Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03295799
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2017-09-18
Brief Title:
Patient-Centred Care for Warfarin Management A Pilot Study to Transition Care to High Risk Patients
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Patient-Centred Care for Warfarin Management A Pilot Study to Transition Care to High Risk Patients
Status:
COMPLETED
Status Verified Date:
2022-05
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:
Warfarin remains the only oral anticoagulant effective in preventing stroke and valve thrombi for patients having mechanical heart valves MHVs Within Edmonton Alberta our pharmacist-directed and staffed Anticoagulation Clinic AC is referred all MHVs implanted and now has 450 active patients The AC mandate is to work with patients to ensure they have a thorough understanding of their warfarin therapy and the factors that may impact its control In European countries patients are often taught to manage their own warfarin therapy Patient Self-Management PSM and achieve good warfarin control and outcomes Despite advocating for a patient-centred approach for healthcare delivery in Alberta no established programs or funding models exist to teach and provide ongoing support for PSM in North America The patient population namely MHVs served at our AC offers a unique opportunity to implement PSM given they are already aware of their therapy and only require some extra training and support to assume their own management While it is anticipated that an increase in pharmacist AC resources would be necessary to teach patients to self-manage the establishment of a PSM program has the potential to free up AC resources in the long-term allowing more patients to be managed with reducing waiting times for the AC With infrastructure in place the AC could serve as a centre of excellence for PSM accepting referrals for this level of care from across the province Given the patient-centred approach to care delivery in Alberta it remains prudent to assess patient acceptability to the PSM approach to anticoagulation care delivery As such the primary objective of this randomized pilot study is to assess the effect of PSM compared to AC care on quality of life Our results will inform a larger scale future trial
Detailed Description:
50 patients will receive a cover letter outlining their random selection for this study along with the patient information sheet and consent form with a return addressed postage paid envelope Patients will be encouraged to contact the AC and speak with the Principal Investigator TB regarding the research study and all questions will be addressed We will continue this mailing process until a total of 50 patients have consented to study PSM within the context of this study may use either POC technology or standard venipuncture with the patient accessing the laboratory for results After receipt of consent patients will be required to pass a foundational exam outlining the basics of anticoagulation therapy most of which should be simple review for the patients managed within our AC410 Upon successfully passing this multiple choice exam patients will be randomized to AC care with no changes implemented or to PSM
PSM Phase I Preparatory Phase of Patient Training 6weeks During the initial preparatory phase lasting 6 weeks 2 weeks the AC will create a patient specific warfarin dosing nomogram discuss the same with the patient and ensure clear understanding while working through various scenarios with the patient Appendix 1 The AC will ensure the patient has an established system to both retrieve INR results via POC technology or standard venipuncture as well as to document the INR results warfarin dosing any pertinent assessment factors and next date to test the INR The AC will empower the patient to be proactive with coming up with warfarin dose changes during this preparatory phase
PSM Phase II Patient Practical Training
The AC will enrol the patient into the PSM practical training phase lasting 3 months 1 month At this time the patient will retrieve their result and establish a future warfarin dose and follow-up plan This information will be transmitted to a single AC team member Contact with anotherdiscussed with an AC team member and the ultimate dosing decision will be tracked to ascertain concordance of the patients original plan to what was implemented during the follow-up visit with the to perform standard AC teamcare and management will occur thereby enabling comparison of the patients plan and the AC plan During this phase the AC plan will be implemented At the end of this phase patients must pass a multiple choice exam that provides practical cases targeting warfarin dose adjustment with next scheduled follow-up visit and will then be positioned into the PSM arm of the study
Patient Self-Management During the PSM phase 6 months - 1 month contact will occur with the AC monthly to retrieve INR results and warfarin dose adjustments information from the patient-based charting system Key points of contact between the patient and the AC will be required such as INR results either 50 or 05 INR units below the lower limit of their desired target INR range initiation of interacting medications illness etc Patients not demonstrating the ability to self-manage their own warfarin therapy will be encouraged to cross-over to AC care At the end of 6 months patient choice of AC care or PSM will be identified
PSM Phase I Preparatory Phase of Patient Training 6weeks During the initial preparatory phase lasting 6 weeks 2 weeks the AC will create a patient specific warfarin dosing nomogram discuss the same with the patient and ensure clear understanding while working through various scenarios with the patient Appendix 1 The AC will ensure the patient has an established system to both retrieve INR results via POC technology or standard venipuncture as well as to document the INR results warfarin dosing any pertinent assessment factors and next date to test the INR The AC will empower the patient to be proactive with coming up with warfarin dose changes during this preparatory phase
PSM Phase II Patient Practical Training
The AC will enrol the patient into the PSM practical training phase lasting 3 months 1 month At this time the patient will retrieve their result and establish a future warfarin dose and follow-up plan This information will be transmitted to a single AC team member Contact with anotherdiscussed with an AC team member and the ultimate dosing decision will be tracked to ascertain concordance of the patients original plan to what was implemented during the follow-up visit with the to perform standard AC teamcare and management will occur thereby enabling comparison of the patients plan and the AC plan During this phase the AC plan will be implemented At the end of this phase patients must pass a multiple choice exam that provides practical cases targeting warfarin dose adjustment with next scheduled follow-up visit and will then be positioned into the PSM arm of the study
Patient Self-Management During the PSM phase 6 months - 1 month contact will occur with the AC monthly to retrieve INR results and warfarin dose adjustments information from the patient-based charting system Key points of contact between the patient and the AC will be required such as INR results either 50 or 05 INR units below the lower limit of their desired target INR range initiation of interacting medications illness etc Patients not demonstrating the ability to self-manage their own warfarin therapy will be encouraged to cross-over to AC care At the end of 6 months patient choice of AC care or PSM will be identified
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None