Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462059
Status:
COMPLETED
Last Update Posted:
2007-04-18
First Post:
2007-04-16
Brief Title:
Assessment of a Medication Reconciliation Program on Transitional Care
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Impact of a Medication Reconciliation Program on Patients Transitioning From an Inpatient Hospitalization to Primary Care
Status:
COMPLETED
Status Verified Date:
2007-04
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 purpose of this study is to assess and compare the effectiveness of the Kaiser Permanente Colorados KPCO Call Centers Medication Reconciliation Program and standard care in regards to their impacts on emergency department ED and urgent care visits inpatient rehospitalizations and adherence to preferred formulary medications
Detailed Description:
This study will be a health services evaluation This study will be a pilot study utilizing a randomized controlled trial design This study will utilize secondary data collected from existing KPCO databases to assess outcomes Interventions will occur over a one-month period The study will take approximately twelve months to conduct including the data collection and analysis results interpretation and manuscript and report preparation The duration of intervention group subject participation will be limited to the length of the medication reconciliation counseling phone call and the 3-month follow-up period while the duration of control group subject participation will be limited to the 3-month follow-up period
KPCO internists discharging patients on medications to ambulatory care from either the Good Samaritan or St Joseph hospitals over a four-week period will send discharge orders to the CPCC via Health Connect Project-dedicated CPCC pharmacists will utilize the inclusion and exclusion criteria to determine patient eligibility Project-dedicated CPCC staff will make several attempts at varying times during the 24 hours following reception of the discharge note in Health Connect to conduct the telephonic consent process among eligible patients If a patient can not be contacted after several attempts the staff member will leave a HIPAA-compliant message if possible to request either the patient or hisher caregiver call the CPCC If the subject doesnt not contact the CPCC after being left such a message the staff member will make two attempts the following day to contact the subject andor hisher caregiver Patients consenting to participate will be categorized by hospital and based on category randomly assigned to the intervention or control group Project-dedicated pharmacists will review intervention group subjects discharge medication orders identify discrepancies between their primary care regimen and the hospital discharge orders and collaborate with the patients primary care physician or discharging provider to reconcile any discrepancies Project-dedicated pharmacists will make several telephonic attempts at varying times during the 24 hours post-assignment to contact an intervention group subject andor hisher caregiver to execute the medication review counseling after performing the medication review If the subject can not be contacted after several attempts the pharmacist will leave a HIPAA-compliant message if possible to request either the subject or hisher caregiver call the CPCC If the subject doesnt not contact the CPCC in the day after being left such a message the pharmacist will make two attempts per day for two more days to contact the subject andor hisher caregiver Assignment dates will be used as an index dates from which rolling baseline and follow-up periods will be determined
Data will be analyzed on an intention-to-treat basis Baseline subject characteristics and study outcomes for each of the cohorts will be reported as means medians and standard deviations for interval- and ratio-level variables eg age and proportions for nominal- and ordinal-level data eg gender hospital discharge diagnoses post-discharge ED and urgent care visits IP readmission Interval-and ratio-level variables will be assessed for normality of their distributions Appropriate parametric eg independent samples t-test or non-parametric eg Wilcoxon rank-sum test statistical tests will then be performed to assess differences in mean or median values Ordinal-level and nominal-level will be assessed with the Pearsons chi-square statistical test Logistic regression modeling will be used to assess the relationships between the group and binary data eg ED and urgent care visits receiving a non-preferred formulary agent while adjusting for potential confounders eg age hospital discharge diagnosis gender CDS
KPCO internists discharging patients on medications to ambulatory care from either the Good Samaritan or St Joseph hospitals over a four-week period will send discharge orders to the CPCC via Health Connect Project-dedicated CPCC pharmacists will utilize the inclusion and exclusion criteria to determine patient eligibility Project-dedicated CPCC staff will make several attempts at varying times during the 24 hours following reception of the discharge note in Health Connect to conduct the telephonic consent process among eligible patients If a patient can not be contacted after several attempts the staff member will leave a HIPAA-compliant message if possible to request either the patient or hisher caregiver call the CPCC If the subject doesnt not contact the CPCC after being left such a message the staff member will make two attempts the following day to contact the subject andor hisher caregiver Patients consenting to participate will be categorized by hospital and based on category randomly assigned to the intervention or control group Project-dedicated pharmacists will review intervention group subjects discharge medication orders identify discrepancies between their primary care regimen and the hospital discharge orders and collaborate with the patients primary care physician or discharging provider to reconcile any discrepancies Project-dedicated pharmacists will make several telephonic attempts at varying times during the 24 hours post-assignment to contact an intervention group subject andor hisher caregiver to execute the medication review counseling after performing the medication review If the subject can not be contacted after several attempts the pharmacist will leave a HIPAA-compliant message if possible to request either the subject or hisher caregiver call the CPCC If the subject doesnt not contact the CPCC in the day after being left such a message the pharmacist will make two attempts per day for two more days to contact the subject andor hisher caregiver Assignment dates will be used as an index dates from which rolling baseline and follow-up periods will be determined
Data will be analyzed on an intention-to-treat basis Baseline subject characteristics and study outcomes for each of the cohorts will be reported as means medians and standard deviations for interval- and ratio-level variables eg age and proportions for nominal- and ordinal-level data eg gender hospital discharge diagnoses post-discharge ED and urgent care visits IP readmission Interval-and ratio-level variables will be assessed for normality of their distributions Appropriate parametric eg independent samples t-test or non-parametric eg Wilcoxon rank-sum test statistical tests will then be performed to assess differences in mean or median values Ordinal-level and nominal-level will be assessed with the Pearsons chi-square statistical test Logistic regression modeling will be used to assess the relationships between the group and binary data eg ED and urgent care visits receiving a non-preferred formulary agent while adjusting for potential confounders eg age hospital discharge diagnosis gender CDS
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