Care Coordination and Proactive Care to Improve Utilization of Resources and Reduce Expenditure in High Risk Inflammatory Bowel Disease (IBD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 1
- 主要终点
- IBD-related charges per person
研究概览
简要总结
The study team performed a randomized controlled trial to evaluate the efficacy of a care coordination intervention composed of proactive symptom monitoring and algorithm-based triggers to improve patient reported outcomes (PROs) and healthcare expenditures for high-risk patients with IBD. Enrolled patients with IBD were randomized to proactive symptom monitoring with the support of a care coordinator or usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding of participants was not possible because telephone visits were only offered to participants in the intervention arm. Investigators were blinded to the randomization order, but patients, staff, and providers were not blinded to arm assignment. The investigators who validated the data and performed the data analysis remained blinded to patient group assignment.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •established diagnosis of IBD (with at least 3 office visits)
- •followed in GI clinic within 1 year of enrollment
- •in top 20th percentile of predicted risk for subsequent healthcare utilization (previously validated model)
排除标准
- •non-IBD driver for high utilization (e.g., active cancer undergoing treatment
- •A life expectancy of less than one year, were excluded from participation.
研究组 & 干预措施
Care Coordination Arm
Patients were assigned an IBD-focused care coordinator who facilitated a symptom-based monitoring algorithm and supported patient navigation to complement usual care.
干预措施: Proactive Symptom Monitoring and Care Coordination (Behavioral)
Usual Care
Participants in the usual care arm underwent symptom monitoring through regular push notifications to participants to complete a validated PRO instrument through the Epic EMR patient portal or telephone. These notifications were scheduled on a monthly basis. Results of the monthly PRO instrument were available to their treating IBD doctor with interventions at their discretion.
passive control arn
To explore whether our usual care arm was influenced by the monthly PRO measurements required for examination of our primary outcome, we compared IBD charges, total charges, ED visits, hospitalizations, and medication utilization at 12 months in the usual care arm to a passive control arm consisting of patients who met eligibility criteria, but were not enrolled in the intervention or usual care arms.
结局指标
主要结局
IBD-related charges per person
时间窗: 12 months
extracted charges where IBD was the primary diagnosis over study period
Change in patient reported outcome (PRO) scores
时间窗: 9 months
Patient Reported Outcome (PRO) measurements were administered on a monthly basis. The validated Crohn's (CD)-PRO or ulcerative colitis (UC)-PRO were used according to the patient's IBD type (Crohn's or ulcerative colitis). Both the CD-PRO and UC-PRO are a set of standardized and validated instruments based on the Crohn's Disease Activity Index and Mayo Clinic Score respectively, which includes six domains: daily bowel movements, functional symptoms, systemic symptoms, daily coping, weekly life impact, and weekly emotional impact. Scores are calculated a composite score across all domains where a score of 0 represents no symptom activity and a score of 40 represents the highest possible symptom burden. These were not two separate outcomes, rather two independent measurement instruments (scored on the same scale) specific to the patient's IBD-type to address the specific needs/concerns of the patients based on disease type.
Total healthcare charges per person
时间窗: 12 months
all extracted charges over study period
次要结局
- Proportion of hospitalizations per person(12 months)
- Emergency Department (ED) visits per person(12 months)
- Change in IBD medication utilization(12 months)
研究者
Peter Higgins
Professor of Internal Medicine
University of Michigan