The Cultural Formulation Interview-Engagement Aid

NCT03044145 | Completed

• 2 other identifiers: 72341K23MH102334
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. 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. 2.To revise the CFI-EA intervention based on patient and clinician feedback on its feasibility and acceptability.
3. 3.To test the revised CFI-EA's feasibility and acceptability among patients and clinicians in a pilot open trial against treatment as usual, and
4. 4.To explore the relationship between the revised CFI-EA's effects on patient-clinician communication and treatment engagement.

Conditions

Communication; Adherence, Patient

Keywords

Cultural Competence; Patient-Clinician communication

Outcome Measures

Primary Outcomes (2)

• CFI-EA feasibility is defined as patient completion rates for all three sessions of the CFI-EA intervention.

  CFI-EA feasibility is defined as patient completion rates for all three sessions of the CFI-EA intervention.

  two months after the third session

• CFI-EA acceptability is defined as patient scores on the CSQ-8.

  CFI-EA acceptability is defined as patient scores on the CSQ-8.

  the third session

Secondary Outcomes (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.

  2 months after the last session of the CFI-EA

Study Arms (3)

Project 1: The Cultural Formulation Interview-Engagement Aid

EXPERIMENTAL

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

Project 2: The Cultural Formulation Interview-Engagement Aid

EXPERIMENTAL

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)

Project 2: Treatment as usual

ACTIVE COMPARATOR

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

Interventions

The Cultural Formulation Interview-Engagement Aid BEHAVIORAL

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.

Project 1: The Cultural Formulation Interview-Engagement Aid

The Cultural Formulation Interview-Engagement Aid (Revised) BEHAVIORAL

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.

Project 2: The Cultural Formulation Interview-Engagement Aid

Treatment as usual BEHAVIORAL

Standard mental health treatment at FHMC

Project 2: Treatment as usual

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Flushing Hospital Medical Center

Flushing, New York, 11355, United States

Location

MeSH Terms

Conditions

Communication; Patient Compliance

Interventions

Reoperation; Therapeutics

Condition Hierarchy (Ancestors)

Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Neil K Aggarwal, M.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 6, 2017
• Study Start: September 20, 2016
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)