- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01402609
Assessing the Efficacy of an Electronic Discharge Communication Tool
A Randomized Controlled Trial Assessing the Efficacy of an Electronic Discharge Communication Tool for Preventing Death or Hospital Readmission
The transition between acute care and community care represents one of the most vulnerable periods in health care delivery, particularly as the complexity of inpatient populations increases. Two recent North American studies found an incidence of post-discharge adverse events between 19-23%, with adverse drug events accounting for 66-72% of these. The vulnerability of this period has been attributed mainly to a failure of care providers to adequately reconcile discrepancies between home medications and discharge medications, as well as a failure to transfer this and other important information about the hospitalization and discharge to community care providers. While discharge communication with the primary care physician has traditionally occurred via a handwritten or dictated summary, major deficits exist with respect to timeliness of information transfer and adequacy of content in discharge summaries.
Computer-enabled discharge communications can potentially avert such problems. This is particularly true for web-based solutions that do not require end users to acquire additional software/training to use them. The purpose of this research is to definitively assess the efficacy of a web-based seamless discharge communication tool that the Medical Ward of the 21st Century (W21C - see www.w21c.org) team in Calgary has developed through iterative consultation with multiple clinical stakeholders as well as patients/families. This tool has great potential to be implemented on a provincial level as well as across Canada and internationally because it operates on a web interface that does not confine its applicability to a single type of hospital information system.
The purpose of this research is to definitively assess the efficacy of the web-based discharge communication tool that our team has developed in partnership with Alberta Health Services. In doing so, our specific objective will be to answer the following research questions:
- Is the seamless discharge communication tool efficacious with respect to reducing hospital readmission and mortality (at 3 months), as well as reducing adverse events and adverse drug events?
- Does the seamless discharge communication tool transfer appropriate, complete, and accurate discharge information in a timely manner compared to traditional discharge communication?
- Is the seamless discharge communication tool efficacious with respect to improving physician and patient satisfaction?
Study Overview
Status
Intervention / Treatment
Detailed Description
The vulnerability of the transition period has been attributed to three main factors. First, changes to patients'medication regimens during hospitalization are numerous, yet failure to reconcile discrepancies between admission and discharge is frequent. Second, the patient/family is required to take over care responsibilities at discharge and must often relay important information to the primary care physician. This can be particularly challenging if discharge information is poorly communicated, presented too rapidly, if instructions are verbal only, or if the patient has low literacy or low health literacy.Finally, crucial information is often not transferred between acute care physicians and community physicians.
Information about the hospitalization (such as medication changes, patient diagnoses, interventions,diagnostic findings, and necessary follow-up) is commonly transferred to the primary care physician via a discharge summary that is typically faxed or mailed. Unfortunately, deficits with respect to timeliness and/or complete failure to transmit are widespread. At the first post-discharge appointment, the discharge summary is unavailable to the primary care physician up to 75% of the time. This negatively impacts the continuity of care provided to many patients. When summaries are received, inconsistent content and inaccuracies are common. Acute care physicians, whether medical or surgical, often neglect to include diagnostic findings, treatment/hospital course, discharge medications, pending tests results, and whether the patient and family received counselling.
Computer-enabled discharge communications have potential to avert such problems. Such communication platforms can provide an immediate link between acute care and primary care physicians, and interfaces can be designed to ensure consistent information transfer. In addition, physicians in both settings have expressed preference for electronic discharge documents over hand written/dictated summaries with respect to clarity, comprehensiveness, and positive impacts on continuity of care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Medical Teaching Unit, Foothills Medical Centre
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Calgary, Alberta, Canada, T2N 4Z6
- The ward of 21st Century (W21C) Foothills Medical Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all patients being discharged from MTU at the Foothill Medical Centre (FMC)
Exclusion Criteria:
Patients will be excluded if the patient and/or family member decline consent; is under 18 years of age; cannot provide contact information; and/or family member lacks English proficiency and the team cannot communicate with them; has a research burden (enrolled in 2 other studies); is admitted under or has their acute care transferred to a clinical service other than the MTU; is not an Alberta resident; was previously enrolled in the study; is being discharged to hospice care; is transferred to another Hospital ("Rapid Transport"); is incoherent; or dies in hospital.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control group, usual care
Control group will receive usual care.
This usual care typically involves paper-based handwritten discharge communications, with subsequent provision of a dictated discharge summary produced some time after hospital discharge, with unpredictable success of delivery, and with unstructured and sometimes haphazard content.
|
Control group will receive usual care.
This usual care typically involves paper-based handwritten discharge communications, with subsequent provision of a dictated discharge summary produced some time after hospital discharge, with unpredictable success of delivery, and with unstructured and sometimes haphazard content.
Other Names:
|
|
Experimental: electronic discharge communication tool
Patients allocated to the experimental arm will receive a copy of the discharge summary that is generated by the electronic discharge communication tool.
The same copy is shared with their healthcare providers using an electronic, web-based, communication platform that allows communication between acute-care and community -care physicians.
The electronic discharge communication tool allows physicians to start generating the discharge summary from time of admission to hospital.
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The intervention will consist of discharges being conducted with the use of the electronic discharge communication tool.For the intervention group, the care team will record the information that they collect directly into the computerized tool during the hospital stay.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
composite of death or readmission
Time Frame: 3 months
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The primary outcomes are identified as such because these are recognized to be major events that we are ultimately trying to prevent through safer health care.
The 3 month time frame is felt to be most relevant, because it is short enough to potentially relate to discharge communications, but also long enough after discharge to permit some events to occur.
The primary outcomes of interest will be assessed through existing linkages to hospitalization data from the Alberta Health Services Health Outcomes Group based in Calgary,for the outcome of readmission to acute care hospitals; and to data from Alberta Bureau of Vitals Statistics to determine all-cause mortality
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
occurrence of post-discharge adverse events and adverse drug events at 1 month post discharge
Time Frame: 1 month post discharge
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1 month post discharge
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William Ghali, MD, Ward of the 21st Century
Publications and helpful links
General Publications
- Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007 Sep;2(5):314-23. doi: 10.1002/jhm.228.
- van Walraven C, Seth R, Laupacis A. Dissemination of discharge summaries. Not reaching follow-up physicians. Can Fam Physician. 2002 Apr;48:737-42.
- Callen JL, Alderton M, McIntosh J. Evaluation of electronic discharge summaries: a comparison of documentation in electronic and handwritten discharge summaries. Int J Med Inform. 2008 Sep;77(9):613-20. doi: 10.1016/j.ijmedinf.2007.12.002. Epub 2008 Feb 21.
- van Walraven C, Laupacis A, Seth R, Wells G. Dictated versus database-generated discharge summaries: a randomized clinical trial. CMAJ. 1999 Feb 9;160(3):319-26.
- Sevick LK, Santana MJ, Ghali WA, Clement F. Prospective economic evaluation of an electronic discharge communication tool: analysis of a randomised controlled trial. BMJ Open. 2017 Dec 14;7(12):e019139. doi: 10.1136/bmjopen-2017-019139.
- Okoniewska BM, Santana MJ, Holroyd-Leduc J, Flemons W, O'Beirne M, White D, Clement F, Forster A, Ghali WA. The Seamless Transfer-of-Care Protocol: a randomized controlled trial assessing the efficacy of an electronic transfer-of-care communication tool. BMC Health Serv Res. 2012 Nov 21;12:414. doi: 10.1186/1472-6963-12-414.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SeamDis2010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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