Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease: A Hybrid Effectiveness-Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- Patient-reported Health-related Quality of Life
研究概览
简要总结
This research study is addressing issues related to Inflammatory bowel disease (IBD), which is a chronic autoimmune disorder that affects over 60,000 Veterans. With close monitoring and timely treatment adjustment, the investigators can stop the natural progression of IBD, improving health-related quality of life (HRQOL) and reducing flares and hospitalizations. However, it is difficult to closely monitor Veterans with IBD between clinic visits. There is a critical need for solutions that support close between visit monitoring of Veterans with IBD. The Measurement-Based Care (MBC) for IBD study will take a systematic approach to collect, share, and act on patient reported outcome (PRO) data that can be used to achieve close monitoring. MBC supports patients' in managing their condition and boosting their confidence in their ability to handle their symptoms and disease, and also supports care teams in early recognition of health issues. The investigators will work with both Veterans and their care teams to understand and assess this program so it can be a model for future initiatives.
详细描述
Inflammatory bowel disease (IBD) is a chronic autoimmune disorder that affects over 60,000 Veterans and leads to highly symptomatic flares and complications. Close monitoring and timely treatment adjustment can stop the natural progression of IBD, improving health-related quality of life (HRQOL) and reducing flares and hospitalizations. However, it is difficult to closely monitor Veterans with IBD between clinic visits. There is a critical need for systematic solutions to support close between visit monitoring of Veterans with IBD without which they will continue to experience preventable impairment and disability. Measurement-based care (MBC) is a systematic approach to collect, share, and act on patient reported outcome (PRO) data that can be used to achieve close monitoring. MBC works by facilitating early recognition of clinical deterioration and timely clinician-driven treatment adjustment. MBC also increases patients' self-efficacy, their confidence in their ability to handle their symptoms and disease.
This project will use a Hybrid Type 1 effectiveness-implementation randomized trial design (n=250 Veterans with IBD) to test the effectiveness of MBC in IBD versus enhanced treatment as usual (E-TAU) on HRQOL and IBD-related events over 12-months and identify barriers and facilitators to MBC in IBD to inform its implementation in practice. The hypothesis is that at 12-month follow-up, Veterans randomized to MBC will have greater improvement in HRQOL and fewer IBD-related events (composite of flares, emergency department visits, hospitalization, surgery) than E-TAU. The primary objective is to test the effectiveness of MBC vs. E-TAU on key patient outcomes: IBD-specific patient reported HRQOL (primary outcome) and IBD-related events obtained via electronic health record data (secondary outcome). The secondary objective is to assess determinants of MBC in IBD implementation and acceptability with process evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for Veteran patients include:
- •receiving IBD care at one of the four sites
- •reporting an impaired IBD-specific HRQOL using the Short IBD Questionnaire (SIBDQ<60, as used by others)
- •willingness and ability to participate in study procedures
- •Clinic staff criteria:
- •relevant clinic staff (gastroenterologists, advanced practice providers, nurses) involved in MBC in IBD at the four study sites (Ann Arbor, Atlanta, Houston, Portland).
排除标准
- •Veteran Patient Exclusion criteria:
- •Presence of an ostomy or ileal-pouch anal anastomosis
- •Severe comorbid medical condition that can confound PRO scores and treatment priorities (e.g., cancer, transplant).
- •Exclusions can be readily determined from chart review and a baseline patient assessment
- •Clinic staff exclusion criteria:
- •Clinic staff without any experience with MBC in IBD.
研究组 & 干预措施
MBC-IBD
Measurement Based Care for Inflammatory Bowel Disease - Intervention group. Veteran participants who are randomized to 12-months of MBC-IBD will be enrolled for 12 months. They will each complete surveys at baseline, 6-months, and 12-months post-randomization. These assessments require completion of self-report questionnaires which will be completed by phone or electronically using VA REDCap. MBC in IBD will not replace but rather provide care continuity between clinic visits. Patients allocated to MBC in IBD will receive automated reminders to complete weekly questionnaires.
干预措施: MBC-IBD Intervention (Behavioral)
E-TAU
Enhanced Treatment as Usual (E-TAU). Participants assigned to E-TAU will receive standard of care, including monitoring and treatment as directed at the discretion of their gastroenterologist. Standard of care is based on current evidence-based professional guidelines, including routine inflammatory biomarker assessments (e.g., annual fecal calprotectin), therapy plans, scheduled and as-needed clinic visits, and scheduled and as-needed telephone calls. Participants will also receive educational videos and fact sheets on various IBD-specific topics.
干预措施: Enhanced Treatment as Usual (E-TAU) (Other)
结局指标
主要结局
Patient-reported Health-related Quality of Life
时间窗: Baseline compared to 12 month follow-up.
Test the effectiveness of MBC vs. E-TAU on key patient outcomes, specifically looking at IBD-specific patient reported HRQOL (primary outcome). Assess IBD-specific HRQOL compared to E-TAU at 12-months follow-up. The investigators will first graphically explore the longitudinal data over time between the MBC and E-TAU groups. As the primary analytic model, the investigators will use an analysis of covariance (ANCOVA), fit using a linear regression model with SIBDQ score at 12 months as the dependent variable to estimate between-group differences in the primary endpoint. The model will include an indicator for treatment group (MBC vs. E-TAU) to estimate the 12-month treatment effect and adjust for baseline SIBDQ scores as a covariate and the stratification factors used for randomization (site, age, IBD type).
次要结局
- IBD-related events(Baseline compared to 12 month follow-up.)