<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04447079</url>
  </required_header>
  <id_info>
    <org_study_id>ARFA</org_study_id>
    <nct_id>NCT04447079</nct_id>
  </id_info>
  <brief_title>Assertive Community Treatment for Alcohol Misuse Disorder Patients Who Are High Utilizers of Emergency Department Services</brief_title>
  <acronym>ARFA</acronym>
  <official_title>Assertive Community Treatment for Alcohol Misuse Disorder Patients Who Are High Utilizers of Emergency Department Services: - A Prospective, Multi-centre, Before-and-After Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khoo Teck Puat Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Khoo Teck Puat Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background Frequent attenders (FAs) at emergency department (ED) in Singapore hospitals have&#xD;
      been increasing over the years. More than half of the FAs are reported to be alcohol-related&#xD;
      frequent attenders (ARFA) and they were found to be using EDs unnecessarily. We aim to assess&#xD;
      if there will be a difference in patient outcomes in terms of ED usage and cost-effectiveness&#xD;
      by implementing an assertive community treatment (ACT) program to manage AFRAs.&#xD;
&#xD;
      Methods This is a prospective, multi-centre, before-and-after, superiority and cohort study&#xD;
      to assess the impact of ACT from 4 study sites. 200-300 patients will be recruited and&#xD;
      followed up for 12 months. The primary objective of the study is to investigate whether there&#xD;
      will be a reduction in AFRA ED attendances. The secondary objective is to estimate the change&#xD;
      in total cost utilization.&#xD;
&#xD;
      Conclusion/Significance All patients who are on ACT programme will be enrolled in this study.&#xD;
      The study intervention will be used as a new mode of care at participating hospitals. We&#xD;
      expect to see reduced alcohol addiction level, reduced isolation level, improved motivation&#xD;
      and better overall health. With reduced alcohol-related hospital visits, we would also expect&#xD;
      to see improved healthcare utilization by ARFAs which will lead to increased cost savings to&#xD;
      the healthcare systems and decreased social costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND Singapore has seen a steady growth in the use of emergency department (ED)&#xD;
      services. ED visits increased from 752,122 in 2007 to 1,006,800 in 2013. Despite efforts to&#xD;
      redirect low acuity ED patients to primary care, EDs continue to be busy and with long waits&#xD;
      for patients. Data suggest that frequent attenders to ED take up a disproportionate share of&#xD;
      the resources. Based on a set of pre-determined criteria, frequent attenders were found to be&#xD;
      more likely to make inappropriate and unwarranted visits to ED. These ED visits would be&#xD;
      better served by a different part of the healthcare system.&#xD;
&#xD;
      Patients with alcohol misuse problems are known to make up a significant proportion of&#xD;
      frequent attenders. Such patients are referred to as Alcohol-Related Frequent Attenders&#xD;
      (ARFAs).This population of patients exist in the community and tend to cycle through the&#xD;
      healthcare system through emergency departments.&#xD;
&#xD;
      ARFA's are characterized by poor physical and mental health and a high level of unmet social&#xD;
      needs, contributing to markedly poor engagement with appropriate services. They belong to the&#xD;
      segment of patients with severe alcohol misuse disorders that have low motivation for change.&#xD;
&#xD;
      It is known that traditional clinic-based alcohol services have difficulty engaging ARFAs.&#xD;
      Traditional treatment focuses on abstinence-based therapies. Its emphasis has been on&#xD;
      patients who are ready to change their drinking and can organize their time sufficiently for&#xD;
      on-site clinic treatment. Traditional treatment excludes ARFAs who are the most severe&#xD;
      alcohol misuse patients. Such an approach has been supported by the argument that it is&#xD;
      therapeutically appropriate to concentrate on patients that want to change while others are&#xD;
      allowed to reach their personal rock bottom.&#xD;
&#xD;
      The traditional approach has been ineffective in treating the ARFA population. The majority&#xD;
      of ARFAs do not present for treatments to reduce their drinking. Amongst alcohol misuse&#xD;
      patients that present for treatment, the drop-out rate is high. Local data from the National&#xD;
      Addictions' Management Service (NAMS) Specialist Outpatient Clinic shows that up to 75% of&#xD;
      such patients drop-out of follow-up with a counsellor in just 3 months. Patients who engage&#xD;
      poorly with addictions treatment tend to present instead to emergency services and have&#xD;
      unplanned hospital admissions for alcohol-related consequences.&#xD;
&#xD;
      With the failure of the traditional, clinic-based, abstinence approach, an alternative means&#xD;
      to treat the ARFA population is needed. Inappropriate and substantial utilization of public&#xD;
      emergency medical resources by ARFAs provides a strong impetus to focus on an alternate&#xD;
      strategy to mitigate demand. Community-based strategies may provide the answer. Treatment in&#xD;
      the community may mean that abstinence remains a lofty goal. With a paradigm shift towards&#xD;
      using harm-reduction strategies, evidence shows that reducing morbidity and mortality is&#xD;
      achievable.&#xD;
&#xD;
      ASSERTIVE COMMUNITY TREATMENT Assertive community treatment (ACT) refers to a model of&#xD;
      community service provided to people with severe mental illness originally pioneered by Stein&#xD;
      and Test20. Key components include: i) rapid access to services, ii) a small case load per&#xD;
      case worker, iii) a high ratio of community to office-based appointments, iv) assertive&#xD;
      engagement - with multiple attempts, v) a shared care approach with care coordinators working&#xD;
      within a multidisciplinary team that meets frequently.&#xD;
&#xD;
      ARFAs have multiple medical issues that may be related to alcohol misuse such as liver&#xD;
      cirrhosis, gouty arthritis, alcoholic gastritis etc. In Singapore, local hospitals' community&#xD;
      health services have access to specialist support and are embedded with community social&#xD;
      services. Hospitals' community health services are well-positioned to serve ARFAs within&#xD;
      their area of coverage. With the guidance and support from addictions specialists from the&#xD;
      NAMS, ACT teams from hospitals' community health services would be able to tackle the alcohol&#xD;
      addiction, manage the multiple medical problems, apply synergies with local community&#xD;
      services in helping these patients.&#xD;
&#xD;
      ACT for ARFAs is well-established in the UK. With differing burden of disease, demographics,&#xD;
      culture and drinking habits, it is unclear if this treatment would be effective here.&#xD;
      Singapore had previously implemented ACT for non-alcohol misuse patients with severe and&#xD;
      persistent psychiatric illness which demonstrated improved outcomes and reduced healthcare&#xD;
      utilization. There is a need to evaluate the impact of ACT on healthcare utilization and&#xD;
      clinical outcomes in Singapore.&#xD;
&#xD;
      Our study will utilize ACT with the aim of reducing ED use, usage of other emergency services&#xD;
      and decrease the addiction to alcohol in the ARFA population.&#xD;
&#xD;
      IMH NAMS - ACT TEAM PILOT This study will be an extended pilot, utilizing and building upon&#xD;
      the system and intervention as established by the NAMS ACT team, which commenced its service&#xD;
      in April 2018.&#xD;
&#xD;
      The NAMS ACT pilot (for its first year of service) led to a 45% reduction in alcohol-related&#xD;
      misuse in a group of 14 patients, for whom 6 months of ACT was provided. The pilot is&#xD;
      currently undergoing write-up and data analysis, with the intention for publishing by the&#xD;
      year-end (Study Title: Alcohol Assertive Community Treatment in Singapore: Reducing&#xD;
      alcohol-related A&amp;E presentations and impact on psychosocial functioning).&#xD;
&#xD;
      HYPOTHESIS The primary objective of the study is to investigate whether the implementation of&#xD;
      ACT can reduce ED attendances by ARFAs. A secondary objective is to estimate the change in&#xD;
      total cost utilisation from the implementation of ACT.&#xD;
&#xD;
      EXPECTED RISKS AND BENEFITS It is intended that all patients on assertive community treatment&#xD;
      will be enrolled in this study. The intervention will be implemented as part of a new&#xD;
      standard of care of the hospitals involved - Khoo Teck Puat Hospital (KTPH), Tan Tock Seng&#xD;
      Hospital (TTSH), Singapore General Hospital (SGH) and Ng Teng Fong Hospital (NTFGH).&#xD;
&#xD;
      Expected risks include poor responses to the intervention. However, based on the experience&#xD;
      with ACT in the UK and in Singapore among non-alcohol misusers, we believe this presents an&#xD;
      acceptable low risk of occurrence. The collection of data poses the usual minimal risk of&#xD;
      privacy breach. Safeguards for study participants will be put in place. Prior to data&#xD;
      analysis, all patients' identifiers will be removed from the dataset to safeguard the&#xD;
      patients' privacy and confidentiality. Data will be securely stored.&#xD;
&#xD;
      Benefits to study participants include reductions in the level of addiction to alcohol,&#xD;
      reduction of isolation, improved motivation and better overall health. Benefits to society&#xD;
      include reduced unnecessary healthcare utilisation by the ARFA population leading to cost&#xD;
      savings to the system and reduced social cost when the level of alcohol misuse is controlled.&#xD;
&#xD;
      STUDY DESIGN AND PROCEDURES/METHODOLOGY This is a prospective, multi-centre,&#xD;
      before-and-after, superiority, cohort study to assess the impact of ACT. We adhered to the&#xD;
      SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guideline for a&#xD;
      clinical trial protocol.&#xD;
&#xD;
      As identifiable data would be collected and intervention in the form of ACT is proposed,&#xD;
      consent for participation will be obtained from study subjects. Consent for participation&#xD;
      will include consent to release retrospective data of 5-years from time of recruitment for&#xD;
      evaluation.&#xD;
&#xD;
      STANDARD TREATMENT PRIOR TO IMPLEMENTATION OF ASSERTIVE COMMUNITY TREATMENT Standard&#xD;
      treatment includes episodic treatment for individual visits depending on the reason for the&#xD;
      ED presentation. Presently, Singapore does not have national clinical guidelines on treatment&#xD;
      of alcohol misuse. Treatment of the ARFA population varies as per local hospital policies and&#xD;
      may include follow-up with psychiatrists, clinical psychologist, counsellors, nurses, social&#xD;
      workers and community support workers. Referrals may be made to the national referral center,&#xD;
      National Addictions Management Service (NAMS) for addictions follow-up. NAMS is a&#xD;
      clinic-based service managed by a multidisciplinary team of specialists, providing individual&#xD;
      counselling and psychotherapy for alcohol addictions.&#xD;
&#xD;
      For patients undergoing ACT, the new standard of care will supersede local hospital policy.&#xD;
&#xD;
      INTERVENTION: ASSERTIVE COMMUNITY TREATMENT Assertive Community Treatment (ACT) is part of a&#xD;
      6-month program ARFAs will undergo.&#xD;
&#xD;
      ACT teams will engage with ARFAs on a dedicated schedule. Each visit would last an average of&#xD;
      60 minutes. There will not be a re-arrangement of no-show visits. ACT teams will re-engage&#xD;
      the ARFA over the phone to plan for the next visit as per the schedule.&#xD;
&#xD;
      In keeping with principles of ACT, ARFA's will be assertively sought out in the community and&#xD;
      provided intensive engagement, with holistic and supportive care alongside a harm reduction&#xD;
      approach. Care will also involve case management and involvement of SSA's.&#xD;
&#xD;
      Each interaction during the treatment period will focus on various aspects covering physical&#xD;
      health, mental health, and addiction 14. ACT team members will explore for problems across 4&#xD;
      life domain categories; Medical, Psychiatric/Psychological, Social, and Substance, also&#xD;
      referred to collectively as an acronym - MPSS. Weekly Multi-Disciplinary Team (MDT) meetings&#xD;
      will be conducted and problems will be discussed according to the MPSS format.&#xD;
&#xD;
      COMPOSITION OF ACT MULTI-DISCIPLINARY TEAM Each hospital's ACT team will be comprised of&#xD;
      nurses and/or allied health practitioners the backbone of the team. Doctors have received the&#xD;
      requisite training by the NAMS will be involved in leadership of these teams. In view of the&#xD;
      intensity of the program, in line with international practice, each ACT team would manage 16&#xD;
