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Clinical Trials/NCT03887390
NCT03887390TerminatedNot Applicable

Implementation of the Depression Medication Choice Decision Aid in a Canadian Context: A Feasibility Trial

Laval University1 site in 1 country3 target enrollmentStarted: July 22, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
3
Locations
1
Primary Endpoint
Changes in decisional conflict assessed by the Decisional Conflict Scale (DCS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Usual Care

No Intervention

Participants in this arm will receive care as usual.

Depression Medication Choice

Experimental

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.

Intervention: Depression Medication Choice (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • Global quality of life assessed by questionnaire(Immediately prior to the first clinical encounter)
  • Changes in severity of symptoms assessed by the Patient Health Questionnaire (PHQ-9)(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(Immediately prior to each participant's first clinical encounter)
  • Participant engagement assessed by the Observing Patient Involvement in Decision Making instrument (OPTION) and video recordings(At each participant's scheduled clinical encounter, for up to 6 months post-recruitment)
  • Changes in medication adherence assessed by participants' pharmacy records(Following the approximate 6-month study intervention completion)
  • Fidelity to the intervention delivery(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(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(Immediately following the first clinical encounter and every subsequent visit for the approximate 6-month study intervention duration)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Annie Leblanc

Associate Professor

Laval University

Study Sites (1)

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