Hospital InpatientsNCT02752321
An Electronic Multimedia Discharge Application
A study testing eDischarge in people with Hospital Inpatients, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the addition of a mobile or web based multimedia discharge application (eDischarge) to the discharge process is effective in improving patient experience, engagement, and clinical outcomes in the early post discharge period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Inpatients
- What is being tested?
- eDischarge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2017
- 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
- Male and female patients ages 18 years and above
- Access to mobile device (phone/tablet) and/or computer at home
- Admission to Lenox Hill Hospital under the Department of Neurosurgery
- Discharge to home and rehab facilities where patients can be accessed
Who cannot join
- Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing)
- Patients not expected to survive to the 30 day visit due to co-morbidities or are Do No Resuscitate/Do Not Intubate (DNR/DNI) status prior to randomization
- Patients transferred to a different hospital service or a nursing home
- Patients on hospital precautions or suicide watch, or are deaf or blind
- Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational technology were initiated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video Assisted Transitions of Care: The Power of Video for Hospital Discharge Process
The purpose of this study is to determine whether the addition of a mobile or web based multimedia discharge application (eDischarge) to the discharge process is effective in improving patient experience, engagement, and clinical outcomes in the early post discharge period.
Read the detailed description
Hospital discharge is an essential transition of a patient's care from the inpatient health care team to the patient and caregiver. While a variety of factors may contribute to the effective discharge process, adequate communication between all parties significantly contributes to better outcomes. However, studies indicate that nearly one in five Medicare patients are re-hospitalized within one month of discharge due to lack of patient understanding and compliance to the post-hospital plan of care.
The standard discharge process, which is similar across all disease etiologies, has not changed significantly in many years and lags behind today's technological advances. Currently, the standard discharge process most commonly is delivered as a written document. This document summarizes the patient's hospitalization and discharge instructions in a plain text format, not significantly personalized, and is reviewed with the patient and caregivers usually at time of the discharge. Patients may not pay attention or understand the clinical information communicated to them and may not remember the dialogues during the discharge. In addition, patients often misplace their discharge papers and will not follow the post discharge instructions.
In early 2009, the Health Information Technology for Economic and Clinical Health (HITECH) Act was adopted to promote the meaningful use of health information technology. Stage 1 of HITECH centered on 5 underlying health outcomes of meaningful use: (1) improve quality, safety, efficiency, and reduce health disparities; (2) engage patients and families in their healthcare; (3) improve care coordination; (4) improve population and public health; and (5) ensure adequate privacy and security protections for personal health information. While the passage of HITECH and application of new database technologies has prompted an increase in the use of electronic health records (EHR), the incentives of meaningful use has not been widely applied (Hsiao and Hing)3.
The current "Age of the Internet" and its ability to deliver data to almost any physical locale instantaneously, including high resolution audio and video, has fostered new ways to create, view and share information - including, potentially, medical records. eDischarge is a new multimedia technology designed to supplement the discharge process and enhance provider-patient communication by facilitating the delivery of discharge and follow-up information to patients. Designed as a secure, HIPPA-compliant, cloud-based software platform, participants are able to access the eDischarge system using a personal computer or a mobile device, which can enhance access to health information for the patient. Through eDischarge, participants are given personalized videos, documents, and images tailored specifically to their particular medical care. eDischarge permits inclusion of both structured health information exchange data as well as medical data to be added to discharge. Providers are able to asynchronously create content throughout a participant's hospital stay, which the participant will be able to access post discharge. The investigators believe that this technology has the potential to improve patient engagement and experience as well as enhance a patient's understanding of his disease process and treatment.
- Conditions
- Hospital Inpatients
- Being tested
- eDischarge
- Keywords
- patient discharge, patient engagement, patient satisfaction, continuity of patient care, hospital discharge, health technology, eDischarge, multimedia, mobile applications, software applications, portable electronic applications
- Medical subject headings
- Patient Participation, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eDischargeDevice
Patients will be enrolled in the eDischarge technology during their inpatient hospital stay. A completed electronic discharge packet (EDP) will be given to patients on the day of hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| eDischarge + Standard Discharge (SDeD) | Experimental | Patients in this arm will be enrolled in the eDischarge technology prior to hospital discharge. Upon hospital discharge, these patients will receive a personalized eDischarge, containing text and multimedia information, in addition to receiving the standard discharge process.
