessing alcohol use. Alcohol use measures included intention to drink in the next 6 months, drinking during the prior 7 days, drinking during the prior 30 days, and heavy drinking (5 or more drinks in a row) in the prior 30 days.

Intervention participants received the STARS for Families intervention - a 20-minute telephone call by a nurse in the days following the sports exam, including a discussion of the risks, purpose of the communication, prevention messages, and recommendation to avoid future alcohol use. Ten prevention postcards were mailed twice weekly to parents/guardians, asking them to take a few minutes to read and talk with their child about the important fact found on each card, designed to help the child stay away from alcohol.

Loss to followup across groups was minimal (8%), and investigators used intention-to-treat analytic procedures. At 6-month followup of the pooled sample of rural and suburban youth, intervention youth were significantly less likely to intend to drink than controls (5.5% vs. 19.2%), were less likely to drink in prior 30 days (3.6% vs. 17.3%), and were less likely to have consumed 5 or more drinks in a row during the prior 30 days (0.0% vs. 9.6%). There were no statistically significant differences between urban intervention and control groups. Intervention costs were estimated to be $16.13 per student.

Key Question 4a: What are the essential elements of efficacious interventions?

Within the adult intervention trials reviewed for KQ4, intervention intensity appeared to explain some of the heterogeneity in the results of the adult trials: 2 of 6 very brief or brief interventions had statistically significant effects on average alcohol consumption, while 5 of 7 trials of more intensive interventions did. Similarly, other alcohol outcomes appeared more likely in brief multi-contact interventions compared with the less intensive interventions. To identify other factors that may be associated with heterogeneity in the results of these trials, we examined how well other intervention elements that have been cited as important to these interventions 40, 55, 64, 105 distinguished between studies with positive and negative effects on average alcohol consumption.

Goal-Setting

The majority of adult intervention arms 111, 117, 119, 120, 122, 124, 126 128 reported goal-setting as an explicit part of their intervention approach. Of the 4 that did not, 3 did not show an intervention effect on average consumption 116 118 and one did. 125

Multiple Versus Single Contacts

Five of the single-contact interventions 116 118, 122, 124 showed little or no intervention effect on average consumption, while 2 others 119, 125 showed intervention effects comparable to other more intensive interventions. Both of these studies tested multiple less and more intensive intervention arms in the same study. Nillsen 125 tested brief and very brief interventions and possible contamination was not addressed. Although the WHO tested very brief and brief interventions, it is interesting to note that there was optional followup in some sites for the latter intervention arm. Since the followup was optional, we chose to categorize the study as brief single contact.

Among those studies with followup (multiple intervention contacts), all offered repeat provider visits 111, 117, 119, 120, 125, 127, 128 except two; one used telephone contact 126 and the other had repeat contacts with a research interventionisits 122 All those with repeat visits except the study arm that was insufficiently delivered 117 reported significant intervention effects on average consumption.

Matching or Tailoring Interventions

Intervention details were not sufficiently reported to allow us to evaluate this question regarding stage-of-change or other tailoring assessments.

Ongoing Assistance

Among the 6 studies that delivered ongoing assistance and were effective in reducing average alcohol consumption, 111, 119, 120, 125, 127, 128 all delivered multiple contacts that extended over 1–12 months to at least some of their patients. Intervention elements included feedback, advice, goal setting, and repeated assistance involving a variety of approaches (information on drinking prevalence and risks, motivational interviewing, problem-solving barriers to change, drinking dairies for self-monitoring, workbooks, drinking cue awareness activities, drinking agreements or “RXs.”) and at times a variety of other health care personnel (nurses, health educators/counselors). 111, 119, 120

Patient Motivation and Problem Awareness

Studies did not report consistent measures of problem orientation or motivation among patients.

Key Question 5: Are there other positive outcomes from behavior counseling interventions to reduce risky/harmful alcohol use?

Few fair- to good-quality studies in adults addressed intervention effects such as health care utilization, 111, 116, 118, 121, 124, 166 or cost effectiveness. Of all the studies that examined health care utilization, only 1 found reduced self-reported hospital days among males in the intervention group compared with controls at 12 months of followup. 111 At longer-term followup (48 months) in the same study, males and females in the intervention group reported significantly fewer hospital days compared with controls. 108 These data reflected self-reported estimates of use rather than analyses of administrative data, as did 1 other study. 124, 166

Out of 100 articles identified in the literature search for economic studies addressing counseling interventions to reduce risky/harmful alcohol use, 14 were retrieved, and 12 of these were excluded: seven were not original economic analyses, 167 173 two included only costs and no measures of effectiveness 174, 175 two examined non-primary care interventions 176, 177 and one reported measures of effectiveness for interventions that could not be disaggregated. 178 In addition to the two studies identified through the literature search, 179, 180 another article relating to one of these studies was identified through expert contact 108 and a third study from examining reference lists. 181 These three original cost-effectiveness studies were abstracted and reviewed by a separate cost working group team, but interpretation of their results was limited because of noncomparability between studies in definitions of drinking misuse/problems and intervention designs, and lack of inclusion of non-medical (e.g., quality of life) as well as medical outcomes. Additionally, most studies lacked a societal perspective in terms of both benefits and effects. Despite these limitations, these studies tended to show that brief interventions are either cost savings or have cost-effectiveness ratios that compare favorably to other commonly endorsed interventions. Firm conclusions from these studies are premature, however, given the limitations cited, particularly the variability in inputs, definitions, and differences in assumptions between studies.

Key Question 6: What are adverse effects associated with behavioral counseling interventions for risky/harmful alcohol use?

As discussed above, higher attrition rates among intervention compared with control groups in some studies suggests that, for some individuals, alcohol misuse interventions may be embarrassing or even offensive. There are no data on adverse effects of treatment, including theoretical reduction in “benefits” from moderate use among patients who may be benefiting from non-risky use. Also, some drinkers with more severe abuse or dependence might be undertreated and harmed if guided towards moderation rather than abstinence. However, literature searches targeted to potential harms retrieved no articles, and no information to address these questions was reported in the screening reviews or the intervention studies included in our review.

Key Question 7: What healthcare system influences are present in effective screening, and screening-related assessments and interventions to reduce risky/harmful alcohol use and/or its outcomes?

Interventions function in a “context” of the network of resources, services, and conditions in the larger health care system and community. 182 To evaluate generalizability (of individual studies on brief alcohol interventions in primary care) and feasibility (of this approach in the current and future health care system), some level of context evaluation considers factors related to the health care team, the service system and environment, and the broader community.

Within the adult intervention studies reviewed for Key Question 4, the little information reported about contextual factors concerned the health care team and, to some extent, the health care system and environment.

Settings/Health Care System Factors

Four 111, 120, 127, 128 of the 12 adult intervention studies were conducted in more research-oriented practice settings, which may have influenced provider adherence to research protocols. Two studies were delivered in HMO settings, 124, 126 1 in an academic setting, 127 and the remainder of US studies in community-based primary care. To identify potential study participants for screening/assessment, 2 used upcoming appointment systems, 126, 127 while others used practice registries. 116, 118, 128

Personnel Involved with the Study

Research staff conducted the screening and screening-related assessments to identify at-risk patients prior to intervention in nearly every study; most of these processes were fairly time-intensive (>30 minutes) and done outside routine care encounters. Only 4 studies used the waiting room to entirely qualify patients; 116 118, 124 others began a longer process with waiting-room patients. 111, 119, 120, 122 As indicated, usual care physicians were involved in most studies. In some studies research staff were also involved in the delivery of some (or all) of the intervention, 119, 122, 124, 126 while in others non-physician health care staff were involved. 111, 120 Research staff often performed important support functions, such as prompting the provider and supplying intervention materials to the chart. 122, 124, 126, 127 None reported using electronic medical record support.

Provider training

Provider training sessions were specifically reported in many studies 111, 116 119, 126, 127 and were relatively brief (15 minutes to 2.5 hours). More recent studies reported both initial and ongoing training. 111, 127

Incentives

Many (9/12) studies did not report using incentives for participating providers or patients, although a few studies did. 111, 120, 122

Summary

Many studies were conducted with usual care primary physicians among a reasonably broad swath of patients recently or currently presenting for care. Some studies were not conducted in research-affiliated primary care 116 118, 122, 124, 126 and may provide more accurate estimates of the effects to be expected in usual primary care. All interventions required sufficient systems support in the provision of screening/assessment services and, in some cases, provider prompting. It would not be realistic to expect even the most modest effects from interventions that did not have such systems in place as well.

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