Communication Clinical Trial
— CFI-EAOfficial title:
The Cultural Formulation Interview-Engagement Aid for Mental Health Treatment
Verified date | January 2019 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | September 5, 2018 |
Est. primary completion date | September 5, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Flushing Hospital Medical Center | Flushing | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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. | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05203146 -
PIMPmyHospital: a Mobile App to Improve Emergency Care Efficiency and Communication
|
N/A | |
Completed |
NCT04105751 -
Testing a Novel Manual Communication System for Mechanically Ventilated ICU Patients
|
N/A | |
Completed |
NCT04595695 -
The Effect of Clear Masks in Improving Patient Relationships
|
N/A | |
Completed |
NCT05540444 -
RadConnect Communication Application
|
||
Recruiting |
NCT04317664 -
Intervention to Improve Driving Practices Among High-Risk Teen Drivers
|
Phase 3 | |
Completed |
NCT05812599 -
Understanding COVID-19 Testing Knowledge and Practices Among 2-1-1 Helpline Callers
|
N/A | |
Completed |
NCT03221985 -
ESM Pilot: Mobile Phones and Psychology
|
N/A | |
Completed |
NCT02619474 -
The Effect of Whiteboards on Patient Satisfaction
|
N/A | |
Completed |
NCT02267265 -
Pilot Study of Novel Postpartum Educational Video Intervention
|
N/A | |
Completed |
NCT02695316 -
Barrier-free Communication in Maternity Care of Allophone Migrants
|
N/A | |
Completed |
NCT03203018 -
Health Literacy and Cardiovascular Knowledge Workshop in Women From Disadvantaged Communities
|
N/A | |
Completed |
NCT01933789 -
Improving Communication About Serious Illness
|
N/A | |
Completed |
NCT01697137 -
Patient and Physician Intervention to Increase Organ Donation
|
N/A | |
Completed |
NCT01459744 -
An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations
|
N/A | |
Recruiting |
NCT01170000 -
Timely End-of-Life Communication to Parents of Children With Brain Tumors
|
N/A | |
Completed |
NCT01040975 -
Teen CHAT: Improving Physician Communication With Adolescents About Healthy Weight
|
N/A | |
Recruiting |
NCT04533126 -
Channels of Communication & Brain Functioning: Pilot fMRI Study
|
||
Withdrawn |
NCT03901547 -
Emotion Regulation and Burnout Impact on Communication Documentation
|
N/A | |
Completed |
NCT06081660 -
Advance Care Planning for Older Latinos With Chronic Illness
|
N/A | |
Completed |
NCT06376188 -
Improving Breaking Bad News in Pediatrics by Simulated Communication
|
N/A |