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| Name | Class |
|---|---|
| University of Wisconsin, Madison | OTHER |
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The purpose of this study is to determine the feasibility, safety, and acceptability of implementing an extended interval of INR follow-up in Veterans on a stable dose of warfarin in the Anticoagulation Clinic at the William S. Middleton Memorial Veterans Hospital.
All participants will be provided usual care from the anticoagulation clinic, except for the interval between INRs. If the participant continues to be on a stable dose of warfarin and the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will be scheduled following an extended interval protocol. Patient satisfaction will be evaluated at various points throughout the study. Additionally provider satisfaction, confidence, and knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic events will be evaluated to ensure the safety of an extended follow-up interval.
The purpose of this study is to determine the feasibility, safety, and acceptability of implementing an extended interval of INR follow-up in Veterans on a stable dose of warfarin in the Anticoagulation Clinic at the William S. Middleton Memorial Veterans Hospital.
All participants will be provided usual care from the anticoagulation clinic, except for the interval between INRs. If the participant continues to be on a stable dose of warfarin and the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will be scheduled following an extended interval protocol, from 5-6 weeks, to 7-8 weeks, to 11-12 weeks and then continued with 11-12 week visits if INRs continue to remain in goal range and appropriate for the patient. Patient satisfaction will be evaluated at baseline, 6-, 12-, and 24-months. Additionally provider satisfaction, confidence, and knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic events will be evaluated to ensure the safety of an extended follow-up interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | All patients in the study will be in the intervention arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Participant Accrual | Number of participants who enroll vs. number of individuals invited | up to 2.25 years |
| Number of Participants Able to be Scheduled for at Least One 12-week Interval | This outcome will determine the number of participants able to be scheduled for at least one 12-week interval | 24 months |
| Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals | The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Frequency of Appointments From Baseline to End of Study | This outcome will evaluate the change in frequency of appointments from baseline to end of study (at 12 and 24 months) | 12 and 24 months |
| Bleeding and Thromboembolic Events From Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Type of Protocol Deviations From Both Participants and Study Staff | This outcome determines the frequency and type of protocol deviations from both participants and study staff | Up to 2.25 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla Staresinic, PharmD | William S. Middleton Memorial Veterans Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31752504 | Derived | Schoen RR, Nagy MW, Porter AL, Margolis AR. Patient Satisfaction With Extended International Normalized Ratio Follow-up Intervals in a Veteran Population. Ann Pharmacother. 2020 May;54(5):442-449. doi: 10.1177/1060028019889414. Epub 2019 Nov 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended INR Follow-up Interval Group | All patients in the study will be in the intervention arm. Warfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | All patients in the study will be in the intervention arm. Warfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rates of Participant Accrual | Number of participants who enroll vs. number of individuals invited | 107 invited to participate in the study, not all enrolled or started the study | Posted | Count of Participants | Participants | up to 2.25 years |
|
|
24 months
Major bleeding was defined as a fatal or symptomatic bleed into a critical area or organ, bleeding leading to hospitalization, or transfusion of two units or more of packed red blood cells. This definition is the standard definition used by the Anticoagulation Clinic to report events.
Serious bleeding was defined as bleeding leading to emergency or urgent care visit or additional testing required.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | All patients in the study will be in the intervention arm. Warfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple myeloma | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolism | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Porter, PharmD | William S. Middleton Memorial Veterans Hospital | 608-890-0742 | andrea.porter@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2017 | Oct 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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|
This outcome will determine the number of bleeding and thromboembolic events from baseline |
| 24 months |
| Change in Time in Therapeutic Range From Baseline | The outcome will evaluate the change in time in therapeutic range (TTR) from baseline (intention-to-treat) | 6, 12, and 24 months |
| Patient Satisfaction Through Total DASS Score | Patient satisfaction through total DASS score. DASS = Duke Anticoagulation Satisfaction Scale. 25-item scale.Higher numbers indicate worsening satisfaction ranging from 25-175. Seven-point ordinal scale ("not at all" = 1, "very much" = 7). | baseline, 6 months, 12 months, 24 months |
| INR goal range changed |
|
| admitted to skilled nursing facility |
|
| INRs drawn by visiting nurse services |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HAS-BLED score | The HAS-BLED score evaluates a patient's bleeding risk. HAS-BLED is the official name of the tool to assess risk. Scores range from 0-9. Scores of 3 or higher indicate a high bleeding risk. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Number of Participants Able to be Scheduled for at Least One 12-week Interval | This outcome will determine the number of participants able to be scheduled for at least one 12-week interval | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Primary | Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals | The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Change in Frequency of Appointments From Baseline to End of Study | This outcome will evaluate the change in frequency of appointments from baseline to end of study (at 12 and 24 months) | 44 participants remained in the study at 12 months | Posted | Mean | Standard Deviation | visits per 12 months | 12 and 24 months |
|
|
|
| Secondary | Bleeding and Thromboembolic Events From Baseline | This outcome will determine the number of bleeding and thromboembolic events from baseline | Posted | Number | events | 24 months |
|
|
|
| Secondary | Change in Time in Therapeutic Range From Baseline | The outcome will evaluate the change in time in therapeutic range (TTR) from baseline (intention-to-treat) | 49 participants at 12 months, 44 participants at 24 months | Posted | Mean | Standard Deviation | change in percentage of TTR | 6, 12, and 24 months |
|
|
|
| Secondary | Patient Satisfaction Through Total DASS Score | Patient satisfaction through total DASS score. DASS = Duke Anticoagulation Satisfaction Scale. 25-item scale.Higher numbers indicate worsening satisfaction ranging from 25-175. Seven-point ordinal scale ("not at all" = 1, "very much" = 7). | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 months, 12 months, 24 months |
|
|
|
| Other Pre-specified | Frequency and Type of Protocol Deviations From Both Participants and Study Staff | This outcome determines the frequency and type of protocol deviations from both participants and study staff | 634 eligible participant visits | Posted | Number | percentage of visits | Up to 2.25 years | participant visits | participant visits |
|
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|
| 0 |
| 50 |
| 15 |
| 50 |
| 19 |
| 50 |
| Aortic valve disease | Cardiac disorders | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | Systematic Assessment |
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| Heart failure | Cardiac disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Colonic hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Hemorrhoidal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Bronchial infection | Infections and infestations | Systematic Assessment |
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| Lung infection | Infections and infestations | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Severe AKI | Renal and urinary disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RLE cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
| Post-op monitoring for vascular procedure | Vascular disorders | Systematic Assessment |
|
| Major bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Serious bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
|
| 24 months |
|
|
| Title | Measurements |
|---|---|
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| 24 months |
|
| Title | Measurements |
|---|---|
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