The Cultural Formulation Interview-Engagement Aid

Completed · Not applicable

Conditions studied: Communication, Adherence, Patient

In brief

This study consists of two projects: Project 1: The study team will create and refine the CFI-EA by enrolling 3 clinicians and 9-12 patients to test the CFI-EA's feasibility and acceptability from patient and clinician feedback in a pre-pilot trial. The study team will first train clinicians in the CFI-EA by reading over the CFI-EA treatment manual and practicing how they can use it in behavioral simulations, and then check whether participants think they can do it (feasibility) and like it (acceptability) through standard measures. Following this the study team will revise the CFI-EA based on their feedback for the comparative open trial in Phase 2. Project 2: The study team will test the revised CFI-EA against treatment as usual in a pilot trial. 3 clinicians and 12-15 patients will be enrolled in each arm. As before, the study team will first train clinicians in the revised CFI-EA by reading over the CFI-EA treatment manual and practicing how they can use it in behavioral simulations. Then, the study team will check whether participants think they can do it (feasibility) and like it (acceptability) through standard measures, and in addition will also explore any initial effects on communication behaviors among patients and clinicians and treatment engagement based on treatment retention. The specific aims are: For Project 1: 1. To pretest the CFI-EA intervention in a mental health setting through a pre-pilot open trial that explores communication mechanisms of action in terms of communication behavior and cultural content, and 2. To revise the CFI-EA intervention based on patient and clinician feedback on its feasibility and acceptability. As real-world community stakeholders for whom the CFI-EA is being developed, patients and clinicians can provide helpful perspectives on how the CFI-EA can help clinicians tailor treatment plans around patient cultural views and treatment preferences to keep patients in care. The CFI-EA will be revised around areas of maximal agreement among patients and clinicians with the help of health disparities and communication experts. For Project 2: 1. To test the revised CFI-EA's feasibility and acceptability among patients and clinicians in a pilot open trial against treatment as usual, and 2. To explore the relationship between the revised CFI-EA's effects on patient-clinician communication and treatment engagement. The study team hypothesize that clinicians using the revised CFI-EA will show more positive communication behaviors compared to clinicians delivering treatment as usual and that CFI-EA patients will stay in treatment longer. Communication behaviors will be assessed through communication analysis techniques such as the Roter Interaction Analysis System.

Key facts

Study ID: NCT03044145
Run by: New York State Psychiatric Institute
People needed: 54
Starts: 2016-09-20
Expected to finish: 2018-09-05
Last updated by the study team: 2026-06-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female patients aged 18-80; Method of ascertainment: Self-report.
New patients at JHMC, referred by the intake coordinator; Method of ascertainment: Intake coordinator.
Willingness and ability to provide written informed consent after full explanation of study procedures. Method of ascertainment: RA informed consent interview that includes a capacity to consent screening form; Clinician referral.
Racial and ethnic minority (African-American, Latino/Hispanic, Asian-American/Pacific Islander, and Native American). Method of ascertainment: Self-report

You may not qualify if…

Actively suicidal or homicidal; Method of ascertainment: Self-report and clinician evaluation
In need of acute detoxification services; Method of ascertainment: Self-report and clinician evaluation
A condition that interferes with participation (i.e., dementia, mental retardation, or florid psychosis); Method of ascertainment: Clinician evaluation; patients ≥ 65 years of age will participate in a mini-cog exam.
Caucasian race; Method of ascertainment: self-report
For Project 2
Inclusion Criteria:
Male and female patients aged 18-80; Method of ascertainment: Self-report.
New patients at JHMC, referred by the intake coordinator; Method of ascertainment: Intake coordinator.
Willingness and ability to provide written informed consent after full explanation of study procedures. Method of ascertainment: RA informed consent interview that includes a capacity to consent screening form; Clinician referral.
Racial and ethnic minority (African-American, Latino/Hispanic, Asian-American/Pacific Islander, and Native American). Method of ascertainment: Self-report
Exclusion Criteria:
Actively suicidal or homicidal; Method of ascertainment: Self-report and clinician evaluation
In need of acute detoxification services; Method of ascertainment: Self-report and clinician evaluation
A condition that interferes with participation (i.e., dementia, mental retardation, or florid psychosis); Method of ascertainment: Clinician evaluation; patients ≥ 65 years of age will participate in a mini-cog exam.
Caucasian race; Method of ascertainment: self-report
Patients in Project 1 will be excluded from Participation in Project 2: Method of assessment: self-report and PI/RA evaluation.

Where it is running

Flushing Hospital Medical Center — Flushing, New York, United States

Full record on ClinicalTrials.gov

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