Trial Outcomes & Findings for Value of Technology to Transfer Discharge Information (NCT NCT00101868)
NCT ID: NCT00101868
Last Updated: 2012-05-15
Results Overview
Number of participants with at least one readmission within 6 months after discharge from index hospital visit
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
631 participants
Primary outcome timeframe
within 6 months after discharge
Results posted on
2012-05-15
Participant Flow
127 hospital physicians assessed for eligibility: 49 excluded for insufficient assignment time on inpatient service, 6 declined informed consent, 2 for other reasons. 6884 inpatients screened between November 2004 and January 2007. 6253 patients were not eligible by protocol exclusion criteria.
Participant milestones
| Measure |
Discharge Communication Software
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
|
Usual Care Discharge Process
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
|
|---|---|---|
|
Overall Study
STARTED
|
316
|
315
|
|
Overall Study
COMPLETED
|
287
|
283
|
|
Overall Study
NOT COMPLETED
|
29
|
32
|
Reasons for withdrawal
| Measure |
Discharge Communication Software
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
|
Usual Care Discharge Process
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
|
|---|---|---|
|
Overall Study
Death
|
10
|
10
|
|
Overall Study
Withdrawal by Subject
|
8
|
9
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
8
|
13
|
Baseline Characteristics
Value of Technology to Transfer Discharge Information
Baseline characteristics by cohort
| Measure |
Discharge Communication Software
n=316 Participants
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
|
Usual Care Discharge Process
n=315 Participants
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
|
Total
n=631 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
233 Participants
n=99 Participants
|
245 Participants
n=107 Participants
|
478 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
83 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=99 Participants
|
168 Participants
n=107 Participants
|
348 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=99 Participants
|
147 Participants
n=107 Participants
|
283 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
316 participants
n=99 Participants
|
315 participants
n=107 Participants
|
631 participants
n=206 Participants
|
|
Hospital admissions during year prior to index admission
zero or one admission
|
247 participants
0.072 • n=99 Participants
|
224 participants
0.076 • n=107 Participants
|
471 participants
n=206 Participants
|
|
Hospital admissions during year prior to index admission
2 or more admissions
|
69 participants
n=99 Participants
|
91 participants
n=107 Participants
|
160 participants
n=206 Participants
|
|
Emergency department visits during 6 months before index admission
zero or one
|
194 participants
n=99 Participants
|
168 participants
n=107 Participants
|
362 participants
n=206 Participants
|
|
Emergency department visits during 6 months before index admission
2 or more
|
122 participants
n=99 Participants
|
147 participants
n=107 Participants
|
269 participants
n=206 Participants
|
|
Heart failure
present
|
80 participants
n=99 Participants
|
67 participants
n=107 Participants
|
147 participants
n=206 Participants
|
|
Heart failure
absent
|
236 participants
n=99 Participants
|
248 participants
n=107 Participants
|
484 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: within 6 months after dischargePopulation: Analysis was intention to treat. All 631 patient participants assigned to interventions were analyzed
Number of participants with at least one readmission within 6 months after discharge from index hospital visit
Outcome measures
| Measure |
Discharge Software
n=316 Participants
Software is computerized-physician-order-entry application for communication at time of hospital discharge to patients, retail pharmacists, and community physicians. Software features included required fields, pick lists, standard drug doses, alerts, reminders, and online reference information. Software prompted discharging physician to enter pending tests and order tests after discharge. Hospital physicians used software on day of discharge and automatically generated 4 discharge documents: personalized letter to outpatient physician with discharge diagnoses, reconciled medication list, diet-activity instructions, patient education materials provided, and follow-up appointments-studies; printed legible prescriptions with information for dispensing pharmacist about changes-deletions in patient's previous regimen; patient instructions with addresses and telephone numbers for follow-up appointments and tests; and printed legible discharge order with aforementioned information.
|
Usual Care Discharge, Handwritten
n=315 Participants
The control intervention was the usual care discharge process. 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, 1 page of which also included medication instructions and prescriptions.
