Marsden John, Anders Paul, Shaw Claire, Amasiatu Chioma, Collate Winnie, Eastwood Brian, Horgan Patrick, Khetani Meetal, Knight Jonathan, Knight Sandy, Melaugh Alexandra, Clark Helen, Stannard Jez
Addictions Department, School of Academic Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom.
Department of Health and Social Care, Addiction and Inclusion, Office for Health Improvement and Disparities, United Kingdom.
EClinicalMedicine. 2024 Jan 18;68:102400. doi: 10.1016/j.eclinm.2023.102400. eCollection 2024 Feb.
Individual Placement and Support (IPS) is a specialist intervention to help people attain employment in the open competitive labour market. IPS has been developed in severe mental illness and other disabilities, but it is of unknown effectiveness for people with alcohol and drug dependence. The Individual Placement and Support-Alcohol and Drug (IPS-AD) is the first superiority trial to evaluate effectiveness and cost-effectiveness.
IPS-AD was a pragmatic, parallel-group, multi-centre, randomised, controlled, phase 3 trial of standard employment support (treatment-as-usual [TAU]) versus IPS. IPS was offered as a single episode for up to 13 months. The study was done at seven community treatment centres for alcohol and drug dependence in England. Study participants were adults (18-65 years), who had been enrolled for at least 14 days in treatment for alcohol use disorder (AUD), opioid use disorder (OUD), or another drug use disorder (DUD; mostly cannabis and stimulants); were unemployed or economically inactive for at least six months; and wished to attain employment in the open competitive labour market. After random allocation to study interventions, the primary outcome was employment during 18-months of follow-up, analysed by mixed-effects logistic regression, using multiple imputation for the management of missing outcome data. There were two cost-effectiveness outcomes: a health outcome expressed as a quality adjusted life year (QALY) using £30,000 and £70,000 willingness-to-pay [WTP] thresholds; and additional days of employment, with a WTP threshold of £200 per day worked. The study was registered with ISRCTN (ISRCTN24159790) and is completed.
Between 8 May 2018 and 30 September 2019, 2781 potentially eligible patients were identified. 812 were excluded before screening, and 1720 participants were randomly allocated to TAU or IPS. In error, nine participants were randomised to study interventions on two occasions-so data for their first randomisation was analysed (modified intention-to-treat). A further 24 participants withdrew consent for all data to be used (full-analysis set therefore 1687 participants [70.1% male; mean age 40.8 years]; TAU, n = 844; IPS, n = 843 [AUD, n = 610; OUD, n = 837; DUD, n = 240]). Standard employment support was received by 559 [66.2%] of 844 participants in the TAU group. IPS was received by 804 [95.37%] of 843 participants in the IPS group. IPS was associated with an increase in attainment of employment compared with TAU (adjusted odds ratio [OR] 1.29; 95% CI 1.02-1.64; p-value 0.036). IPS was effective for the AUD and DUD groups (OR 1.48; 95% CI 1.14-1.92; p-value 0.004; OR 1.45, 95% CI 1.03-2.04, p-value 0.031, respectively), but not the OUD group. IPS returned an incremental QALY outcome gain of 0.01 (range 0.003-0.02) per participant with no evidence of cost-effectiveness at either WTP threshold-but QALY gains were cost-effective for the AUD and DUD groups at the £70,000 WTP threshold (probability 0.52 and 0.97, respectively). IPS was cost-effective for additional days of employment (probability 0.61), with effectiveness relating to the AUD group only (probability >0.99). Serious Adverse Events were reported by 39 participants (13 [1.5%] of 844 participants in the TAU group and 23 [2.7%] of 43 participants in the IPS group). There was a total of 25 deaths (1.5%; 9 in the TAU group and 16 in the IPS group)-none judged related to study interventions.
In this first superiority randomised controlled trial of IPS in alcohol and drug dependence, IPS helped more people attain employment in the open competitive labour market than standard employment support. IPS was cost-effective for a QALY health outcome (£70,000 WTP threshold) for the AUD and DUD groups, and for additional days of employment for the AUD group (£200 per day worked WTP threshold).
UK government Work and Health Unit.
个体安置与支持（IPS）是一种专门干预措施，旨在帮助人们在开放的竞争性劳动力市场中获得就业。IPS已在严重精神疾病和其他残疾人群中开展，但对酒精和药物依赖者的有效性尚不清楚。个体安置与支持-酒精和药物（IPS-AD）是首个评估有效性和成本效益的优效性试验。
IPS-AD是一项务实的、平行组、多中心、随机、对照的3期试验，比较标准就业支持（常规治疗[TAU]）与IPS。IPS作为单次干预提供，最长可达13个月。该研究在英格兰的7个酒精和药物依赖社区治疗中心进行。研究参与者为成年人（18-65岁），他们因酒精使用障碍（AUD）、阿片类物质使用障碍（OUD）或其他药物使用障碍（DUD；主要是大麻和兴奋剂）已登记接受治疗至少14天；失业或经济不活跃至少6个月；并希望在开放的竞争性劳动力市场中获得就业。随机分配到研究干预措施后，主要结局是随访18个月期间的就业情况，采用混合效应逻辑回归分析，对缺失的结局数据采用多重填补法处理。有两个成本效益结局：一个健康结局，使用30000英镑和70000英镑的支付意愿（WTP）阈值表示为质量调整生命年（QALY）；以及额外的就业天数，WTP阈值为每天工作200英镑。该研究已在ISRCTN注册（ISRCTN24159790），现已完成。
在2018年5月8日至2019年9月30日期间，确定了2781名潜在合格患者。812人在筛查前被排除，1720名参与者被随机分配到TAU或IPS。错误地，9名参与者两次被随机分配到研究干预措施中，因此分析了他们第一次随机分配的数据（修正意向性分析）。另外24名参与者撤回了使用所有数据的同意（因此完整分析集为1687名参与者[70.1%为男性；平均年龄40.8岁]；TAU组，n = 844；IPS组，n = 843[AUD组，n = 610；OUD组，n = 837；DUD组，n = 240]）。TAU组844名参与者中有559名[66.2%]接受了标准就业支持。IPS组843名参与者中有804名[95.37%]接受了IPS。与TAU相比，IPS与就业达成率的增加相关（调整后的优势比[OR]为1.29；95%置信区间1.02-1.64；p值0.036）。IPS对AUD组和DUD组有效（OR分别为1.48；95%置信区间1.14-1.92；p值0.004；OR为1.45，95%置信区间1.03-2.04，p值0.031），但对OUD组无效。IPS每位参与者的增量QALY结局增益为0.01（范围0.003-0.02），在任何一个WTP阈值下均无成本效益证据，但在70000英镑的WTP阈值下，AUD组和DUD组的QALY增益具有成本效益（概率分别为0.52和0.97）。IPS在额外就业天数方面具有成本效益（概率0.61），且有效性仅与AUD组相关（概率>0.99）。39名参与者报告了严重不良事件（TAU组844名参与者中有13名[1.5%]，IPS组843名参与者中有23名[2.7%]）。共有25人死亡（1.5%；TAU组9人，IPS组16人），均判定与研究干预措施无关。
在这项IPS治疗酒精和药物依赖的首个优效性随机对照试验中，与标准就业支持相比，IPS帮助更多人在开放的竞争性劳动力市场中获得就业。对于AUD组和DUD组，IPS在QALY健康结局（70000英镑WTP阈值）以及AUD组额外就业天数（每天工作200英镑WTP阈值）方面具有成本效益。
英国政府工作与健康部门。
