PREDICT: Developing Enhanced Prediction Models

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT02983812
Collaborator
(none)
500
1
34.4
14.5

Study Details

Study Description

Brief 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.

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Developing Enhanced Prediction Models to Identify Patients at Risk for Hospital Readmission by Collecting Patient-Generated Health Data
Actual Study Start Date :
Jan 23, 2017
Actual Primary Completion Date :
Jun 7, 2019
Actual Study Completion Date :
Dec 7, 2019

Arms and Interventions

Arm Intervention/Treatment
Activity Monitoring - Smartphone

Patients in the activity monitoring - smartphone group will be randomly assigned to track their data using a smartphone app (which collects step counts) for 6 months. There will be no intervention for either group, both are being passively monitored.

Activity Monitoring - Wearable

Patients in the activity monitoring - wearable device group will be randomly assigned to track their data using a wearable activity tracker (which collects step counts and sleep patterns/duration). There will be no intervention for either group, both are being passively monitored.

Outcome Measures

Primary Outcome Measures

  1. Hospital readmission within 30 days of discharge [30 days]

    Patient readmission within 30 days of initial discharge

Secondary Outcome Measures

  1. The secondary outcome measures include re-hospitalization within 90 days of discharge. [90 days]

    Patient readmission within 90 days of initial discharge

  2. Re-hospitalization within 6 months of discharge [6 months]

    Patient readmission within 6 months of initial discharge

  3. Emergency department visits within 6 months of discharge [6 months]

    Patient visit to the emergency department within 6 months of initial discharge

  4. Total health care cost utilization in 6 months after discharge [6 months]

    The cost of health care services for patient within 6 months of initial discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Penn Medicine Philadelphia Pennsylvania United States 19103

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

  • Principal Investigator: Mitesh Patel, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02983812
Other Study ID Numbers:
  • 825189
First Posted:
Dec 6, 2016
Last Update Posted:
Feb 6, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2020