Other Diagnoses, Comorbidities, and ComplicationsNCT01402609
Assessing the Efficacy of an Electronic Discharge Communication Tool
A study testing electronic discharge communication tool in people with Other Diagnoses, Comorbidities, and Complications, run by Ward of the 21st Century at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Diagnoses, Comorbidities, and Complications
- What is being tested?
- electronic discharge communication tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,399 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2011to Apr 2016
- 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
- all patients being discharged from MTU at the Foothill Medical Centre (FMC)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Medical Teaching Unit, Foothills Medical Centre
Calgary, Alberta, T2N 2T9
The ward of 21st Century (W21C) Foothills Medical Centre
Calgary, Alberta, T2N 4Z6
About this study
Official title: 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.
Read more
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?
Read the 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.
- Being tested
- electronic discharge communication tool, Usual care
- Keywords
- Continuity of care, Patient safety, Communication between acute and community care providers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic discharge communication toolDevice
Also called seamless discharge
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.
Usual careDevice
Also called dictation discharge
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group, usual care | Placebo comparator | 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. Receives: Device: Usual care |
| electronic discharge communication tool | Experimental | 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. Receives: Device: electronic discharge communication tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of death or readmission
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
Measured: 3 months
Secondary outcomes (1)
occurrence of post-discharge adverse events and adverse drug events at 1 month post discharge
Measured: 1 month 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 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Other Diagnoses, Comorbidities, and ComplicationsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ward of the 21st Century
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Health services, University of Calgary
- Responsible party
- Principal investigator, William Ghali, Ward of the 21st Century
- Investigators
- William Ghali, MD, Principal investigator, Ward of the 21st Century
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402609
- Sponsor's protocol ID
- SeamDis2010
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2011
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
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.
PubMed 17935242van Walraven C, Seth R, Laupacis A. Dissemination of discharge summaries. Not reaching follow-up physicians. Can Fam Physician. 2002 Apr;48:737-42.
PubMed 12046369Callen 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.
PubMed 18294904van 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.
PubMed 10065073Sevick 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.
PubMed 29247110Okoniewska 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.
PubMed 23170814
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Assessing the Efficacy of an Electronic Discharge Communication Tool for Preventing Death or Hospital Readmission
- ClinicalTrials.gov ID
- NCT01402609
- Acronym / sponsor ID
- SeamDis2010
- Keywords
- Continuity of care, Patient safety, Communication between acute and community care providers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,399 participants (actual)
- Lead sponsor
- Ward of the 21st CenturyUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Health services, University of Calgary
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 26 Jul 2011 (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 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?
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group, usual care | Placebo comparator | Device: Usual careControl 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. |
| electronic discharge communication tool | Experimental | Device: electronic discharge communication toolPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients being discharged from MTU at the Foothill Medical Centre (FMC)
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| electronic discharge communication toolAlso: seamless dischargeThe 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. | Device | electronic discharge communication tool |
| Usual careAlso: dictation dischargeControl 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. | Device | Control group, usual care |
Primary outcome
composite of death or readmission
Time frame: 3 months
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
1 secondary outcome
occurrence of post-discharge adverse events and adverse drug events at 1 month post discharge
Time frame: 1 month post discharge
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 1 Aug 2016.
- Background: PubMed 17935242Kripalani 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.
- Background: PubMed 12046369van Walraven C, Seth R, Laupacis A. Dissemination of discharge summaries. Not reaching follow-up physicians. Can Fam Physician. 2002 Apr;48:737-42.
- Background: PubMed 18294904Callen 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.
- Background: PubMed 10065073van 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.
- Derived from this study: PubMed 29247110Sevick 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.
- Derived from this study: PubMed 23170814Okoniewska 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.
- Research and Innovation centre located within the University of CalgaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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.
William Ghali, MD principal investigator
Ward of the 21st Century
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic discharge communication tool in people with Other Diagnoses, Comorbidities, and Complications, run by Ward of the 21st Century at 2 sites in Canada.
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 1 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 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. 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?
composite of death or readmission (time frame: 3 months). 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 NCT01402609, which also lists 6 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 1 Aug 2016.