Patient-Centred Care for Warfarin Management: A Pilot Study to Transition Care to High Risk Patients
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|ClinicalTrials.gov Identifier: NCT03295799|
Recruitment Status : Unknown
Verified September 2017 by Tammy Bungard, University of Alberta.
Recruitment status was: Recruiting
First Posted : September 28, 2017
Last Update Posted : September 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life||Other: Patient Self-Management||Not Applicable|
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 AC).4,10 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 patient's 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 patient's 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 > 5.0 or 0.5 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Patient-Centred Care for Warfarin Management: A Pilot Study to Transition Care to High Risk Patients|
|Actual Study Start Date :||September 17, 2017|
|Estimated Primary Completion Date :||September 17, 2018|
|Estimated Study Completion Date :||September 17, 2018|
Experimental: Patient Self-Management
Patients will go through a preparatory phase (creation of warfarin dosing chart, process for documentation and retrieval of labs), a practical training phase (formulate warfarin management plan with support) and then perform patient-self management of their own warfarin.
Other: Patient Self-Management
Patient will manage their own warfarin therapy.
No Intervention: Anticoagulation Clinic Care
Patients will not have their care altered, and will continue to be managed by our Anticoagulation Clinic.
- The change in quality of life score (using the validated instruments DASS and Sawicki scale) between PSM and AC care. [ Time Frame: 6 months ]Duke Anticoagulation Satisfaction Scale (DASS) and Sawicki Scale
- The proportion of patients completing PSM [ Time Frame: 9 months ]Beginning from consent and capturing stage at which patients withdrew (if applicable) namely the preparatory and practical training phases or PSM as well as those electing to continue PSM after study
- Difference in the time in therapeutic INR range between those randomized to AC care versus PSM. [ Time Frame: 6 months ]Time in range will be calculated using the Rosendaal method.
- The rate of ER and hospitalization for anticoagulant and non-anticoagulant reasons between AC care and PSM. [ Time Frame: 6 months ]presentations to hospital
- The amount of time spent by the AC team for the AC group relative to the PSM group. [ Time Frame: 9 months ]the number of minutes taken for each arm, as a measure of resource use within the AC team.
- Amongst the PSM group, to determine if strategies for self-managing warfarin therapy have made patients do so for other chronic diseases. [ Time Frame: 6 months ]a descriptive measure of translation of proactive management
- Number of participants in AC care vs PSM that are dead at 5 years. [ Time Frame: 5 years following study completion ]mortality measure
- Number of encounters in the PSM group that put forward warfarin dosing that is concordant with that of the AC and to provide descriptions of warfarin dose changes. [ Time Frame: 3 months ]assessed prior to entering the PSM phase
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295799
|Contact: Tammy J Bungard, BSP, PharmDfirstname.lastname@example.org|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada, T6G 2J3|
|Contact: Tammy J Bungard, BSP, PharmD|
|Sub-Investigator: Micheal S McMurtry, MD|
|Sub-Investigator: Steven Meyer, MD|
|Sub-Investigator: Bruce Ritchie, MD|
|Sub-Investigator: Ross T Tsuyuki, MD|
|Principal Investigator:||Tammy Bungard, BSP, PharmD||University of Alberta|