InpatientNCT01970852
Addressing Hospital Patient Information Needs Using Information Technology
A study testing Standard tablet computer and Enhanced tablet computer in people with Inpatient, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inpatient
- What is being tested?
- Standard tablet computer and Enhanced tablet computer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jun 2018
- Phase
- Interventional
- 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
Who may be able to join
- Speaks English or Spanish
- Admitted to unit where study is ongoing
Who cannot join
- Does not pass Mini-mental status exam
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Addressing Hospital Patient Information Needs Using a Personal Health Record Portal
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.
Read the 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.
- Conditions
- Inpatient
- Being tested
- Standard tablet computer, Enhanced tablet computer
- Keywords
- Inpatient, PHR Portal, Information Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard tablet computerOther
No special enhancements or links to personal health information.
Enhanced tablet computerOther
Tablet computer with personalized access to data from the patient's electronic health record.
| Study group | Role | What they receive |
|---|---|---|
| Standard tablet computer | Experimental | 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. Receives: Other: Standard tablet computer |
| Usual Care | No intervention | Patients will receive usual care and will answer surveys during the usual time-frame specified. |
| Enhanced tablet computer | Experimental | 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.) Receives: Other: Enhanced tablet computer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Admission to Unit and 3-5 days after
Secondary outcomes (1)
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)
Measured: 3-5 days after admission to study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startMar 2014
- Primary completionMay 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InpatientStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), National Library of Medicine (NLM)
- Responsible party
- Principal investigator, David Vawdrey, Columbia University
- Investigators
- David Vawdrey, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970852
- Sponsor's protocol ID
- AAAF0264
- Other IDs
- R01HS021816, T15LM00707
- Status last verified
- Jul 2018
- First submitted
- 18 Oct 2013
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22195206Greysen 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.
PubMed 31934868Masterson 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.
PubMed 30534990
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Hospital Patient Information Needs Using a Personal Health Record Portal
- ClinicalTrials.gov ID
- NCT01970852
- Acronym / sponsor ID
- AAAF0264
- Conditions
- Inpatient
- Keywords
- Inpatient, PHR Portal, Information Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), National Library of Medicine (NLM)
- Study start
- Mar 2014 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 28 Oct 2013 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard tablet computer | Experimental | Other: Standard tablet computerPatient 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. |
| Usual Care | No intervention | –Patients will receive usual care and will answer surveys during the usual time-frame specified. |
| Enhanced tablet computer | Experimental | Other: Enhanced tablet computerPatients 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.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Speaks English or Spanish
- Admitted to unit where study is ongoing
Key exclusion criteria (1 listed)
- Does not pass Mini-mental status exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard tablet computerNo special enhancements or links to personal health information. | Other | Standard tablet computer |
| Enhanced tablet computerTablet computer with personalized access to data from the patient's electronic health record. | Other | Enhanced tablet computer |
Primary outcome
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.
1 secondary outcome
Patient Satisfaction
Time frame: 3-5 days after admission to study
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 18 Jul 2018.
- Background: PubMed 22195206Vawdrey 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.
- Derived from this study: PubMed 31934868Greysen 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.
- Derived from this study: PubMed 30534990Masterson 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.
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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.
David Vawdrey, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard tablet computer and Enhanced tablet computer in people with Inpatient, run by Columbia University 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 2 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 18 Jul 2018. 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?
Change in Patient Activation Measure (time frame: Admission to Unit and 3-5 days after). 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 NCT01970852, which also lists 3 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 18 Jul 2018.