Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-26 @ 8:37 AM
Study NCT ID:
NCT00101868
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2005-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Value of Technology to Transfer Discharge Information
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016347', 'term': 'Medical Records Systems, Computerized'}, {'id': 'D059065', 'term': 'Medication Reconciliation'}], 'ancestors': [{'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D008508', 'term': 'Medication Errors'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019300', 'term': 'Medical Errors'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D008509', 'term': 'Medication Systems'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jfg@uic.edu', 'phone': '309-655-7734', 'title': 'James F. Graumlich, MD, Professor of Medicine', 'organization': 'University of Illinois'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Required medication reconciliation in both groups might have reduced the adverse event rates in both groups.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Discharge Communication Software', 'description': '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', 'otherNumAtRisk': 316, 'otherNumAffected': 17, 'seriousNumAtRisk': 316, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Usual Care Discharge Process', 'description': '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', 'otherNumAtRisk': 315, 'otherNumAffected': 17, 'seriousNumAtRisk': 315, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'adverse drug event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hospital Readmission, at Least One', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Discharge Software', 'description': "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."}, {'id': 'OG001', 'title': 'Usual Care Discharge, Handwritten', 'description': '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.'}], 'classes': [{'title': 'at least one readmission', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'no readmission', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 6 months after discharge', 'description': 'Number of participants with at least one readmission within 6 months after discharge from index hospital visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat. All 631 patient participants assigned to interventions were analyzed'}, {'type': 'SECONDARY', 'title': "Patients' Perception of Discharge Process, Effectiveness, Satisfaction, Preparedness", 'timeFrame': '1 week after discharge', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': "Patients' Perception of Discharge Process, Satisfaction", 'timeFrame': '1 week after discharge', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacist Needed to Clarify the Discharge Prescription', 'timeFrame': '1 day after discharge', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': "Pharmacist's Satisfaction With Discharge Prescription", 'timeFrame': '1 day after discharge', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'At Least One Adverse Event Within One Month After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Discharge Communication Software', 'description': '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'}, {'id': 'OG001', 'title': 'Usual Care Discharge Process', 'description': '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'}], 'classes': [{'title': 'at least one adverse event', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'No adverse events', 'categories': [{'measurements': [{'value': '293', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after discharge', 'description': 'Number of participants with at least one adverse event within one month after discharge', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': "Patient's Satisfaction With Drug Information", 'timeFrame': '1 week after discharge', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': "Primary Care Physician's Perception, Effectiveness", 'timeFrame': '10 days after discharge', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': "Primary Care Physician's Perception, Satisfaction", 'timeFrame': '10 days after discharge', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Discharge Physician Satisfaction With Discharge Process', 'timeFrame': '6 months after using discharge process', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Outpatient Visits', 'timeFrame': 'within 6 months after discharge', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Emergency Department Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Discharge Communication Software', 'description': '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'}, {'id': 'OG001', 'title': 'Usual Care Discharge Process', 'description': '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'}], 'classes': [{'title': 'At least one visit', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}, {'title': 'No visits', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 6 months after discharge', 'description': 'Number of participants with at least one emergency department visit within six months after discharge', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Physician Time Spent to Complete the Discharge Application', 'timeFrame': 