NCT03006718

SCD-PROMIS: A Software Platform to Enhance Self-efficacy and Patient-provider Engagement for Patients With Sickle Cell Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Julia Finkel · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Accepted

Summary

The overall goal of the project is to reduce pain-related, 30-day readmission rates for sickle cell disease (SCD) patients. The investigators want to see if a mobile phone application (app) can help decrease the need for repeat admission to the hospital because of sickle cell pain.

Detailed description

Pain is the main reason why SCD patients are admitted and readmitted to the hospital. In fact, readmission rates of SCD patients are higher than those of asthmatics and diabetics. In order to reduce 30-day hospital readmission rates and improve patient care quality, the Affordable Care Act and Centers for Medicare and Medicaid Services have established the Readmissions Reduction Program. In keeping with this effort, the investigators propose a methodology and supporting technology that has the potential to change the way SCD patients are monitored after hospital discharge and in turn, decrease readmission rates. This methodology also has the potential to enhance the quality of life of SCD patients by improving patient reporting, self-efficacy, and increasing patient/provider engagement when there is worsening pain and increased admission/readmission risk. This software platform uses validated Patient Reported Outcome Measurement Information System (PROMIS) measures to remotely monitor SCD patients' pain and related outcomes after hospital discharge. With this initial study, the investigators propose to use this monitoring platform to identify the predictors of readmission, to develop a readmission prediction engine, and to design the next version of the app with built in interventions to address those readmission risks. This monitoring platform could also increase healthcare provider engagement when there is a worsening of patients' pain and/or an increased risk of readmission. In order to build and optimize this monitoring platform, the investigators have assembled a team of engineers, hematologists, pain researchers, and statisticians that have worked together, and who collectively have the expertise to develop and test the feasibility and predictive value of the application in a large population of SCD patients.

Conditions

• Sickle Cell Disease
• Anemia
• Anemia, Hemolytic
• Anemia, Sickle Cell
• Hematologic Diseases

Interventions

Type	Name	Description
OTHER	PROMIS for Pain Management App	At hospital discharge, the investigators will collect baseline surveys, a blood sample, and download the PROMIS for Pain Management App onto the subject's mobile device. For five consecutive weeks, PROMIS measures will be collected through weekly surveys. The investigators plan to compensate patients for their time. Patients will come back to the hospital after 35 days for a final blood draw and set of surveys. In the event a patient gets readmitted, the investigators will record that admission. The investigators will also collect Proxy PROMIS measures from parents of participants between the ages of 8 and 17-years who have agreed to participate in the study. It is the goal of the investigators to engage one of the parents in the reporting of weekly validated Proxy PROMIS measures.

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-09-01
• Completion: 2019-09-01
• First posted: 2016-12-30
• Last updated: 2021-02-24

Locations

1 site across 1 country: United States