The Cultural Formulation Interview-Engagement Aid

Summary

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.

Conditions

• Communication
• Adherence, Patient

Interventions

BEHAVIORAL

The Cultural Formulation Interview-Engagement Aid

Culture affects how all people communicate and understand the world. Culture is important because patients and clinicians from different cultural backgrounds may have different preferences for communication. Mismatch in the clinician's approach and the patient's expectations of care can lead to patient dissatisfaction and discontinuation with treatment. Patients and clinicians may also have different views about what caused an illness, how it functions, what makes it better or worse, and the types of treatment needed. The CFI-EA is a series of questions over three sessions that clinicians can use to clarify patient views about treatment and communication so that patients stay in treatment longer. Clinicians can use the CFI-EA to customize their current treatment plans.

BEHAVIORAL

The Cultural Formulation Interview-Engagement Aid (Revised)

The study team will revise the CFI-EA based on patient and clinician feedback. The study team expects that the revisions will consist of changes to the questions such as adding or subtracting specific items or revising the wording of the content. The study team do not anticipate other changes, though we will let our empirical data analyses guide revisions in consultation with the K23 mentor team.

BEHAVIORAL

Treatment as usual

Standard mental health treatment at FHMC

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• New York State Psychiatric Institute

  lead OTHER

Principal Investigators

• Neil K Aggarwal, M.D. · New York State Psychiatric Institute

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-20

Primary Completion

2018-09-05

Completion

2018-09-05

Countries

• United States

Study Locations