DECISION+, a Training Program to Improve Optimal Drug Prescription (Decision+)
30 januari 2013 bijgewerkt door: France Legare, CHU de Quebec-Universite Laval
DECISION+: Une Formation Pour Les médecins de Famille Sur la Prise de décision partagée Afin d'Optimiser Les décisions Cliniques Concernant l'Utilisation d'Antibiotiques Pour Les Infections aiguës Des Voies Respiratoires (IAVR)
Decisions about the use of antibiotics for acute respiratory infections are the most frequently reported reason for consulting a family physician.
Although it varies according to the specific type of acute respiratory infections, the use of antibiotics is estimated to be 63% to 67%, well above the expected prevalence of bacterial infections thus suggesting overuse of antibiotics.
Consequently, there is an urgent need for helping family physicians and their patients to improve the clinical decision making process regarding the use of antibiotics for acute respiratory infections.
We will evaluate the impact of DECISION +, a multifaceted intervention program that includes training in shared decision making, reminders and feedback targeting physicians, and decision support tools targeting patients on the decision to use antibiotics for acute respiratory infections.
Results from this study will lay the ground for a national strategy targeting the improvement of the clinical decision making process regarding antibiotic use for acute respiratory infections in primary care.
In turn, this will increase quality of care and patient safety.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
712
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Quebec, Canada
- Centre Hospitalier Université Laval - Hôpital St-François d'Assise
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
FAMILY PHYSICIANS:
Inclusion Criteria:
- All FP (teachers and residents) providing care in the walk-in clinic in each Family Practice Teaching Unit (FPTU) will be eligible to participate in the trial.
Exclusion Criteria:
- he/she was involved or participated in the DECISION + pilot RCT
- he/she is not expected to be practicing at the FPTU for the whole duration of the study (e.g. residents ending their residency program or doing rotations outside of the FPTU, planned pregnancy/delivery, planned retirement).
PATIENTS:
Inclusion Criteria:
- if 17 years old and under, must be accompanied by a parents or a guardians)
- they are consulting a participating physician for an ARI, for which treatment with an antibiotic is considered
- they are able (patients or the accompanying parent or guardians) to read, understand and write French (expected level: 8th grade)
- they give informed consent
Exclusion Criteria:
- Patients with a condition requiring emergency care will be excluded.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Controle
Gebruikelijke zorg
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Experimenteel: DECISION+ Program
Exposure to the Decision+ Program
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DECISION+ is a multifaceted intervention program that includes: On site course and Internet-based courses (2x120 min), reminders of expected behaviours and feedback.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Proportion of patients reporting a decision for "immediate antibiotics."
Tijdsspanne: After index consultation
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After index consultation
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Decision to use antibiotics
Tijdsspanne: After index consultation
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After an index consultation, we will ask patients: "Was a prescription for an antibiotic or a sample of antibiotic provided to treat an ARI (acute otitis media, acute bronchitis, acute pharyngitis, or acute rhinosinusitis)?" Possible answers will be:
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After index consultation
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Decisional conflict
Tijdsspanne: After index consultation
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Will be assessed with the Decisional Conflict Scale (DCS) after the index consultation.
This questionnaire is similar for physicians and patients and includes 19 items, on a five-point Likert scale, divided into five subscales that are i)uncertainty and its modifiable deficits: ii) knowledge, iii) values clarification, iv) support and v) perception of an effective choice.
Both the physician and patient versions of the DCS have adequate psychometric properties and have the same meaning for both physicians and patients.
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After index consultation
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Adherence to the decision that was made
Tijdsspanne: 2 weeks after the index consultation
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2 weeks after the index consultation, patients will be asked via a telephone interview: "What was the decision made with the FP about antibiotic use for ARI two weeks ago?" and "Have you complied with this decision?"
(yes or no).
If patients answer "no", research assistants, using an open-ended question, will inquire about the reasons and the options that were adhered to.
Interviewers will be unaware of the study group and will be instructed not to ask questions that could reveal the study group.
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2 weeks after the index consultation
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Decisional regret
Tijdsspanne: 2 weeks after the index consultation
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2 weeks after the index consultation, decisional regret will be assessed in patients using the Decisional Regret Scale (DRS) via a telephone interview.
The DRS is a 5-item scale with adequate psychometric properties that correlates strongly with decision satisfaction and overall QOL.
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2 weeks after the index consultation
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Quality of life (QOL)
Tijdsspanne: Baseline and 2 weeks after the index consultation
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For patients only, before and two weeks after the index consultation (via a telephone interview), QOL will be assessed using the Short Form-12 (SF-12V2 Health survey).
This questionnaire measures general health status from the patient's point of view and includes eight concepts commonly represented in health status: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and emotional and mental health.
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Baseline and 2 weeks after the index consultation
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Intention to engage in SDM in future consultations dealing with antibiotic use for ARI
Tijdsspanne: Baseline and 2 weeks after the index consultation
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In FP and their patients, this intention will be assessed based on the Theory of planned behavior (TPB).
The questionnaire includes 15 items, on a 7-point Likert scale, that cover the constructs of the TPB, namely attitudes, social norm, perceived behavioral control and intention.
Patients will complete this questionnaire before and 2 weeks after the index consultation; physicians will complete it once during the baseline data collection period and after the last encounter of the post-intervention data collection period.
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Baseline and 2 weeks after the index consultation
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Legare F, Labrecque M, Godin G, LeBlanc A, Laurier C, Grimshaw J, Castel J, Tremblay I, Fremont P, Cauchon M, Lemieux K, Rheaume C. Training family physicians and residents in family medicine in shared decision making to improve clinical decisions regarding the use of antibiotics for acute respiratory infections: protocol for a clustered randomized controlled trial. BMC Fam Pract. 2011 Jan 26;12:3. doi: 10.1186/1471-2296-12-3.
- Legare F, Labrecque M, Cauchon M, Castel J, Turcotte S, Grimshaw J. Training family physicians in shared decision-making to reduce the overuse of antibiotics in acute respiratory infections: a cluster randomized trial. CMAJ. 2012 Sep 18;184(13):E726-34. doi: 10.1503/cmaj.120568. Epub 2012 Jul 30.
- Legare F, Guerrier M, Nadeau C, Rheaume C, Turcotte S, Labrecque M. Impact of DECISION + 2 on patient and physician assessment of shared decision making implementation in the context of antibiotics use for acute respiratory infections. Implement Sci. 2013 Dec 26;8:144. doi: 10.1186/1748-5908-8-144.
- Guerrier M, Legare F, Turcotte S, Labrecque M, Rivest LP. Shared decision making does not influence physicians against clinical practice guidelines. PLoS One. 2013 Apr 24;8(4):e62537. doi: 10.1371/journal.pone.0062537. Print 2013.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2010
Primaire voltooiing (Werkelijk)
1 april 2011
Studie voltooiing (Werkelijk)
1 april 2011
Studieregistratiedata
Eerst ingediend
3 mei 2010
Eerst ingediend dat voldeed aan de QC-criteria
3 mei 2010
Eerst geplaatst (Schatting)
4 mei 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
1 februari 2013
Laatste update ingediend die voldeed aan QC-criteria
30 januari 2013
Laatst geverifieerd
1 januari 2013
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FRSQ20131
- 35247 (Andere identificatie: CHUQ)
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