Clinical trial NCT00755235: Feasibility of Depression Care Management by E-mail
Official title: Pilot Trial of Depression Care Management by Electronic Secure Messaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Primary care
Effectiveness
Care management
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-09-18
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will test whether an electronic system that monitors and sends messages to help people with depression could be feasible, acceptable, and potentially effective as a treatment.

Detailed description: Symptoms of depression, such as persistent sadness, problems sleeping, and inability to feel pleasure, interfere with the daily lives of more than 20 million Americans. Previous research indicates that telephone care management systems improve the quality and outcomes of depression care, but are too expensive to be used widely. Using secure messaging over e-mail would be more cost effective than telephone care. This study will examine whether a secure messaging care management program would be feasible, based on whether participants are willing to sign up for and continue with the program, and whether the program has a positive effect on those participants enrolled in the program.

Potential participants for this study will be contacted via e-mail, with a follow-up telephone call if they do not respond to the e-mail message. Only people who have used e-mails in the past year and who are starting antidepressant treatment will be contacted. The percentage of people contacted who enroll will be recorded.

Participation in this study will last 6 months. Participants will be randomly assigned to receive either a secure messaging care management program, based on effective telephone management programs, or their usual care with no intervention. Those receiving the secure messaging program will receive an initial welcome message and monitoring messages approximately 2, 6, and 10 weeks after treatment has begun. The monitoring messages will include structured assessments of depression severity, medication adherence, medication side effects, and barriers to continuing treatment. Participants who do not respond to monitoring messages will receive up to two e-mailed reminders. Care managers will analyze the results of monitoring messages, provide feedback and recommendations to physicians, coordinate physician follow-ups, and facilitate emergency care or specialty referrals. Care managers will also provide patients with motivation, based on semi-scripted protocols, and education concerning their disorder and treatment. Measures of the success of the study will be taken at enrollment and after 6 months of participation. Specific measurements will include the response rate of recruitment e-mails, response rate for follow-up data collection, proportion of those in the secure messaging program who complete the monitoring assessments, effects of the program on antidepressant treatment, and effects of the program on patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Patient at Capitol Hill or Rainier clinics of Group Health Cooperative in Seattle
* New prescription of an antidepressant, defined by an interval of at least 180 days since a previous antidepressant prescription
* Indication of depression, defined by a visit diagnosis of major depressive disorder (Internal Classification of Diseases 9th Revision \[ICD9\] codes 296.2x or 296.3x) within 30 days of the first prescription
* Has used secure messaging, or e-mailing, at least twice in the last 12 months

Exclusion Criteria:

* Any diagnosis of psychotic disorder or bipolar disorder in the prior 2 years
* Any prescription for mood stabilizer or antipsychotic medication in the prior 2 years

Primary outcomes:
measure: 20-Item Symptom Checklist Depression Scale
timeFrame: Measured at baseline and after 6 months of treatment
Secondary outcomes:
measure: Treatment Satisfaction
timeFrame: Measured after 6 months of treatment
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Cooperative Center for Health Studies
state: Washington
Study officials:
affiliation: Group Health Cooperative Center for Health Studies
name: Gregory E. Simon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simon GE, Ralston JD, Savarino J, Pabiniak C, Wentzel C, Operskalski BH. Randomized trial of depression follow-up care by online messaging. J Gen Intern Med. 2011 Jul;26(7):698-704. doi: 10.1007/s11606-011-1679-8. Epub 2011 Mar 8.