- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03295799
Patient-Centred Care for Warfarin Management: A Pilot Study to Transition Care to High Risk Patients
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2J3
- University of Alberta
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Ingen indgriben: Anticoagulation Clinic Care
Patients will not have their care altered, and will continue to be managed by our Anticoagulation Clinic.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The change in quality of life score (using the validated instruments DASS and Sawicki scale) between PSM and AC care.
Tidsramme: 6 months
|
Duke Anticoagulation Satisfaction Scale (DASS) and Sawicki Scale
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The proportion of patients completing PSM
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 3 months
|
assessed prior to entering the PSM phase
|
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Tammy Bungard, BSP, PharmD, University of Alberta
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Pro00052090
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Livskvalitet
-
NorthShore University HealthSystemUkendt
-
Marlene FischerAfsluttetPostoperativ Quality of Recovery på postanæstesiafdelingenTyskland
-
Ankara Yildirim Beyazıt UniversityIkke rekrutterer endnuOrtopædkirurgi | Komfort | Sygepleje | Quality of Recovery 40
-
University Hospital, Clermont-FerrandAfsluttetOral Health Related Quality of Life (OHRQoL)Frankrig
-
Chinese University of Hong KongIkke rekrutterer endnuHepatektomi | Intertransversal procesblok | Quality of Recovery (QoR-15)
-
Ondokuz Mayıs UniversityAfsluttetKejsersnit | Intratekal morfin | Quality of Recovery 40Kalkun
-
Universitätsklinikum Hamburg-EppendorfIkke rekrutterer endnuPostoperativ restitutionskvalitet | Postoperativ Quality of Recovery på postanæstesiafdelingen
-
Anqing Municipal HospitalAfsluttetDexmedetomidin | Lidokain | Quality of Recovery (QoR-40), præoperativ og postoperativKina
-
Aydin Adnan Menderes UniversityIkke rekrutterer endnuOpioidforbrug | Quality of Recovery (QoR-40), præoperativ og postoperativ
-
Cairo UniversityRekrutteringQuality of Recovery (QoR-15) | Sadelblok-anæstesi | Klart til udskrivelseEgypten
Kliniske forsøg med Patient Self-Management
-
Shifa Tameer-e-Millat UniversityAfsluttet
-
University of North Carolina, Chapel HillCenters for Disease Control and PreventionAfsluttetKronisk sygdomForenede Stater
-
Massachusetts General HospitalNational Institute on Minority Health and Health Disparities (NIMHD)AfsluttetPsykiske lidelserForenede Stater, Puerto Rico
-
University of WashingtonNational Institute of Nursing Research (NINR); East Carolina UniversityRekrutteringImplanterbar defibrillatorbruger | Stress reaktion | Ptsd | Stresshåndtering | Social kognitiv teoriForenede Stater
-
University of MichiganNational Institutes of Health (NIH); National Institute on Aging (NIA); Blue...Afsluttet
-
Karamanoğlu Mehmetbey UniversityKaraman Training and Research HospitalAfsluttetKoronararteriesygdomKalkun
-
University College London HospitalsAfsluttetNeuromuskulære sygdommeDet Forenede Kongerige
-
Hacettepe UniversityAfsluttetHjerte-kar-sygdomme | Forhøjet blodtryk | Sundhedsadfærd | Selveffektivitet | Behandlingsoverholdelse og complianceKalkun
-
University of Missouri-ColumbiaEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereRekrutteringSlagForenede Stater
-
Universiti Putra MalaysiaUniversity of LahoreIkke rekrutterer endnu