Using mHealth to Optimize Pharmacotherapy Regimens

New York State Psychiatric Institute

Status: Completed

Conditions: Schizophrenia; First-Episode Psychosis

Treatments: Other: mHealth Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04248517

7900 (Other Identifier)

P50MH115843 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This project will use a smartphone technology to improve medication prescribing for individuals with FEP. We will collect real-time symptom and functioning data via smartphones to provide prescribers and other clinical team members with clinically relevant and time-sensitive information that will inform and promote shared decision making (SDM) and personalized interventions. The result will be a time-sensitive, data-driven, collaborative process to optimize medication regimens in order to maximize benefits, minimize harms, and promote adherence.

Full description

Comprehensive early treatment of individuals experiencing schizophrenia has the potential to alter the course of illness and improve long-term outcomes. Psychotropic medications are a critical component of early treatment strategies. First-episode psychosis (FEP) is a critical time to optimize prescribing but evidence suggests that prescribing for this population is suboptimal.

A contributing factor to these difficulties is thought to be the lack of accurate information about the effects of medications on symptoms, their side effects, as well as their behavioral, cognitive, and emotional correlates. At medication management appointments, prescribers typically rely on patients' recollection of how they were doing over periods of weeks. Such retrospective assessments are problematic as they are vulnerable to the influence of memory difficulties, cognitive biases including recency effects and frequency illusions, and reframing. Recent advances in smartphone technologies (mobile Health; mHealth) may help to overcome many of the limitations of retrospective assessments.

This pilot study will be a collaboration with OnTrackNY, an innovative coordinated specialty care (CSC) program for individuals aged 16-30 who are experiencing FEP. OnTrackNY originated as part of the NIMH Recovery After an Initial Schizophrenia Episode (RAISE) Implementation and Evaluatoin Study. The initial phase of this project will use input from stakeholders including patients, front-line providers, clinical leaders, and members of the research team to adapt and refine the mHealth intervention to improve feasibility and clinical utility. A pilot study at 3 OnTrackNY sites will then examine its feasibility and effectiveness by comparing the management and outcomes of 60 patients randomly assigned to the mHealth application or usual care.

Enrollment: 23 patients

Sex: All

Ages: 16 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female OnTrackNY participants, ages 16 to 30, of any race/ethnicity
• Able and willing to give informed consent and participate in the intervention
• Participating in OnTrackNY for less than 1 year because this group may be more in need of medication adjustments and will be less likely to graduate from the program before 6 months of participation.

Exclusion criteria

• Suicidal at baseline with C-SSRS score 4 or 5.
• PANSS baseline score of 5 (moderately severe) or greater on the Conceptual Disorganization item (P2)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

mHealth intervention group

Experimental group

Description:

participants in the mHealth Group will download the app on to their smartphone and complete ecological momentary assessments on 3 consecutive weekdays every 2 weeks for 6 months.

Treatment:

Other: mHealth Intervention

Treatment as Usual group

No Intervention group

Description:

participants will undergo their routine treatment.