Protocol of the impact of alternative social assistance disbursement on drug-related harm (TASA) study: a randomized controlled trial to evaluate changes to payment timing and frequency among people who use illicit drugs

Lindsey Richardson, Allison Laing, M-J Milloy, Russ Maynard, Bohdan Nosyk, Brandon Marshall, Eric Grafstein, Patricia Daly, Evan Wood, Julio Montaner, Thomas Kerr, Lindsey Richardson, Allison Laing, M-J Milloy, Russ Maynard, Bohdan Nosyk, Brandon Marshall, Eric Grafstein, Patricia Daly, Evan Wood, Julio Montaner, Thomas Kerr

Abstract

Background: Government social assistance payments seek to alleviate poverty and address survival needs, but their monthly disbursement may cue increases in illicit drug use. This cue may be magnified when assistance is disbursed simultaneously across the population. Synchronized payments have been linked to escalations in drug use and unintended but severe drug-related harms, including overdose, as well as spikes in demand for health, social, financial and police services.

Methods/design: The TASA study examines whether changing payment timing and frequency can mitigate drug-related harm associated with synchronized social assistance disbursement. The study is a parallel arm multi-group randomized controlled trial in which 273 participants are randomly allocated for six assistance cycles to a control or one of two intervention arms on a 1:1:1 basis. Intervention arm participants receive their payments: (1) monthly; or (2) semi-monthly, in each case on days that are not during the week when cheques are normally issued. The study partners with a community-based credit union that has developed a system to vary social assistance payment timing. The primary outcome is a 40 % increase in drug use during the 3 days beginning with cheque issue day compared to other days of the month. Bi-weekly follow-up interviews collect participant information on this and secondary outcomes of interest, including drug-related harm (e.g. non-fatal overdose), exposure to violence and health service utilization. Self-reported data will be supplemented with participant information from health, financial, police and government administrative databases. A longitudinal, nested, qualitative parallel process evaluation explores participant experiences, and a cost-effectiveness evaluation of different disbursement scenarios will be undertaken. Outcomes will be compared between control and intervention arms to identify the impacts of alternative disbursement schedules on drug-related harm resulting from synchronized income assistance.

Discussion: This structural RCT benefits from strong community partnerships, highly detailed outcome measurement, robust methods of randomization and data triangulation with third party administrative databases. The study will provide evidence regarding the potential importance of social assistance program design as a lever to support population health outcomes and service provision for populations with a high prevalence of substance use.

Trial registration: NCT02457949 Registered 13 May 2015.

Keywords: Drug use; Drug-related harm; Social assistance; Structural intervention.

