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Depression Medication Choice Decision Aid

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ClinicalTrials.gov Identifier: NCT03887390
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
Réseau-1 Québec
CERSSPL
Information provided by (Responsible Party):
Annie Leblanc, Laval University

Brief Summary:

The quality of care for patients facing depression, one of the most prevalent chronic diseases, needs improvement. Despite its high incidence, depression remains sub-optimally managed, particularly in primary care, where most patients suffering from depression receive care. Successfully treated depressive patients can potentially improve their burden of disease and significantly improve their quality of life, but not without the best treatment adapted to their contexts, preferences, and expectations. Clinical research provides essential knowledge for the delivery of quality care which is unfortunately seldom applied in daily practice.

One of the preferred methods for overcoming this lack of quality of care is shared decision making: a collaborative process between a clinician and patient that relies on the consideration of scientific evidence, in addition to the values and preferences of the patient. The use of decision aids supports this process by presenting scientific information in an accessible manner while focusing on patient-centered discussion. We developed and rigorously evaluated, in the United States, a decision aid regarding pharmaceutical treatment options for depression, Depression Medication Choice, to be used by health professionals and patients during clinical encounters. The integration and impact of Depression Medication Choice, in primary care practices in a Canadian context is unknown.

The specific objectives of this study are threefold: (i) Evaluate the potential impact of the use of Depression Medication Choice by health professionals and patients during clinical encounters on measures of the quality of the decisional process and on health issues important to the patient and health professional; (ii) Document the processes and optimal measures to take to successfully realize projects on a larger scale; and (iii) Evaluate the feasibility of performing patient-centered studies in a realistic context, minimally disturbing to the study environment, in the primary care context in Quebec, Canada.

Once completed, the estimated potential impact of this decision aid and shared decision making in primary care in a Canadian context will have been measured, progressing toward high-quality patient-centered care. Moreover, it will be possible to optimally perform future studies in realistic contexts while minimizing the burden on the clinics, their health professionals, and their patients.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Depression Medication Choice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a mixed-method feasibility study centered on a pilot clinical trial in family medicine groups in Quebec, Canada, accompanied by a realistic qualitative evaluation of process.
Masking: None (Open Label)
Masking Description: Patients will be randomly assigned to one of two groups (intervention or usual care) using a computer-generated sequence. Due to the nature of the study, patients, health professionals, and members of the research team cannot be masked to the allocation.
Primary Purpose: Health Services Research
Official Title: Implementation of the Depression Medication Choice Decision Aid in a Canadian Context: A Feasibility Trial
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Participants in this arm will receive care as usual.
Experimental: Depression Medication Choice
Participants in this arm will have the Depression Medication Choice decision aid be made available to their clinician to be used during their clinical encounter.
Behavioral: Depression Medication Choice
The Depression Medication Choice tool is a series of cards emphasizing issues that are important for the patient and the health care professional when choosing antidepressants: weight change, sexual issues, sleep, cost, side effects, and stopping approach. The Depression Medication Choice tool uses clear language and is designed to improve the understanding of patients regarding the different attributes of antidepressants, and for use during clinical encounters.




Primary Outcome Measures :
  1. Changes in decisional conflict assessed by the Decisional Conflict Scale (DCS) [ Time Frame: Immediately following each participant's first clinical encounter and every subsequent scheduled visit for the approximate 6-month study intervention duration ]
    Participants and clinicians will complete a Decisional Conflict Scale so that their level of decisional conflict may be measured. This measure, validated in French, comprises 16-items grouped into factors impacting the feeling of comfort toward making the decision. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). A participant version as well as a clinician version of the DCS will be used.


Secondary Outcome Measures :
  1. Participant engagement assessed by the Observing Patient Involvement in Decision Making instrument (OPTION) and video recordings [ Time Frame: At each participant's scheduled clinical encounter, for up to 6 months post-recruitment ]
    The level to which the clinicians engage the participants in decision making will be evaluated via the 12-item OPTION scale, an observational measurement scored 0 to 100 percent. Independent reviewers will assess the level of engagement using video recordings of the clinical encounters.

