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Acute Respiratory InfectionsPhase 1Decision+NCT01116076

DECISION+, a Training Program to Improve Optimal Drug Prescription

A Phase 1 study testing Decision+ program (to improve optimal drug prescription for ARI) in people with Acute Respiratory Infections, run by CHU de Quebec-Universite Laval at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Respiratory Infections
What is being tested?
Decision+ program (to improve optimal drug prescription for ARI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
712 participants
Where
1 siteCanada
Study dates
May 2010to Apr 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • 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

Who cannot join

  • 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:
  • Patients with a condition requiring emergency care will be excluded.

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

    Québec, Quebec

Other trials in Canada

About this study

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)

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.

Being tested
Decision+ program (to improve optimal drug prescription for ARI)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decision+ program (to improve optimal drug prescription for ARI)Behavioural

    DECISION+ is a multifaceted intervention program that includes: On site course and Internet-based courses (2x120 min), reminders of expected behaviours and feedback.

Study groups in NCT01116076
Study groupRoleWhat they receive
DECISION+ ProgramExperimentalExposure to the Decision+ Program
Receives: Behavioral: Decision+ program (to improve optimal drug prescription for ARI)
ControlNo interventionUsual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: After index consultation

Secondary outcomes (6)

  1. 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).

    Measured: After index consultation

  2. 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.

    Measured: After index consultation

  3. 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.

    Measured: 2 weeks after the index consultation

  4. 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.

    Measured: 2 weeks after the index consultation

  5. 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.

    Measured: Baseline and 2 weeks after the index consultation

  6. 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.

    Measured: Baseline and 2 weeks after the index consultation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionApr 2011
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
712 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01116076
Sponsor's protocol ID
FRSQ20131
Other IDs
35247
Acronym
Decision+
Status last verified
Jan 2013
First submitted
3 May 2010
Last updated
1 Feb 2013
Results posted
No

Publications

  • 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.

    PubMed 21269509

  • 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.

    PubMed 22847969

  • 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.

    PubMed 24369771

  • 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.

    PubMed 23638111

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Decision+ program (to improve optimal drug prescription for ARI) in people with Acute Respiratory Infections, run by CHU de Quebec-Universite Laval at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients reporting a decision for "immediate antibiotics." (time frame: After index consultation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01116076, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2013.

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