Clinical trial NCT00144027: Patient-Centered Medication Adherence Intervention for Schizophrenia
Official title: Patient-Centered Medication Adherence Intervention for Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: patient non-adherence
intervention studies
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-09-02
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).

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.

Primary outcomes:
measure: Antipsychotic Medication Adherence
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: No. Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
state: Arkansas
Study officials:
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
name: Jeffrey M. Pyne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.