An interventional study of Depression Medication Choice in Depression, sponsored by Laval University. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by Laval University · Not applicable, Interventional, and Health services research
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.
8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 3 is below the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →Laval University is the lead sponsor of 380 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Participants in this arm will receive care as usual.
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.
Changes in decisional conflict assessed by the Decisional Conflict Scale (DCS)
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.
Time frame: Immediately following each participant's first clinical encounter and every subsequent scheduled visit for the approximate 6-month study intervention duration
Participant engagement assessed by the Observing Patient Involvement in Decision Making instrument (OPTION) and video recordings
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.
Time frame: At each participant's scheduled clinical encounter, for up to 6 months post-recruitment
Changes in severity of symptoms assessed by the Patient Health Questionnaire (PHQ-9)
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).
Time frame: Immediately prior to each participant's first clinical encounter and every subsequent scheduled visit for the approximate 6-month study intervention duration
Decision making preference assessed by questionnaire
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.
Time frame: Immediately prior to each participant's first clinical encounter
Global quality of life assessed by questionnaire
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).
Time frame: Immediately prior to the first clinical encounter
Changes in medication adherence assessed by participants' pharmacy records
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).
Time frame: Following the approximate 6-month study intervention completion
Fidelity to the intervention delivery
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.
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
Changes in knowledge assessed by questionnaire
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.
Time frame: Immediately following each participant's clinical encounter and every subsequent visit for the approximate 6-month study intervention duration
Changes in satisfaction and acceptability by questionnaire
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.
Time frame: Immediately following the first clinical encounter and every subsequent visit for the approximate 6-month study intervention duration
Plan to share: Undecided
Ran from Jul 2019 to primary completion in Feb 2020, 7 months.
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This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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