Patient-Centered Medication Adherence Intervention for Schizophrenia

NCT ID: NCT00144027

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2009-07-31

Brief Summary

Efficacious antipsychotic medication treatments for schizophrenia are available; however , antipsychotic regimens frequently do not achieve their potential because of poor medication adherence. To date, medication adherence interventions have not been widely adopted or sustained in "real-world" practice settings. One reason for this is the substantial resource investment necessary to implement and sustain available interventions. In response to these problems, we developed a patient-centered adherence intervention based on patient-identified barriers, facilitators, and motivators (BFMs) for medication adherence. The intervention includes a BFM survey (checklist and preference weighting exercise to determine the patient's most important BFM) and a brief list of adherence enhancing suggestions (Options List) tailored to the patient-identified BFMs and compatible with CPRS. The long-term objective of this proposed research is to improve antipsychotic medication adherence and clinical outcomes for patients with schizophrenia using a cost-effective medication adherence intervention. The short-term objectives are to refine and test a patient-centered medication adherence intervention for VA patients with schizophrenia and specifically to: 1. Enhance the feasibility and acceptability of the BFM intervention by reducing the burden on patients and mental health providers through BFM checklist item reduction, provider intervention input, and patient intervention input. We hypothesize that our use of end-user input will result in at least 80% of intervention patients having documentation of a BFM intervention in CPRS. 2. Compare the effects of the BFM intervention versus usual care on changes in medication adherence and schizophrenia symptom severity. We hypothesize that the intervention will result in a) greater medication adherence and b) lower schizophrenia symptom severity than usual care. 3. Exploratory objective: compare the effects of the BFM intervention versus usual care on changes in patient health-related quality of life. We hypothesize that the intervention will result in greater health-related quality of life than usual care.

Detailed Description

BFM intervention refinement will be accomplished in five phases. Phase one will include reducing the number of items in the BFM checklist by administering the expanded checklist to at least 50 patients with schizophrenia and using the standard psychometric item-reduction strategies to create a shorter checklist. In phase two we will conduct mental health provider focus groups to discuss the content of the Options List and the delivery of the intervention. In phase three we will automate the BFM intervention using an existing web-based computer touch-screen platform. In phase four we will conduct individual patient debriefing interviews with 30 patients to evaluate the understandability of the BFM survey. In phase five we will evaluate the test/re-test reliability of the survey in a new sample of 30 patients. BFM intervention implementation will include a stratified randomization of patients to the BFM intervention or usual care. BFM intervention evaluation will include testing the feasibility, acceptability, and outcomes associated with the intervention versus usual care in a single trial with 200 patients (100 intervention and 100 usual care).

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Control

The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Antipsychotic adherence intervention

Antipsychotic Medication Adherence Intervention which included the Barriers, Facilitators, and Motivators Checklist summary and Adherence tips provided in hard copy to patient and electronic copy to mental health provider.

Group Type: EXPERIMENTAL

Antipsychotic medication adherence intervention

Intervention Type: BEHAVIORAL

The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits.

Interventions

Antipsychotic medication adherence intervention

The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• medical chart diagnosis of schizophrenia or schizoaffective disorder;
• currently prescribed outpatient antipsychotic medication (oral or depot);
• patient must have adequate capacity to provide informed consent, understand the nature of the study, and sign an informed consent document.

Exclusion Criteria

• significant cognitive impairment as indicated by a score > 10 on the Blessed Orientation-Memory-Concentration (BOMC) Test.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey M. Pyne, MD

Role: PRINCIPAL_INVESTIGATOR

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Locations

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

No. Little Rock, Arkansas, United States

Countries

United States

References

Pyne JM, Fischer EP, Gilmore L, McSweeney JC, Stewart KE, Mittal D, Bost JE, Valenstein M. Development of a Patient-Centered Antipsychotic Medication Adherence Intervention. Health Educ Behav. 2014 Jun;41(3):315-24. doi: 10.1177/1090198113515241. Epub 2013 Dec 25.

Reference Type: RESULT

PMID: 24369177 (View on PubMed)

Other Identifiers

IIR 03-257

Identifier Type: -

Identifier Source: org_study_id