Reeves Mathew J, Fritz Michele C, Woodward Amanda T, Hughes Anne K, Coursaris Constantinos K, Swierenga Sarah J, Nasiri Mojdeh, Freddolino Paul P
Department of Epidemiology and Biostatistics, College of Human Medicine (M.J.R., M.C.F., M.N.), Michigan State University, East Lansing.
School of Social Work, College of Social Science (A.T.W., A.K.H., P.P.F.), Michigan State University, East Lansing.
Circ Cardiovasc Qual Outcomes. 2019 Jul;12(7):e005493. doi: 10.1161/CIRCOUTCOMES.119.005493. Epub 2019 Jul 12.
To test whether access to home-based social worker-led case management (SWCM) program or SWCM program combined with a website providing stroke-related information improves patient-reported outcomes in patients with stroke, relative to usual care.
The MISTT (Michigan Stroke Transitions Trial), an open (unblinded) 3-group parallel-design clinical trial, randomized 265 acute patients with stroke to 3 treatment groups: Usual Care (group-1), SWCM (group-2), and SWCM+MISTT website (group-3). Patients were discharged directly home or returned home within 4 weeks of discharge to a rehabilitation facility. The SWCM program provided in-home and phone-based case management services. The website provided patient-orientated information covering stroke education, prevention, recovery, and community resources. Both interventions were provided for up to 90 days. Outcomes data were collected by telephone at 7 and 90 days. Primary patient-reported outcomes included Patient-Reported Outcomes Measurement Information System Global-10 Quality-of-Life (Physical and Mental Health subscales) and the Patient Activation Measure. Treatment efficacy was determined by comparing the change in mean response (90 days minus 7 days) between the 3 treatment groups using a group-by-time interaction. Subjects were aged 66 years on average, 49% were female, 21% nonwhite, and 86% had ischemic stroke. There were statistically significant changes in Patient-Reported Outcomes Measurement Information System Physical Health ( P=0.003) and Patient Activation Measure ( P=0.042), but not Patient-Reported Outcomes Measurement Information System Mental Health ( P=0.56). The mean change in Patient-Reported Outcomes Measurement Information System Physical Health scores for group-3 (SWCM+MISTT Website) was significantly higher than both group-2 (SWCM; difference, +2.4; 95% CI, 0.46-4.34; P=0.02) and group-1 (usual care; difference, +3.4; 95% CI, 1.41-5.33; P<0.001). The mean change in Patient Activation Measure scores for group-3 was significantly higher than group-2 (+6.7; 95% CI, 1.26-12.08; P=0.02) and marginally higher than group-1 (+5.0; 95% CI, -0.47 to 10.52; P=0.07).
An intervention that combined SWCM with access to online stroke-related information produced greater gains in patient-reported physical health and activation compared with usual care or case management alone. There was no intervention effect on mental health.
URL: https://www.clinicaltrials.gov . Unique identifier: NCT02653170.
为了测试与常规护理相比，接受由居家社会工作者主导的病例管理（SWCM）项目或该项目与提供中风相关信息的网站相结合，是否能改善中风患者的患者报告结局。
MISTT（密歇根中风过渡试验）是一项开放（非盲法）的3组平行设计临床试验，将265例急性中风患者随机分为3个治疗组：常规护理组（第1组）、SWCM组（第2组）和SWCM+MISTT网站组（第3组）。患者在出院后直接回家或在出院后4周内返回康复机构。SWCM项目提供居家和电话病例管理服务。该网站提供以患者为导向的信息，涵盖中风教育、预防、康复和社区资源。两种干预措施均提供长达90天。在第7天和第90天通过电话收集结局数据。主要的患者报告结局包括患者报告结局测量信息系统全球10项生活质量（身体和心理健康子量表）以及患者激活量表。通过使用组间时间交互作用比较3个治疗组之间的平均反应变化（90天减去7天）来确定治疗效果。受试者平均年龄为66岁，49%为女性，21%为非白人，86%患有缺血性中风。患者报告结局测量信息系统身体健康（P=0.003）和患者激活量表（P=0.042）有统计学显著变化，但患者报告结局测量信息系统心理健康（P=0.56）没有变化。第3组（SWCM+MISTT网站）的患者报告结局测量信息系统身体健康评分的平均变化显著高于第2组（SWCM；差异为+2.4；95%CI，0.46-4.34；P=0.02）和第1组（常规护理；差异为+3.4；95%CI，1.41-5.33；P<0.001）。第3组患者激活量表评分的平均变化显著高于第2组（+6.7；95%CI，1.26-12.08；P=0.02），略高于第1组（+5.0；95%CI，-0.47至10.52；P=0.07）。
与常规护理或单独的病例管理相比，将SWCM与获取在线中风相关信息相结合的干预措施在患者报告的身体健康和激活方面取得了更大的改善。对心理健康没有干预效果。
网址：https://www.clinicaltrials.gov 。唯一标识符：NCT02653170。