      active patients over a period of 6 months.&#xD;
&#xD;
      INTERVENTION FIDELITY ACT workers providing care to participants will complete a contact log&#xD;
      detailing the care provided for each patient following each contact. There will not be a&#xD;
      replacement for non-contact visits. The contact log will include details about the member of&#xD;
      staff involved, the mode (i.e. telephone or face-to-face) and setting of the contact (i.e.&#xD;
      patient's home, community setting etc).&#xD;
&#xD;
      SAMPLE SIZE AND STATISTICAL METHODS Determination of Sample Size As this is a real-life&#xD;
      implementation study, we aim to recruit all eligible patients in the ARFA program.&#xD;
&#xD;
      Based on a single hospital's data, the ARFAs utilize Emergency Department services at a mean&#xD;
      of 30.15 visits/year (Standard deviation of 23.47). Assuming a 40% decrease in usage, a&#xD;
      standard deviation of 23 visits, a power of 80% and alpha of 0.05, we calculate the required&#xD;
      sample size to be 29 patients. Assuming a 15% drop-out rate, we will require 34 patients.&#xD;
&#xD;
      Statistical and Analytical Plans Using complete set data analysis, cases undergoing ACT will&#xD;
      be compared to their own historical outcomes as controls. ED, EMS utilization, variables from&#xD;
      SPF, CISS and UCLA 3-point loneliness scales will be compared. Using the paired sample t-test&#xD;
      or Wilcoxon Signed Rank test, the post-intervention utilization of ARFAs undergoing ACT will&#xD;
      be compared to the pre-intervention utilization. To adjust for potential confounders linear&#xD;
      regression analysis will be undertaken. Normality of the variables included in the model will&#xD;
      be assessed using PP plots. Interactions will be tested for [Variables] that are clinically&#xD;
      relevant and if found statistically significant. Model adequacy will be assessed through&#xD;
      coefficients of determination (R2) and by plotting error terms against predicted values.&#xD;
      Presence of multicollinearity will be evaluated by VIF statistics.&#xD;
&#xD;
      Should complete set analysis show efficacy, we will proceed to analyse data using an&#xD;
      intention-to-treat analysis.&#xD;
&#xD;
      The incremental costs of delivering the intervention will be estimated and compared to any&#xD;
      observed cost savings from reduce usage of ED services and other health services.&#xD;
      Uncertainties will be modelled and an estimate of the change to total costs made.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">August 2027</completion_date>
  <primary_completion_date type="Anticipated">August 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Emergency Department (ED) attendance</measure>
    <time_frame>2 years</time_frame>
    <description>The primary outcome will be the rate of ED visits when comparing the pre-intervention period (12 months) with the post-intervention period (12 months). We anticipate a 25% reduction because of the ACT intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emergency Medical Services (EMS) 995 calls</measure>
    <time_frame>2 years (12 months pre-intervention, 12 months post-intervention)</time_frame>
    <description>The secondary outcome will be a change in the rate of calls to our EMS system when comparing the pre-intervention period (12 months) and the post-intervention period (12 months). We anticipate a 25% reduction in the rate of calls to EMS by those who met the criteria for a patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained reduction in ED attendance and EMS calls</measure>
    <time_frame>3 years (12 months pre-intervention, 24 months post-intervention)</time_frame>
    <description>Decrease in mean ED and EMS visits by 25% when comparing the pre-intervention 12-month period with the post-intervention 13-24 month period. During the post-intervention period, there would not be any active follow-up. This outcome would demonstrate the sustained effect of this intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Alcohol Dependence by Christo Inventory of Substance-misuse services (CISS score)</measure>
    <time_frame>6 months (Baseline and 6 months post-intervention)</time_frame>
    <description>Christo Inventory of Substance-misuse services (CISS) scores are a validated marker of the severity of alcohol dependence. It is a quantitative, outcome evaluation tool to be completed by a trained healthcare professional from direct patient interviews. It consists of 10 items reflecting patients' problems with social functioning, general health, sexual/injecting risk behavior, psychological functioning, occupation, criminal involvement, drug/alcohol use, ongoing support, compliance and working relationships. The simplicity, brevity and flexibility of CISS make it a useful tool to allow comparison before, during and after treatment. The minimum score is 0 while the maximum score is 20. Lower scores indicate better outcomes.&#xD;
Improvement in Christo Inventory of Substance-misuse services (CISS) scores by 25% at the end of up to 6 months of treatment when compared to pre-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UCLA 3-point Loneliness Scale</measure>
    <time_frame>6 months (Baseline and 6 months post-intervention)</time_frame>
    <description>The University of California Los Angeles (UCLA) 3-point Loneliness Scale is a validated, interviewer-administered questionnaire developed from the Revised UCLA Loneliness Scale. It provides a quick and succinct method to collect information about social isolation. The minimum score is 3 and the maximum score is 9. Lower scores indicate better outcomes.&#xD;
Improvement in UCLA 3-point Loneliness Scale by 2 points at the end of up to 6 months of treatment when compared to pre-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall cost savings per patient</measure>
    <time_frame>2 years (12 months pre-intervention, 12 months post-intervention)</time_frame>
    <description>This is estimated by the cost of new services per patient against the cost savings to the healthcare system per patient. The difference between cost of ACT in the intervention period and the cost savings from reduced ED and EMS encounters in the 12 months post-intervention would give the overall cost savings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Police Arrests</measure>
    <time_frame>2 years (12 months pre-intervention, 12 months post-intervention)</time_frame>
    <description>Arrests made by the police is usually for chargeable crimes e.g., petty theft, molestation, etc. Decrease in mean arrests by 25% when comparing the pre-intervention 12-month period with the post-intervention 12-month period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Police Offences</measure>
