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Addressing Hospital Patient Information Needs Using Information Technology

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ClinicalTrials.gov Identifier: NCT01970852
Recruitment Status : Active, not recruiting
First Posted : October 28, 2013
Last Update Posted : January 25, 2018
Agency for Healthcare Research and Quality (AHRQ)
National Library of Medicine (NLM)
Information provided by (Responsible Party):
David Vawdrey, Columbia University

Brief Summary:
The aim of this study is to evaluate the impact of an inpatient personal health record (PHR) portal intervention within the hospital environment. The intervention hopes to improve patient engagement with their care and to measure patient activation and satisfaction. Additional clinical measure (e.g. number of adverse events that occur during the stay, changes to medication orders, etc.) will also be studied. Characterization of hospital patient and clinician attitudes towards patient engagement will also be formalized.

Condition or disease Intervention/treatment
Inpatient Other: Standard tablet computer Other: Enhanced tablet computer

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 : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Addressing Hospital Patient Information Needs Using a Personal Health Record Portal
Study Start Date : March 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
Other: Standard tablet computer
No special enhancements or links to personal health information.
No Intervention: Usual Care
Patients will receive usual care and will answer surveys during the usual time-frame specified.
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.)
Other: Enhanced tablet computer
Tablet computer with personalized access to data from the patient's electronic health record.

Primary Outcome Measures :
  1. Change in Patient Activation Measure [ Time Frame: Admission to Unit and 3-5 days after ]
    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.

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Speaks English or Spanish
  • Admitted to unit where study is ongoing

Exclusion Criteria:

  • Does not pass Mini-mental status exam

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970852

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Agency for Healthcare Research and Quality (AHRQ)
National Library of Medicine (NLM)
Principal Investigator: David Vawdrey, PhD Columbia University

Responsible Party: David Vawdrey, Assistant Professor of Clinical Biomedical Informatics, Columbia University
ClinicalTrials.gov Identifier: NCT01970852     History of Changes
Other Study ID Numbers: AAAF0264
R01HS021816 ( U.S. AHRQ Grant/Contract )
T15LM00707 ( Other Grant/Funding Number: National Library of Medicine )
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by David Vawdrey, Columbia University:
PHR Portal
Information Technology