An Integrated Telemedicine-Home Visitation Program to Increase Outcomes for Children With Medical Complexity: A Quality Improvement (QI) Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 422
- 试验地点
- 2
- 主要终点
- Days of care outside the home
研究概览
简要总结
Children with medical complexity (CMC) account for <1% of all children but approximately 40% of all pediatric deaths and inpatient care spending in the U.S.1 Optimizing their outcomes requires a comprehensive approach to augmenting care in all settings: clinic, hospital, and home. The clinic component of the comprehensive care (CC) program provides 24/7 access to an experienced team of primary care providers and subspecialists and reduced their serious illnesses and hospital and ICU days by 47-69% and health-system costs by >$10,000 per child-year.2,3 The hospital component (inpatient consultation service) is further improving outcomes. Having improved both inpatient and outpatient care, the investigators now propose to complete a 360 degree approach by developing and rigorously assessing an integrated telemedicine-home-visitation program (THVP) to augment care for CMC in their homes to reduce the need for clinic visits as well hospitalizations. Building on prior experience in using telemedicine for children at UTH and evidence of benefits in other populations, 4,5 the providers will use a convenient, inexpensive, HIPAA-compliant telemedicine platform to make observations in the home to augment care, help address acute problems remotely at any hour, better coordinate care with healthcare personnel, and thereby reduce clinic visits, ED visits, and hospitalizations. Home visits will be conducted by a nurse home visitor whenever considered likely to be beneficial for any of the CMC and at least once by the primary care providers (PCPs) immediately following enrollment of children with chronic respiratory failure requiring mechanical ventilation at home. To promote reimbursements and further grant funding, the investigators will test the integrated THVP in a randomized quality improvement (QI) pilot study to verify its effectiveness in reducing total days of care outside the home.
详细描述
Background Children with medical complexity (CMC) have one or more chronic illnesses, require treatment from multiple specialists, and often depend on medical technology for respiratory and nutritional support.6 Their care is fragmented, ineffective, and inefficient,2,7 and while they represent only 0.4% of all children in the US, they account for approximately 40% of pediatric deaths and hospital charges.6
Optimizing their outcomes is likely to require a comprehensive approach to their care in all settings: clinic, hospital, and home. The investigators have developed effective programs for their clinic and hospital care and now propose to add an innovative program to improve care in the home and verify its incremental cost effectiveness.
The clinic component is provided in the High-Risk Children's Clinic (HRCC), an enhanced medial home for CMC staffed by a highly experienced team of nurse practitioners, pediatricians, and pediatric subspecialists. The multiple features to promote prompt effective care at all hours include 24/7 cell-phone access to the PCPs. As shown in the prior randomized trial (funded by a CMS Health Care Innovation Award), this program reduced ED visits, hospital days, and ICU days by 47-69%, and health system costs by $10,258 per child-year below that with usual care. This trial was published in JAMA,2 highlighted by CMS, and attracted national attention as the most rigorous evidence to date supporting medical homes for patient group.8,9 The remarkable cost effectiveness of this program was found in later cohort analyses to have been well maintained or enhanced when the program was expanded to include all eligible CMC, including prior control children and new enrollees.3
The hospital component is an inpatient consultation service in which the HRCC staff consult and follow their patients admitted to Children's Memorial Hermann Hospital (CMHH) to make treatment recommendations, coordinate care, and plan their discharge. The investigators randomized half of HRCC patients to receive this service in pilot testing. Results indicate a major reduction in inpatient days for patients given the service vs. those not given the service: 289 vs. 615 total hospital days/100 child-years with a 95% (posterior) probability of reduced hospital days in Bayesian analysis (rate ratio [RR], 0.62 [0.36, 1.09]). Having improved both inpatient and outpatient care, the investigators now propose to develop and rigorously assess a novel integrated telemedicine-home-visitation program (THVP) to also augment care for CMC in their home. The investigators will test the program in a clinical trial to verify its effectiveness and cost-effectiveness in reducing total days of care outside the home and to augment clinical practice and health policy.
Rationale and Evidence Base
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
- Single (Investigator)
盲法说明
While the families and HRCC staff cannot be blinded, the healthcare economist and the statistician will remain blinded to treatment group when performing the analyses.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children attending the High-Risk Children's Clinic
- •1 or more chronic conditions
- •High healthcare utilization in the year prior to enrollment (of ≥3 ED visits, ≥2 hospitalizations, or ≥1 pediatric ICU admissions)
- •>50% estimated risk of hospitalization in the year after enrollment (as judged by Program's Director [Dr. R. Mosquera] based on patient's diagnosis, clinical course, and socioeconomic risk factor).
排除标准
- •Unrepaired congenital heart disease
- •Mitochondrial disorders
- •Active cancer
- •Do-Not-Resuscitate (DNR) order
- •Patients receiving compassionate care
- •No Internet access
结局指标
主要结局
Days of care outside the home
时间窗: Up to 24 months
Days of care in the hospital, ER, or clinic \[excluding well-child checks\]
次要结局
- Number of PICU admissions(Up to 24 months)
- Number of 30-day hospital readmissions(Up to 30 days following a discharge from a hospital)
- Number of admissions(Up to 24 months)
- Number of ER visits(Up to 24 months)
- Rate of serious illness(Up to 24 months)
- Health system costs(Up to 24 months)
- Number of well-child checks(Up to 24 months)
- Maternal ratings of care as assessed by The Consumer Assessment of Healthcare Providers and Systems (CAHPS) Child 12-Month Survey(Up to 24 months)
研究者
Elenir BC Avritscher
Assistant Professor
The University of Texas Health Science Center, Houston