    <time_frame>2 years (12 months pre-intervention, 12 months post-intervention)</time_frame>
    <description>The police may apprehend an ARFA for intoxication and/or disorderly behaviour. Depending on the severity of the offence, the ARFA may or may not be arrested. Decrease in mean offences by 25% when comparing the pre-intervention 12-month period with the post-intervention 12-month period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10)</measure>
    <time_frame>5 months (Baseline and 5 months post-intervention</time_frame>
    <description>The Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) is a validated, self-reported measure of depression. Range of scores from 0 to 30. A score of 10 or above is considered depressed. Lower scores indicate better outcomes. We anticipate an improvement in CESD-R-10 scores by 15% at the end of 5 months.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Alcoholism and Alcohol Abuse</condition>
  <condition>Alcohol Use Disorder</condition>
  <condition>Emergencies</condition>
  <arm_group>
    <arm_group_label>'Before' and 'After' Arm</arm_group_label>
    <description>Before Arm - This refers to the rate of Emergency Department visits in the pre-intervention period (12 months).&#xD;
After Arm - This refers to the rate of Emergency Department visits in the post-intervention period (12 months) following the START of intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Assertive Community Treatment (ACT)</intervention_name>
    <description>Assertive Community Treatment (ACT) is part of a 6-month program ARFAs will undergo.&#xD;
ACT teams will engage with ARFAs on a dedicated schedule. Each visit would last an average of 60 minutes. There will not be a re-arrangement of no-show visits. ACT teams will re-engage the ARFA over the phone to plan for the next visit as per the schedule.&#xD;
In keeping with principles of ACT, ARFA's will be assertively sought out in the community and provided intensive engagement, with holistic and supportive care alongside a harm reduction approach. Care will also involve case management and involvement of SSA's.&#xD;
Each interaction during the treatment period will focus on various aspects covering physical health, mental health, and addiction</description>
    <arm_group_label>'Before' and 'After' Arm</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Singapore has a population of 5.7 million, served by 7 adult EDs. Based on unpublished&#xD;
        data, we estimate a population of 200-300 patients who would meet the criteria to be&#xD;
        classified as ARFA in Singapore. Our study will implement the community-based intervention&#xD;
        in ARFAs from 4 adult EDs.&#xD;
&#xD;
        Once patients are recruited, individual, identifiable 5-year historical data from the point&#xD;
        of study enrolment will be obtained from the electronic medical records system. This data&#xD;
        will include dates of ED visits and ED diagnosis.&#xD;
&#xD;
        Each intervention site will recruit up to 32 patients per year. The ACT teams will see a&#xD;
        maximum of 16 patients over a period of 6 months (Appendix 1). Four hospitals will&#xD;
        participate in the study over a period of 4 years with different initiation dates at each&#xD;
        site. The setting up of such a service requires on-site specialist guidance and the&#xD;
        specialist addictions team from NAMS is only able to guide one hospital's ACT team at a&#xD;
        time for a period of 12 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients who are not on active follow-up at the National Addictions Management&#xD;
             Service at the Institute of Mental Health (IMH).&#xD;
&#xD;
               -  Patients who speak English or Mandarin.&#xD;
&#xD;
               -  Patients who are 21 years of age or older.&#xD;
&#xD;
               -  ≧2 SNOMED alcohol-related ED visits in last 12 months AND ≧5 Emergency Department&#xD;
                  visits (All-cause)&#xD;
&#xD;
               -  Patients who are cognitively intact and able to understand and appreciate the&#xD;
                  contents of the consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patients who are on active follow-up at the NAMS at the Institute of Mental Health&#xD;
             (IMH).&#xD;
&#xD;
               -  Patients who are uncontactable by phone AND through opportunistic recruitment.&#xD;
&#xD;
               -  Patients who do not give consent.&#xD;
&#xD;
               -  Patients who do not speak English or Mandarin.&#xD;
&#xD;
               -  Patients who are under 21 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Hughes NR, Houghton N, Nadeem H, Bell J, McDonald S, Glynn N, Scarfe C, Mackay B, Rogers A, Walters M, Smith M, McDonald A, Dalton D. Salford alcohol assertive outreach team: a new model for reducing alcohol-related admissions. Frontline Gastroenterol. 2013 Apr;4(2):130-134. doi: 10.1136/flgastro-2012-100260. Epub 2013 Jan 23.</citation>
    <PMID>23502815</PMID>
  </results_reference>
  <results_reference>
    <citation>Christo G, Spurrell S, Alcorn R. Validation of the Christo Inventory for Substance-misuse Services (CISS): a simple outcome evaluation tool. Drug Alcohol Depend. 2000 May 1;59(2):189-97. doi: 10.1016/s0376-8716(99)00117-9.</citation>
    <PMID>10891633</PMID>
  </results_reference>
  <results_reference>
    <citation>Boh C, Li H, Finkelstein E, Haaland B, Xin X, Yap S, Pasupathi Y, Ong ME. Factors Contributing to Inappropriate Visits of Frequent Attenders and Their Economic Effects at an Emergency Department in Singapore. Acad Emerg Med. 2015 Sep;22(9):1025-33. doi: 10.1111/acem.12738. Epub 2015 Aug 18.</citation>
    <PMID>26284824</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>As this involves a vulnerable patient group (Alcohol misuse patients) and a sensitive outcome (Alcohol addiction levels), there are no plans to share this individual-level data with other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04447079
org study id: ARFA
nct id: NCT04447079
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background Frequent attenders (FAs) at emergency department (ED) in Singapore hospitals have
      been increasing over the years. More than half of the FAs are reported to be alcohol-related
      frequent attenders (ARFA) and they were found to be using EDs unnecessarily. We aim to assess
      if there will be a difference in patient outcomes in terms of ED usage and cost-effectiveness
      by implementing an assertive community treatment (ACT) program to manage AFRAs.

