Antidepressant Adherence Via AD_IVR

NCT01188135 | Completed Phase 3 DMC

• 1 other identifier: 1R01MH090160
• Study Type: interventional
• Target: 6,058
• Locations: 1 country
• Sites: 1

Brief Summary

Antidepressants are the most frequently prescribed class of psycho¬tropic medications and the most common treatment for depression and anxiety disorders-yet patient adherence is poor and is widely viewed as contributing to reduced effectiveness. However, traditionally-delivered adherence promotion programs are complex, staff-intensive, and costly-barriers to wider adoption, implementation, and maintenance of these programs in real-world settings. Our aim is to carry out a trial of a low-cost, IT-enabled Antidepressants adherence program, specifically a direct-to-patient, automated telephone interactive voice recognition (IVR) intervention to boost patient Antidepressants persistence. We will conduct a randomized clinical trial enrolling at least 6,000 Kaiser Permanente NW Region health plan members ages 21 to 75, who had recently started on Antidepressants medications for depression and/or anxiety diagnoses. Participants will be randomized one of four arms;1. a no contact control arm, 2. a treatment as usual (TAU) control condition 3. to TAU plus the IVR automated telephone program and 4. a TAU plus the IVR automated telephone program plus receipt of psycho-education materials about antidepression medication use. Recruitment will continue for up to 18 months, with periodic participant-level follow-up assessment for the intervention participants for 40 weeks. The IVR intervention portion of the program will deliver reminder and/or tardy calls timed to projected Antidepressants refill dates. The intervention also optionally offers brief psycho-education, or transfer to a live pharmacist or the Kaiser mail refill pharmacy. The primary outcome will be the Estimated Level of Persistence with Therapy (continued us of Antidepressants medications). This will be based on prescription refill data abstracted from the Kaiser's electronic medical record (EMR). We hypothesize that participants in the IVR + psycho-education materials study arm will have a significantly higher rate of Antidepressants persistence than those in the TAU control condition ons only IRV call arms. We will also conduct cost-effectiveness analyses to assess the value-for-money (cost per depression free day gained, and cost per quality adjusted life year gained) of the IVR technology compared to TAU. Costs will include IVR development and implementation as well as EMR-derived healthcare utilization data (visits, medications, etc.), augmented with participant report of out-of-plan services.

Conditions

Major Depressive Disorder

Keywords

depression; interactive voice messaging; patient persistence with antidepressant medication treatment

Outcome Measures

Primary Outcomes (1)

• Participants in the IVR study arm will have a significantly higher rate of AD persistence (ELPT) than those in the TAU control condition

  A randomized controlled trial of adult members of a (HMO) starting an incident episode of antidepressant treatment, (a) nocontact control,(b) treatment as usual (TAU) versus (c) TAU plus the IVR automated telephone adherence program, (d)TAU plus the IVR automated telephone adherence program plus mailed psycho-education materials. The primary outcome will be antidepressant persistence, operationalized as the Estimated Level of Persistence with Therapy. Secondary outcomes will include patient and provider satisfaction, healthcare utilization, and patient self-reported depression and anxiety.

  assessments at 4, 8,12 and 40 weeks

Secondary Outcomes (1)

• cost-effectiveness analyses

  at the end of week 40

Study Arms (3)

Interactive Voice messaging

EXPERIMENTAL

Participants will receive three kinds of interventions calls from the IVR phone system. (1) The first call is to orient the participant to the IVR system, ask permission to leave detailed messages in the future, and to encourage adherence in this initial period of great risk for premature discontinuation. (2) The Refill Reminder Call is to remind patients that a refill their antidepressant medications and occurs approximately 6 days before the prior dispense of medication is due to run out. (3) The "Tardy" Refill Call is made to participants for whom EMR records indicate that a scheduled refill was missed

Behavioral: Interactive voice messaging or Interactive voice messaging + psycho ed materials

Usual care arm

NO INTERVENTION

usual care treatment with no interactive phone reminder calls phone

IVR messaging w/ Psycho-ed. materials

EXPERIMENTAL

Participants will receive three kinds of interventions calls from the IVR phone system. (1) The first call is to orient the participant to the IVR system, ask permission to leave detailed messages in the future, and to encourage adherence in this initial period of great risk for premature discontinuation. (2) The Refill Reminder Call is to remind patients that a refill their antidepressant medications and occurs approximately 6 days before the prior dispense of medication is due to run out. (3) The "Tardy" Refill Call is made to participants for whom EMR records indicate that a scheduled refill was missed. In addition, participants will receive educational material about antidepressant medication.

Behavioral: Interactive voice messaging or Interactive voice messaging + psycho ed materials

Interventions

Interactive voice messaging or Interactive voice messaging + psycho ed materials BEHAVIORAL

Interactive voice telephone messages reminder participants to continue to take their antidepressive medications

IVR messaging w/ Psycho-ed. materials; Interactive Voice messaging

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be Kaiser Permanente NW Region health plan members ages of 21 and 75 and be members for at least 6 months prior to the initial antidepressive medications dispense.
• Participants must have an EMR chart diagnosis or presenting complaint of a unipolar mood diagnosis, anxiety disorder, or any subclinical or "not otherwise categorized" (NOC) variant of these.
• The participants' providers must give permission to study staff for their patients' enrollment in the study. There must be no indication of pending HMO disenrollment in the membership data.
• Participants must have an initial dispense of an antidepressant medication, with no dispense of any of these agents in the prior 6 months.

You may not qualify if:

• Participants must have no EMR chart diagnosis that is likely to impair participant ability to complete evaluations or take part in the intervention. These include psychiatric diagnoses such as bipolar disorder I (BP II is acceptable), schizophrenia, schizo-affective disorder, or similar diagnoses indicating psychosis.
• The investigators will also exclude individuals with any chart diagnosis indicating significant intellectual impairment, such as any dementia disorder, mental retardation, or profound developmental disorder such as autism.

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• Greg N Clarke, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 25, 2010
• Study Start: February 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: November 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

US (1)