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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

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.

Condition or disease Intervention/treatment Phase
Quality of Life Other: Patient Self-Management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. The rate of ER and hospitalization for anticoagulant and non-anticoagulant reasons between AC care and PSM. [ Time Frame: 6 months ]
    presentations to hospital

  4. 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.

  5. 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

  6. Number of participants in AC care vs PSM that are dead at 5 years. [ Time Frame: 5 years following study completion ]
    mortality measure

  7. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03295799

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Contact: Tammy J Bungard, BSP, PharmD 7804078597

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Canada, Alberta
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         
Sponsors and Collaborators
University of Alberta
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Principal Investigator: Tammy Bungard, BSP, PharmD University of Alberta
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Responsible Party: Tammy Bungard, Associate Professor of Medicine, University of Alberta Identifier: NCT03295799    
Other Study ID Numbers: Pro00052090
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No