      Methods This is a prospective, multi-centre, before-and-after, superiority and cohort study
      to assess the impact of ACT from 4 study sites. 200-300 patients will be recruited and
      followed up for 12 months. The primary objective of the study is to investigate whether there
      will be a reduction in AFRA ED attendances. The secondary objective is to estimate the change
      in total cost utilization.

      Conclusion/Significance All patients who are on ACT programme will be enrolled in this study.
      The study intervention will be used as a new mode of care at participating hospitals. We
      expect to see reduced alcohol addiction level, reduced isolation level, improved motivation
      and better overall health. With reduced alcohol-related hospital visits, we would also expect
      to see improved healthcare utilization by ARFAs which will lead to increased cost savings to
      the healthcare systems and decreased social costs.
BACKGROUND Singapore has seen a steady growth in the use of emergency department (ED)
      services. ED visits increased from 752,122 in 2007 to 1,006,800 in 2013. Despite efforts to
      redirect low acuity ED patients to primary care, EDs continue to be busy and with long waits
      for patients. Data suggest that frequent attenders to ED take up a disproportionate share of
      the resources. Based on a set of pre-determined criteria, frequent attenders were found to be
      more likely to make inappropriate and unwarranted visits to ED. These ED visits would be
      better served by a different part of the healthcare system.

