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

24 mai 2022 mis à jour par: University of Alberta
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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

58

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Alberta
      • Edmonton, Alberta, Canada, T6G 2J3
        • University of Alberta

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

17 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Patient will manage their own warfarin therapy.
Aucune intervention: Anticoagulation Clinic Care
Patients will not have their care altered, and will continue to be managed by our Anticoagulation Clinic.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The change in quality of life score (using the validated instruments DASS and Sawicki scale) between PSM and AC care.
Délai: 6 months
Duke Anticoagulation Satisfaction Scale (DASS) and Sawicki Scale
6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The proportion of patients completing PSM
Délai: 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
9 months
Difference in the time in therapeutic INR range between those randomized to AC care versus PSM.
Délai: 6 months
Time in range will be calculated using the Rosendaal method.
6 months
The rate of ER and hospitalization for anticoagulant and non-anticoagulant reasons between AC care and PSM.
Délai: 6 months
presentations to hospital
6 months
The amount of time spent by the AC team for the AC group relative to the PSM group.
Délai: 9 months
the number of minutes taken for each arm, as a measure of resource use within the AC team.
9 months
Amongst the PSM group, to determine if strategies for self-managing warfarin therapy have made patients do so for other chronic diseases.
Délai: 6 months
a descriptive measure of translation of proactive management
6 months
Number of participants in AC care vs PSM that are dead at 5 years.
Délai: 5 years following study completion
mortality measure
5 years following study completion
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.
Délai: 3 months
assessed prior to entering the PSM phase
3 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Tammy Bungard, BSP, PharmD, University of Alberta

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

17 septembre 2017

Achèvement primaire (Réel)

31 janvier 2022

Achèvement de l'étude (Réel)

31 janvier 2022

Dates d'inscription aux études

Première soumission

18 septembre 2017

Première soumission répondant aux critères de contrôle qualité

22 septembre 2017

Première publication (Réel)

28 septembre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 mai 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 mai 2022

Dernière vérification

1 mai 2022

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • Pro00052090

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Qualité de vie

Essais cliniques sur Patient Self-Management

3
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