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

Primary Purpose

Acute Respiratory Infections

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Decision+ program (to improve optimal drug prescription for ARI)
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Respiratory Infections

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Université Laval - Hôpital St-François d'Assise

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DECISION+ Program

Control

Arm Description

Exposure to the Decision+ Program

Usual Care

Outcomes

Primary Outcome Measures

Proportion of patients reporting a decision for "immediate antibiotics."

Secondary Outcome Measures

Decision to use antibiotics
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
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
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
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)
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
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.

Full Information

First Posted
May 3, 2010
Last Updated
January 30, 2013
Sponsor
CHU de Quebec-Universite Laval
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1. Study Identification

Unique Protocol Identification Number
NCT01116076
Brief Title
DECISION+, a Training Program to Improve Optimal Drug Prescription
Acronym
Decision+
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infections

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
712 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DECISION+ Program
Arm Type
Experimental
Arm Description
Exposure to the Decision+ Program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Decision+ program (to improve optimal drug prescription for ARI)
Intervention Description
DECISION+ is a multifaceted intervention program that includes: On site course and Internet-based courses (2x120 min), reminders of expected behaviours and feedback.
Primary Outcome Measure Information:
Title
Proportion of patients reporting a decision for "immediate antibiotics."
Time Frame
After index consultation
Secondary Outcome Measure Information:
Title
Decision to use antibiotics
Description
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).
Time Frame
After index consultation
Title
Decisional conflict
Description
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.
Time Frame
After index consultation
Title
Adherence to the decision that was made
Description
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.
Time Frame
2 weeks after the index consultation
Title
Decisional regret
Description
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.
Time Frame
2 weeks after the index consultation
Title
Quality of life (QOL)
Description
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.
Time Frame
Baseline and 2 weeks after the index consultation
Title
Intention to engage in SDM in future consultations dealing with antibiotic use for ARI
Description
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.
Time Frame
Baseline and 2 weeks after the index consultation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Centre Hospitalier Université Laval - Hôpital St-François d'Assise
City
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21269509
Citation
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.
Results Reference
background
PubMed Identifier
22847969
Citation
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.
Results Reference
result
PubMed Identifier
24369771
Citation
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.
Results Reference
derived
PubMed Identifier
23638111
Citation
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.
Results Reference
derived
Links:
URL
http://decision.chaire.fmed.ulaval.ca/index.php?id=66&L=2
Description
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DECISION+, a Training Program to Improve Optimal Drug Prescription

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