Clinical trial NCT03887390: Depression Medication Choice Decision Aid
Official title: Implementation of the Depression Medication Choice Decision Aid in a Canadian Context: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Keywords: Depression
Decision Aid
Shared Decision Making
Primary Care
Comparative Effectiveness Research
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Réseau-1 Québec
name: CERSSPL
First posted: 2019-03-25
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Changes in decisional conflict assessed by the Decisional Conflict Scale (DCS)
timeFrame: Immediately following each participant's first clinical encounter and every subsequent scheduled visit for the approximate 6-month study intervention duration
Secondary outcomes:
measure: Participant engagement assessed by the Observing Patient Involvement in Decision Making instrument (OPTION) and video recordings
timeFrame: At each participant's scheduled clinical encounter, for up to 6 months post-recruitment
measure: Changes in severity of symptoms assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: Immediately prior to each participant's first clinical encounter and every subsequent scheduled visit for the approximate 6-month study intervention duration
measure: Decision making preference assessed by questionnaire
timeFrame: Immediately prior to each participant's first clinical encounter
measure: Global quality of life assessed by questionnaire
timeFrame: Immediately prior to the first clinical encounter
measure: Changes in medication adherence assessed by participants' pharmacy records
timeFrame: Following the approximate 6-month study intervention completion
measure: Fidelity to the intervention delivery
timeFrame: 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
measure: Changes in knowledge assessed by questionnaire
timeFrame: Immediately following each participant's clinical encounter and every subsequent visit for the approximate 6-month study intervention duration
measure: Changes in satisfaction and acceptability by questionnaire
timeFrame: Immediately following the first clinical encounter and every subsequent visit for the approximate 6-month study intervention duration
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Groupe de médecine de famille universitaire Maizerets
Study officials:
affiliation: Laval University
name: Annie LeBlanc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: LeBlanc A, Herrin J, Williams MD, Inselman JW, Branda ME, Shah ND, Heim EM, Dick SR, Linzer M, Boehm DH, Dall-Winther KM, Matthews MR, Yost KJ, Shepel KK, Montori VM. Shared Decision Making for Antidepressants in Primary Care: A Cluster Randomized Trial. JAMA Intern Med. 2015 Nov;175(11):1761-70. doi: 10.1001/jamainternmed.2015.5214.