Figures

Fig. 1
Fig. 1
Flow of participants through the TASA trial

References

    1. Boychuk GW. Patchworks of Purpose: The Development of Provincial Social Assistance Regimes in Canada. Montreal: McGill-Queens University Press; 1999.
    1. Nelson K. Mechanisms of poverty alleviation: anti-poverty effects of non-means-tested and means-tested benefits in five welfare states. J Eur Soc Policy. 2004;14:371–390. doi: 10.1177/0958928704046879.
    1. Stephens M. 3rd of tha month”: Do social security recipients smooth consumption between checks? Am Econ Rev. 2003;93:406–422. doi: 10.1257/000282803321455386.
    1. Epstein DH, Willner-Reid J, Vahabzadeh M, Mezghanni M, Lin JL, Preston KL. Real-time electronic diary reports of cue exposure and mood in the hours before cocaine and heroin craving and use. Arch Gen Psychiatry. 2009;66:88–94. doi: 10.1001/archgenpsychiatry.2008.509.
    1. Zlotorzynska M, Milloy M, Richardson L, Montaner J, Wood E, Kerr T. Timing of social assistance payment and overdose patterns at a Canadian supervised injection facility. Int J Drug Pol. 2014;25:736–739. doi: 10.1016/j.drugpo.2014.03.014.
    1. Small W, Shoveller J, Moore D, Tyndall M, Wood E, Kerr T. Injection drug users’ access to a supervised injection facility in Vancouver, Canada: the influence of operating policies and local drug culture. Qual Health Res. 2011;21:743–756. doi: 10.1177/1049732311400919.
    1. Verheul G, Singer SM, Christenson JM. Mortality and morbidity associated with the distribution of monthly welfare payments. Acad Emerg Med. 1997;4:118–123. doi: 10.1111/j.1553-2712.1997.tb03717.x.
    1. Rosen MI. The ‘check effect’ reconsidered. Addiction. 2011;106:1071–1077. doi: 10.1111/j.1360-0443.2011.03409.x.
    1. Chan AC, Palepu A, Guh DP, Sun H, Schechter MT, O’Shaughnessy MV, Anis AH. HIV-positive injection drug users who leave the hospital against medical advice: the mitigating role of methadone and social support. J Acquir Immune Defic Syndr. 2004;35:56–9.
    1. Shaner A, Eckman TA, Roberts LJ, Wilkins JN, Tucker DE, Tsuang JW, Mintz J. Disability income, cocaine use, and repeated hospitalization among schizophrenic cocaine abusers—a government-sponsored revolving door? N Engl J Med. 1995;333:777–83.
    1. Brunette DD, Kominsky J, Ruiz E. Correlation of emergency health care use, 911 volume, and jail activity with welfare check distribution. Ann Emerg Med. 1991;20:739–742. doi: 10.1016/S0196-0644(05)80834-0.
    1. Riddell C, Riddell R. Welfare checks, drug consumption, and health evidence from Vancouver injection drug users. J Hum Resour. 2006;41:138–161. doi: 10.3368/jhr.XLI.1.138.
    1. Catalano R, McConnell W. Psychiatric emergencies: the check effect revisited. J Health Soc Behav. 1999;40:79. doi: 10.2307/2676380.
    1. Richardson L, Milloy M, Kerr T, Guillemi S, Hogg R, Harrigan R, Montaner J, Wood E. Socio-economic marginalization and virologic suppression among antiretroviral therapy-exposed individuals who use illicit drugs. AIDS. 2015;29:2487–95.
    1. Debeck K, Shannon K, Wood E, Li K, Montaner J, Kerr T. Income generating activities of people who inject drugs. Drug Alcohol Depend. 2007;91:50–56. doi: 10.1016/j.drugalcdep.2007.05.003.
    1. Dobkin C, Puller SL. The effects of government transfers on monthly cycles in drug abuse, hospitalization and mortality. J Pub Econ. 2007;91:2137–2157. doi: 10.1016/j.jpubeco.2007.04.007.
    1. Li X, Sun H, Marsh DC, Anis AH. Impact of welfare cheque issue days on a service for those intoxicated in public. Harm Reduct J. 2007;4:1–4. doi: 10.1186/1477-7517-4-1.
    1. Catalano R, McConnell W, Forster P, Mcfareland B, Shumway M, Thornton D. Does the Disbursement of Income Increase Psychiatric Emergencies Involving Drugs and Alcohol? Health Serv Res. 2000;35:813–823.
    1. Halpern SD, Mechem CC. Declining rate of substance abuse throughout the month. Am J Med. 2001;110:347–351. doi: 10.1016/S0002-9343(00)00749-X.
    1. Phillips DP, Christenfeld N, Ryan NM. An increase in the number of deaths in the united states in the first week of the month—an association with substance abuse and other causes of death. N Engl J Med. 1999;341:93–98. doi: 10.1056/NEJM199907083410206.
    1. Otterstatter MC, Amlani A, Guan H, Richardson L, Buxton J. Illicit drug overdose deaths resulting from income assistance payments: Analysis of the ‘check effect’ using daily mortality data. Int J Drug Pol. 2016;33: 83–7. In Press.
