Acute Myocardial Infraction or Chest PainPREDICTNCT02983812
Developing Enhanced Prediction Models
An observational study of Acute Myocardial Infraction or Chest Pain and Chronic Obstructive Pulmonary Disease (COPD), run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infraction or Chest Pain, Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF)
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2017to 7 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be drawn from adults admitted to one of the University of Pennsylvania Health System hospitals. Patients will be invited to participate by a member of the research team prior to hospital discharge.
Who may be able to join
- Be 18 years or older
- Be able to provide informed consent
- Be admitted to the Hospital of the University of Pennsylvania or Penn Presbyterian Medical Center
- Have a smartphone or tablet compatible with activity tracking devices
- Plan to be discharged to home
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing Enhanced Prediction Models to Identify Patients at Risk for Hospital Readmission by Collecting Patient-Generated Health Data
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.
Read the 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.
- Conditions
- Acute Myocardial Infraction or Chest Pain, Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), Diabetes, Pneumonia
- Medical subject headings
- Chest Pain, Pulmonary Disease, Chronic Obstructive, Heart Failure, Diabetes Mellitus, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital readmission within 30 days of discharge
Patient readmission within 30 days of initial discharge
Measured: 30 days
Secondary outcomes (4)
The secondary outcome measures include re-hospitalization within 90 days of discharge.
Patient readmission within 90 days of initial discharge
Measured: 90 days
Re-hospitalization within 6 months of discharge
Patient readmission within 6 months of initial discharge
Measured: 6 months
Emergency department visits within 6 months of discharge
Patient visit to the emergency department within 6 months of initial discharge
Measured: 6 months
Total health care cost utilization in 6 months after discharge
The cost of health care services for patient within 6 months of initial discharge
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start23 Jan 2017
- Primary completion7 Jun 2019
- Study completion7 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infraction or Chest PainStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitesh Patel, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983812
- Sponsor's protocol ID
- 825189
- Acronym
- PREDICT
- Status last verified
- Feb 2020
- First submitted
- 16 Nov 2016
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be made available.
Publications
Patel MS, Polsky D, Kennedy EH, Small DS, Evans CN, Rareshide CAL, Volpp KG. Smartphones vs Wearable Devices for Remotely Monitoring Physical Activity After Hospital Discharge: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Feb 5;3(2):e1920677. doi: 10.1001/jamanetworkopen.2019.20677.
PubMed 32031643Evans CN, Volpp KG, Polsky D, Small DS, Kennedy EH, Karpink K, Djaraher R, Mansi N, Rareshide CAL, Patel MS. Prediction using a randomized evaluation of data collection integrated through connected technologies (PREDICT): Design and rationale of a randomized trial of patients discharged from the hospital to home. Contemp Clin Trials. 2019 Aug;83:53-56. doi: 10.1016/j.cct.2019.06.018. Epub 2019 Jun 29.
PubMed 31265915
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Enhanced Prediction Models to Identify Patients at Risk for Hospital Readmission by Collecting Patient-Generated Health Data
- ClinicalTrials.gov ID
- NCT02983812
- Acronym / sponsor ID
- PREDICT / 825189
- Conditions
- Acute Myocardial Infraction or Chest Pain, Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), Diabetes, Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Dec 2019 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be drawn from adults admitted to one of the University of Pennsylvania Health System hospitals. Patients will be invited to participate by a member of the research team prior to hospital discharge.
Key inclusion criteria (5 listed)
- Be 18 years or older
- Be able to provide informed consent
- Be admitted to the Hospital of the University of Pennsylvania or Penn Presbyterian Medical Center
- Have a smartphone or tablet compatible with activity tracking devices
- Plan to be discharged to home
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital readmission within 30 days of discharge
Time frame: 30 days
Patient readmission within 30 days of initial discharge
4 secondary outcomes
The secondary outcome measures include re-hospitalization within 90 days of discharge.
Time frame: 90 days
Re-hospitalization within 6 months of discharge
Time frame: 6 months
Emergency department visits within 6 months of discharge
Time frame: 6 months
Total health care cost utilization in 6 months after discharge
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Derived from this study: PubMed 32031643Patel MS, Polsky D, Kennedy EH, Small DS, Evans CN, Rareshide CAL, Volpp KG. Smartphones vs Wearable Devices for Remotely Monitoring Physical Activity After Hospital Discharge: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Feb 5;3(2):e1920677. doi: 10.1001/jamanetworkopen.2019.20677.
- Derived from this study: PubMed 31265915Evans CN, Volpp KG, Polsky D, Small DS, Kennedy EH, Karpink K, Djaraher R, Mansi N, Rareshide CAL, Patel MS. Prediction using a randomized evaluation of data collection integrated through connected technologies (PREDICT): Design and rationale of a randomized trial of patients discharged from the hospital to home. Contemp Clin Trials. 2019 Aug;83:53-56. doi: 10.1016/j.cct.2019.06.018. Epub 2019 Jun 29.
- Individual participant dataSharing planned: No. Individual participant data will not be made available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitesh Patel principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infraction or Chest Pain and Chronic Obstructive Pulmonary Disease (COPD), run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital readmission within 30 days of discharge (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02983812, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.