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The Impact of Alternative Social Assistance Disbursement on Drug-related Harm (TASA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02457949
Recruitment Status : Terminated (Interim analyses produced signal of intervention efficacy for primary outcomes and weaker signal of increased exposure to violence. Therefore, DSMC recommended stopping recruitment in May 2018. Enrolled participants completed intervention by Aug 2018)
First Posted : May 29, 2015
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
BC Centre on Substance Use
Information provided by (Responsible Party):
Lindsey Richardson, University of British Columbia

Tracking Information
First Submitted Date  ICMJE May 13, 2015
First Posted Date  ICMJE May 29, 2015
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE October 27, 2015
Actual Primary Completion Date January 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
Illicit drug use on government cheque issue days [ Time Frame: 26 weeks ]
Timeline Follow Back (TLFB) assessed increase of drug use defined as an increase in the frequency of drug use of at least 40% or an increase in the number of drugs used during the 3 days beginning with government cheque issue day, compared to non-cheque issue days.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
  • Illicit drug use on non-government cheque issue days [ Time Frame: 26 weeks ]
    Timeline Follow Back (TLFB) assessed increase of drug use defined as an increase in the frequency of drug use of at least 40% or an increase in the number of drugs used during the 3 days beginning with individual cheque issue day (among intervention participants), compared to non-cheque issue days.
  • Hospital admissions on government cheque issue days [ Time Frame: 26 weeks ]
    Emergency Department, Emergency Department Mental Health and substance use hospitalizations in the three days beginning with government cheque issue day compared to non-cheque issue days.
  • Overdose [ Time Frame: 26 weeks ]
    Self-reported non-fatal overdose and hospital record verified fatal overdose on the three days beginning with government cheque issue day compared to non-cheque issue days.
  • Police service utilization [ Time Frame: 26 weeks ]
    Self-reported and police record-verified interactions with police or use of police services on the three days beginning with government cheque issue day compared to non-cheque issue days.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Alternative Social Assistance Disbursement on Drug-related Harm
Official Title  ICMJE The Impact of Alternative Social Assistance Disbursement on Drug-Related Harm: a Randomized Control Trial
Brief Summary This study evaluates whether altering the timing and frequency of social assistance disbursement reduces drug related-harms that increase on the days surrounding monthly synchronized government social assistance cheque issue.
Detailed Description

Coordinated monthly income assistance payments, while seeking to alleviate poverty, can also have negative and unintended impacts, particularly among people who use illicit drugs (PWUD). Observational research has identified escalations in drug-related harm coinciding with monthly assistance payments, such as overdose, treatment interruption, hospital admissions and public disorder. This project varies the timing and frequency of income assistance disbursement, and evaluates whether varying income assistance disbursement reduces drug-related harm coinciding with coordinated income assistance.

Conducted among 273 PWUD, participants will be allocated for 6 income assistance cycles to a control or one of two intervention arms. Participants in the control arm will receive payments according to the existing monthly government schedule. Participants in the intervention arm will receive their income assistance: (1) monthly on a day different from government cheque issue; or (2) semi-monthly on days different from government cheque issue. The intervention will be evaluated using qualitative and quantitative methods for its impact on drug use and related harms.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Condition  ICMJE Drug Use
Intervention  ICMJE
  • Other: Non-synchronized social assistance receipt
    Social assistance disbursement outside government cheque issue week
    Other Name: Staggered
  • Other: cheque divided into two equal disbursements
    Social assistance disbursement divided into two equal payments
    Other Name: Split
Study Arms  ICMJE
  • No Intervention: Treatment As Usual (TAU)
    Receipt of social assistance on government cheque issue days for 6 income assistance cycles (approx 26 weeks).
  • Experimental: Staggered Arm
    Receipt of social assistance once monthly on a randomly assigned day that does not fall during the week of government cheque issue (Non-synchronized social assistance receipt), for 6 income assistance cycles (approx 26 weeks).
    Intervention: Other: Non-synchronized social assistance receipt
  • Experimental: Staggered and Split Arm
    Receipt of social assistance twice monthly on equally spaced randomly assigned days that do not fall during the week of government cheque issue (Non-synchronized social assistance receipt, cheque divided into two equal disbursements), for 6 income assistance cycles (approx 26 weeks).
    Interventions:
    • Other: Non-synchronized social assistance receipt
    • Other: cheque divided into two equal disbursements
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 13, 2020)
194
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2015)
273
Actual Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date January 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • be ≥19 years of age or older
  • reside in greater Vancouver, Canada
  • report regular use of illicit drugs other than cannabis
  • receive monthly provincial income assistance
  • are not currently administered (where cheque issue/money is externally managed)
  • be eligible and willing to be a client of the local credit union who will administer the intervention
  • report intensified drug use around government cheque issue days
  • provide written informed consent
  • be willing to comply with study procedures

Exclusion Criteria:

  • plan to relocate outside Vancouver
  • have plans to discontinue income assistance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02457949
Other Study ID Numbers  ICMJE H14-02401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lindsey Richardson, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE BC Centre on Substance Use
Investigators  ICMJE
Principal Investigator: Lindsey Richardson, DPhil University of British Columbia
PRS Account University of British Columbia
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP