DepressioniADAPTNCT01502891
Making Decisions About Depression Medications
A study testing Decision Aid in people with Depression, run by Victor Montori at 4 sites in United States.
Trial summary
The purpose of this study is to determine whether the Depression Medication Choice decision aid is effective in involving patients with depression in making deliberate choices when considering medication treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2011to Oct 2013
- 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
- Presumed diagnosis of depression (PHQ-9 of 10 or greater)
- As judged by clinician, need to initiate drug treatment for depression
- Identify primary care clinician as main depression provider
- Agree to be available for follow-up survey 6 months after treatment decision
Who cannot join
- Has prior diagnosis of bipolar disorder
- Has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in same language)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin, 54601
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Mayo Clinic
Rochester, Minnesota, 55905
Entira Family Clinics (formerly known as Family Health Services Minnesota)
Saint Paul, Minnesota, 55117
About this study
Official title: Translation of Comparative Effectiveness of Depression Medications Into Practice
The purpose of this study is to determine whether the Depression Medication Choice decision aid is effective in involving patients with depression in making deliberate choices when considering medication treatment.
Read the detailed description
To determine the ability of decision aids to effectively translate a depression comparative effectiveness research (CER) review into practice, the investigators have developed a literacy-sensitive depression treatment decision aid, DEPRESSION MEDICATION CHOICE, which adapts the Agency for Healthcare Research and Quality (AHRQ)'s Effective Healthcare comparative effectiveness review and associated patient guide about antidepressant medicines to satisfy the needs of clinicians, patients, and other major stakeholders. The investigators will conduct a randomized study to estimate the effect of the decision aid on patient knowledge, patient involvement in decision making and decision-making quality, and on three and six-month measures of medication adherence and mental health, when compared with usual care.
- Conditions
- Depression
- Being tested
- Decision Aid
- Keywords
- Comparative Effectiveness Research, Decision Support Techniques, Decision Making
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
The decision aid, Depression Medication Choice, uses plain language and is designed to enhance patient understanding and satisfy the International Patient Decision Aid Standards (IPDAS) requirements for a safe and unbiased decision aid.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid | Active comparator | DEPRESSION CHOICE decision aid is provided to clinician to share with patient Receives: Other: Decision Aid |
| Normal care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Decision Making
A modified Decisional Conflict Scale will be used to ascertain decisional quality and satisfaction with decision making. The OPTION scale will be used to assess patient involvement in decision-making by reviewing video recordings of primary care visits with inter-rater reliability. Satisfaction with decision making will be assessed also by using two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support like what they received during the visit.
Measured: Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.
Knowledge Transfer
Questions have been crafted to assess knowledge about depression treatment contained in the decision aid. These questions use a response format "true/false/unsure," and are to be answered with full access to the decision aids since they are not a test of recall, but of 'use of information.'
Measured: Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.
Secondary outcomes (4)
Reach and Fidelity of Use of Decision Aids
Reach will be estimated by the proportion of the eligible patients who received the intervention of the entire eligible population allocated to its use. Fidelity will be determined using a checklist for each encounter to determine the proportion of visits in which more than >80% of decision aid items were delivered.
Measured: At end of study (approximately 2 years)
Medication Adherence to Antidepressants
Investigators will obtain pharmacy records to determine anti-depressant use, adherence, and persistence based on prescription refills.
Measured: Six months post-prescription
Depression Control
Investigators will assess patients at baseline, 3 and 6 months using the Patient Health Questionnaire 9 (PHQ-9) to measure the extent to which their depressed symptoms changed over time.
Measured: At six months post index visit
Clinician Satisfaction with Decision Aids
Investigators will survey clinicians at the end of each index visit with a standardized clinician satisfaction questionnaire.
Measured: Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victor Montori
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor-investigator, Victor Montori, Mayo Clinic
- Investigators
- Victor Montori, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502891
- Sponsor's protocol ID
- 11-003507
- Acronym
- iADAPT
- Status last verified
- Dec 2015
- First submitted
- 23 Dec 2011
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kunneman M, Branda ME, Ridgeway JL, Tiedje K, May CR, Linzer M, Inselman J, Buffington ALH, Coffey J, Boehm D, Deming J, Dick S, van Houten H, LeBlanc A, Liesinger J, Lima J, Nordeen J, Pencille L, Poplau S, Reed S, Vannelli A, Yost KJ, Ziegenfuss JY, Smith SA, Montori VM, Shah ND. Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention. Endocrine. 2022 Feb;75(2):377-391. doi: 10.1007/s12020-021-02861-4. Epub 2021 Sep 9.
