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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01970852
Other study ID # AAAF0264
Secondary ID R01HS021816T15LM
Status Completed
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date June 2018

Study information

Verified date July 2018
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 426
Est. completion date June 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Speaks English or Spanish

- Admitted to unit where study is ongoing

Exclusion Criteria:

- Does not pass Mini-mental status exam

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Standard tablet computer
No special enhancements or links to personal health information.
Enhanced tablet computer
Tablet computer with personalized access to data from the patient's electronic health record.

Locations

Country Name City State
United States Columbia University Medical Center New York New York

Sponsors (3)

Lead Sponsor Collaborator
Columbia University Agency for Healthcare Research and Quality (AHRQ), National Library of Medicine (NLM)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Patient Activation Measure 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. Admission to Unit and 3-5 days after
Secondary Patient Satisfaction 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) 3-5 days after admission to study
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