NCT06195007

Brief Summary

Motivational interviewing (MI) is a style of communication designed to elicit a person's own reasons for change to drive commitment toward a goal. The goal of this study is to assess the effect of trainee-led MI on patients diagnosed with acute stroke or TIA attributable to modifiable risk factors in comparison to conventional post-stroke counseling, based on patient outcomes, and meaning of work and sense of fulfillment for trainees.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 21, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

Same day

First QC Date

December 21, 2023

Last Update Submit

August 19, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Smoking cessation at 90-day post-discharge follow up

    Yes or no

    90 days post-discharge

  • Patient rating of ability to improve their health

    Patient answers question "I am confident that I can work together with my care team to improve my health" with a rating from 1 (do not agree at all) to 10 (completely agree)

    90 days post-discharge

  • Recurrence of stroke / TIA symptoms

    Yes or no

    90 days post-discharge

Secondary Outcomes (1)

  • Patient ability to take stroke prevention medications as prescribed

    90 days post-discharge

Study Arms (2)

Motivational Interview

EXPERIMENTAL

Patients included in the study who are being treated by a resident in the MI intervention group will have a motivational interview during their initial hospitalization.

Behavioral: Motivational Interview

Control

NO INTERVENTION

Patients included in the study who are being treated by a resident in the Control group will not have a motivational interview during their hospitalization.

Interventions

The motivational interview (MI) is a 10-15 minute patient-centered conversation which will focus on tobacco use. Multiple communication strategies can be employed during the MI, including open-ended questions, affirmative statements, reflective listening, use of a 'confidence ruler', and summarizing. The 'confidence ruler' technique in this patient population involves asking the patient "On a scale of zero to ten, how confident are you that you can stop using tobacco?", and then requesting further information about why they selected a certain number. These communication strategies and techniques are designed to uncover and foster a patient's own internal motivations to change the target behavior.

Motivational Interview

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient presentation consistent with a stroke or TIA
  • Patient is a current tobacco user and tobacco use contributed to the stroke
  • Resident enrolled in study assigned to Vascular Neurology service during patient admission.

You may not qualify if:

  • Patient unable or unwilling to follow up in the outpatient stroke clinic after discharge
  • Patient has cognitive impairment or aphasia that would preclude meaningful participation in motivational interview (defined as a score of 0 on the National Institute of Health Stroke Scale \[NIHSS\] questions 1 and 9)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Christina Wilson, MD PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 8, 2024

Study Start

December 20, 2023

Primary Completion

December 20, 2023

Study Completion

January 1, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations