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DECISION+, a Training Program to Improve Optimal Drug Prescription (Decision+)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01116076
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : February 1, 2013
Sponsor:
Information provided by (Responsible Party):
France Legare, CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date  ICMJE May 3, 2010
First Posted Date  ICMJE May 4, 2010
Last Update Posted Date February 1, 2013
Study Start Date  ICMJE May 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2010)
Proportion of patients reporting a decision for "immediate antibiotics." [ Time Frame: After index consultation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01116076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2010)
  • Decision to use antibiotics [ Time Frame: After index consultation ]
    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:
    • Yes,(Immediate antibiotics);
    • Yes,(Delayed antibiotics);
    • No (no antibiotics).
  • Decisional conflict [ Time Frame: After index consultation ]
    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.
  • Adherence to the decision that was made [ Time Frame: 2 weeks after the index consultation ]
    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.
  • Decisional regret [ Time Frame: 2 weeks after the index consultation ]
    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.
  • Quality of life (QOL) [ Time Frame: Baseline and 2 weeks after the index consultation ]
    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.
  • Intention to engage in SDM in future consultations dealing with antibiotic use for ARI [ Time Frame: Baseline and 2 weeks after the index consultation ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2010)
  • Decision to use antibiotics [ Time Frame: After index consultation ]
    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:
    • Yes,(Immediate antibiotics);
    • Yes,(Delayed antibiotics);
    • No (no antibiotics).
  • Decisional conflict [ Time Frame: After index consultation ]
    Will be assessed with the Decisional Conflict Scale (DCS) after the index consultation. This questionnaire is similar for physicians and patients and includes 16 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.
  • Adherence to the decision that was made [ Time Frame: 2 weeks after the index consultation ]
    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.
  • Decisional regret [ Time Frame: 2 weeks after the index consultation ]
    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.
  • Quality of life (QOL) [ Time Frame: Baseline and 2 weeks after the index consultation ]
    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-12). 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.
  • Intention to engage in SDM in future consultations dealing with antibiotic use for ARI [ Time Frame: Baseline and 2 weeks after the index consultation ]
    In FP and their patients, this intention will be assessed based on the Theory of planned behavior (TPB). The questionnaire includes 12 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DECISION+, a Training Program to Improve Optimal Drug Prescription
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Acute Respiratory Infections
Intervention  ICMJE Behavioral: Decision+ program (to improve optimal drug prescription for ARI)
DECISION+ is a multifaceted intervention program that includes: On site course and Internet-based courses (2x120 min), reminders of expected behaviours and feedback.
Study Arms  ICMJE
  • Experimental: DECISION+ Program
    Exposure to the Decision+ Program
    Intervention: Behavioral: Decision+ program (to improve optimal drug prescription for ARI)
  • No Intervention: Control
    Usual Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2013)
712
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2010)
840
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01116076
Other Study ID Numbers  ICMJE FRSQ20131
35247 ( Other Identifier: CHUQ )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party France Legare, CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CHU de Quebec-Universite Laval
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP