The Cultural Formulation Interview-Engagement Aid
Condition: Communication; Adherence, Patient
Study type: Interventional

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.
    

Detailed description: 
      Members of underserved racial/ethnic minority groups who participate more actively in the
      treatment process have almost three times the odds of staying in treatment and following up
      with appointments compared to standard treatment. Improving patient-clinician communication
      may therefore improve treatment engagement, from starting and participating in treatment
      actively to maintaining treatment for the successful resolution of symptoms and improvements
      in quality of life. Interventions that enhance communication behaviors by asking patients
      about their cultural views, using open-ended questions, establishing rapport, and using
      patient terms can increase patient participation and satisfaction. Interventions that expose
      clinicians to cultural content by asking patients about preferences for treatment, barriers
      to accessing services, the role of support from family or friends, and that encourage
      information exchange also improve treatment engagement. The goal of this study is to develop
      a communication intervention that improves treatment engagement for members of underserved
      racial and ethnic minority groups by improving clinician communication behaviors and exposing
      them to patient cultural content. Here, culture is understood as a dynamic process of meaning
      making between the patient and clinician. This intervention is not designed for patients
      belonging to a specific racial or ethnic group, but to improve general communication between
      patients and clinicians. The intervention improves communication by making communication
      behaviors and cultural content topics of explicit conversation rather than allowing
      clinicians to make cultural assumptions and take them for granted. We are focusing on racial
      and ethnic minorities because of significant evidence documenting disparities in health
      communication and care.

      In session 1, the clinician does the full CFI in DSM-5 (~15 minutes) and then completes the
      full standard intake with information not already obtained through the CFI (~35 minutes). In
      sessions 2 and 3, the clinician integrates the CFI-EA (~5 minutes) within regular care in
      standard appointments. At JHMC, Session 2 lasts 60 minutes and is for treatment initiation.
      Session 3 lasts 20-30 minutes and is to check for treatment continuation. Because this is a
      grant to train in developing mental health interventions, the study team is following an NIMH
      model known as the Stage Model of Intervention Development. The first project is creating the
      intervention through patient and clinician feedback at JHMC and expert consensus with the K23
      mentoring team. The second project is testing the intervention in a trial that compares the
      CFI-EA to treatment as usual. Patients for Project 1 will be recruited through a sample of
      convenience among patients accessing care on the days the research assistant is in the
      waiting area. For project 2, patients will be sampled consecutively by the JHMC's intake
      coordinator from the time that the project starts until the target enrollment is reached. The
      intake coordinator will keep a record of all patients who agree and do not agree to enroll in
      the study. Patients who agree to be enrolled during Project 2 will be recruited by the
      research assistant in the waiting area and then assigned randomly to either CFI-EA clinicians
      or treatment-as-usual clinicians based on a random number generator. The study team is using
      the same study measures in both projects to examine whether revisions to the CFI-EA conducted
      at the end of Project 1 show improvements in outcomes after Project 2.
    

Intervention name(s): The Cultural Formulation Interview-Engagement Aid; The Cultural Formulation Interview-Engagement Aid (Revised); Treatment as usual
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; Standard mental health treatment at FHMC
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study follows an NIMH model known as the Stage Model of Intervention Development. The first project is creating a cross-cultural communication intervention designed to improve patient adherence in mental health services through patient and clinician feedback at JHMC and expert consensus with my K23 mentoring team. The second project is testing the intervention in a trial that compares the CFI-EA to treatment as usual.
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Cultural Competence; Patient-Clinician communication