Depression Medication Choice Decision Aid

NCT03887390 | Terminated

• 1 other identifier: 120560
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Decision Aid; Shared Decision Making; Primary Care; Comparative Effectiveness Research

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately following each participant's first clinical encounter and every subsequent scheduled visit for the approximate 6-month study intervention duration

Secondary Outcomes (8)

• 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 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

• Global quality of life assessed by questionnaire

  Immediately prior to the first clinical encounter

• Changes in medication adherence assessed by participants' pharmacy records

  Following the approximate 6-month study intervention completion

Study Arms (2)

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.

Behavioral: Depression Medication Choice

Interventions

Depression Medication Choice BEHAVIORAL

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.

Depression Medication Choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Réseau-1 Québec: collaborator
• CERSSPL: collaborator

Study Sites (1)

Groupe de médecine de famille universitaire Maizerets

Québec, G1J 2G1, Canada

Location

Related Publications (1)

• 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.

  PMID: 26414670 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Annie LeBlanc, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 25, 2019
• Study Start: July 22, 2019
• Primary Completion: February 28, 2020
• Study Completion: March 20, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

CA (1)