Caremap: A Digital Personal Health Record for Complex Care Coordination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in patient-reported health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey
研究概览
简要总结
This study will implement a new mobile application ('app') called Caremap to improve care coordination for patients with complex health needs. The goal is to pilot test the mobile app with patients/families and clinic doctors to gather input on how well the app works and how to make it better. Investigators plan to enroll up to 40 participants from Duke University for this study. The study is sponsored by Duke's Institute for Health Innovation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •for parents/caregivers of children/youth with special health care needs (CYSHCN):
- •Adult parent/legal guardian (age 18 or older) of a CYSHCN
- •Established care for their child/youth at Duke Pediatrics Primary Care or Duke Children's Cystic Fibrosis clinic (established = one or more completed visits in the past 12 months at the clinic)
- •High level of complex medical needs that could benefit from additional care coordination support (determined by clinical provider at the pilot site)
- •Primary provider enrolled in the study as a provider participant/clinical provider site champion
- •Active Duke MyChart (online EHR patient portal) account
- •Full proxy access activated/enabled for parent to the child/youth's medical record in Epic
- •Apple iOS device compatible with Caremap app requirements at time of consent
- •Inclusion criteria for adult patients with multiple chronic conditions (MCC):
- •Adult patient (age 18 or older) with MCC
- •Established care for the patient at Duke Geriatrics clinic or Duke Pulmonary Transplant clinic (established = one or more completed visits in the past 12 months at the clinic)
- •High level of complex medical needs that could benefit from additional care coordination support (determined by clinical provider at the participating clinic site)
- •Primary provider enrolled in the study as a provider participant/clinical provider site champion
- •Active Duke MyChart (online EHR patient portal) account
- •Apple iOS device compatible with Caremap app requirements at time of consent
- •Inclusion criteria for clinical provider site champions (to participate in interviews and quantitative provider-reported surveys):
- •Currently practicing at Duke Health
- •Primary site of work is participating clinic site
排除标准
- •Non-English speaking
- •Living in long-term, congregate settings - e.g., living in institutionalized settings such as long-term care facility, nursing/long-term rehab facilities
- •Lacks requisite technology to access and use mobile app (e.g., device/tablet/smartphone, home internet, active Epic MyChart account)
- •Lack of decision-making capacity (clinician-determined; e.g., patients with advanced dementia)
结局指标
主要结局
Change in patient-reported health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey
时间窗: Baseline, 3 months, 6 months
For participants who are adult patients with complex health needs, the PROMIS Global Health Survey is a 10-item patient-reported survey that gathers patient perspectives on their own overall HR-QOL. Six of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; one of the 9 survey items uses a 5-level Likert scale with 1=not at all and 5=completely; one of the 9 survey items uses a 5-level Likert scale with 1=never and 5=always; one of the 9 survey items uses a 5-level Likert scale with 1=none and 5=very severe; and one of the 9 survey items uses a 0-10 scale (0=no pain; 10=worst pain imaginable).
Implementation feasibility as measured by feasibility intervention measure (FIM)
时间窗: 6 months
The feasibility intervention measure is a 4 item survey using a 5-level Likert scale (1=completely disagree; 5=completely agree).
Change in parent report of their child's health-related quality of life (HR-QOL), as measured by the PROMIS (7+2) Parent Proxy Global Health Survey
时间窗: Baseline, 3 months, 6 months
For participants who are parents of children with complex health needs, the PROMIS (7+2) Pediatric Global Health Survey is a 9-item parent-reported survey that gathers parent perspectives on their child's overall HR-QOL. Four of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; three of the 9 survey items use a 5-level Likert scale with 1=never and 5=always; and three of the 9 survey items use a 5-level Likert scale with 1=never and 5=almost always.
Technical feasibility as measured by proportion of Fast Healthcare Interoperability Resources (FHIR)-enabled data transfer request that were successfully executed
时间窗: Weekly, up to 6 months
Technical feasibility will be defined as proportion of requests for transfer of patient-level data between the electronic health record (EHR) and the app that were successfully completed.
Changes in perceptions of care integration as measured by Pediatric Integrated care survey (PICS)
时间窗: Baseline, 6 months
The PICS is a 20-item survey that gathers parents perspectives on the degree of care integration received by their child using a 6-level Likert scale (1=never; 6=always).
次要结局
- Changes in adoption as measured by quantitative measurement of app engagement by provider(Monthly, up to 6 months)
- Mobile app usability as measured by the System Usability Scale (SUS)(6 months)
- Change in parent/caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM)(Baseline, 6 months)
- Changes in adoption as measured by quantitative measurement of app engagement by patient or parent/caregiver(Weekly, up to 6 months)
- Changes in caregiver or patient report of global health status as measured by a numeric rating scale of 1 (poor) to 10 (excellent)(Weekly for 6 months)
- Changes in acute and outpatient healthcare utilization, as measured by summary of clinical encounters(Baseline, 6 months)
- Changes in adoption as measured by quantitative measurement of app prescription by provider(Monthly, up to 6 months)
- Adaptations made by families and providers during real-world use as measured by survey(Monthly, up to 6 months)
- Change in patient activation and ability to self manage chronic conditions, as measured by the Patient Activation Measure (PAM)(Baseline, 6 months)