Clinical trial NCT01188135: Antidepressant Adherence Via AD_IVR
Official title: Antidepressant Adherence Via Telephonic Interactive Voice Recognition (IVR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: depression
interactive voice messaging
patient persistence with antidepressant medication treatment
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-08-25
Enrollment: 6058
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participants in the IVR study arm will have a significantly higher rate of AD persistence (ELPT) than those in the TAU control condition
timeFrame: assessments at 4, 8,12 and 40 weeks
Secondary outcomes:
measure: cost-effectiveness analyses
timeFrame: at the end of week 40
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Greg N Clarke, PhD
role: PRINCIPAL_INVESTIGATOR
References: