Abstract
Keywords
Psychosocial interventions can have a significant impact on the outcome of AUD. The model presented in this article is effective and scalable. If adopted, it can help address the huge treatment gap in AUD.Key Messages:
Alcohol consumption significantly contributes to the global burden of disease. 1 In the past decade, alcohol consumption has decreased in high-income countries. At the same time, it has seen an increase in some low- and middle-income nations in Southeast Asia, such as India. In 2019 alone, alcohol use in India led to 3.4 million fatalities and 14.7 million years of life with disability. 2
Based on World Health Organization (WHO) projections, the per capita consumption of alcohol among adults in India experienced a significant surge from 2.4 L in 2005 to 5.7 L in 2016. It is anticipated to rise to approximately 7.9 L by 2025.3,4 This escalating trend highlights the urgency of addressing alcohol use disorders (AUD) as a critical public health concern, requiring immediate attention from all stakeholders.
A considerable proportion of persons in India with AUD do not have access to treatment for their alcohol-related disorders, resulting in an 86% treatment gap. 5 Community-based care options are limited; treatment for AUD is mainly dependent upon institutional care, which is both limited and strained. AUD includes a range of drinking behaviors from hazardous to severely dependent patterns. Detoxification is the initial stage in the treatment for clinically significant AUD. It can take place in the community or an inpatient facility; the option is based on the severity of the alcohol use. Though patients are routinely advised home detoxification, there is scarce data on the outcomes of home detoxification in India, with one study showing only 35% having a favorable outcome. 6 There is evidence indicating that community-based detoxification is more favorable compared to inpatient detoxification in terms of overall success, cost-effectiveness, feasibility, reduction of treatment gaps, and client satisfaction. 6
Domiciliary alcohol detoxification is a process where the management of detoxification is advised at the level of the patient’s home, where a person with AUD is safely detoxified without admission to an inpatient unit. However, in assisted domiciliary alcohol detoxification, additional monitoring is provided while the patient undergoes detoxification in the community. 7 The Mental Health Care Act 2017 recommends patient treatment in the community; thus, domiciliary detoxification is a step in that direction. 8 There is an urgent need to find effective ways to assist patients in accessing care in their community for AUD.
The objective was to examine the results of assisted domiciliary alcohol detoxification compared to routine domiciliary detoxification in a randomized controlled trial. The assistance included two sessions of brief intervention (BI) and daily monitoring via phone calls until successful detoxification. The success of detoxification and abstinence at the one-month mark were used as outcome measures.
Methods
Study Setting
This study was based in the outpatient department of a tertiary care psychiatry hospital in India.
Study Design
It was a randomized controlled trial.
Sample Size
One hundred patients were included in the study. Though the sample size was a pragmatic estimate based on feasibility, post hoc analyses showed a power of 100% at 0.05 alpha.
Inclusion Criteria
Consenting male patients aged between 18 and 65 years presenting in an alcohol withdrawal state with a CIWA score of 8 or more and who were advised domiciliary detoxification by the treating doctor were included.
Exclusion Criteria
There were no exclusion criteria.
Procedure
Eligible patients were approached, and written consent was obtained after a detailed explanation of the study. The advice for home detoxification was a clinical decision by treating doctors; the investigating team had no role. Recruitment was done from January to December 2020. A baseline assessment of all participants was done using the following: (a) the Severity of Alcohol Dependence Questionnaire (SAD-Q) for the severity of alcohol dependence. The SAD-Q has been extensively used in several studies in India.9,10 (b) Readiness to Change Questionnaire, Treatment Version (RCQ-TV) for motivation to quit alcohol. This scale is based on Prochaska and DiClemente’s stages of change model for assigning excessive drinkers to pre-contemplation, contemplation, and action stages.11,12 Researchers worldwide have used this questionnaire as a simple means to assess the stage of motivation of an individual.13-15 (c) Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) for the severity of withdrawal. A cut-off of 8 was considered for intake, as scores below 8 usually do not need medical management.16-18 A vernacular version of the scales was generated using the translation–back translation method. A predesigned semi-structured questionnaire was used to assess the socio-demographic variables and drinking-related variables.
Randomization
Following baseline assessment, randomization was done using pre-randomized sealed envelopes to assign the subject to an intervention or control group. Randomization was done by a third party not involved in the study. No blinding was carried out owing to the nature of the intervention. Both groups (intervention and control) received care for alcohol withdrawal state as is routinely provided at the center by their respective treating doctors and followed up as directed. The respective treating doctors made all treatment and follow-up decisions. The study team did not have any role in it.