      Patients with alcohol misuse problems are known to make up a significant proportion of
      frequent attenders. Such patients are referred to as Alcohol-Related Frequent Attenders
      (ARFAs).This population of patients exist in the community and tend to cycle through the
      healthcare system through emergency departments.

      ARFA's are characterized by poor physical and mental health and a high level of unmet social
      needs, contributing to markedly poor engagement with appropriate services. They belong to the
      segment of patients with severe alcohol misuse disorders that have low motivation for change.

      It is known that traditional clinic-based alcohol services have difficulty engaging ARFAs.
      Traditional treatment focuses on abstinence-based therapies. Its emphasis has been on
      patients who are ready to change their drinking and can organize their time sufficiently for
      on-site clinic treatment. Traditional treatment excludes ARFAs who are the most severe
      alcohol misuse patients. Such an approach has been supported by the argument that it is
      therapeutically appropriate to concentrate on patients that want to change while others are
      allowed to reach their personal rock bottom.

      The traditional approach has been ineffective in treating the ARFA population. The majority
      of ARFAs do not present for treatments to reduce their drinking. Amongst alcohol misuse
      patients that present for treatment, the drop-out rate is high. Local data from the National
      Addictions' Management Service (NAMS) Specialist Outpatient Clinic shows that up to 75% of
      such patients drop-out of follow-up with a counsellor in just 3 months. Patients who engage
      poorly with addictions treatment tend to present instead to emergency services and have
      unplanned hospital admissions for alcohol-related consequences.

      With the failure of the traditional, clinic-based, abstinence approach, an alternative means
      to treat the ARFA population is needed. Inappropriate and substantial utilization of public
      emergency medical resources by ARFAs provides a strong impetus to focus on an alternate
      strategy to mitigate demand. Community-based strategies may provide the answer. Treatment in
      the community may mean that abstinence remains a lofty goal. With a paradigm shift towards
      using harm-reduction strategies, evidence shows that reducing morbidity and mortality is
      achievable.

      ASSERTIVE COMMUNITY TREATMENT Assertive community treatment (ACT) refers to a model of
      community service provided to people with severe mental illness originally pioneered by Stein
      and Test20. Key components include: i) rapid access to services, ii) a small case load per
      case worker, iii) a high ratio of community to office-based appointments, iv) assertive
      engagement - with multiple attempts, v) a shared care approach with care coordinators working
      within a multidisciplinary team that meets frequently.

      ARFAs have multiple medical issues that may be related to alcohol misuse such as liver
      cirrhosis, gouty arthritis, alcoholic gastritis etc. In Singapore, local hospitals' community
      health services have access to specialist support and are embedded with community social
      services. Hospitals' community health services are well-positioned to serve ARFAs within
      their area of coverage. With the guidance and support from addictions specialists from the
      NAMS, ACT teams from hospitals' community health services would be able to tackle the alcohol
      addiction, manage the multiple medical problems, apply synergies with local community
      services in helping these patients.

      ACT for ARFAs is well-established in the UK. With differing burden of disease, demographics,
      culture and drinking habits, it is unclear if this treatment would be effective here.
      Singapore had previously implemented ACT for non-alcohol misuse patients with severe and
      persistent psychiatric illness which demonstrated improved outcomes and reduced healthcare
      utilization. There is a need to evaluate the impact of ACT on healthcare utilization and
      clinical outcomes in Singapore.

      Our study will utilize ACT with the aim of reducing ED use, usage of other emergency services
      and decrease the addiction to alcohol in the ARFA population.

      IMH NAMS - ACT TEAM PILOT This study will be an extended pilot, utilizing and building upon
      the system and intervention as established by the NAMS ACT team, which commenced its service
      in April 2018.

      The NAMS ACT pilot (for its first year of service) led to a 45% reduction in alcohol-related
      misuse in a group of 14 patients, for whom 6 months of ACT was provided. The pilot is
      currently undergoing write-up and data analysis, with the intention for publishing by the
      year-end (Study Title: Alcohol Assertive Community Treatment in Singapore: Reducing
      alcohol-related A&E presentations and impact on psychosocial functioning).

      HYPOTHESIS The primary objective of the study is to investigate whether the implementation of
      ACT can reduce ED attendances by ARFAs. A secondary objective is to estimate the change in
      total cost utilisation from the implementation of ACT.

      EXPECTED RISKS AND BENEFITS It is intended that all patients on assertive community treatment
      will be enrolled in this study. The intervention will be implemented as part of a new
      standard of care of the hospitals involved - Khoo Teck Puat Hospital (KTPH), Tan Tock Seng
      Hospital (TTSH), Singapore General Hospital (SGH) and Ng Teng Fong Hospital (NTFGH).

      Expected risks include poor responses to the intervention. However, based on the experience
      with ACT in the UK and in Singapore among non-alcohol misusers, we believe this presents an
      acceptable low risk of occurrence. The collection of data poses the usual minimal risk of
      privacy breach. Safeguards for study participants will be put in place. Prior to data
      analysis, all patients' identifiers will be removed from the dataset to safeguard the
      patients' privacy and confidentiality. Data will be securely stored.

      Benefits to study participants include reductions in the level of addiction to alcohol,
      reduction of isolation, improved motivation and better overall health. Benefits to society
      include reduced unnecessary healthcare utilisation by the ARFA population leading to cost
      savings to the system and reduced social cost when the level of alcohol misuse is controlled.

      STUDY DESIGN AND PROCEDURES/METHODOLOGY This is a prospective, multi-centre,
      before-and-after, superiority, cohort study to assess the impact of ACT. We adhered to the
      SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guideline for a
      clinical trial protocol.

      As identifiable data would be collected and intervention in the form of ACT is proposed,
      consent for participation will be obtained from study subjects. Consent for participation
      will include consent to release retrospective data of 5-years from time of recruitment for
      evaluation.