    1. Anis AH, Sun H, Guh DP, Palepu A, Schechter MT, O’Shaughnessy MV. Leaving hospital against medical advice among HIV-positive patients. CMAJ. 2002;167:633–637.
    1. Svikis DS, Pickens RW, Schweitzer W, Johnson E, Haug N. Weekly patterns of drug treatment attendance. Am J Public Health. 1999;89:752–755. doi: 10.2105/AJPH.89.5.752.
    1. Pickett T, Stenstrom R, Abu-Laban R. Association between mental health apprehensions by police and monthly income assistance (welfare) payments. Can J Psychiatry. 2015;60:146–150.
    1. Parsons CA, Van Wesep ED. The timing of pay. J Financ Econ. k2013;109:373–97.
    1. Anakwenze U, Zuberi D. Mental health and poverty in the inner city. Health Soc Work. 2013;38:147–157. doi: 10.1093/hsw/hlt013.
    1. Liu S, Blomley N. Making news and making space: framing Vancouver’s downtown eastside. Can Geogr. 2013;57:119–132. doi: 10.1111/j.1541-0064.2012.00453.x.
    1. Krebs E, Wang L, Olding M, Hayashi K, Milloy M, DeBeck K, Wood E, Kerr T, Nosyk B. Increased drug use and the timing of social assistance receipt among people who use illicit drugs. Under Review.
    1. Blankenship KM, Friedman SR, Dworkin S, Mantell JE. Structural interventions: concepts, challenges and opportunities for research. J Urban Health. 2006;83:59–72. doi: 10.1007/s11524-005-9007-4.
    1. Robinson SM, Sobell LC, Sobell MB, Leo GI. Reliability of the timeline followback for cocaine, cannabis, and cigarette use. Psychol Addict Behav. 2014;28:154–162. doi: 10.1037/a0030992.
    1. Hjorthøj CR, Hjorthøj AR, Nordentoft M. Validity of timeline follow-back for self-reported use of cannabis and other illicit substances—systematic review and meta-analysis. Addict Behav. 2012;37:225–233. doi: 10.1016/j.addbeh.2011.11.025.
    1. Oakley A, Strange V, Bonell C, Allen E, Stephenson J, RIPPLE Study Team Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006;332:413–416. doi: 10.1136/bmj.332.7538.413.
    1. Nutt DJ, King LA, Phillips LD, Independent Scientific Committee On Drugs Drug harms in the UK: a multicriteria decision analysis. Lancet. 2010;376:1558–1565. doi: 10.1016/S0140-6736(10)61462-6.
    1. Strathdee SA, Patrick DM, Currie SL, Cornelisse PGA, Rekart ML, Montaner JSG, Schechter MT, O'Shaughnessy MV. Needle exchange is not enough: lessons from the Vancouver injecting drug use study. AIDS. 1997;11:F59–65.
    1. Milloy MJ, Kerr T, Bangsberg DR, Buxton J, Parashar S, Guillemi S, Montaner J, Wood E. Homelessness as a structural barrier to effective antiretroviral therapy among HIV-seropositive illicit drug users in a Canadian setting. AIDS Patient Care STDS. 2012;26:60–7.
    1. Urban Health Research Initiative. Drug Situation in Vancouver, 2nd Ed. Urban Health Research Initiative, British Columbia Centre for Excellence in HIV/AIDS, June 2013.
    1. Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011;8:15–20. doi: 10.3390/ijerph8010015.
    1. Buu A, Li R, Walton MA, Yang H, Zimmerman MA, Cunningham RM. Changes in Substance Use-Related Health Risk Behaviors on the Timeline Follow-Back Interview as a Function of Length of Recall Period. Subst Use Misuse 2014
    1. Patton MQ. Qualitative evaluation and research methods. Newbery Park: Sage; 1990.
    1. Teddlie C, Yu F. Mixed methods sampling: a typology with examples. J Mixed Methods Res. 2007;1:77–100. doi: 10.1177/2345678906292430.
    1. Kerr T, Kimber J, Rhodes T. Drug use settings: an emerging focus for research and intervention. Int J Drug Policy. 2007;18:1–4. doi: 10.1016/j.drugpo.2006.12.016.
    1. Davidson P, Page K. Research participation as work: comparing the perspectives of researchers and economically marginalized populations. Am J Public Health. 2012;102:1254–1259. doi: 10.2105/AJPH.2011.300418.
    1. Shannon K, Ishida T, Lai C, Tyndall MW. The impact of unregulated single room occupancy hotels on the health status of illicit drug users in Vancouver. Int J Drug Pol. 2006;17:107–114. doi: 10.1016/j.drugpo.2005.09.002.
    1. Magill M, Ray LA. Cognitive-behavioral treatment with adult alcohol and illicit drug users: a meta-analysis of randomized controlled trials. J Stud Alcohol Drugs. 2009;70:516–527. doi: 10.15288/jsad.2009.70.516.
    1. Kilmer B, Everingham SS, Caulkins JP, Midgette G, Pacula RL, Reuter PH, Burns RM, Han B, Lundberg R, Corporation R. What Americas users spend on illegal drugs, 2000–2010. Washington: Office of National Drug Control Policy; 2014.
