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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
France Legare, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01116076
First received: May 3, 2010
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Infections
Behavioral: Decision+ program (to improve optimal drug prescription for ARI)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • Proportion of patients reporting a decision for "immediate antibiotics." [ Time Frame: After index consultation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decision to use antibiotics [ Time Frame: After index consultation ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 712
Study Start Date: May 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DECISION+ Program
Exposure to the Decision+ Program
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.
No Intervention: Control
Usual Care

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116076

Locations
Canada
Centre Hospitalier Université Laval - Hôpital St-François d'Assise
Quebec, Canada
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: France Legare, Canada Research Chair in Implementation of Shared Decision Making in Primary Care, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT01116076     History of Changes
Other Study ID Numbers: FRSQ20131, 35247
Study First Received: May 3, 2010
Last Updated: January 30, 2013
Health Authority: Canada: Fonds de la recherche en santé du Québec

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014