      STANDARD TREATMENT PRIOR TO IMPLEMENTATION OF ASSERTIVE COMMUNITY TREATMENT Standard
      treatment includes episodic treatment for individual visits depending on the reason for the
      ED presentation. Presently, Singapore does not have national clinical guidelines on treatment
      of alcohol misuse. Treatment of the ARFA population varies as per local hospital policies and
      may include follow-up with psychiatrists, clinical psychologist, counsellors, nurses, social
      workers and community support workers. Referrals may be made to the national referral center,
      National Addictions Management Service (NAMS) for addictions follow-up. NAMS is a
      clinic-based service managed by a multidisciplinary team of specialists, providing individual
      counselling and psychotherapy for alcohol addictions.

      For patients undergoing ACT, the new standard of care will supersede local hospital policy.

      INTERVENTION: ASSERTIVE COMMUNITY TREATMENT Assertive Community Treatment (ACT) is part of a
      6-month program ARFAs will undergo.

      ACT teams will engage with ARFAs on a dedicated schedule. Each visit would last an average of
      60 minutes. There will not be a re-arrangement of no-show visits. ACT teams will re-engage
      the ARFA over the phone to plan for the next visit as per the schedule.

      In keeping with principles of ACT, ARFA's will be assertively sought out in the community and
      provided intensive engagement, with holistic and supportive care alongside a harm reduction
      approach. Care will also involve case management and involvement of SSA's.

      Each interaction during the treatment period will focus on various aspects covering physical
      health, mental health, and addiction 14. ACT team members will explore for problems across 4
      life domain categories; Medical, Psychiatric/Psychological, Social, and Substance, also
      referred to collectively as an acronym - MPSS. Weekly Multi-Disciplinary Team (MDT) meetings
      will be conducted and problems will be discussed according to the MPSS format.

      COMPOSITION OF ACT MULTI-DISCIPLINARY TEAM Each hospital's ACT team will be comprised of
      nurses and/or allied health practitioners the backbone of the team. Doctors have received the
      requisite training by the NAMS will be involved in leadership of these teams. In view of the
      intensity of the program, in line with international practice, each ACT team would manage 16
      active patients over a period of 6 months.

      INTERVENTION FIDELITY ACT workers providing care to participants will complete a contact log
      detailing the care provided for each patient following each contact. There will not be a
      replacement for non-contact visits. The contact log will include details about the member of
      staff involved, the mode (i.e. telephone or face-to-face) and setting of the contact (i.e.
      patient's home, community setting etc).

      SAMPLE SIZE AND STATISTICAL METHODS Determination of Sample Size As this is a real-life
      implementation study, we aim to recruit all eligible patients in the ARFA program.

      Based on a single hospital's data, the ARFAs utilize Emergency Department services at a mean
      of 30.15 visits/year (Standard deviation of 23.47). Assuming a 40% decrease in usage, a
      standard deviation of 23 visits, a power of 80% and alpha of 0.05, we calculate the required
      sample size to be 29 patients. Assuming a 15% drop-out rate, we will require 34 patients.

      Statistical and Analytical Plans Using complete set data analysis, cases undergoing ACT will
      be compared to their own historical outcomes as controls. ED, EMS utilization, variables from
      SPF, CISS and UCLA 3-point loneliness scales will be compared. Using the paired sample t-test
      or Wilcoxon Signed Rank test, the post-intervention utilization of ARFAs undergoing ACT will
      be compared to the pre-intervention utilization. To adjust for potential confounders linear
      regression analysis will be undertaken. Normality of the variables included in the model will
      be assessed using PP plots. Interactions will be tested for [Variables] that are clinically
      relevant and if found statistically significant. Model adequacy will be assessed through
      coefficients of determination (R2) and by plotting error terms against predicted values.
      Presence of multicollinearity will be evaluated by VIF statistics.

      Should complete set analysis show efficacy, we will proceed to analyse data using an
      intention-to-treat analysis.