Follow-up interviews and surveys will be conducted at 7-14 days post discharge, and at 30-45 days post discharge. Receives: Device: eDischarge |
| Standard Discharge (SD) | No intervention | Patients in this arm will receive the standard discharge process upon hospital discharge. Follow-up interviews and surveys will be conducted at 7-14 days post discharge, and at 30-45 days post discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Discharge Survey
to determine patient knowledge/awareness of their diagnosis
Measured: 7-14 Days Post-Discharge
Post Discharge Survey
to determine patient knowledge/awareness of their medications
Measured: 7-14 Days Post-Discharge
Secondary outcomes (4)
Patient Discharge Experience (eDischarge Questionnaire)
to compare patients experiences with their discharge between the SDeD and the SD groups.
Measured: 7-14 Days Post-Discharge
Patient Discharge Experience (Standard Discharge Questionnaire)
to compare patients experiences with their discharge between the SDeD and the SD groups.
Measured: 7-14 Days Post-Discharge
Hospital Readmission Rate
to compare readmission rates between the SDeD and SD groups.
Measured: 30-45 Days Post Discharge
ED Visit Rate
to compare emergency department visit rates between the SDeD and SD groups.
Measured: 30-45 Days Post Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: There was a software server issue. Investigators were no longer able to sign patients up to the software program.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hospital InpatientsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Langer, Northwell Health
- Investigators
- David J. Langer, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752321
- Sponsor's protocol ID
- 15-260
- Status last verified
- Jan 2018
- First submitted
- 15 Apr 2016
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Feb 4;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.
PubMed 12558354Lai M, Kheterpal S. Creating a real return-on-investment for information system implementation: life after HITECH. Anesthesiol Clin. 2011 Sep;29(3):413-38. doi: 10.1016/j.anclin.2011.05.005.
PubMed 21871403Hsiao CJ, Hing E. Use and characteristics of electronic health record systems among office-based physician practices: United States, 2001-2013. NCHS Data Brief. 2014 Jan;(143):1-8.
PubMed 24439138Berkman ND, Dewalt DA, Pignone MP, Sheridan SL, Lohr KN, Lux L, Sutton SF, Swinson T, Bonito AJ. Literacy and health outcomes. Evid Rep Technol Assess (Summ). 2004 Jan;(87):1-8. No abstract available.
PubMed 15819598
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Assisted Transitions of Care: The Power of Video for Hospital Discharge Process
- ClinicalTrials.gov ID
- NCT02752321
- Acronym / sponsor ID
- 15-260
- Conditions
- Hospital Inpatients
- Keywords
- patient discharge, patient engagement, patient satisfaction, continuity of patient care, hospital discharge, health technology, eDischarge, multimedia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was a software server issue. Investigators were no longer able to sign patients up to the software program.
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Apr 2016 (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 purpose of this study is to determine whether the addition of a mobile or web based multimedia discharge application (eDischarge) to the discharge process is effective in improving patient experience, engagement, and clinical outcomes in the early post discharge period.
Detailed description
Hospital discharge is an essential transition of a patient's care from the inpatient health care team to the patient and caregiver. While a variety of factors may contribute to the effective discharge process, adequate communication between all parties significantly contributes to better outcomes. However, studies indicate that nearly one in five Medicare patients are re-hospitalized within one month of discharge due to lack of patient understanding and compliance to the post-hospital plan of care.
The standard discharge process, which is similar across all disease etiologies, has not changed significantly in many years and lags behind today's technological advances. Currently, the standard discharge process most commonly is delivered as a written document. This document summarizes the patient's hospitalization and discharge instructions in a plain text format, not significantly personalized, and is reviewed with the patient and caregivers usually at time of the discharge. Patients may not pay attention or understand the clinical information communicated to them and may not remember the dialogues during the discharge. In addition, patients often misplace their discharge papers and will not follow the post discharge instructions.
In early 2009, the Health Information Technology for Economic and Clinical Health (HITECH) Act was adopted to promote the meaningful use of health information technology. Stage 1 of HITECH centered on 5 underlying health outcomes of meaningful use: (1) improve quality, safety, efficiency, and reduce health disparities; (2) engage patients and families in their healthcare; (3) improve care coordination; (4) improve population and public health; and (5) ensure adequate privacy and security protections for personal health information. While the passage of HITECH and application of new database technologies has prompted an increase in the use of electronic health records (EHR), the incentives of meaningful use has not been widely applied (Hsiao and Hing)3.
