Antidepressant Adherence Via AD_IVR
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): Interactive voice messaging or Interactive voice messaging + psycho ed materials
Intervention type(s): Behavioral
Intervention description(s): Interactive voice telephone messages reminder participants to continue to take their antidepressive medications
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; interactive voice messaging; patient persistence with antidepressant medication treatment