DepressionNCT03887390
Depression Medication Choice Decision Aid
A study testing Depression Medication Choice in people with Depression, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Depression Medication Choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jul 2019to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Groupe de médecine de famille universitaire Maizerets
Québec, G1J 2G1
About this study
Official title: Implementation of the Depression Medication Choice Decision Aid in a Canadian Context: A Feasibility Trial
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.
Read more
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
- Being tested
- Depression Medication Choice
- Keywords
- Depression, Decision Aid, Shared Decision Making, Primary Care, Comparative Effectiveness Research
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depression Medication ChoiceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Depression Medication Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately following the first clinical encounter and every subsequent visit for the approximate 6-month study intervention duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start22 Jul 2019
- Primary completion28 Feb 2020
- Study completion20 Mar 2020
Why it stopped: First the study failed to recruit the required sample size. Second, we no longer have acess to the clinics, due to the coronavirus outbreak
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Réseau-1 Québec, CERSSPL
- Responsible party
- Principal investigator, Annie Leblanc, Laval University
- Investigators
- Annie LeBlanc, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887390
- Sponsor's protocol ID
- 120560
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26414670
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Depression Medication Choice Decision Aid in a Canadian Context: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03887390
- Acronym / sponsor ID
- 120560
- Conditions
- Depression
- Keywords
- Depression, Decision Aid, Shared Decision Making, Primary Care, Comparative Effectiveness Research
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: First the study failed to recruit the required sample size. Second, we no longer have acess to the clinics, due to the coronavirus outbreak
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Réseau-1 Québec, CERSSPL
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants in this arm will receive care as usual. |
| Depression Medication Choice | Experimental | Behavioral: Depression Medication ChoiceParticipants in this arm will have the Depression Medication Choice decision aid be made available to their clinician to be used during their clinical encounter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depression Medication ChoiceThe 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. | Behavioural | Depression Medication Choice |
Primary outcome
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.
8 secondary outcomes
Participant engagement assessed by the Observing Patient Involvement in Decision Making instrument (OPTION) and video recordings
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)
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
Time frame: Immediately prior to each participant's first clinical encounter
Global quality of life assessed by questionnaire
Time frame: Immediately prior to the first clinical encounter
Changes in medication adherence assessed by participants' pharmacy records
Time frame: Following the approximate 6-month study intervention completion
Fidelity to the intervention delivery
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
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
Time frame: Immediately following the first clinical encounter and every subsequent visit for the approximate 6-month study intervention duration
Results and safety
The study was stopped early (reason given: First the study failed to recruit the required sample size. Second, we no longer have acess to the clinics, due to the coronavirus outbreak). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 26414670LeBlanc 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annie LeBlanc, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depression Medication Choice in people with Depression, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: First the study failed to recruit the required sample size. Second, we no longer have acess to the clinics, due to the coronavirus outbreak). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03887390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020; AzTrials last refreshed its copy on 3 Nov 2026.