NCT03044145: CFI-EA

The Cultural Formulation Interview-Engagement Aid

Completed NA Last updated 25 January 2019

What this trial tests

NA trial testing The Cultural Formulation Interview-Engagement Aid in Communication in 45 participants. Completed in 5 September 2018.

Timeline

20 September 2016

Primary endpoint
5 September 2018

5 September 2018

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	health services research
Enrollment	45
Start date	20 September 2016
Primary completion	5 September 2018
Estimated completion	5 September 2018
Sites	1 location across United States

Drugs / interventions tested

• The Cultural Formulation Interview-Engagement Aid
• The Cultural Formulation Interview-Engagement Aid (Revised)
• Treatment as usual

Conditions studied

• Communication — all drugs for Communication →
• Adherence, Patient — all drugs for Adherence, Patient →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 18 to 80, any sex, with Communication or Adherence, Patient. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of consumers and health providers working in partnership on health services planning, delivery and evaluation.
   Lowe D, Ryan R, Schonfeld L, Merner B, et al · · 2021 · cited 30× · PMID 34523117 · DOI 10.1002/14651858.cd013373.pub2
2. Implementing the Cultural Formulation Interview in a Community Clinic to Improve Appointment Retention: A Pilot Study.
   Aggarwal NK, Chen D, Lam P, Lewis-Fernández R. · · 2022 · cited 7× · PMID 34157856 · DOI 10.1176/appi.ps.202000925