|
|---|---|---|
|
Hospital Readmission, at Least One
at least one readmission
|
117 participants
|
119 participants
|
|
Hospital Readmission, at Least One
no readmission
|
199 participants
|
196 participants
|
SECONDARY outcome
Timeframe: 1 week after dischargeOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week after dischargeOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 day after dischargeOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 day after dischargeOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month after dischargePopulation: intention to treat
Number of participants with at least one adverse event within one month after discharge
Outcome measures
| Measure |
Discharge Software
n=316 Participants
Software is computerized-physician-order-entry application for communication at time of hospital discharge to patients, retail pharmacists, and community physicians. Software features included required fields, pick lists, standard drug doses, alerts, reminders, and online reference information. Software prompted discharging physician to enter pending tests and order tests after discharge. Hospital physicians used software on day of discharge and automatically generated 4 discharge documents: personalized letter to outpatient physician with discharge diagnoses, reconciled medication list, diet-activity instructions, patient education materials provided, and follow-up appointments-studies; printed legible prescriptions with information for dispensing pharmacist about changes-deletions in patient's previous regimen; patient instructions with addresses and telephone numbers for follow-up appointments and tests; and printed legible discharge order with aforementioned information.
|
Usual Care Discharge, Handwritten
n=315 Participants
The control intervention was the usual care discharge process. 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, 1 page of which also included medication instructions and prescriptions.
|
|---|---|---|
|
At Least One Adverse Event Within One Month After Discharge
at least one adverse event
|
23 participants
|
23 participants
|
|
At Least One Adverse Event Within One Month After Discharge
No adverse events
|
293 participants
|
292 participants
|
SECONDARY outcome
Timeframe: 1 week after dischargeOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 days after dischargeOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 days after dischargeOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months after using discharge processOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within 6 months after dischargeOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within 6 months after dischargePopulation: intention to treat
Number of participants with at least one emergency department visit within six months after discharge
Outcome measures
| Measure |
Discharge Software
n=316 Participants
Software is computerized-physician-order-entry application for communication at time of hospital discharge to patients, retail pharmacists, and community physicians. Software features included required fields, pick lists, standard drug doses, alerts, reminders, and online reference information. Software prompted discharging physician to enter pending tests and order tests after discharge. Hospital physicians used software on day of discharge and automatically generated 4 discharge documents: personalized letter to outpatient physician with discharge diagnoses, reconciled medication list, diet-activity instructions, patient education materials provided, and follow-up appointments-studies; printed legible prescriptions with information for dispensing pharmacist about changes-deletions in patient's previous regimen; patient instructions with addresses and telephone numbers for follow-up appointments and tests; and printed legible discharge order with aforementioned information.
|
Usual Care Discharge, Handwritten
n=315 Participants
The control intervention was the usual care discharge process. 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, 1 page of which also included medication instructions and prescriptions.
|
|---|---|---|
|
Number of Emergency Department Visits
At least one visit
|
112 participants
|
128 participants
|
|
Number of Emergency Department Visits
No visits
|
204 participants
|
187 participants
|
SECONDARY outcome
Timeframe: averaged over 2 years of patient enrollmentOutcome measures
Outcome data not reported
Adverse Events
Discharge Communication Software
Serious events: 10 serious events
Other events: 17 other events
Deaths: 0 deaths
Usual Care Discharge Process
Serious events: 10 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Discharge Communication Software
n=316 participants at risk
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
|
Usual Care Discharge Process
n=315 participants at risk
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
|
|---|---|---|
|
General disorders
Death
|
3.2%
10/316 • Number of events 10 • 6 months
|
3.2%
10/315 • Number of events 10 • 6 months
|
Other adverse events
| Measure |
Discharge Communication Software
n=316 participants at risk
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
|
Usual Care Discharge Process
n=315 participants at risk
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
|
|---|---|---|
|
General disorders
adverse drug event
|
5.4%
17/316 • Number of events 17 • 6 months
|
5.4%
17/315 • Number of events 17 • 6 months
|
Additional Information
James F. Graumlich, MD, Professor of Medicine
University of Illinois
Phone: 309-655-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place