The current "Age of the Internet" and its ability to deliver data to almost any physical locale instantaneously, including high resolution audio and video, has fostered new ways to create, view and share information - including, potentially, medical records. eDischarge is a new multimedia technology designed to supplement the discharge process and enhance provider-patient communication by facilitating the delivery of discharge and follow-up information to patients. Designed as a secure, HIPPA-compliant, cloud-based software platform, participants are able to access the eDischarge system using a personal computer or a mobile device, which can enhance access to health information for the patient. Through eDischarge, participants are given personalized videos, documents, and images tailored specifically to their particular medical care. eDischarge permits inclusion of both structured health information exchange data as well as medical data to be added to discharge. Providers are able to asynchronously create content throughout a participant's hospital stay, which the participant will be able to access post discharge. The investigators believe that this technology has the potential to improve patient engagement and experience as well as enhance a patient's understanding of his disease process and treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eDischarge + Standard Discharge (SDeD) | Experimental | Device: eDischargePatients in this arm will be enrolled in the eDischarge technology prior to hospital discharge. Upon hospital discharge, these patients will receive a personalized eDischarge, containing text and multimedia information, in addition to receiving the standard discharge process. Follow-up interviews and surveys will be conducted at 7-14 days post discharge, and at 30-45 days post discharge. |
| Standard Discharge (SD) | No intervention | –Patients in this arm will receive the standard discharge process upon hospital discharge. Follow-up interviews and surveys will be conducted at 7-14 days post discharge, and at 30-45 days post discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients ages 18 years and above
- Access to mobile device (phone/tablet) and/or computer at home
- Admission to Lenox Hill Hospital under the Department of Neurosurgery
- Discharge to home and rehab facilities where patients can be accessed
Key exclusion criteria (6 listed)
- Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing)
- Patients not expected to survive to the 30 day visit due to co-morbidities or are Do No Resuscitate/Do Not Intubate (DNR/DNI) status prior to randomization
- Patients transferred to a different hospital service or a nursing home
- Patients on hospital precautions or suicide watch, or are deaf or blind
- Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
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 |
|---|---|---|
| eDischargePatients will be enrolled in the eDischarge technology during their inpatient hospital stay. A completed electronic discharge packet (EDP) will be given to patients on the day of hospital discharge. | Device | eDischarge + Standard Discharge (SDeD) |
Primary outcome
Post Discharge Survey
Time frame: 7-14 Days Post-Discharge
to determine patient knowledge/awareness of their diagnosis
Post Discharge Survey
Time frame: 7-14 Days Post-Discharge
to determine patient knowledge/awareness of their medications
4 secondary outcomes
Patient Discharge Experience (eDischarge Questionnaire)
Time frame: 7-14 Days Post-Discharge
Patient Discharge Experience (Standard Discharge Questionnaire)
Time frame: 7-14 Days Post-Discharge
Hospital Readmission Rate
Time frame: 30-45 Days Post Discharge
ED Visit Rate
Time frame: 30-45 Days Post Discharge
Results and safety
The study was stopped early (reason given: There was a software server issue. Investigators were no longer able to sign patients up to the software program.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Background: PubMed 12558354Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Feb 4;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.
- Background: PubMed 21871403Lai M, Kheterpal S. Creating a real return-on-investment for information system implementation: life after HITECH. Anesthesiol Clin. 2011 Sep;29(3):413-38. doi: 10.1016/j.anclin.2011.05.005.
- Background: PubMed 24439138Hsiao CJ, Hing E. Use and characteristics of electronic health record systems among office-based physician practices: United States, 2001-2013. NCHS Data Brief. 2014 Jan;(143):1-8.
- Background: PubMed 15819598Berkman ND, Dewalt DA, Pignone MP, Sheridan SL, Lohr KN, Lux L, Sutton SF, Swinson T, Bonito AJ. Literacy and health outcomes. Evid Rep Technol Assess (Summ). 2004 Jan;(87):1-8. No abstract available.
- Individual participant dataSharing planned: No
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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 J. Langer, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eDischarge in people with Hospital Inpatients, run by Northwell Health 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Jan 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 was stopped early (reason given: There was a software server issue. Investigators were no longer able to sign patients up to the software program.). Results are not available in the source record.
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?
Post Discharge Survey (time frame: 7-14 Days Post-Discharge). The study lists 2 primary outcomes in all. 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 NCT02752321, which also lists 4 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 10 Jan 2018.