    1. Singleton N, Murray R, Tinsley L. Measuring different aspects of problem drug use: methodological developments. 2006. Home Office London. . Accessed 14 February 2016.
    1. Fairbairn N, Small W, Van Borek N, Wood E, Kerr T. Social structural factors that shape assisted injecting practices among injection drug users in Vancouver. Can: qual study Harm Reduct J. 2010;7:20.
    1. Kerr T, Small W, Buchner C, Zhang R, Li K, Montaner J, Wood E. Syringe sharing and HIV incidence among injection drug users and increased access to sterile syringes. Am J Public Health. 2010;100:1449–53.
    1. Miller CL, Kerr T, Frankish JC, Spittal PM, Li K, Schechter MT, Wood E. Binge drug use independently predicts HIV seroconversion among injection drug users: implications for public health strategies. Subst Use Misuse. 2006;41:199–210.
    1. Ivsins A, Roth E, Benoit C, Fischer B. Crack pipe sharing in context: How sociostructural factors shape risk practices among noninjection drug users. Contemp Drug Problems. 2013;40:481–503. doi: 10.1177/009145091304000403.
    1. Small W, Rhodes T, Wood E, Kerr T. Public injection settings in Vancouver: physical environment, social context and risk. Int J Drug Policy. 2007;18:27–36. doi: 10.1016/j.drugpo.2006.11.019.
    1. Kerr T, Small W, Johnston C, Li K, Montaner JS, Wood E. Characteristics of injection drug users who participate in drug dealing: implications for drug policy. J Psychoactive Drugs. 2008;40:147–152. doi: 10.1080/02791072.2008.10400624.
    1. Potier C, Laprévote V, Dubois-Arber F, Cottencin O, Rolland B. Supervised injection services: what has been demonstrated? a systematic literature review. Drug Alcohol Depend. 2014;145:48–68. doi: 10.1016/j.drugalcdep.2014.10.012.
    1. Werb D, Rowell G, Guyatt G, Kerr T, Montaner J, Wood E. Effect of drug law enforcement on drug market violence: a systematic review. Int J Drug Policy. 2011;22:87–94. doi: 10.1016/j.drugpo.2011.02.002.
    1. Debeck K, Wood E, Zhang R, Tyndall M, Montaner J, Kerr T. Police and public health partnerships: evidence from the evaluation of Vancouver’s supervised injection facility. Subst Abuse Treat Prev Policy. 2008;3:1–5. doi: 10.1186/1747-597X-3-11.
    1. Richardson L, Long C, Nguyen P, Debeck K, Milloy MJ, Wood E, Kerr T. Socio-economic marginalization in the structural production of vulnerability to violence among people who use illicit drugs. J Epidemiol Community Health. 2015;69:686–92.
    1. Maynard C, Cox GB. Association between week of the month and hospitalization for substance abuse. Psychiatr Serv. 2000;51:31. doi: 10.1176/ps.51.1.31.
    1. Long C, Debeck K, Feng C, Montaner J, Wood E, Kerr T. Income level and drug related harm among people who use injection drugs in a Canadian setting. Int J Drug Pol. 2014;25:458–464. doi: 10.1016/j.drugpo.2013.11.011.
    1. Ompad DC, Nandi V, Cerdá M, Crawford N, Galea S, Vlahov D. Beyond income: material resources among drug users in economically-disadvantaged New York city neighborhoods. Drug Alcohol Depend. 2012;120:127–134. doi: 10.1016/j.drugalcdep.2011.07.008.
    1. Bansback N, Tsuchiya A, Brazier J, Anis A. Canadian valuation of EQ-5D health states: preliminary value set and considerations for future valuation studies. PLoS One. 2012;7 doi: 10.1371/journal.pone.0031115.
    1. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5 L). Qual Life Res. 2011;20:1727–36.
    1. Nosyk B, Sun H, Guh DP, Oviedo-Joekes E, Marsh DC, Brissette S, Schechter MT, Anis AH. The quality of eight health status measures were compared for chronic opioid dependence. J Clin Epidemiol. 2010;63:1132–44.
    1. Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5:233–237. doi: 10.1016/0149-7189(82)90074-X.
    1. Leape LL. Reporting of adverse events. N Engl J Med. 2002;347:1633–1638. doi: 10.1056/NEJMNEJMhpr011493.
    1. Avants SK, Margolin A, Holford TR, Kosten TR. A randomized controlled trial of auricular acupuncture for cocaine dependence. Arch Intern Med. 2000;160:2305–2312. doi: 10.1001/archinte.160.15.2305.
    1. Hansten ML, Downey L, Rosengren DB, Donovan DM. Relationship between follow-up rates and treatment outcomes in substance abuse research: more is better but when is “enough” enough? Addiction. 2000;95:1403–1416. doi: 10.1046/j.1360-0443.2000.959140310.x.
