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Improving Anticoagulation Control in VISN 1

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ClinicalTrials.gov Identifier: NCT01653405
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Anticoagulants
Atrial Fibrillation
Venous Thromboembolism
Intervention Other: Multifaceted behavioral intervention
Enrollment 1260576
Recruitment Details  
Pre-assignment Details  
Arm/Group Title VISN1 (Intervention Group) Outside VISN1 (Control Group)
Hide Arm/Group Description VA patients receiving care at anticoagulation clinics at 8 sites within VISN 1 VA patients receiving care at anticoagulation clinics at 116 sites outside of VISN 1.
Period Title: Overall Study
Number of participants Number of units (VA sites) Number of participants Number of units (VA sites)
Started 11794 8 1248782 116
Completed 8029 [1] 8 179979 [1] 116
Not Completed 3765 0 1068803 0
[1]
These patients had enough data to calculate TTR.
Arm/Group Title Intervention Group Control Group Total
Hide Arm/Group Description VA patients receiving anticoagulation clinic services at 8 sites in VISN 1. VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1. Total of all reporting groups
Overall Number of Baseline Participants 8029 179979 188008
Hide Baseline Analysis Population Description
Analysis was conducted at the site level and not the patient level.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8029 participants 179979 participants 188008 participants
77.7  (11.0) 75.3  (11.2) 75.4  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8029 participants 179979 participants 188008 participants
Female
181
   2.3%
4340
   2.4%
4521
   2.4%
Male
7848
  97.7%
175639
  97.6%
183487
  97.6%
Average TTR  
Mean (Standard Deviation)
Unit of measure:  Percentage of time in target INR range
Number Analyzed 8029 participants 179979 participants 188008 participants
66.4  (3.4) 65.9  (3.7) 65.9  (3.7)
Percentage of instances where INR<=1.5 was followed by a second INR within 7 days   [1] 
Measure Type: Number
Unit of measure:  Percentage of instances
Number Analyzed 8029 participants 179979 participants 188008 participants
36 28 28
[1]
Measure Description: Participants can contribute more than one instance each.
Percentage of instances where an INR >= 4.0 was followed by a second INR within 7 days   [1] 
Measure Type: Number
Unit of measure:  Percentage of instances
Number Analyzed 8029 participants 179979 participants 188008 participants
50 42 42
[1]
Measure Description: Participants can contribute more than one instance each.
Gaps in monitoring per patient-year   [1] 
Mean (Standard Deviation)
Unit of measure:  Gaps per patient-year
Number Analyzed 8029 participants 179979 participants 188008 participants
0.31  (0.15) 0.37  (0.18) 0.37  (0.18)
[1]
Measure Description: Mean gaps in monitoring per patient year of therapy
Percentage of patients whose mean INR value was between 2.3 and 2.7  
Measure Type: Number
Unit of measure:  Percentage of patients
Number Analyzed 8029 participants 179979 participants 188008 participants
50 47 47
1.Primary Outcome
Title Percent Change in Time in Therapeutic Range (TTR)
Hide Description We compared TTR after the intervention to before the intervention. We used a difference in differences analysis to compare the absolute percentage change over time in the intervention group vs. the control group.
Time Frame Baseline and 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients receiving care at specified sites. Patient-level analyses were aggregated to the site level.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
VA patients receiving anticoagulation clinic services at 8 sites within VISN 1. We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges.
VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.
Overall Number of Participants Analyzed 8029 179979
Measure Type: Number
Unit of Measure: percent change
2.8 0.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Difference in differences
Comments [Not Specified]
2.Secondary Outcome
Title Change in Gaps in Monitoring Per Patient-year Among Patients Receiving Anticoagulation With Warfarin
Hide Description We compared the rate of 56-day gaps per patient year in the pre-intervention and post-intervention period. We used a difference in differences analysis to compare the intervention and control group. We are reporting absolute change.
Time Frame Baseline and 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
VA patients receiving anticoagulation clinic services at 8 sites within VISN 1. We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges.
VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.
Overall Number of Participants Analyzed 8029 179979
Mean (Standard Deviation)
Unit of Measure: gaps per patient year
-0.03  (0.10) -0.01  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method test of differences
Comments [Not Specified]
3.Secondary Outcome
Title Change in Percentage of Patients With Follow-up Within 7 Days After a High INR Value (>4.0)
Hide Description We compared the percentage of patients with follow-up within 7 days before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups.
Time Frame Baseline and 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
VA patients receiving anticoagulation clinic services at 8 sites within VISN 1. We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges.
VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.
Overall Number of Participants Analyzed 8029 179979
Measure Type: Number
Unit of Measure: percentage change
15 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method difference in differences
Comments [Not Specified]
4.Secondary Outcome
Title Change in Percentage of Patients With Follow-up Within 7 Days After a Low INR Value (1.5 or Lower)
Hide Description We compared the percentage of patients before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups. Absolute percentage is reported.
Time Frame Baseline and 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
VA patients receiving anticoagulation clinic services at 8 sites within VISN 1. We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges.
VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.
Overall Number of Participants Analyzed 8029 179979
Measure Type: Number
Unit of Measure: percentage change
15 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Difference in differences
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Patients With Mean INR Value Between 2.3 - 2.7
Hide Description We compared the absolute percentage of patients with a mean INR of 2.3 - 2.7 before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups.
Time Frame Baseline and 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
VA patients receiving anticoagulation clinic services at 8 sites within VISN 1. We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges.
VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.
Overall Number of Participants Analyzed 8029 179979
Measure Type: Number
Unit of Measure: percentage change
6 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method difference in differences
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not monitored or assessed.
 
Arm/Group Title VISN1 (Intervention Group) Outside VISN1 (Control Group)
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
VISN1 (Intervention Group) Outside VISN1 (Control Group)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
VISN1 (Intervention Group) Outside VISN1 (Control Group)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VISN1 (Intervention Group) Outside VISN1 (Control Group)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Adam Rose
Organization: Rand Corporation
Phone: 617-338-2059 ext 8672
EMail: arose@rand.org
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01653405     History of Changes
Other Study ID Numbers: SDP 12-249
First Submitted: July 6, 2012
First Posted: July 31, 2012
Results First Submitted: September 26, 2017
Results First Posted: April 15, 2019
Last Update Posted: April 15, 2019