Electronic-Measurement Based Care for Major Depressive Disorder



Status:Withdrawn
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:2/7/2019
Start Date:June 2011
End Date:December 2016

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Electronic-Measurement Based Care (e-MBC) for Major Depressive Disorder (MDD)

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.

Major Depressive Disorder (MDD) is a serious, debilitating illness that affects persons of
all ages, races, and socioeconomic backgrounds. Despite the availability of new and effective
treatments over the last 20 years, recent evidence continues to demonstrate high rates of
inadequate antidepressant medication treatment in practice settings. Practitioners vary
widely in how they assess treatment outcomes, including symptoms, function, side-effect
frequency and burden. In contrast to other chronic medical conditions such as diabetes
mellitus, back/neck problems, or hypertension, clinicians treating patients with depression
do not routinely evaluate measurement-based care (MBC) treatment parameters. MBC provides an
essential framework for physicians to approach depression treatment consistent with their
approach for other common disorders. MBC is an effective means to provide patient-centered
care for MDD, personalizing treatment decisions based on patient progress and their ability
to tolerate the medication.

A key barrier to patient adherence with MBC treatment is that the approach requires patients
to return to the clinic for several follow-up visits. The necessity of treatment visits
varies widely among patients. Thus far, physicians using MBC for the treatment of MDD do not
have a complete set of tools that are practical to use and allow treatment to be truly
personalized patient-centered care.

One solution to this problem is to use an enhanced electronic personal health record, such as
the MyChart system. This system could be easily modified to include the central elements of
MBC for depression to allow for the systematic assessment of a patient's depressive symptom
severity, antidepressant tolerability, and adherence to treatment in a timely fashion. This
information would be available to allow the physician to provide patient-centered care by
utilizing standardized assessment to personalize treatment for depression. The proposed
electronic-MBC (e-MBC) addresses a critical gap in depression treatment by providing
regularly-scheduled drug monitoring and continuity of care, in the face of limited patient
and clinic resources.

Information technology (IT) systems have been effectively integrated into the medical
treatment of patients but have yet to have substantial impact at the point-of-care. Applying
e-MBC methods allows physicians to utilize existing information technology systems to improve
depression treatment at the point-of-care. The key features of the proposed e-MBC approach
are that it can be seamlessly integrated into standard clinical practice, and requires no
additional IT knowledge or training to be effectively utilized by physicians and clinical
staff.

In this pilot study the investigators will compare standard treatment (office based
antidepressant management) to a group receiving scheduled electronic MBC assessments via an
enhanced personal health record system (e-MBC). To date, no one has published feasibility
studies evaluating the use of personal health records for measurement-based care of
depression patients.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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