    1. Newell DJ. Intention-to-treat analysis: implications for quantitative and qualitative research. Int J Epidemiol. 1992;21:837–841. doi: 10.1093/ije/21.5.837.
    1. Little R, Yau L. Intent-to-treat analysis for longitudinal studies with drop-outs. Biometrics. 1996;52:1324–1333. doi: 10.2307/2532847.
    1. Yang Z, Hardin JW, Addy CL, Vuong QH. Testing approaches for overdispersion in Poisson regression versus the generalized Poisson model. Biom J. 2007;49:565–584. doi: 10.1002/bimj.200610340.
    1. Bellack AS, Bennett ME, Gearon JS, Brown CH, Yang Y. A randomized clinical trial of a new behavioral treatment for drug abuse in people with severe and persistent mental illness. Arch Gen Psychiatry. 2006;63:426–432. doi: 10.1001/archpsyc.63.4.426.
    1. Comer SD, Sullivan MA, Yu E, Rothenberg JL, Kleber HD, Kampman K, Dackis C, O'Brien CP. Injectable, sustained-release naltrexone for the treatment of opioid dependence: a randomized, placebo-controlled trial. Arch Gen Psychiatry. 2006;63:210–8.
    1. Fielding S, Fayers P, Ramsay CR. Analysing randomised controlled trials with missing data: choice of approach affects conclusions. Contemp Clin Trials. 2012;33:461–469. doi: 10.1016/j.cct.2011.12.002.
    1. Brooner RK, Kidorf MS, King VL, Stoller KB, Neufeld KJ, Kolodner K. Comparing adaptive stepped care and monetary-based voucher interventions for opioid dependence. Drug Alcohol Depend. 2007;88(Suppl 2):S14–S23. doi: 10.1016/j.drugalcdep.2006.12.006.
    1. Little RJ, D’Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, Frangakis C, Hogan JW, Molenberghs G, Murphy SA, Neaton JD, Rotnitzky A, Scharfstein D, Shih WJ, Siegel JP, Stern H. The prevention and treatment of missing data in clinical trials. N Engl J Med. 2012;367:1355–60.
    1. Porta N, Bonet C, Cobo E. Discordance between reported intention-to-treat and per protocol analyses. J Clin Epidemiol. 2007;60:663–669. doi: 10.1016/j.jclinepi.2006.09.013.
    1. Wright CC, Sim J. Intention-to-treat approach to data from randomized controlled trials: a sensitivity analysis. J Clin Epidemiol. 2003;56:833–842. doi: 10.1016/S0895-4356(03)00155-0.
    1. Nosyk B, Guh DP, Bansback NJ, Oviedo-Joekes E, Brissette S, Marsh DC, Meikleham E, Schechter MT, Anis AH. Cost-effectiveness of diacetylmorphine versus methadone for chronic opioid dependence refractory to treatment. CMAJ. 2012;184:E317–28.
    1. Weinstein MC, Torrance G, McGuire A. QALYs: the basics. Value Health. 2009;12:S5–S9. doi: 10.1111/j.1524-4733.2009.00515.x.
    1. Sculpher M, Fenwick E, Claxton K. Assessing quality in decision analytic cost-effectiveness models: a suggested framework and example of application. Pharmacoeconomics. 2000;17:461–477. doi: 10.2165/00019053-200017050-00005.
    1. Hoch JS, Briggs AH, Willan AR. Something old, something new, something borrowed, something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis. Health Econ. 2002;11:415–430. doi: 10.1002/hec.678.
    1. Briggs A. Handling uncertainty in economic evaluation and presenting the results. In: Drummond M, McGuire A, editors. Economic evaluation in health care: merging theory with practice. Oxford: Oxford University Press; 2001. pp. 172–214.
    1. Nosyk B, Sharif B, Sun H, Cooper C, Anis AH. An economic evaluation and value of information analysis of three influenza vaccination strategies for patients with HIV/AIDS. PLoS One. 2011;6 doi: 10.1371/journal.pone.0027059.
    1. Brouwer WB, Koopmanschap M. How to calculate indirect costs in economic evaluations. Pharmacoeconomics. 1998;13:563–569. doi: 10.2165/00019053-199813050-00008.
    1. Swartz JA, Hsieh CM, Baumohl J. Disability payments, drug use and representative payees: an analysis of the relationships. Addiction. 2003;98:965–975. doi: 10.1046/j.1360-0443.2003.00414.x.
    1. Jepson RG, Harris FM, Platt S, Tannahill C. The effectiveness of interventions to change six health behaviours: a review of reviews. BMC Public Health. 2010;10:538. doi: 10.1186/1471-2458-10-538.
    1. Klimas J, Field CA, Cullen W, O’Gorman CS, Glynn LG, Keenan E, Saunders J, Bury G, Dunne C. Psychosocial interventions to reduce alcohol consumption in concurrent problem alcohol and illicit drug users: Cochrane review. Syst Rev. 2013;2:3.
    1. Hunt GE, Siegfried N, Morley K, Sitharthan T, Cleary M. Psychosocial interventions for people with both severe mental illness and substance misuse. Cochrane Database Syst Rev. 2013;10

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa