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

NCT03295799 | Completed

• 1 other identifier: Pro00052090
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

• The change in quality of life score (using the validated instruments DASS and Sawicki scale) between PSM and AC care.

  Duke Anticoagulation Satisfaction Scale (DASS) and Sawicki Scale

  6 months

Secondary Outcomes (7)

• The proportion of patients completing PSM

  9 months

• Difference in the time in therapeutic INR range between those randomized to AC care versus PSM.

  6 months

• The rate of ER and hospitalization for anticoagulant and non-anticoagulant reasons between AC care and PSM.

  6 months

• The amount of time spent by the AC team for the AC group relative to the PSM group.

  9 months

• Amongst the PSM group, to determine if strategies for self-managing warfarin therapy have made patients do so for other chronic diseases.

  6 months

Study Arms (2)

Patient Self-Management

EXPERIMENTAL

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

Anticoagulation Clinic Care

NO INTERVENTION

Patients will not have their care altered, and will continue to be managed by our Anticoagulation Clinic.

Interventions

Patient Self-Management OTHER

Patient will manage their own warfarin therapy.

Patient Self-Management

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2J3, Canada

Location

Study Officials

• Tammy Bungard, BSP, PharmD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 28, 2017
• Study Start: September 17, 2017
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)