- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03208530
Motivational Interview Intervention to Help Patients Formulate Their Goals for Medical Care in the Emergency Department
A Pilot Study to Test the Acceptability and Feasibility of Brief Motivational Interview Intervention to Help Patients Formulate Their Goals for Medical Care in the Emergency Department
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥65 years of age
- English-speaking
- Capacity to consent
- AND ≥1 Serious illness (New York Heart Association stage 3 or 4 heart failure, oxygen-dependent chronic obstructive lung disease, chronic kidney disease on dialysis, and metastatic cancer.) OR determined by the emergency department provider that the patient has a high likelihood of death in the next 12 months ("I would not be surprised if this patient died in the next 12 months.").
Exclusion Criteria:
- Acute physical or emotional distress
- Determined by emergency department provider not to be appropriate
- Clearly documented goals for medical care already exists (e.g. medical order for life sustaining treatment - MOLST).
- Already enrolled in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Arm
This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.
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A brief (<7minutes) interview by an emergency department clinician to empower patients to formulate and communicate their goals for medical care with patients' outpatient clinicians.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Who Found the Intervention Acceptable and Provided Suggestions for Improvement
Time Frame: Immediately following the intervention in the emergency department.
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The investigator will measure quantitatively and qualitatively whether patients found this intervention acceptable and provided suggestions for its improvement.
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Immediately following the intervention in the emergency department.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of the Intervention by Administering Clinicians.
Time Frame: Immediately following the intervention in the emergency department.
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The investigators will ask the emergency department clinicians who administered the intervention to report the intervention acceptability using a Likert scale survey.
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Immediately following the intervention in the emergency department.
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Patient's Quality of Life
Time Frame: At baseline (in-person) and 1 month after (over the phone) the intervention.
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The investigators will measure patient's quality of life using a validated survey measure (Quality of life at the end of life, QUAL-E, Steinhauser et al. 2004) at baseline and after the intervention.
QUAL-E consists of 25-items and measures 4 domains (symptom impact, relationship with the healthcare provider, preparation for the end of life, and life completion).
Each item is in a 5-point Likert scale ranging from (1 Not at all to 5 Completely), and lower scores indicate better outcomes for all domains except for the preparation for the end of life domain and life completion domain where higher scores indicate better outcomes.
The mean composite score is compared between baseline and 1 month after the intervention.
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At baseline (in-person) and 1 month after (over the phone) the intervention.
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Advance Care Planning Engagement Behavior
Time Frame: At baseline (in-person) and 1 month after (over the phone) the intervention.
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The investigators will measure patient's behaviors and actions for completing advance care planning using a validated survey measure (advance care planning engagement survey, Sudore et al 2017) at baseline and after the intervention.
The measure is a 4-item survey measuring actions and behaviors of advance care planning.
The additive composite score is calculated and ranges from 1 (least engagement) to 5 (most engagement).
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At baseline (in-person) and 1 month after (over the phone) the intervention.
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Patient Empowerment
Time Frame: At baseline (in-person) and 1 month after (over the phone) the intervention.
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The investigators will measure patient empowerment by using a validated survey measure (Patient Activation Measure, PAM™) at baseline and after the intervention.
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At baseline (in-person) and 1 month after (over the phone) the intervention.
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Patient Distress
Time Frame: Within 7 days after the intervention.
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The investigators will measure patient anxiety/distress regarding a particular event (in this case, our intervention) by using a validated survey measure (Impact of Event Scale - Revised, IES-R, Weiss 1996) within a week after the intervention. IES-R is a 22-item, 5-point Likert scale measure (ranging from 0 Not at all to 4 Extremely). Results consist of the mean rating for the total score and raw scores for three subscales: The Avoidance Scale, Intrusion Scale, and the Hyperarousal Scale. The scores give an indication of the level of impairment from post traumatic stress, where: 0 = No symptoms 1 = Few symptoms 2 = Moderate symptoms 3 = A High level of symptoms 4 = An Extremely high level of symptoms |
Within 7 days after the intervention.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kei Ouchi, MD, MPH, Brigham and Women's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016P002637
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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