  2. Changes in severity of symptoms assessed by the Patient Health Questionnaire (PHQ-9) [ Time Frame: Immediately prior to each participant's first clinical encounter and every subsequent scheduled visit for the approximate 6-month study intervention duration ]
    Participants will complete the PHQ-9, a severity of depression measurement using a 4-point Likert-type scale. Scores range between 0 and 27 and correspond to depression severity. Depression severity may be: none-minimal (0 to 4), mild (5 to 9), moderate (10-14), moderately severe (15-19), or severe (20-27).

  3. Decision making preference assessed by questionnaire [ Time Frame: Immediately prior to each participant's first clinical encounter ]
    Participants will be asked to answer a single question with a 5-point Likert-type scale to rate their decision making preferences. Lower values indicate participants' preference for making decisions themselves while higher values indicate a preference for their doctor to make the decision for them. An intermediate value indicates participants' preference for shared decision making.

  4. Global quality of life assessed by questionnaire [ Time Frame: Immediately prior to the first clinical encounter ]
    Participants will be asked to answer a single question with a 10-point Likert-type scale to rate their quality of life. The question is scored from 1 (very bad) to 10 (very good).

  5. Changes in medication adherence assessed by participants' pharmacy records [ Time Frame: Following the approximate 6-month study intervention completion ]
    The following data will be extracted for the duration of trial participation: new prescriptions filled and the associated renewal dates as well as the types of medication (depression-related).

  6. Fidelity to the intervention delivery [ Time Frame: The entire duration of the discussion between the clinician and participant regarding depression medication during each scheduled visit for the approximate 6-month study intervention duration ]
    Independent reviewers will evaluate the fidelity with which the Depression Medication Choice tool is used during the clinical encounters via video observation. The control of fidelity list is specific to the Depression Medication Choice tool. This will also allow us to validate the contamination level of the clinicians who will navigate between both groups.

  7. Changes in knowledge assessed by questionnaire [ Time Frame: Immediately following each participant's clinical encounter and every subsequent visit for the approximate 6-month study intervention duration ]
    Participants will be asked to complete a questionnaire assessing their knowledge of the illness (depression) and the advantages and disadvantages of 15 pharmacological treatments. Participants may choose to answer true, false, or unsure. Correct answeres are are given a score of 1 and incorrect answers (or if a participant answered "unsure") is given a score of 0. A mean knowledge score is calculated from the totaled items for comparison.

  8. Changes in satisfaction and acceptability by questionnaire [ Time Frame: Immediately following the first clinical encounter and every subsequent visit for the approximate 6-month study intervention duration ]
    Participants and clinicians will be asked to rate their level of satisfaction and acceptability of the decision aid by completing a 5-question questionnaire. The 7-point Likert-type scale is scored from 5 to 35 with higher values corresponding to higher levels of satisfaction and acceptability.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Already have or receive a depression diagnosis (according to the treating clinician)
  • Speak English of French
  • Have no major obstacles providing clear written consent
  • Discuss the possibility of taking antidepressants during the clinical encounter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887390


Contacts
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Contact: Catherine Vandal, MBA (418) 663-5712 catherine.vandal.ciussscn@ssss.gouv.qc.ca

Locations
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Canada
Groupe de médecine de famille universitaire Maizerets Recruiting
Québec, Canada, G1J 2G1
Sponsors and Collaborators
Laval University
Réseau-1 Québec
CERSSPL
Investigators
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Principal Investigator: Annie LeBlanc, PhD Laval University

Publications:
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Responsible Party: Annie Leblanc, Associate Professor, Laval University
ClinicalTrials.gov Identifier: NCT03887390     History of Changes
Other Study ID Numbers: 120560
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Annie Leblanc, Laval University:
Depression
Decision Aid
Shared Decision Making
Primary Care
Comparative Effectiveness Research
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders