- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01970852
Addressing Hospital Patient Information Needs Using Information Technology
Addressing Hospital Patient Information Needs Using a Personal Health Record Portal
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will utilize an enhanced inpatient PHR portal to allow patients to view their care team, documented allergies and medications (home and hospital) as well as electronically document questions and concerns related to their care. These questions and concerns are visible to members of the patients' care teams within our commercial inpatient electronic health record (EHR). We will study the impact of the technology using a randomized trial of 426 cardiology and cardiothoracic surgery patients at Columbia University Medical Center in Upper Manhattan. We hypothesize that the use of the inpatient PHR portal will identify and address patients' information needs, improve patient activation, engagement and satisfaction, and encourage PHR use after hospital discharge. We also hypothesize that information entered by patients into the PHR portal will be useful to clinicians. There is no compensation for participating in this study.
The specific aims of the proposal are to:
Aim 1: Evaluate the impact of an inpatient PHR portal intervention using a randomized controlled trial. The primary outcomes will be patient activation, engagement and satisfaction. We will also determine whether access to the inpatient PHR portal is correlated with greater use of the PHR after hospital discharge.
Aim 2: Characterize information needs of hospital patients and assess clinicians' attitudes toward patient engagement in the hospital setting. We will analyze the questions and comments that patients record within the PHR portal application and assess the salience of patient-entered information to issues of care quality and safety. This aim will expand our previous work in taxonomy development and hazard and near-miss recognition. A survey will be administered to collect clinicians' perceptions of the barriers to and facilitators of system use. EHR documentation will be reviewed to assess whether patient-entered information was acknowledged by clinicians, and whether changes were made to the patient's plan of care as a result.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Speaks English or Spanish
- Admitted to unit where study is ongoing
Exclusion Criteria:
- Does not pass Mini-mental status exam
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard tablet computer
Patient will receive tablet computer within 18 hours of admission and will continue to have access to it for the rest of his/her stay.
Tablet has typical applications including access to the internet and entertainment.
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No special enhancements or links to personal health information.
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No Intervention: Usual Care
Patients will receive usual care and will answer surveys during the usual time-frame specified.
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Experimental: Enhanced tablet computer
Patients will receive a tablet computer within 18 hours of admission.
Tablet will give access to a personalized inpatient personal health record portal.
Will also provide access to standard tablet applications (e.g.
video calling, streaming movies, etc.)
|
Tablet computer with personalized access to data from the patient's electronic health record.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Activation Measure
Time Frame: Admission to Unit and 3-5 days after
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The PAM assesses the knowledge, skills and confidence essential to managing one's own health and healthcare.
It segments consumers into one of four progressively higher activation levels.
The PAM score has been used to predict healthcare outcomes including medication adherence, ER utilization and hospitalization.
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Admission to Unit and 3-5 days after
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction
Time Frame: 3-5 days after admission to study
|
We will measure patient patient satisfaction using a survey instrument along with data obtained from EHR and PHR system logs.
The Patient Survey instrument measures information needs, satisfaction, patient engagement, and system usefulness.
It is derived from the 26-item Telemedicine Satisfaction and Usefulness Questionnaire (Bakken, 2006)
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3-5 days after admission to study
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Vawdrey, PhD, Columbia University
Publications and helpful links
General Publications
- Vawdrey DK, Wilcox LG, Collins SA, Bakken S, Feiner S, Boyer A, Restaino SW. A tablet computer application for patients to participate in their hospital care. AMIA Annu Symp Proc. 2011;2011:1428-35. Epub 2011 Oct 22.
- Greysen SR, Magan Y, Rosenthal J, Jacolbia R, Auerbach AD, Harrison JD. Patient Recommendations to Improve the Implementation of and Engagement With Portals in Acute Care: Hospital-Based Qualitative Study. J Med Internet Res. 2020 Jan 14;22(1):e13337. doi: 10.2196/13337.
- Masterson Creber RM, Grossman LV, Ryan B, Qian M, Polubriaginof FCG, Restaino S, Bakken S, Hripcsak G, Vawdrey DK. Engaging hospitalized patients with personalized health information: a randomized trial of an inpatient portal. J Am Med Inform Assoc. 2019 Feb 1;26(2):115-123. doi: 10.1093/jamia/ocy146.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AAAF0264
- R01HS021816 (U.S. AHRQ Grant/Contract)
- T15LM00707 (Other Grant/Funding Number: National Library of Medicine)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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