University of Vermont, United States of America.
University of Vermont Medical Center, United States of America.
Contemp Clin Trials. 2023 Jun;129:107174. doi: 10.1016/j.cct.2023.107174. Epub 2023 Apr 3.
Participation in phase 2 cardiac rehabilitation (CR) is associated with significant decreases in morbidity and mortality. Unfortunately, attendance at CR is not optimal and certain populations, such as those with lower-socioeconomic status (SES), are less likely to participate. In order to remedy this disparity we have designed a trial to examine the efficacy of early case management and/or financial incentives for increasing CR participation among lower-SES patients.
We will employ a randomized controlled trial with a sample goal of 209 patients who will be randomized 2:3:3:3 to either a usual care control, to receive a case manager starting in-hospital, to receive financial incentives for completing CR sessions, or to receive both interventions.
Treatment conditions will be compared on attendance at CR and end-of-intervention (four months) improvements in cardiorespiratory fitness, executive function, and health-related quality of life. The primary outcome measures for this project will be number of CR sessions completed and the percentage who complete ≥30 sessions. Secondary outcomes will include improvements in health outcomes by condition, as well as the cost-effectiveness of the intervention with a focus on potential reductions in emergency department visits and hospitalizations. We hypothesize that either intervention will perform better than the control and that the combination of interventions will perform better than either alone.
This systematic examination of interventions will allow us to test the efficacy and cost-effectiveness of approaches that have the potential to increase CR participation substantially and significantly improve health outcomes among patients with lower-SES.
参与第二期心脏康复(CR)与发病率和死亡率的显著降低有关。不幸的是,CR 的参与度并不理想,某些人群,如社会经济地位较低(SES)的人群,参与度较低。为了弥补这一差距,我们设计了一项试验,以检验早期病例管理和/或经济激励措施对提高 SES 较低患者参与 CR 的效果。
我们将采用随机对照试验,样本目标为 209 名患者,他们将被随机分为 2:3:3:3 组,分别接受常规护理对照、住院期间开始接受病例管理员、完成 CR 课程获得经济激励或同时接受两种干预措施。
将在 CR 出勤率和干预结束时(四个月)的心肺功能、执行功能和健康相关生活质量的改善方面比较治疗条件。该项目的主要结果指标将是完成的 CR 课程数量和完成≥30 次课程的百分比。次要结果将包括按条件改善健康结果,以及干预措施的成本效益,重点是减少急诊就诊和住院的可能性。我们假设任何干预措施都将优于对照组,而两种干预措施的联合使用将优于任何一种单独使用。
对干预措施的系统检查将使我们能够测试增加 CR 参与度并显著改善 SES 较低患者健康结果的潜在方法的有效性和成本效益。