Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Patient-Centred Care for Warfarin Management: A Pilot Study to Transition Care to High Risk Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Tammy Bungard, University of Alberta

Tracking Information
First Submitted Date  ICMJE September 18, 2017
First Posted Date  ICMJE September 28, 2017
Last Update Posted Date September 29, 2017
Actual Study Start Date  ICMJE September 17, 2017
Estimated Primary Completion Date September 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03295799 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Patient-Centred Care for Warfarin Management: A Pilot Study to Transition Care to High Risk Patients
Official Title  ICMJE Patient-Centred Care for Warfarin Management: A Pilot Study to Transition Care to High Risk Patients
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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Quality of Life
Intervention  ICMJE Other: Patient Self-Management
Patient will manage their own warfarin therapy.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Patient Self-Management
  • No Intervention: Anticoagulation Clinic Care
    Patients will not have their care altered, and will continue to be managed by our Anticoagulation Clinic.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 22, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 17, 2018
Estimated Primary Completion Date September 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • mechanical heart valve as the indication for warfarin
  • > 16 years of age
  • Warfarin therapy managed by the AC for at least the preceding 6 months
  • Anticipated duration of warfarin therapy to be lifelong
  • Previously adherent with medication
  • Competence judged by demonstrated ability to use drug-adjustment nomograms

Exclusion Criteria:

  • • Severe psychiatric disease

    • Significant language barrier
    • Clinician's judgment that the patient would be a poor candidate for study (with reason specified)
    • Known or anticipated procedure/surgery/intervention in the next year
    • Active participation in another study
    • Lack of access to the internet / email
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03295799
Other Study ID Numbers  ICMJE Pro00052090
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tammy Bungard, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tammy Bungard, BSP, PharmD University of Alberta
PRS Account University of Alberta
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP