- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02746107
Intention to Prescribe/Take OAC Depending on the Number of Risk Diagrams , and Period for the Estimation of the Risk.
RCT Concerning the Intention to Prescribe/Take Oral Anticoagulants for Atrial Fibrillation Depending on the Number of Risk Diagrams (w Treatment +/- w/Out Treatment), and Number of Years (1 or 5) for the Estimation of the Risk of Stroke.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Objectives:
To answer the questions:
- Concerning the decision to prescribe (take) treatment on the basis of a decision aid, are there necessary both diagrams (that with risk without treatment, and that with risk under treatment), or it is enough only the second (risk under treatment, which normally gives all the needed information)?
- Concerning the decision to prescribe (take) treatment, is it a difference between the effects of the presentation on decision aid of the risk of stroke for the next 1 year, and the presentation of the estimated risk of stroke for the next 5 years?
- Is the decision different if physicians prescribe the anticoagulant treatment to patients, over if they should take it themselves?
Study: 2x3 factorial randomized controlled trial (RCT) for comparison:
- Between the decision aid with 2 images (without treatment + with treatment) and the one with 1 image (risk only with treatment)
- Between the effect of the presentation of the stroke risk chart for 1 year and the stroke risk chart for 5 years.
- The decision to prescribe to patients over the decision to take the treatment themselves.
The comparison will be made for the spectrum of risks (scores CHA2DS2-VASC) from 1-5.
Sample size: was calculated a sample of 948 participants (474 + 474) for p = 0.05, power = 80% statistical difference between decisions of 5% (from 95% to 90%). The study does not have enough power neither to compare the 5 groups CHA2DS2-VASC (but we will make these comparisons with exploratory purpose), nor to test interactions.
Participants: physicians participating to the National Congress of Internal Medicine, physicians participating to courses, professional manifestations.
Randomization: randomization will be done on graph type (1 or 2 pictures), duration of risk estimate (1 year and 5 years) and the size of CHA2DS2-VASC risk score (1 to 5), and target prescription (patient or the doctor himself), a total of 40 possibilities. Randomization will be done in blocks of 40.
Participants will be asked to decide, depending on the risk chart, if the patient (or himself) will be treated, ignoring the risk of bleeding.
The chart will contain the pictogram according to the CHA2DS2-VASC risk score, without communicating the actual score, and the physician will have to make the decision to treat or not, depending on the perceived risk, and not on treatment guidelines.
No. questionnaire: first digit = number of risk diagrams (1 or 2); second digit = number of years for which the risk of stroke is calculated (1 or 5); third digit = CHA2DS2-VASC score (1-5). Ex: 253: 2 decision aid diagrams (with and without treatment), with an estimated risk of stroke for the next five years, in a patient with CHA2DS2-VASC score =3.
Effect (outcome): decision to treat / not to treat the patient / physician himself, with oral anticoagulants.
Statistical analysis: It will look for differences in bivariate analysis, and multivariate = logistic regression (dependent variable = treatment decision, the independent variables = number of charts, period for risk assessment (one or 5 years), prescription target (patient or the physician himself), CHA2DS2-VASC score, time from graduation, medical/teaching grade, working in hospital / ambulatory, the size of the city the physician works in, specialty, gender, age, if the physician has/had someone close with stroke (data from questionnaires).
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Bucharest, Roemenië, 020125
- Colentina Clinica Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- physicians who prescribe anticoagulant treatment for atrial fibrillation (cardiology, internal medicine, family medicine, hematology) or who deal with patients with stroke (neurology, pathology) or bleeding (gastroenterology)
Exclusion Criteria:
- physicians who never prescribe anticoagulant treatments, or do not deal with patients with stroke or bleeding because of anticoagulants
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: risk presented on 1 diagram
decision aid with risk of stroke presented on 1 diagram (risk under OAC treatment)
|
decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
|
Actieve vergelijker: risk presented on 2 diagrams
decision aid with risk of stroke presented on 2 diagrams (one presenting risk without and one presenting risk with treatment)
|
decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
|
Actieve vergelijker: 1year risk estimate
risk of stroke presented over a timeframe of 1 year
|
decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
|
Experimenteel: 5year risk estimate
risk of stroke presented over a timeframe of 5 years
|
decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
|
Ander: CHA2DS2-VASC risk score 1
CHA2DS2-VASC risk score =1
|
decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
|
Ander: CHA2DS2-VASC risk score 2
CHA2DS2-VASC risk score =2
|
decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
|
Ander: CHA2DS2-VASC risk score 3
CHA2DS2-VASC risk score =3
|
decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
|
Ander: CHA2DS2-VASC risk score 4
CHA2DS2-VASC risk score =4
|
decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
|
Ander: CHA2DS2-VASC risk score 5
CHA2DS2-VASC risk score =5
|
decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
|
Actieve vergelijker: prescription to virtual patient
prescription is done for a virtual patient
|
decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
|
Experimenteel: prescription to physician himself
prescription is done to physician himself
|
decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Number of Decision Aid Diagrams
Tijdsspanne: after seeing the decision aid (5 min)
|
after regarding the risk diagram, the physician will decide to prescribe/take or not the treatment
|
after seeing the decision aid (5 min)
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Timeframe for Risk Presentation (1 vs 5 Years)
Tijdsspanne: 5 minutes
|
the proportion of physicians deciding to prescribe OAC after seeing risk estimation on 1 vs 5 years
|
5 minutes
|
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Target of Prescription (Patient vs. Physician Himself)
Tijdsspanne: 5 min
|
the participant physicians were randomized to prescribe to virtual patients or to imagine that the risk seen in the diagram was that of themselves
|
5 min
|
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the CHA2D2s-VASC Risk Score
Tijdsspanne: 5 min
|
The proportion of OAC prescription for the range 1-5 of CHA2D2s-VASC scores.
CHA2D2S-VASC risk score ranges from 1-5, with higher scores indicating a greater risk of stroke.
|
5 min
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Cristian Baicus, PhD, Carol Davila University of Medicine and Pharmacy Bucharest - Colentina Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Studiul Cozia
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op decision aid
-
Chinese University of Hong KongNog niet aan het werven
-
Radboud University Medical CenterVoltooid
-
Servicio Canario de SaludVoltooidGegeneraliseerde angststoornis | GADSpanje
-
University of CalgaryAlberta Health services; University of Alberta; Covenant HealthVoltooid
-
Hospital San Carlos, MadridFundacion Investigacion Interhospitalaria CardiovascularWervingMyocardiale ischemie | Coronaire hartziekte | Coronair vasospasme | Microvasculaire angina | Chronisch Coronair SyndroomSpanje
-
Chinese University of Hong KongVoltooidScreening colonoscopieHongkong
-
Nemours Children's ClinicNog niet aan het werven
-
VA Office of Research and DevelopmentWervingSchizofrenie | Schizo-affectieve stoornis | Waanstoornis | Ernstige depressieve stoornis met psychotische kenmerkenVerenigde Staten
-
Christina Murphey, RN, PhDGeschorstDepressie | Slapeloosheid | Ongerustheid | SlaapkwaliteitVerenigde Staten
-
Northwestern UniversityUniversity of California, Los Angeles; National Institute on Aging (NIA); University... en andere medewerkersAanmelden op uitnodigingPolyfarmacieVerenigde Staten