      The incremental costs of delivering the intervention will be estimated and compared to any
      observed cost savings from reduce usage of ED services and other health services.
      Uncertainties will be modelled and an estimate of the change to total costs made.
observational model: Cohort
time perspective: Prospective
measure: Emergency Department (ED) attendance
time frame: 2 years
description: The primary outcome will be the rate of ED visits when comparing the pre-intervention period (12 months) with the post-intervention period (12 months). We anticipate a 25% reduction because of the ACT intervention.
measure: Emergency Medical Services (EMS) 995 calls
time frame: 2 years (12 months pre-intervention, 12 months post-intervention)
description: The secondary outcome will be a change in the rate of calls to our EMS system when comparing the pre-intervention period (12 months) and the post-intervention period (12 months). We anticipate a 25% reduction in the rate of calls to EMS by those who met the criteria for a patient.
measure: Sustained reduction in ED attendance and EMS calls
time frame: 3 years (12 months pre-intervention, 24 months post-intervention)
description: Decrease in mean ED and EMS visits by 25% when comparing the pre-intervention 12-month period with the post-intervention 13-24 month period. During the post-intervention period, there would not be any active follow-up. This outcome would demonstrate the sustained effect of this intervention.
measure: Level of Alcohol Dependence by Christo Inventory of Substance-misuse services (CISS score)
time frame: 6 months (Baseline and 6 months post-intervention)
description: Christo Inventory of Substance-misuse services (CISS) scores are a validated marker of the severity of alcohol dependence. It is a quantitative, outcome evaluation tool to be completed by a trained healthcare professional from direct patient interviews. It consists of 10 items reflecting patients' problems with social functioning, general health, sexual/injecting risk behavior, psychological functioning, occupation, criminal involvement, drug/alcohol use, ongoing support, compliance and working relationships. The simplicity, brevity and flexibility of CISS make it a useful tool to allow comparison before, during and after treatment. The minimum score is 0 while the maximum score is 20. Lower scores indicate better outcomes.
Improvement in Christo Inventory of Substance-misuse services (CISS) scores by 25% at the end of up to 6 months of treatment when compared to pre-intervention.
measure: UCLA 3-point Loneliness Scale
time frame: 6 months (Baseline and 6 months post-intervention)
description: The University of California Los Angeles (UCLA) 3-point Loneliness Scale is a validated, interviewer-administered questionnaire developed from the Revised UCLA Loneliness Scale. It provides a quick and succinct method to collect information about social isolation. The minimum score is 3 and the maximum score is 9. Lower scores indicate better outcomes.
Improvement in UCLA 3-point Loneliness Scale by 2 points at the end of up to 6 months of treatment when compared to pre-intervention.
measure: Overall cost savings per patient
time frame: 2 years (12 months pre-intervention, 12 months post-intervention)
description: This is estimated by the cost of new services per patient against the cost savings to the healthcare system per patient. The difference between cost of ACT in the intervention period and the cost savings from reduced ED and EMS encounters in the 12 months post-intervention would give the overall cost savings.
measure: Police Arrests
time frame: 2 years (12 months pre-intervention, 12 months post-intervention)
description: Arrests made by the police is usually for chargeable crimes e.g., petty theft, molestation, etc. Decrease in mean arrests by 25% when comparing the pre-intervention 12-month period with the post-intervention 12-month period.
measure: Police Offences
time frame: 2 years (12 months pre-intervention, 12 months post-intervention)
description: The police may apprehend an ARFA for intoxication and/or disorderly behaviour. Depending on the severity of the offence, the ARFA may or may not be arrested. Decrease in mean offences by 25% when comparing the pre-intervention 12-month period with the post-intervention 12-month period.
measure: Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10)
time frame: 5 months (Baseline and 5 months post-intervention
description: The Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) is a validated, self-reported measure of depression. Range of scores from 0 to 30. A score of 10 or above is considered depressed. Lower scores indicate better outcomes. We anticipate an improvement in CESD-R-10 scores by 15% at the end of 5 months.
arm group label: 'Before' and 'After' Arm
description: Before Arm - This refers to the rate of Emergency Department visits in the pre-intervention period (12 months).
After Arm - This refers to the rate of Emergency Department visits in the post-intervention period (12 months) following the START of intervention.
intervention type: Behavioral
intervention name: Assertive Community Treatment (ACT)
description: Assertive Community Treatment (ACT) is part of a 6-month program ARFAs will undergo.
ACT teams will engage with ARFAs on a dedicated schedule. Each visit would last an average of 60 minutes. There will not be a re-arrangement of no-show visits. ACT teams will re-engage the ARFA over the phone to plan for the next visit as per the schedule.
In keeping with principles of ACT, ARFA's will be assertively sought out in the community and provided intensive engagement, with holistic and supportive care alongside a harm reduction approach. Care will also involve case management and involvement of SSA's.
Each interaction during the treatment period will focus on various aspects covering physical health, mental health, and addiction
arm group label: 'Before' and 'After' Arm
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
citation: Hughes NR, Houghton N, Nadeem H, Bell J, McDonald S, Glynn N, Scarfe C, Mackay B, Rogers A, Walters M, Smith M, McDonald A, Dalton D. Salford alcohol assertive outreach team: a new model for reducing alcohol-related admissions. Frontline Gastroenterol. 2013 Apr;4(2):130-134. doi: 10.1136/flgastro-2012-100260. Epub 2013 Jan 23.
PMID: 23502815
citation: Christo G, Spurrell S, Alcorn R. Validation of the Christo Inventory for Substance-misuse Services (CISS): a simple outcome evaluation tool. Drug Alcohol Depend. 2000 May 1;59(2):189-97. doi: 10.1016/s0376-8716(99)00117-9.
PMID: 10891633
citation: Boh C, Li H, Finkelstein E, Haaland B, Xin X, Yap S, Pasupathi Y, Ong ME. Factors Contributing to Inappropriate Visits of Frequent Attenders and Their Economic Effects at an Emergency Department in Singapore. Acad Emerg Med. 2015 Sep;22(9):1025-33. doi: 10.1111/acem.12738. Epub 2015 Aug 18.
PMID: 26284824
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Alcoholism
sharing ipd: No
ipd description: As this involves a vulnerable patient group (Alcohol misuse patients) and a sensitive outcome (Alcohol addiction levels), there are no plans to share this individual-level data with other researchers