Antidepressant Adherence Via AD_IVR

Antidepressants (AD) 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. Fortunately, AD
adherence can be improved via interventions consistent with the Chronic Care Model (CCM).
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 AD adherence
program, specifically a direct-to-patient, automated telephone interactive voice recognition
(IVR) intervention to boost patient AD persistence. This intervention is consistent with the
Chronic Care Model but is much more amenable to widespread dissemination over a large
population. In an initial startup period the investigators will adapt and pilot existing IVR
adherence calls and scripts, informed by formative focus groups and interviews with key
informants (patients, providers). Following this, the investigators will conduct a
pragmatic, randomized clinical trial at approximately 6,000 HMO members ages 21 to 75,
recently started on an incident course of AD medications for associated unipolar depression
and/or anxiety diagnoses. Participants will be randomized (1:1:1:1); 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 for 40 weeks. The two IVR
interventions will deliver reminder and/or tardy calls timed to projected AD refill dates.
The intervention arms also optionally offers transfer to a live pharmacist or the HMO mail
refill pharmacy. The primary outcome will be the Estimated Level of Persistence with Therapy
(ELPT) for ADs, based on prescription refill data abstracted from the HMO's electronic
medical record (EMR). We hypothesize that participants in the IVR study plus psycho-ed. arm
will have a significantly higher rate of AD persistence than those in the TAU control
condition or IVR only. Secondary medication adherence outcomes include continuous measure of
medication acquisition (CMA) and continuous measure of medication gaps (CMG). Other
secondary outcomes include self-report depression and anxiety symptoms, general health
status, patient and provider satisfaction, and healthcare costs and usage. We will also
conduct cost-effectiveness analyses (CEA) 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. Finally, evaluative qualitative interviews will
be conducted with key stakeholders to identify barriers/facilitators of intervention
implementation—keys for future dissemination.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.