Developing Enhanced Prediction Models

Diabetes Clinical Trial

— PREDICT  

Official title:

Developing Enhanced Prediction Models to Identify Patients at Risk for Hospital Readmission by Collecting Patient-Generated Health Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983812
• Other study ID #: 825189
• Status: Completed
• Start date: January 23, 2017
• Est. completion date: December 7, 2019

Study information

• Verified date: February 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, patients will be prospectively enrolled for data collection to design prediction models that integrate claims data (inpatient, outpatient, and pharmacy), electronic health record data (on clinical, social, and behavioral indicators), and patient-generated activity data. Patients will be randomized to use either a smartphone or a wearable activity tracking device to capture patient-generated health data.

Description:

Many hospital readmissions could be prevented if higher risk patients were identified and effective interventions then targeted towards these individuals. However, most existing claims-based predictive models perform poorly and do not provide timely and actionable information. In this study, researchers will prospectively enroll patients for data collection to design prediction models that integrate claims data (inpatient, outpatient, and pharmacy), electronic health record data (on clinical, social, and behavioral indicators), and use wearable devices or smartphones to collect patient-generated data (physical activity and sleep patterns). Patients will be randomized to use either a smartphone or a wearable activity tracking device to capture patient-generated health data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Be 18 years or older

2. Be able to provide informed consent

3. Be admitted to the Hospital of the University of Pennsylvania or Penn Presbyterian Medical Center

4. Have a smartphone or tablet compatible with activity tracking devices

5. Plan to be discharged to home

Exclusion Criteria:

Have no medical condition which prohibits them from ambulating or plan for any medical procedure over the next 6 months that would prohibit them from ambulating.

Related Conditions & MeSH terms

• Acute Myocardial Infraction or Chest Pain
• Chest Pain
• Chronic Obstructive Pulmonary Disease (COPD)
• Congestive Heart Failure (CHF)
• Diabetes
• Heart Failure
• Lung Diseases, Obstructive
• Pneumonia
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	Penn Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital readmission within 30 days of discharge	Patient readmission within 30 days of initial discharge	30 days
Secondary	The secondary outcome measures include re-hospitalization within 90 days of discharge.	Patient readmission within 90 days of initial discharge	90 days
Secondary	Re-hospitalization within 6 months of discharge	Patient readmission within 6 months of initial discharge	6 months
Secondary	Emergency department visits within 6 months of discharge	Patient visit to the emergency department within 6 months of initial discharge	6 months
Secondary	Total health care cost utilization in 6 months after discharge	The cost of health care services for patient within 6 months of initial discharge	6 months