Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101868
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2005-01-14
Brief Title:
Value of Technology to Transfer Discharge Information
Sponsor:
Agency for Healthcare Research and Quality AHRQ
Organization:
Agency for Healthcare Research and Quality AHRQ
Study Overview
Official Title:
Value of Technology to Transfer Discharge Information
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The transition from hospital to home is a high-risk period in a patients 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 US 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 eg information is never delivered and delays in generation ie dictation or transcription or transmission Root causes include recall error increased physician workloads interface failures eg 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
Detailed Description:
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
STUDY HYPOTHESES
The 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
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
METHODS 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
Research personnel will obtain informed consent from potentially eligible inpatients Informed consent from patients will occur during the screening visit
Screening 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 05 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 05 and above will have at least one hospital admission or 099 - 024 hospital admissions per person-year survived mean - SE Research personnel will offer informed consent to patients with PRA score 04 and above
Research personnel will record limited information for patients who are ineligible or who refuse consent
Baseline 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 patients 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
Intervention 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 inclusionexclusion criteria Treatment assignment will be in a 11 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
Dispense patient logbook The purpose of the patient logbook is to promote ascertainment of study endpoints
Patient 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 patients 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
Primary 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
Patient 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
Hospitalist discharging physician questionnaire The purpose of the survey is to address secondary hypothesis 7
Patient 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
Guess treatment assignment by blinded observers The purpose of the guess is to measure the effectiveness of the blind
Conditions 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
Sample 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 282 and is the empirical boundary for quantitative significance
The 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 3631296 of potentially eligible patients In the same study 72 262363 of enrolled patients completed the 6-month assessment Our hospitalist service discharges 297 patients per month We estimate we will screen 5456 patients within 1837 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 550764 of enrolled patients will continue in the study until the 6-month assessment
After 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 050 to 040
STUDY HYPOTHESES
The 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
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
METHODS 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
Research personnel will obtain informed consent from potentially eligible inpatients Informed consent from patients will occur during the screening visit
Screening 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 05 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 05 and above will have at least one hospital admission or 099 - 024 hospital admissions per person-year survived mean - SE Research personnel will offer informed consent to patients with PRA score 04 and above
Research personnel will record limited information for patients who are ineligible or who refuse consent
Baseline 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 patients 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
Intervention 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 inclusionexclusion criteria Treatment assignment will be in a 11 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
Dispense patient logbook The purpose of the patient logbook is to promote ascertainment of study endpoints
Patient 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 patients 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
Primary 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
Patient 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
Hospitalist discharging physician questionnaire The purpose of the survey is to address secondary hypothesis 7
Patient 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
Guess treatment assignment by blinded observers The purpose of the guess is to measure the effectiveness of the blind
Conditions 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
Sample 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 282 and is the empirical boundary for quantitative significance
The 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 3631296 of potentially eligible patients In the same study 72 262363 of enrolled patients completed the 6-month assessment Our hospitalist service discharges 297 patients per month We estimate we will screen 5456 patients within 1837 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 550764 of enrolled patients will continue in the study until the 6-month assessment
After 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 050 to 040
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HS015084-02 | AHRQ | None | httpsreporternihgovquickSearch1R01HS015084-02 |