'averaged over 2 years of patient enrollment', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Discharge Communication Software', 'description': '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'}, {'id': 'FG001', 'title': 'Usual Care Discharge Process', 'description': '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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '35 hospital physicians allocated to discharge software', 'groupId': 'FG000', 'numSubjects': '316'}, {'comment': '35 hospital physicians allocated to usual care discharge', 'groupId': 'FG001', 'numSubjects': '315'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '1 hospital physician with zero patients lost to follow up', 'groupId': 'FG000', 'numSubjects': '287'}, {'comment': 'zero hospital physician with zero patients lost to follow up', 'groupId': 'FG001', 'numSubjects': '283'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '631', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Discharge Communication Software', 'description': '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'}, {'id': 'BG001', 'title': 'Usual Care Discharge Process', 'description': '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'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '478', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '316', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '631', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hospital admissions during year prior to index admission', 'classes': [{'title': 'zero or one admission', 'categories': [{'measurements': [{'value': '247', 'spread': '0.072', 'groupId': 'BG000'}, {'value': '224', 'spread': '0.076', 'groupId': 'BG001'}, {'value': '471', 'groupId': 'BG002'}]}]}, {'title': '2 or more admissions', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Emergency department visits during 6 months before index admission', 'classes': [{'title': 'zero or one', 'categories': [{'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}]}, {'title': '2 or more', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Heart failure', 'classes': [{'title': 'present', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}, {'title': 'absent', 'categories': [{'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'History of heart failure from patient interview or hospital record', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 631}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-16', 'studyFirstSubmitDate': '2005-01-14', 'resultsFirstSubmitDate': '2012-03-18', 'studyFirstSubmitQcDate': '2005-01-14', 'lastUpdatePostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-16', 'studyFirstPostDateStruct': {'date': '2005-01-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Readmission, at Least One', 'timeFrame': 'within 6 months after discharge', 'description': 'Number of participants with at least one readmission within 6 months after discharge from index hospital visit'}], 'secondaryOutcomes': [{'measure': "Patients' Perception of Discharge Process, Effectiveness, Satisfaction, Preparedness", 'timeFrame': '1 week after discharge'}, {'measure': "Patients' Perception of Discharge Process, Satisfaction", 'timeFrame': '1 week after discharge'}, {'measure': 'Pharmacist Needed to Clarify the Discharge Prescription', 'timeFrame': '1 day after discharge'}, {'measure': "Pharmacist's Satisfaction With Discharge Prescription", 'timeFrame': '1 day after discharge'}, {'measure': 'At Least One Adverse Event Within One Month After Discharge', 'timeFrame': '1 month after discharge', 'description': 'Number of participants with at least one adverse event within one month after discharge'}, {'measure': "Patient's Satisfaction With Drug Information", 'timeFrame': '1 week after discharge'}, {'measure': "Primary Care Physician's Perception, Effectiveness", 'timeFrame': '10 days after discharge'}, {'measure': "Primary Care Physician's Perception, Satisfaction", 'timeFrame': '10 days after discharge'}, {'measure': 'Discharge Physician Satisfaction With Discharge Process', 'timeFrame': '6 months after using discharge process'}, {'measure': 'Number of Outpatient Visits', 'timeFrame': 'within 6 months after discharge'}, {'measure': 'Number of Emergency Department Visits', 'timeFrame': 'within 6 months after discharge', 'description': 'Number of participants with at least one emergency department visit within six months after discharge'}, {'measure': 'Physician Time Spent to Complete the Discharge Application', 'timeFrame': 'averaged over 2 years of patient enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aged', 'Hospitalists', 'Outcome and process assessment (health care)', 'Human', 'Hospitals, teaching', 'Physicians, family', 'Medical records', 'Quality assurance, health care', 'Medical errors'], 'conditions': ['Information Dissemination', 'Interprofessional Relations']}, 'referencesModule': {'references': [{'pmid': '10797163', 'type': 'BACKGROUND', 'citation': 'Andersen HE, Schultz-Larsen K, Kreiner S, Forchhammer BH, Eriksen K, Brown A. Can readmission after stroke be prevented? Results of a randomized clinical study: a postdischarge follow-up service for stroke survivors. Stroke. 2000 May;31(5):1038-45. doi: 10.1161/01.str.31.5.1038.'