NCT00101868

Brief Summary

The transition from hospital to home is a high-risk period in a patient's illness. Poor communication between healthcare providers at hospital discharge is common and contributes to adverse events affecting patients after discharge. The importance of good communication at discharge will increase as more primary care providers delegate inpatient care to hospitalists. Any process that improves information transfer among providers at discharge might improve the health and safety of patients discharged from U.S. hospitals each year, and to appreciably reduce unnecessary healthcare expenditures. Information transfer among healthcare providers and their patients can be undermined because of inaccuracies, omissions, illegibility, logistical failure (e.g., information is never delivered), and delays in generation (i.e., dictation or transcription) or transmission. Root causes include recall error, increased physician workloads, interface failures (e.g., physician-clerical) and poor training of physicians in the discharge process. Many of the deficiencies in the current process of information transfer at hospital discharge could be effectively addressed by the application of information technology. The proposed study will measure the value of a software application to facilitate information transfer at hospital discharge. The study is designed to compare the benefits of discharge health information technology versus usual care in high-risk patients recently discharged from acute care hospitalization. The design is a randomized, single-blind, controlled trial. The outcomes are readmission within 6 months, adverse events, and effectiveness and satisfaction with the discharge process from the patient and physician perspectives. The cost outcome is the physician time required to use the discharge software.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
631

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

May 15, 2012

Completed
Last Updated

May 15, 2012

Status Verified

April 1, 2012

Enrollment Period

2.7 years

First QC Date

January 14, 2005

Results QC Date

March 18, 2012

Last Update Submit

April 16, 2012

Conditions

Keywords

AgedHospitalistsOutcome and process assessment (health care)HumanHospitals, teachingPhysicians, familyMedical recordsQuality assurance, health careMedical errors

Outcome Measures

Primary Outcomes (1)

  • Hospital Readmission, at Least One

    Number of participants with at least one readmission within 6 months after discharge from index hospital visit

    within 6 months after discharge

Secondary Outcomes (12)

  • Patients' Perception of Discharge Process, Effectiveness, Satisfaction, Preparedness

    1 week after discharge

  • Patients' Perception of Discharge Process, Satisfaction

    1 week after discharge

  • Pharmacist Needed to Clarify the Discharge Prescription

    1 day after discharge

  • Pharmacist's Satisfaction With Discharge Prescription

    1 day after discharge

  • At Least One Adverse Event Within One Month After Discharge

    1 month after discharge

  • +7 more secondary outcomes

Study Arms (2)

Discharge communication software

EXPERIMENTAL

Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order

Device: Discharge communication software

Usual care discharge process

ACTIVE COMPARATOR

Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions

Other: Usual care discharge process

Interventions

Computerized physician order entry software used by discharging physician

Also known as: Discharge assistant, Hospital Information Systems, Medical Records Systems-Computerized, Electronic Discharge Summary, Medication Reconciliation
Discharge communication software

Handwritten

Also known as: Usual care, handwritten
Usual care discharge process

Eligibility Criteria

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

You may qualify if:

  • Inpatients at OSF Saint Francis Medical Center
  • Discharged by the hospitalist service or other inpatient services
  • High risk for poor post-discharge outcomes defined as probability of readmission (PRA) 0.4 or above

You may not qualify if:

  • Less than 18 years old
  • Unwilling or unable to provide written consent
  • Life expectancy less than 6 months
  • Will receive outpatient care from a primary care physician who is the same as the discharging physician
  • Do not speak English or Spanish
  • Not alert and oriented when admitted
  • Do not have telephone for post-discharge contact
  • Do not reside in Central Illinois
  • Will be discharged to a nursing home
  • Previously enrolled as subjects in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

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MeSH Terms

Interventions

Medical Records Systems, ComputerizedMedication Reconciliation

Intervention Hierarchy (Ancestors)

Medical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthMedication ErrorsDrug TherapyTherapeuticsMedical ErrorsHealth ServicesHealth Care Facilities Workforce and ServicesMedication SystemsPatient Care Management

Limitations and Caveats

Required medication reconciliation in both groups might have reduced the adverse event rates in both groups.

Results Point of Contact

Title
James F. Graumlich, MD, Professor of Medicine
Organization
University of Illinois

Study Officials

  • James F Graumlich, MD

    University of Illinois College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

January 14, 2005

First Posted

January 17, 2005

Study Start

December 1, 2004

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

May 15, 2012

Results First Posted

May 15, 2012

Record last verified: 2012-04

Locations