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Making Decisions About Depression Medications (iADAPT)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Sponsored by
Victor Montori
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring Comparative Effectiveness Research, Decision Support Techniques, Decision Making

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Has prior diagnosis of bipolar disorder
  • Has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in same language)

Sites / Locations

  • Hennepin County Medical Center
  • Mayo Clinic
  • Entira Family Clinics (formerly known as Family Health Services Minnesota)
  • Mayo Clinic Health System - Franciscan Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Decision aid

Normal care

Arm Description

DEPRESSION CHOICE decision aid is provided to clinician to share with patient

Outcomes

Primary Outcome Measures

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.
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.'

Secondary Outcome Measures

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.
Medication Adherence to Antidepressants
Investigators will obtain pharmacy records to determine anti-depressant use, adherence, and persistence based on prescription refills.
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.
Clinician Satisfaction with Decision Aids
Investigators will survey clinicians at the end of each index visit with a standardized clinician satisfaction questionnaire.

Full Information

First Posted
December 23, 2011
Last Updated
December 30, 2015
Sponsor
Victor Montori
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01502891
Brief Title
Making Decisions About Depression Medications
Acronym
iADAPT
Official Title
Translation of Comparative Effectiveness of Depression Medications Into Practice
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Victor Montori
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Comparative Effectiveness Research, Decision Support Techniques, Decision Making

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decision aid
Arm Type
Active Comparator
Arm Description
DEPRESSION CHOICE decision aid is provided to clinician to share with patient
Arm Title
Normal care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Decision Aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Decision Making
Description
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.
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.
Title
Knowledge Transfer
Description
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.'
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.
Secondary Outcome Measure Information:
Title
Reach and Fidelity of Use of Decision Aids
Description
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.
Time Frame
At end of study (approximately 2 years)
Title
Medication Adherence to Antidepressants
Description
Investigators will obtain pharmacy records to determine anti-depressant use, adherence, and persistence based on prescription refills.
Time Frame
Six months post-prescription
Title
Depression Control
Description
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.
Time Frame
At six months post index visit
Title
Clinician Satisfaction with Decision Aids
Description
Investigators will survey clinicians at the end of each index visit with a standardized clinician satisfaction questionnaire.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Has prior diagnosis of bipolar disorder Has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in same language)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Montori, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Entira Family Clinics (formerly known as Family Health Services Minnesota)
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55117
Country
United States
Facility Name
Mayo Clinic Health System - Franciscan Healthcare
City
LaCrosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34499328
Citation
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. Erratum In: Endocrine. 2023 Jan;79(1):221-222.
Results Reference
derived
PubMed Identifier
26414670
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.
Results Reference
derived
PubMed Identifier
23782672
Citation
LeBlanc 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.
Results Reference
derived
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

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Making Decisions About Depression Medications

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