- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02943109
High Tech and High Touch (HT2): Transforming Patient Engagement Through Portal Technology at the Bedside
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The appropriate use of technology to actively engage with patients who suffer from multiple chronic conditions, called multimorbidity, is one of the frontiers of both research and practice. For multimorbid patients, engagement in disease management activities is particularly critical, and evidence shows that enhanced patient self-management can lead to better control of chronic illness. One tool finding increasing use is the patient portal, and its pervasiveness is supported by virtue of its role as a component of the Meaningful Use criteria. A patient portal is a tethered personal health record (tPHR) that links to the patient's electronic health record, facilitating communication and engagement activities with healthcare providers. While most tPHRs have been focused on outpatient activities, a new class of tools focused on the inpatient experience has begun deployment in 2014.
In response, this study supports the conduct of the first, large-scale randomized control trial (RCT) of the impact and use of an inpatient tablet-based patient portal embedded in a larger mixed methods study to examine changes in patient experiences and outcomes, and subsequent ambulatory patient portal usage. The investigators aim to study how access to a patient portal tailored to the inpatient stay can improve patient experience and increase patient engagement by improving patients' perception of the process of care while in the hospital (patient experience), increasing patients' self-efficacy for managing their chronic conditions (patient engagement), and facilitating use of a patient portal for care management activities after discharge (patient engagement).
The study site is a world-class healthcare facility with the ability to provide access to a patient portal designed specifically for the inpatient experience, bridging to outside the hospital after discharge.
Currently, this inpatient technology exists in only one other hospital in the US, but the investigators expect that as inpatient PHRs become more readily available, the need for clarity on this issue will only increase. The investigator's evaluation is a mixed-methods design consisting of primary data collection through surveys and interviews throughout the study period, and secondary data collection from the electronic health record and health system metadata. This study will offer insight into a potentially important mechanism to facilitate patient self-management.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- patient accepted MyChart Bedside tablet
- patient available in their room
- capable of providing informed consent
Exclusion criteria:
- Patient in a pilot unit where Full Tech was available prior to study start
- Patient was less than 18 years of age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High tech, high touch
Patient receives the full version of MyChart Bedside.
Patient receives training/intervention from technology navigator
|
Participants receives an in person visit from an "technology navigator" who helps to explain the technology to the patient.
Patient receives full-suite access to an inpatient patient portal with bi-directional communication enabled.
|
|
Experimental: Low tech, high touch
Patient receives the non-interactional version of MyChart Bedside.
Patient receives training/intervention from technology navigator
|
Participants receives an in person visit from an "technology navigator" who helps to explain the technology to the patient.
Patient receives a limited access version of the inpatient patient portal with bi-directional communication disabled.
|
|
Experimental: High tech, low touch
Patient receives the full version of MyChart Bedside.
Patient receives online training, only
|
Patient receives full-suite access to an inpatient patient portal with bi-directional communication enabled.
Participants receives a visit from a "patient navigator" who helps to explain how to navigate the hospital system (active control).
|
|
Experimental: Low tech, low touch
Patient receives the non-interactional version of MyChart Bedside.
Patient receives online training, only
|
Patient receives a limited access version of the inpatient patient portal with bi-directional communication disabled.
Participants receives a visit from a "patient navigator" who helps to explain how to navigate the hospital system (active control).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inpatient Portal Use Frequency
Time Frame: At hospital discharge.
|
The count of MyChart Bedside (inpatient portal) sessions for the admission associated with study enrollment.
|
At hospital discharge.
|
|
Inpatient Portal Comprehensiveness of Use
Time Frame: At hospital discharge.
|
Based on the use of all available MyChart Bedside (inpatient portal) functions, a comprehensive inpatient portal user was one who used all three functions - for patients in the low tech assignment - or used eight or more functions - for patients in the high tech assignment.
|
At hospital discharge.
|
|
Inpatient Portal Functions Proportion of Use
Time Frame: At hospital discharge.
|
For each MyChart Bedside (inpatient portal) function available to patients assigned to high tech, a proportion of total use is calculated for each patient as the sum of actions in a given function divided for the total sum of user actions during the hospital admission associated with study enrollment.
|
At hospital discharge.
|
|
Patient Satisfaction With Care - Responses From Healthcare Professionals
Time Frame: 15 days after discharge
|
Questions from the satisfaction and experience domains of the 15-day Post-discharge surveys were used to assess patient satisfaction with their care.
Answers to the following 5-point Likert scale survey item were explored: "In your most recent hospital experience, how satisfied were you with how well your healthcare professionals responded to your concerns?
".
Responses were dichotomized to one "most positive" response versus all other responses.
|
15 days after discharge
|
|
Patient Satisfaction With Care - Interactions With Healthcare Professionals
Time Frame: 15 days after discharge
|
Questions from the satisfaction and experience domains of the 15-day Post-discharge surveys were used to assess patient satisfaction with their care.
Answers to the following 5-point Likert scale survey item were explored: "In your most recent hospital experience, how satisfied were you with the interactions you had with your healthcare professionals?
".
Responses were dichotomized to one "most positive" response versus all other responses.
|
15 days after discharge
|
|
Patient Satisfaction With Care - Responses From Healthcare Professionals
Time Frame: 6 months after discharge
|
Questions from the satisfaction and experience domains of the 6-month Post-discharge surveys were used to assess patient satisfaction with their care.
Answers to the following 5-point Likert scale survey item were explored: "In the past 6 months, how satisfied were you with how well your healthcare professionals responded to your concerns?
