Expired Study
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Portland, Oregon 97227


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

1R01MH090160


NCT ID:

NCT01188135


Secondary ID:

1R01MH090160


Study Acronym:

AD_IVR


Brief Title:

Antidepressant Adherence Via AD_IVR


Official Title:

Antidepressant Adherence Via Telephonic Interactive Voice Recognition (IVR)


Overall Status:

Active, not recruiting


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Kaiser Permanente


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

3100


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Greg N Clarke, PhD
Principal Investigator
Kaiser Permanente

Study Dates

Start Date:February 2011
Completion Date:April 2014
Completion Type:Anticipated
Primary Completion Date:February 2013
Primary Completion Type:Actual
Verification Date:July 2012
Last Changed Date:January 30, 2014
First Received Date:August 23, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Participants in the IVR study arm will have a significantly higher rate of AD persistence (ELPT) than those in the TAU control condition
Time Frame:assessments at 4, 8,12 and 40 weeks
Safety Issues:False
Description: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 a
Outcome Type:Secondary Outcome
Measure:cost-effectiveness analyses
Time Frame:at the end of week 40
Safety Issues:False
Description:We will also conduct cost-effectiveness analyses comparing the arms of the study. We will employ healthcare utilization data (visits, medications, etc.) obtained from the electronic medical record, augmented with participant report of out-of-plan healthca

Study Interventions

Intervention Type:Behavioral
Name:Interactive voice messaging or Interactive voice
Description:Interactive voice telephone messages reminder participants to continue to take their antidepressive medications
Arm Name:Interactive Voice messaging

Study Arms

Study Arm Type:Experimental
Arm Name:IVR messaging w/ Psycho-ed. materials
Description: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)
Study Arm Type:No Intervention
Arm Name:Usual care arm
Description:usual care treatment with no interactive phone reminder calls phone
Study Arm Type:Experimental
Arm Name:Interactive Voice messaging
Description: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)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Kaiser Permanente
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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