}, {'pmid': '6436703', 'type': 'BACKGROUND', 'citation': 'Anderson GF, Steinberg EP. Hospital readmissions in the Medicare population. N Engl J Med. 1984 Nov 22;311(21):1349-53. doi: 10.1056/NEJM198411223112105.'}, {'pmid': '14973952', 'type': 'BACKGROUND', 'citation': 'Shepperd S, Parkes J, McClaren J, Phillips C. Discharge planning from hospital to home. Cochrane Database Syst Rev. 2004;(1):CD000313. doi: 10.1002/14651858.CD000313.pub2.'}, {'pmid': '10119187', 'type': 'BACKGROUND', 'citation': 'Beers MH, Sliwkowski J, Brooks J. Compliance with medication orders among the elderly after hospital discharge. Hosp Formul. 1992 Jul;27(7):720-4.'}, {'pmid': '4331354', 'type': 'BACKGROUND', 'citation': 'Brook RH, Appel FA, Avery C, Orman M, Stevenson RL. Effectiveness of inpatient follow-up care. N Engl J Med. 1971 Dec 30;285(27):1509-14. doi: 10.1056/NEJM197112302852705. No abstract available.'}, {'pmid': '2254764', 'type': 'BACKGROUND', 'citation': 'Burnand B, Kernan WN, Feinstein AR. Indexes and boundaries for "quantitative significance" in statistical decisions. J Clin Epidemiol. 1990;43(12):1273-84. doi: 10.1016/0895-4356(90)90093-5.'}, {'pmid': '3558716', 'type': 'BACKGROUND', 'citation': 'Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.'}, {'pmid': '1563955', 'type': 'BACKGROUND', 'citation': 'Corrigan JM, Martin JB. Identification of factors associated with hospital readmission and development of a predictive model. Health Serv Res. 1992 Apr;27(1):81-101.'}, {'pmid': '1607900', 'type': 'BACKGROUND', 'citation': 'Deyo RA, Cherkin DC, Ciol MA. 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Written and verbal information versus verbal information only for patients being discharged from acute hospital settings to home. Cochrane Database Syst Rev. 2003;2003(4):CD003716. doi: 10.1002/14651858.CD003716.'}, {'pmid': '11180308', 'type': 'BACKGROUND', 'citation': 'Kerry SM, Bland JM. Unequal cluster sizes for trials in English and Welsh general practice: implications for sample size calculations. Stat Med. 2001 Feb 15;20(3):377-90. doi: 10.1002/1097-0258(20010215)20:33.0.co;2-n.'}, {'pmid': '10600061', 'type': 'BACKGROUND', 'citation': 'Kiefe CI, Heudebert G, Box JB, Farmer RM, Michael M, Clancy CM. Compliance with post-hospitalization follow-up visits: rationing by inconvenience? Ethn Dis. 1999 Autumn;9(3):387-95.'}, {'pmid': '7890481', 'type': 'BACKGROUND', 'citation': 'Manos PJ, Wu R. The ten point clock test: a quick screen and grading method for cognitive impairment in medical and surgical patients. 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Ann Pharmacother. 2001 Jul-Aug;35(7-8):953-8. doi: 10.1345/aph.10244.'}, {'pmid': '15026403', 'type': 'BACKGROUND', 'citation': 'Phillips CO, Wright SM, Kern DE, Singa RM, Shepperd S, Rubin HR. Comprehensive discharge planning with postdischarge support for older patients with congestive heart failure: a meta-analysis. JAMA. 2004 Mar 17;291(11):1358-67. doi: 10.1001/jama.291.11.1358.'}, {'pmid': '12218769', 'type': 'BACKGROUND', 'citation': 'Reuben DB, Keeler E, Seeman TE, Sewall A, Hirsch SH, Guralnik JM. Development of a method to identify seniors at high risk for high hospital utilization. Med Care. 2002 Sep;40(9):782-93. doi: 10.1097/00005650-200209000-00008.'}, {'pmid': '10737448', 'type': 'BACKGROUND', 'citation': 'Romano PS, Chan BK. Risk-adjusting acute myocardial infarction mortality: are APR-DRGs the right tool? Health Serv Res. 2000 Mar;34(7):1469-89.'}, {'pmid': '7950043', 'type': 'BACKGROUND', 'citation': 'Sands DZ, Safran C. Closing the loop of patient care--a clinical trial of a computerized discharge medication program. Proc Annu Symp Comput Appl Med Care. 1994:841-5.'}, {'pmid': '11123491', 'type': 'BACKGROUND', 'citation': 'Sexton J, Ho YJ, Green CF, Caldwell NA. Ensuring seamless care at hospital discharge: a national survey. J Clin Pharm Ther. 2000 Oct;25(5):385-93. doi: 10.1046/j.1365-2710.2000.00305.x.'}, {'pmid': '11186504', 'type': 'BACKGROUND', 'citation': 'Shelton P, Sager MA, Schraeder C. The community assessment risk screen (CARS): identifying elderly persons at risk for hospitalization or emergency department visit. Am J Manag Care. 2000 Aug;6(8):925-33.'}, {'pmid': '11106884', 'type': 'BACKGROUND', 'citation': 'Smith DM, Giobbie-Hurder A, Weinberger M, Oddone EZ, Henderson WG, Asch DA, Ashton CM, Feussner JR, Ginier P, Huey JM, Hynes DM, Loo L, Mengel CE. Predicting non-elective hospital readmissions: a multi-site study. Department of Veterans Affairs Cooperative Study Group on Primary Care and Readmissions. J Clin Epidemiol. 2000 Nov;53(11):1113-8. doi: 10.1016/s0895-4356(00)00236-5.'}, {'pmid': '10065073', 'type': 'BACKGROUND', 'citation': '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': '11929504', 'type': 'BACKGROUND', 'citation': 'van Walraven C, Seth R, Austin PC, Laupacis A. Effect of discharge summary availability during post-discharge visits on hospital readmission. J Gen Intern Med. 2002 Mar;17(3):186-92. doi: 10.1046/j.1525-1497.2002.10741.x.'}, {'pmid': '12046369', 'type': 'BACKGROUND', 'citation': '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': '8618584', 'type': 'BACKGROUND', 'citation': 'Weinberger M, Oddone EZ, Henderson WG. Does increased access to primary care reduce hospital readmissions? Veterans Affairs Cooperative Study Group on Primary Care and Hospital Readmission. N Engl J Med. 1996 May 30;334(22):1441-7. doi: 10.1056/NEJM199605303342206.'}, {'pmid': '17059700', 'type': 'RESULT', 'citation': 'Nace GS, Graumlich JF, Aldag JC. Software design to facilitate information transfer at hospital discharge. Inform Prim Care. 2006;14(2):109-19. doi: 10.14236/jhi.v14i2.621.'}, {'pmid': '19084894', 'type': 'RESULT', 'citation': 'Graumlich JF, Novotny NL, Aldag JC. Brief scale measuring patient preparedness for hospital discharge to home: Psychometric properties. J Hosp Med. 2008 Nov-Dec;3(6):446-54. doi: 10.1002/jhm.316.'}, {'pmid': '19084895', 'type': 'RESULT', 'citation': "Graumlich JF, Grimmer-Somers K, Aldag JC. Discharge planning scale: community physicians' perspective. J Hosp Med. 2008 Nov-Dec;3(6):455-64. doi: 10.1002/jhm.371."}, {'pmid': '19479782', 'type': 'RESULT', 'citation': 'Graumlich JF, Novotny NL, Stephen Nace G, Kaushal H, Ibrahim-Ali W, Theivanayagam S, William Scheibel L, Aldag JC. Patient readmissions, emergency visits, and adverse events after software-assisted discharge from hospital: cluster randomized trial. J Hosp Med. 2009 Sep;4(7):E11-9. doi: 10.1002/jhm.469.'}, {'pmid': '19621342', 'type': 'RESULT', 'citation': 'Graumlich JF, Novotny NL, Nace GS, Aldag JC. Patient and physician perceptions after software-assisted hospital discharge: cluster randomized trial. J Hosp Med. 2009 Jul;4(6):356-63. doi: 10.1002/jhm.565.'}, {'pmid': '19018215', 'type': 'RESULT', 'citation': 'Novotny NL, Anderson MA. Prediction of early readmission in medical inpatients using the Probability of Repeated Admission instrument. Nurs Res. 2008 Nov-Dec;57(6):406-15. doi: 10.1097/NNR.0b013e31818c3e06.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "Objectives: 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.\n\nSTUDY HYPOTHESES:\n\nThe primary efficacy endpoint is the proportion of patients readmitted at least once within 6 months after the index admission. Readmission is for any reason and includes observation status and full admission status.\n\nPrimary hypothesis: Among high-risk patients recently discharged from acute care hospitalization, there is a significant decrease in the primary efficacy endpoint for patients who receive discharge health information technology versus usual care discharge instructions.\n\nSecondary hypothesis 1A: In the same patient population, the time to first readmission is greater for patients who receive discharge health information technology versus usual care discharge instructions.\n\nSecondary hypothesis 1B: In the same patient population, the mean number of hospital days per patient within 6 months after index hospital discharge is lower for patients who receive discharge health information technology versus usual care discharge instructions.\n\nSecondary hypothesis 2: In the same patient population, the mean score for effectiveness and satisfaction with discharge process is greater for patients who receive discharge health information technology versus usual care discharge instructions.\n\nSecondary hypothesis 3: In the same patient population, the proportion of patients who report their pharmacist needed to clarify the discharge prescription is lower for patients who receive discharge health information technology versus usual care discharge instructions.\n\nSecondary hypothesis 4: In the same patient population, the proportion of patients with at least one adverse event within 4 weeks after hospital discharge is lower for patients who receive discharge health information technology versus usual care discharge instructions.\n\nSecondary hypothesis 5: In the same population, the mean satisfaction score with drug information will be higher for patients who receive discharge health information technology versus usual care discharge instructions.\n\nSecondary hypothesis 6: Among primary care physicians who provide post-discharge care to high-risk patients, the mean score for discharge process effectiveness and satisfaction will be greater for patients who receive discharge health information technology versus usual care discharge instructions.\n\nSecondary hypothesis 7: Among hospitalist physicians who discharge high-risk patients, the mean score for physicians' satisfaction with the discharge process will be greater for physicians assigned to discharge health information technology versus usual care discharge instructions.\n\nMETHODS: The trial design is a randomized cluster, single-blind (outcome assessors blind), controlled trial. The study design conforms to recent guidelines for randomized controlled trials. The test intervention is discharge application of health information technology. The control intervention is usual care (hand-written discharge instructions) described below. Each patient will remain in the study for 6 months. Enrollment in the study will last approximately 18 months. There will be no interim analysis.\n\nResearch personnel will obtain informed consent from potentially eligible inpatients. Informed consent from patients will occur during the screening visit.\n\nScreening visit: Investigators will train research personnel to perform screening and informed consent. The screening visit may occur within 2 days of the planned discharge. After obtaining informed consent, research personnel will record items in the baseline assessment. Research personnel will ask patients about self-rated health, coronary artery disease (including angina pectoris myocardial infarction), diabetes mellitus in past year, hospitalization in past year, number of doctor visits in past year, presence of an informal caregiver able to care for the patient for several days, age, and gender. The screening questionnaire was validated. Research personnel will calculate a PRA score during the screening visit. PRA scores 0.5 and above define high-risk patients who have a 50% probability of being admitted to a hospital two or more times within 4 years. When the PRA score is applied to Medicaid beneficiaries followed for one year, 57% of patients with PRA 0.5 and above will have at least one hospital admission or 0.99 +/- 0.24 hospital admissions per person-year survived (mean +/- SE). Research personnel will offer informed consent to patients with PRA score 0.4 and above.\n\nResearch personnel will record limited information for patients who are ineligible or who refuse consent.\n\nBaseline Assessment: The baseline assessment will occur after informed consent and before discharge. The ten-point clock test will be used as the screening instrument for orientation. Research personnel will record patient's name, address, age, stated race, gender, and discharge medication prescription. Research personnel will record patient contact information and alternate contact information in order to perform post-hospital telephone interviews required by the protocol.\n\nIntervention allocation: The time of random treatment allocation will be after the baseline assessment and before discharge. Patients will not receive study treatment if they fail to consent or if they fail the inclusion/exclusion criteria. Treatment assignment will be in a 1:1 ratio to either discharge application of health information technology or usual care discharge instructions. The unit of randomization will be the hospitalist physician who performs the discharge process. The randomization process is designed to assure random allocation by cluster with the cluster determined by the discharging physician. Allocation concealment is not possible since all the enrolled patients who are discharged by the hospitalist physician will receive the same study intervention.\n\nDispense patient logbook: The purpose of the patient logbook is to promote ascertainment of study endpoints.\n\nPatient telephone interview: discharge process effectiveness and satisfaction The purpose of the first telephone interview is to acquire data to measure secondary endpoints 2, 3, and 5. One week (5 to 9 days) after the hospital discharge date, research personnel will perform a telephone interview with the patient. Interviewers will instruct the patient to avoid mentioning the random intervention assignment. To address secondary hypothesis 2, interview questions will follow the PREPARED text. The PREPARED instrument surveys four key process domains: information exchange (community services and equipment), medication management, preparation for coping after discharge and control of discharge circumstances. The questions in PREPARED measure the patient's overall satisfaction with discharge, whether equipment and community service needs were met, and use of health services and health related costs post-discharge. The telephone interviewers will ask patients if their pharmacist had to call the doctor when attempting to fill the discharge prescriptions. The purpose of the question about pharmacists is to address secondary hypothesis 3. The telephone interviewers will ask questions from the Satisfaction with Information about Medicines Scale (SIMS). The SIMS is a 17-item survey with internal consistency and test-retest reliability. The SIMS survey instrument addresses secondary hypothesis 5.\n\nPrimary care physician questionnaire: discharge process effectiveness and satisfaction. The primary care physician questionnaire addresses secondary hypothesis 6. Within 10 to 18 days after the hospital discharge date, research personnel will contact the primary care physician to perform a survey.\n\nPatient interview: adverse event assessment. The purpose of the second patient interview is to address secondary hypothesis 4. Approximately 4 weeks (20 to 40 days) after the index hospital discharge date, research physician personnel will perform a telephone interview with the patient. Physicians trained to assess adverse events will perform the telephone interview. Interviewers will instruct the patient to avoid mentioning the random intervention assignment. The interview tool is a modification of a validated survey instrument.\n\nHospitalist (discharging) physician questionnaire: The purpose of the survey is to address secondary hypothesis 7.\n\nPatient interview: readmission assessment. The purpose of the third patient interview is to ascertain the primary endpoint, secondary endpoints (1A, 1B), and tertiary endpoints. Approximately 6 months (170 to 190 days) after the hospital discharge date, research personnel who are blinded to intervention assignment will perform a telephone interview with the patient. Interviewers will instruct the patient to avoid mentioning the random intervention assignment. Interviewers will ask the patient to consult their patient logbook while answering questions. Interviewers will record the admissions to the hospital, dates of admission, duration of hospital stay, number of outpatient physician visits, and number of emergency department visits that did not result in hospital admission.\n\nGuess treatment assignment by blinded observers: The purpose of the guess is to measure the effectiveness of the blind.\n\nConditions for Early Withdrawal of Treatment: Patients may terminate study intervention at any time and return to the standard care if they withdraw their consent. If a patient withdraws from the study for any reason, then research personnel will conduct an end-of-study visit.\n\nSample size determination: The primary analysis is the difference in proportion of patients in the two study groups who achieve the primary efficacy endpoint of readmission within 6 months of discharge. The estimated event rate in the standard therapy group is 37%, which is the control group event rate from a systematic review of randomized controlled trials of discharge interventions. The minimum clinically relevant difference, 13%, corresponds to a standardized increment of 28.2% and is the empirical boundary for quantitative significance.\n\nThe required sample size for the primary analysis is 275 patients in the group assigned to discharge application of health information technology and 275 patients in the group assigned to control (usual care) therapy. In a previous study of discharge planning, the investigators enrolled 28% (363/1296) of potentially eligible patients. In the same study, 72% (262/363) of enrolled patients completed the 6-month assessment. Our hospitalist service discharges 297 patients per month. We estimate we will screen 5456 patients within 18.37 months. We estimate 50% of screened patients will be potentially eligible according to the Pra criteria. Among potentially eligible patients, we estimate 28% will consent to study enrollment. Therefore, the number of enrolled patients will be 5456 x 50% x 28% = 764. We estimate 72% (550/764) of enrolled patients will continue in the study until the 6-month assessment.\n\nAfter 3 months of patient enrollment, we found the rate of enrollment was too low to achieve the required sample size. In 2005, we requested and received approval from Agency Healthcare Research Quality and Institutional Review Board to lower patient inclusion criterion, probability or repeat admission (PRA), from 0.50 to 0.40."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients at OSF Saint Francis Medical Center\n* Discharged by the hospitalist service or other inpatient services\n* High risk for poor post-discharge outcomes defined as probability of readmission (PRA) 0.4 or above\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Unwilling or unable to provide written consent\n* Life expectancy less than 6 months\n* Will receive outpatient care from a primary care physician who is the same as the discharging physician\n* Do not speak English or Spanish\n* Not alert and oriented when admitted\n* Do not have telephone for post-discharge contact\n* Do not reside in Central Illinois\n* Will be discharged to a nursing home\n* Previously enrolled as subjects in the trial'}, 'identificationModule': {'nctId': 'NCT00101868', 'briefTitle': 'Value of Technology to Transfer Discharge Information', 'organization': {'class': 'FED', 'fullName': 'Agency for Healthcare Research and Quality (AHRQ)'}, 'officialTitle': 'Value of Technology to Transfer Discharge Information', 'orgStudyIdInfo': {'id': '1R01HS015084-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HS015084-01', 'type': 'AHRQ'}, 'secondaryIdInfos': [{'id': '1R01HS015084-02', 'link': 'https://reporter.nih.gov/quickSearch/1R01HS015084-02', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Discharge communication software', 'description': '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', 'interventionNames': ['Device: Discharge communication software']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care discharge process', 'description': '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', 'interventionNames': ['Other: Usual care discharge process']}], 'interventions': [{'name': 'Discharge communication software', 'type': 'DEVICE', 'otherNames': ['Discharge assistant', 'Hospital Information Systems', 'Medical Records Systems-Computerized', 'Electronic Discharge Summary', 'Medication Reconciliation'], 'description': 'Computerized physician order entry software used by discharging physician', 'armGroupLabels': ['Discharge communication software']}, {'name': 'Usual care discharge process', 'type': 'OTHER', 'otherNames': ['Usual care', 'handwritten'], 'description': 'Handwritten', 'armGroupLabels': ['Usual care discharge process']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF Saint Francis Medical Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}], 'overallOfficials': [{'name': 'James F Graumlich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}, 'collaborators': [{'name': 'University of Illinois at Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'james f. graumlich', 'investigatorAffiliation': 'Agency for Healthcare Research and Quality (AHRQ)'}}}}