".
Responses were dichotomized to one "most positive" response versus all other responses.
|
6 months after discharge
|
|
Patient Satisfaction With Care - Interactions With Healthcare Professionals
Time Frame: 6 months after discharge
|
Questions from the satisfaction and experience domains of the 6-month Post-discharge surveys were used to assess patient satisfaction with their care.
Answers to the following 5-point Likert scale survey item were explored: "In your most recent hospital experience, how satisfied were you with the interactions you had with your healthcare professionals?
".
Responses were dichotomized to one "most positive" response versus all other responses.
|
6 months after discharge
|
|
Patient Involvement With Care - Questions About Health Management
Time Frame: 15 days after discharge.
|
Questions from the involvement with care domain of the 15-day Post-discharge surveys were used to assess patient involvement with their care.
Answers to the following 5-point Likert scale survey item were explored: "All of my questions about managing my health, including my medications, were addressed before I left the hospital.".
Responses were dichotomized to one "most positive" response versus all other responses.
|
15 days after discharge.
|
|
Patient Involvement With Care - Finding Answers to Health Management Questions
Time Frame: 15 days after discharge.
|
Questions from the involvement with care domain of the 15-day Post-discharge surveys were used to assess patient involvement with their care.
Answers to the following multiple-choice survey item were explored: "If you had a question about your care while you were in the hospital, what steps did you take to find an answer?
(mark all that apply)".
|
15 days after discharge.
|
|
Patient Involvement With Care - Tablet's Activities
Time Frame: 15 days after discharge.
|
Questions from the involvement with care domain of the 15-day Post-discharge surveys were used to assess patient involvement with their care.
Answers to the following multiple-choice survey item were explored: "What kind of activities did you use the table for?
(mark all that apply)".
|
15 days after discharge.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Outpatient Portal Adoption
Time Frame: 3 months post-discharge
|
MyChart (outpatient portal) accounts activated by participants after their enrollment in the study (based on log file analysis).
|
3 months post-discharge
|
|
Outpatient Portal Frequency of Use
Time Frame: 3 months post-discharge
|
Count of MyChart (outpatient portal) sessions (based on log file analysis).
|
3 months post-discharge
|
|
Self-Efficacy
Time Frame: Baseline
|
5-point Likert scale built on the participant responses to 6 self-efficacy-related items from the admission survey. Self-efficacy measures the belief in one's capacity to complete a task, rather than the relevant skills possessed. Scale developed on the basis of Bandura, A. (2006). Guide for constructing self-efficacy scales. In F. Pajares & T. Urdan (Eds.). Self-Efficacy Beliefs of Adolescent. Greenwich, CT: Information Age Publishing, pp. 307-337. Self-Efficacy scale:
|
Baseline
|
|
Self-Efficacy
Time Frame: 15 days post-discharge
|
5-point Likert scale built on the participant responses to 6 self-efficacy-related items from the admission survey. Self-efficacy measures the belief in one's capacity to complete a task, rather than the relevant skills possessed. Scale developed on the basis of Bandura, A. (2006). Guide for constructing self-efficacy scales. In F. Pajares & T. Urdan (Eds.). Self-Efficacy Beliefs of Adolescent. Greenwich, CT: Information Age Publishing, pp. 307-337. Self-Efficacy scale:
|
15 days post-discharge
|
|
Self-Efficacy
Time Frame: 6 months post-discharge
|
5-point Likert scale built on the participant responses to 6 self-efficacy-related items from the admission survey. Self-efficacy measures the belief in one's capacity to complete a task, rather than the relevant skills possessed. Scale developed on the basis of Bandura, A. (2006). Guide for constructing self-efficacy scales. In F. Pajares & T. Urdan (Eds.). Self-Efficacy Beliefs of Adolescent. Greenwich, CT: Information Age Publishing, pp. 307-337. Self-Efficacy scale:
|
6 months post-discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ann S McAlearney, ScD, Ohio State University
Publications and helpful links
General Publications
- McAlearney AS, Sieck CJ, Hefner JL, Aldrich AM, Walker DM, Rizer MK, Moffatt-Bruce SD, Huerta TR. High Touch and High Tech (HT2) Proposal: Transforming Patient Engagement Throughout the Continuum of Care by Engaging Patients with Portal Technology at the Bedside. JMIR Res Protoc. 2016 Nov 29;5(4):e221. doi: 10.2196/resprot.6355.
- McAlearney AS, Walker DM, Sieck CJ, Fareed N, MacEwan SR, Hefner JL, Di Tosto G, Gaughan A, Sova LN, Rush LJ, Moffatt-Bruce S, Rizer MK, Huerta TR. Effect of In-Person vs Video Training and Access to All Functions vs a Limited Subset of Functions on Portal Use Among Inpatients: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231321. doi: 10.1001/jamanetworkopen.2022.31321.
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 (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HS024091 (U.S. AHRQ Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Data types: Deidentified participant data.
How to access data: Data may be requested from the PI via a request to ht2study@osumc.edu.
IPD Sharing Time Frame
Starting date: 2023-07-01
End date: 2027-06-30
IPD Sharing Access Criteria
Who can access the data: Open to all requesters who provide a methodologically sound proposal whose use has also been approved by an independent review committee.
Types of analyses: There are no a priori limits. Limits are based on approved proposals.
Mechanisms of data availability: Secure Data transfer. Interested parties will be required to complete an institutional Data Use Agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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