NCT01402609

Brief 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. 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:

  1. 1.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?
  2. 2.Does the seamless discharge communication tool transfer appropriate, complete, and accurate discharge information in a timely manner compared to traditional discharge communication?
  3. 3.Is the seamless discharge communication tool efficacious with respect to improving physician and patient satisfaction?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,399

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

2.3 years

First QC Date

July 25, 2011

Last Update Submit

July 28, 2016

Conditions

Keywords

Continuity of carePatient safetyCommunication between acute and community care providers

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (1)

  • occurrence of post-discharge adverse events and adverse drug events at 1 month post discharge

    1 month post discharge

Study Arms (2)

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.

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.

Device: electronic discharge communication tool

Interventions

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.

Also known as: seamless discharge
electronic discharge communication tool

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.

Also known as: dictation discharge
Control group, usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients being discharged from MTU at the Foothill Medical Centre (FMC)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Teaching Unit, Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

The ward of 21st Century (W21C) Foothills Medical Centre

Calgary, Alberta, T2N 4Z6, Canada

Location

Related Publications (6)

  • 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.

    PMID: 17935242BACKGROUND
  • van Walraven C, Seth R, Laupacis A. Dissemination of discharge summaries. Not reaching follow-up physicians. Can Fam Physician. 2002 Apr;48:737-42.

    PMID: 12046369BACKGROUND
  • 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.

    PMID: 18294904BACKGROUND
  • 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.

    PMID: 10065073BACKGROUND
  • 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.

Related Links

Study Officials

  • William Ghali, MD

    Ward of the 21st Century

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 26, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2013

Study Completion

April 1, 2016

Last Updated

August 1, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Locations