Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Cultural Formulation Interview-Engagement Aid (CFI-EA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044145
Recruitment Status : Completed
First Posted : February 6, 2017
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Neil Krishan Aggarwal, New York State Psychiatric Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Communication Adherence, Patient Behavioral: The Cultural Formulation Interview-Engagement Aid Behavioral: The Cultural Formulation Interview-Engagement Aid (Revised) Behavioral: Treatment as usual Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
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
Official Title: The Cultural Formulation Interview-Engagement Aid for Mental Health Treatment
Actual Study Start Date : September 20, 2016
Actual Primary Completion Date : September 5, 2018
Actual Study Completion Date : September 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Project 1: The Cultural Formulation Interview-Engagement Aid
The first project is creating the intervention through patient and clinician feedback at JHMC and expert consensus with the K23 mentoring team. The CFI-EA is a list of questions that clinicians can use to customize patient treatment plans based on a cultural competence assessment.
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.

Experimental: Project 2: The Cultural Formulation Interview-Engagement Aid
In this arm the study team will test the revised CFI-EA against treatment as usual in a pilot trial.
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.

Active Comparator: Project 2: Treatment as usual
Treatment as usual at JHMC consists of clinicians creating treatment plans for patients without any specific training in medical communication or treatment negotiation.
Behavioral: Treatment as usual
Standard mental health treatment at FHMC




Primary Outcome Measures :
  1. CFI-EA feasibility is defined as patient completion rates for all three sessions of the CFI-EA intervention. [ Time Frame: two months after the third session ]
    CFI-EA feasibility is defined as patient completion rates for all three sessions of the CFI-EA intervention.

  2. CFI-EA acceptability is defined as patient scores on the CSQ-8. [ Time Frame: the third session ]
    CFI-EA acceptability is defined as patient scores on the CSQ-8.


Secondary Outcome Measures :
  1. Treatment engagement defined as the percentage of patients staying within treatment 2 months after the third and last session of the CFI-EA has been delivered. [ Time Frame: 2 months after the last session of the CFI-EA ]
    Defined as the percentage of patients staying within treatment 2 months after the third and last session of the CFI-EA has been delivered.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For Project 1

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044145


Locations
Layout table for location information
United States, New York
Flushing Hospital Medical Center
Flushing, New York, United States, 11355
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Neil K Aggarwal, M.D. New York State Psychiatric Institute

Layout table for additonal information
Responsible Party: Neil Krishan Aggarwal, Research Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03044145    
Other Study ID Numbers: 7234
1K23MH102334 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neil Krishan Aggarwal, New York State Psychiatric Institute:
Cultural Competence
Patient-Clinician communication