Electronic-Measurement Based Care for Major Depressive Disorder

NCT01583998 | Withdrawn DMC

• 1 other identifier: 1R03MH092509-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The pilot study will evaluate whether electronic-Measurement Based Care (e-MBC) using the UT Southwestern MyChart personal health record is feasible, associated with patient and health care team satisfaction, and improves treatment outcomes compared to a standard treatment model. The project will be conducted in the Simmons Cancer Center Clinic at the University of Texas Southwestern Medical Center, Dallas as a collaborative effort between the Departments of Psychiatry, Oncology, and Family and Community Medicine. The primary patient population will include adults with significant depression and/or starting an antidepressant treatment and/or experiencing a treatment change. The study will compare two groups, an e-MBC group and an office-based standard care MBC group. Study staff will explain the study to the patients, specifically explaining that study participants will receive either office-based MBC or e-MBC. Eligible participants must be willing to receive either form of treatment monitoring. Participating patients will be randomly assigned to receive either e-MBC or office-based MBC. In the e-MBC group once a month the study nurse will send a prompt from the participating patients treating physician requesting the patient to use the MyChart system to fill-out the MBC scales. Beyond these monthly assessments, patients will be encouraged to utilize the MyChart MBC assessments (e-MBC) at any time to communicate with their physician. Patients experiencing difficulties using the e-MBC system will be given additional instruction by the study nurse. Patients and physicians will be trained in the use of the eMBC system. In the office-based MBC group the study nurse will schedule monthly treatment visits and request the patient call as needed to report symptoms. The evaluation period will be 6 months.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; MDD; Depression; Measurement Based Care; MBC; electronic health records; EHR; electronic medical records; EMR

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  Depression severity assessment

  Every 30 days for 6 months

Secondary Outcomes (4)

• Frequency, Intensity, and Burden of Side Effect Rating (FIBSER)

  Every 30 days for 6 months

• Patient Satisfaction Questionnaire (PSQ)

  At the end of study treament (6 months from the first assessment)

• Physician Evaluation of Ease of Use Survey (EEUS)

  At the end of study treament (6 months from the first assessment)

• Physician Evaluation of Usefulness Survey (EUS)

  At the end of study treament (6 months from the first assessment)

Study Arms (2)

e-MBC

ACTIVE COMPARATOR

Patients will receive e-MBC

Behavioral: e-MBC

Treatment as Usual Control

NO INTERVENTION

Patients receive standard treatment

Interventions

e-MBC BEHAVIORAL

antidepressant treatment

Also known as: e-MBC for MDD

e-MBC

Eligibility Criteria

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

You may qualify if:

• Patients must plan to continue living in the clinic area throughout the study
• Patients must be 18 to 65 years of age
• Patients must give written informed consent
• Patient must have clinically significant depression and/or starting an antidepressant treatment and/or experiencing a antidepressant treatment change
• Patients must be willing and able to use MyChart to communicate with their physician

You may not qualify if:

• Patients with a current Axis I diagnosis of Bipolar disorder or Schizophrenia
• Patients who cannot read and understand English since all research instruments are not yet translated and validated in Spanish or other languages
• Patients whose clinical status requires inpatient treatment at the time of baseline interview.
• Current substance abuse or dependence
• Patients with current suicidal ideation
• Patients with general medical conditions that contraindicate antidepressant medications

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 24, 2012
• Study Start: June 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

US (1)