Patient-Centered Medication Adherence Intervention for Schizophrenia

NCT00144027 | Completed Results

• 1 other identifier: IIR 03-257
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

patient non-adherence; intervention studies

Outcome Measures

Primary Outcomes (1)

• Antipsychotic Medication Adherence

  The self-report adherence measure asked patients to think about the past four weeks and report to what extent they took their medication for mental, emotional, or nervous problems and report the result on a 5-point Likert scale ranging from 'I never missed taking my medicine' to 'I stopped taking the medicine altogether'. Patients who received depot injections were asked to think about the past six months. Self-report adherence was defined as 1=I never missed taking my medicine' and 0=any other response to the medication adherence question.

  6-months

Study Arms (2)

Control

NO INTERVENTION

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

Antipsychotic adherence intervention

EXPERIMENTAL

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.

Behavioral: Antipsychotic medication adherence intervention

Interventions

Antipsychotic medication adherence intervention 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.

Antipsychotic adherence intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

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

No. Little Rock, Arkansas, 72114-1706, United States

Location

Related Publications (1)

• 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.

  PMID: 24369177 RESULT

MeSH Terms

Conditions

Schizophrenia; Patient Compliance

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Jeff Pyne
• Organization: Central Arkansas Veterans Healthcare System

jeffrey.pyne@va.gov

501-257-1083

Study Officials

• Jeffrey M. Pyne, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: December 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 24, 2015
• Results First Posted: December 23, 2014

Record last verified: 2014-07

Locations

US (1)