Intervention
The intervention group, in addition to routine care, received a session (approx. 15 min) of BI for alcohol at the time of recruitment and again after completing detoxification. The BI session was delivered on structured lines based on psychoeducation and personalized feedback. It focused on making patients aware of the potential harm if alcohol was continued, mainly in terms of medical, social, and financial aspects, and encouraged abstinence. 19 The BI model was selected to keep the intervention simple and feasible. Further, the patient or designated caregiver received daily phone calls, and information was provided regarding any queries related to their withdrawal or detoxification process. Adverse outcomes such as sedation, seizure, and confusion were enquired for, and records were maintained. The patient was encouraged to continue the treatment and report for scheduled follow-ups. In adverse outcomes, the patient was asked to report to the treating doctor, and an appointment was facilitated. Phone calls were discontinued once detoxification was achieved.
Patients in the control group received the same care routinely provided at the hospital. Those patients who had resumed drinking at the end of the trial period received brief counseling regarding drinking and were directed to visit for further assistance.
Outcome Assessment
Outcome measurement for successful detoxification was done at every follow-up visit (as recommended by the treating doctor) for both groups. A CIWA score of less than 8 was considered a successful completion of detoxification. Similarly, outcome assessment for abstinence at one month was done using the Time Line Follow Back (TLFB) method after one month of detoxification either in person or by phone call. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking. People give retrospective estimates of their daily drinking over a specified period that can vary up to 12 months from the interview date using a calendar. This method has been used across wide settings.20-23
Data Analysis and Interpretation
Data was analysed using the Statistical Package for Social Sciences (SPSS) for Windows software (version 22.0; SPSS Inc., Chicago). Descriptive statistics such as mean and standard deviation (SD) for continuous variables and frequencies and percentages for categorical variables were calculated. The association between the study group and other categorical variables was analysed using a chi-square test of independence and an unpaired t-test for continuous variables. The level of significance was set at
Results
One hundred participants were included in the study, with 49 patients randomized to the intervention group and 51 patients to the control group. Two participants in the intervention and three in the control group were lost to follow-up. Those lost to follow-up were considered as relapsed and were considered for analysis (Figure 1).
Socio-demographic and Alcohol-related Measures
The average age (SD) of participants in the intervention group was 45 (10.4) years, and in the control group it was 46 (9.5) years. Most belonged to the Hindu religion (77.6% vs. 76.5%), had high school education (28.6% vs. 33.3%), were skilled workers (38.8% vs. 37.3%), and were in the lower middle-income group (49% vs. 39.2%). On drinking parameters, most had moderate severity of drinking on SAD-Q (63.3% vs. 64.7%) and experienced moderate withdrawal on the CIWA-Ar scale (63.3% vs. 56.9%). There was no statistically significant difference between the two groups in terms of socio-demographics or alcohol-related variables. The only difference between the groups was seen in the readiness to change the scale (to quit alcohol). On the RCQ, patients were seen to be in the pre-contemplation (40%) or contemplation stage (59%), with a significantly larger number from the control group (70.6%) in the contemplation stage compared to those in the intervention group (46.9%) (Table 1).
Socio-demographic and Alcohol-related Parameters.
Detoxification Outcomes
Of all participants, 74% had a successful detoxification. However, a significantly higher number completed detoxification in the intervention group compared to the control group (85.7% vs. 62.7%,
Detoxification Results.
Abstinence at One Month
The other outcome of the intervention was the number of days abstinent at the end of one month using the TLFB method. Participants in the intervention group abstained for significantly more days than those in the control group (22.6 vs. 10.2,
Abstinence Outcome at One Month.
Data Processing
In all, 318 phone calls were made; most were received by the patient (51%), spouse (22%), or others (27%). On average, each participant received seven phone calls with an average duration of 78 seconds. The nature of queries from the participants was recorded at each call. Common queries were related to follow-up visits (5.3%), medication dose (4.4%), treatment duration (2.8%), seeking reassurance (2.8%), adverse events (1.9%), availability of the doctor (1.6%), side effects (1.6%), restarting alcohol (1.2%), craving for alcohol (0.9%), or rehabilitation option (0.6%). No queries were raised in 76.8% of the calls.
Discussion
This was a non-blinded, randomized controlled trial of an intervention aimed at improving the outcomes of domiciliary alcohol detoxification. The intervention included daily phone call monitoring and two sessions of BI. Patients were randomly allocated to either an intervention or a control group. On comparison, there was no significant difference in socio-demographic and drinking-related variables between the two groups, indicating an adequate randomization of the study sample, thus eliminating the possibility of any confounders. Therefore, this study’s findings can be concluded to be a direct effect of the intervention alone.
The key outcome measures of this study were successful completion of detoxification and abstention rates at the end of one month. The intervention proved to be effective in both outcome measures. A significantly higher number of participants in the intervention group completed detoxification without relapsing into drinking behavior (85.7% vs. 62.7%,
The effectiveness of BI for AUDs is well established, which shows favorable outcomes in terms of quantity, frequency, intensity of drinking, and adverse effects. 24 A systematic review conducted by Yuan-Cheng et al. in 2020 to determine the most effective interventions in patients who received detoxification treatment highlighted the role of psychosocial interventions like cognitive behavioral therapy, motivational enhancement therapy, coping skill training, home visit, contingency management, etc. 25 Such evidence, along with the findings of our study, highlights the importance of combining psychosocial intervention with the medical management of AUD. Relying only on medical detoxification alone may not lead to any significant change in alcohol-drinking behavior, with most patients dropping out of care.
Further, this simple intervention’s treatment effect persisted much longer, as demonstrated by the significantly higher abstention rates at one month. This finding is of great clinical importance and adds to the scarce data on community-based interventions for detoxification. Higher completion of detoxification when intervention is provided in the community has been reported in a trial that used lay health workers to monitor home detoxification. 26 This is also consistent with reports from other studies that suggest community detoxification has higher completion and better drinking outcomes. 27 A Brazilian study compared traditional outpatient treatment for alcohol dependence with outpatient treatment enhanced by home visits. 28 The latter was superior in a range of clinical outcomes.
We also monitored adverse outcomes such as excessive sedation, seizures, and hospitalization. Most patients (80%) across both groups did not experience any adverse outcomes. Nadkarni et al. have reported similar findings. 27 Thus, domiciliary detoxification is a reasonably safe and helpful approach in the management of AUDs.
In the absence of proper care models, home detoxification can have poor outcomes. In a study done by Nemlekar et al., patients undergoing home detoxification had a favorable outcome in only 35% of cases, while 65% either relapsed or had to be re-admitted. 7 Our model, which uses phone calls and the existing setup of hospital care, is a feasible template for large-scale adaptation. Our process data show that the phone calls are of short durations with simple queries, which could be addressed by ancillary staff of any hospital, such as social workers, with minimal training. In a resource-constrained country like India, this holds significant policy implications regarding expanding services.
The WHO established the importance of domiciliary detoxification in 1951, yet our setting has no clear policies or guidelines. Inpatient care for AUD is costly, whereas home detoxification can be up to eight times cheaper. 29 According to Cooper, home detoxification treatment costs 26% less than inpatient treatment, and patients who detox at home are more likely to complete treatment and remain abstinent for longer than those who detox in a hospital. Other advantages include reducing the stigma associated with inpatient treatment, increasing family involvement and support, and minimizing the waiting list. According to Bartu and Saunders, home detoxification is substantially more realistic in terms of alcohol detoxification since patients are not isolated from drinking-related cues and triggers. 29 Home detoxification, therefore, needs the urgent attention of policymakers as an effective strategy to address the enormous burden of AUD.
Limitations of the Study
The sample size was calculated based on the feasibility of the study; however, post hoc analyses showed it to be adequate. The nature of the study did not allow for blinding of the intervention. A single investigator did the study, which would have likely led to observer bias. However, to minimize the bias, all assessments were done prior to randomization, and final evaluations were done using patient-rated objective scales. Minimization and socially desired responses are a norm in substance use inquiry. Since the same investigator delivered the intervention and assessed the outcome, we cannot rule out a reporting bias by intervention group participants on the TLFB scores. However, such a bias would exist in both groups, and the significant difference in the scores gives us confidence that the intervention had a positive impact. Lastly, since the study included only those who were advised domiciliary detoxification, it cannot be applied to all persons needing detoxification, thus limiting its generalizability.
Conclusions
AUD is a significant public health issue with a high treatment gap. Detoxification is the first step in the effective management of this condition. Inpatient care can be expensive and not universally available in a resource-poor country like ours. On the other hand, outpatient-based detoxification alone is mired with poor follow-up and relapse. We have, through this randomized trial, demonstrated that a simple intervention that included two sessions of BI (15 minutes each) coupled with daily phone calls (lasting approximately a minute) during the active detoxification phase led to high abstention rates at the end of one month when compared to the control group. It was also safe, without any significant adverse outcomes. This study thus provides an alternative model of care for assisted domiciliary detoxification that is both effective and feasible. Minimally trained health workers can quickly deliver this intervention, which has significant policy implications for extending mental health services to the community. This study also contributes to the limited evidence base for home detoxification for AUD, an area that is poorly researched. 27 Future research in this area should focus on eligibility criteria for home detoxification, diverse detoxification settings, the use of ancillary hospital staff in monitoring, and the role of communication technology like video conferencing for intervention delivery.