跳至主要内容
临床试验/NCT03887390
NCT03887390终止不适用

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

Laval University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Changes in decisional conflict assessed by the Decisional Conflict Scale (DCS)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Changes in decisional conflict assessed by the Decisional Conflict Scale (DCS)

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Annie Leblanc

Associate Professor

Laval University

研究点 (2)

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