PubMed 34499328LeBlanc 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 26414670LeBlanc A, Bodde AE, Branda ME, Yost KJ, Herrin J, Williams MD, Shah ND, Houten HV, Ruud KL, Pencille LJ, Montori VM. Translating comparative effectiveness of depression medications into practice by comparing the depression medication choice decision aid to usual care: study protocol for a randomized controlled trial. Trials. 2013 May 7;14:127. doi: 10.1186/1745-6215-14-127.
PubMed 23782672
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of Comparative Effectiveness of Depression Medications Into Practice
- ClinicalTrials.gov ID
- NCT01502891
- Acronym / sponsor ID
- iADAPT / 11-003507
- Conditions
- Depression
- Keywords
- Comparative Effectiveness Research, Decision Support Techniques, Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Victor MontoriUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Dec 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 2 Jan 2012 (estimated)
- 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 purpose of this study is to determine whether the Depression Medication Choice decision aid is effective in involving patients with depression in making deliberate choices when considering medication treatment.
Detailed description
To determine the ability of decision aids to effectively translate a depression comparative effectiveness research (CER) review into practice, the investigators have developed a literacy-sensitive depression treatment decision aid, DEPRESSION MEDICATION CHOICE, which adapts the Agency for Healthcare Research and Quality (AHRQ)'s Effective Healthcare comparative effectiveness review and associated patient guide about antidepressant medicines to satisfy the needs of clinicians, patients, and other major stakeholders. The investigators will conduct a randomized study to estimate the effect of the decision aid on patient knowledge, patient involvement in decision making and decision-making quality, and on three and six-month measures of medication adherence and mental health, when compared with usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision aid | Active comparator | Other: Decision AidDEPRESSION CHOICE decision aid is provided to clinician to share with patient |
| Normal care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presumed diagnosis of depression (PHQ-9 of 10 or greater)
- As judged by clinician, need to initiate drug treatment for depression
- Identify primary care clinician as main depression provider
- Agree to be available for follow-up survey 6 months after treatment decision
Key exclusion criteria (2 listed)
- Has prior diagnosis of bipolar disorder
- Has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in same language)
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 |
|---|---|---|
| Decision AidThe decision aid, Depression Medication Choice, uses plain language and is designed to enhance patient understanding and satisfy the International Patient Decision Aid Standards (IPDAS) requirements for a safe and unbiased decision aid. | Other | Decision aid |
Primary outcome
Quality of Decision Making
Time frame: Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.
A modified Decisional Conflict Scale will be used to ascertain decisional quality and satisfaction with decision making. The OPTION scale will be used to assess patient involvement in decision-making by reviewing video recordings of primary care visits with inter-rater reliability. Satisfaction with decision making will be assessed also by using two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support like what they received during the visit.
Knowledge Transfer
Time frame: Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.
Questions have been crafted to assess knowledge about depression treatment contained in the decision aid. These questions use a response format "true/false/unsure," and are to be answered with full access to the decision aids since they are not a test of recall, but of 'use of information.'
4 secondary outcomes
Reach and Fidelity of Use of Decision Aids
Time frame: At end of study (approximately 2 years)
Medication Adherence to Antidepressants
Time frame: Six months post-prescription
Depression Control
Time frame: At six months post index visit
Clinician Satisfaction with Decision Aids
Time frame: Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Derived from this study: PubMed 34499328Kunneman M, Branda ME, Ridgeway JL, Tiedje K, May CR, Linzer M, Inselman J, Buffington ALH, Coffey J, Boehm D, Deming J, Dick S, van Houten H, LeBlanc A, Liesinger J, Lima J, Nordeen J, Pencille L, Poplau S, Reed S, Vannelli A, Yost KJ, Ziegenfuss JY, Smith SA, Montori VM, Shah ND. Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention. Endocrine. 2022 Feb;75(2):377-391. doi: 10.1007/s12020-021-02861-4. Epub 2021 Sep 9.
- Derived from this study: 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.
- Derived from this study: PubMed 23782672LeBlanc A, Bodde AE, Branda ME, Yost KJ, Herrin J, Williams MD, Shah ND, Houten HV, Ruud KL, Pencille LJ, Montori VM. Translating comparative effectiveness of depression medications into practice by comparing the depression medication choice decision aid to usual care: study protocol for a randomized controlled trial. Trials. 2013 May 7;14:127. doi: 10.1186/1745-6215-14-127.
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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.
Victor Montori, MD principal investigator
Mayo Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Depression, run by Victor Montori at 4 sites in United States.
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 2 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: finished, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Decision Making (time frame: Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.). The study lists 2 primary outcomes in all. 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 NCT01502891, which also lists 3 linked publications.
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 31 Dec 2015.