Trial Outcomes & Findings for Motivational Interview Intervention to Help Patients Formulate Their Goals for Medical Care in the Emergency Department (NCT NCT03208530)
NCT ID: NCT03208530
Last Updated: 2022-01-13
Results Overview
The investigator will measure quantitatively and qualitatively whether patients found this intervention acceptable and provided suggestions for its improvement.
COMPLETED
NA
75 participants
Immediately following the intervention in the emergency department.
2022-01-13
Participant Flow
Participant milestones
| Measure |
Intervention Arm
This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.
Brief motivational interview intervention: 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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|---|---|
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Overall Study
STARTED
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75
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Overall Study
COMPLETED
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48
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Overall Study
NOT COMPLETED
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27
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Motivational Interview Intervention to Help Patients Formulate Their Goals for Medical Care in the Emergency Department
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=75 Participants
This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.
Brief motivational interview intervention: 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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|---|---|
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Age, Continuous
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72.68 years
n=5 Participants
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Sex: Female, Male
Female
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39 Participants
n=5 Participants
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Sex: Female, Male
Male
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36 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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9 Participants
n=5 Participants
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Race (NIH/OMB)
White
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60 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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4 Participants
n=5 Participants
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Region of Enrollment
United States
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75 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Immediately following the intervention in the emergency department.The investigator will measure quantitatively and qualitatively whether patients found this intervention acceptable and provided suggestions for its improvement.
Outcome measures
| Measure |
Intervention Arm
n=48 Participants
This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.
Brief motivational interview intervention: 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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|---|---|
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Number of Patients Who Found the Intervention Acceptable and Provided Suggestions for Improvement
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48 Participants
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SECONDARY outcome
Timeframe: Immediately following the intervention in the emergency department.Population: The clinicians administrating the intervention are part of the research team and are not subjects of the clinical trial per NIH definition because they are not prospectively assigned to an intervention (they are the intervention itself), and the outcomes assessed from them were not health-related. The mean acceptability using a Likert scale (0 not acceptable, 1-4 somewhat unacceptable, 6-9 somewhat acceptable, and 10 completely acceptable).
The investigators will ask the emergency department clinicians who administered the intervention to report the intervention acceptability using a Likert scale survey.
Outcome measures
| Measure |
Intervention Arm
n=14 Participants
This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.
Brief motivational interview intervention: 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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|---|---|
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Acceptability of the Intervention by Administering Clinicians.
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7 score on a scale
Standard Deviation 1
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SECONDARY outcome
Timeframe: At baseline (in-person) and 1 month after (over the phone) the intervention.Population: Patients found this survey too long to complete when they just left the emergency department after acute health decline. Further, the questions were making patients think more about the end of life, which may skew our aim. Therefore, we decided to stop collecting this outcome after the first 9 patients. Only 3 out of those 9 participants completed their 1-month QUAL-E assessment.
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.
Outcome measures
| Measure |
Intervention Arm
n=9 Participants
This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.
Brief motivational interview intervention: 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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|---|---|
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Patient's Quality of Life
Baseline Overall Score (Mean)
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3.69 score on a scale
Standard Deviation 0.28
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Patient's Quality of Life
1-month Overall Score (Mean)
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3.72 score on a scale
Standard Deviation 0.20
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Patient's Quality of Life
Baseline Symptoms Impact Subscale (Mean)
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3.70 score on a scale
Standard Deviation 0.14
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Patient's Quality of Life
1-month Symptoms Impact Subscale (Mean)
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3.00 score on a scale
Standard Deviation 0.98
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Patient's Quality of Life
Baseline Relationship with Healthcare Provider Subscale (Mean)
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4.00 score on a scale
Standard Deviation 0.71
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Patient's Quality of Life
1-month Relationship with Healthcare Provider Subscale (Mean)
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4.40 score on a scale
Standard Deviation 0.60
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Patient's Quality of Life
Baseline Preparation for the End of Life Subscale (Mean)
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2.60 score on a scale
Standard Deviation 0.31
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Patient's Quality of Life
1-month Preparation for the End of Life Subscale (Mean)
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2.58 score on a scale
Standard Deviation 0.96
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Patient's Quality of Life
Baseline Life Completion Subscale (Mean)
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4.00 score on a scale
Standard Deviation 0.33
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Patient's Quality of Life
1-month Life Completion Subscale (Mean)
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4.14 score on a scale
Standard Deviation 0.50
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SECONDARY outcome
Timeframe: At baseline (in-person) and 1 month after (over the phone) the intervention.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).
Outcome measures
| Measure |
Intervention Arm
n=51 Participants
This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.
Brief motivational interview intervention: 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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|---|---|
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Advance Care Planning Engagement Behavior
Baseline
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3.8 score on a scale
Standard Deviation 0.8
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Advance Care Planning Engagement Behavior
Post-intervention (3 month)
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4.3 score on a scale
Standard Deviation 0.9
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SECONDARY outcome
Timeframe: At baseline (in-person) and 1 month after (over the phone) the intervention.Population: We did not collect this outcome as the "advance care planning engagement survey" was felt to be better suited for this study.
The investigators will measure patient empowerment by using a validated survey measure (Patient Activation Measure, PAM™) at baseline and after the intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days after the intervention.Population: We stopped collecting this outcome after the first 8 patients because patients did not express any clinically meaningful anxiety/distress due to our intervention. Furthermore, a much more traumatic event for these patients seemed to be the recent emergency department visit or hospitalization, which made this scale not appliable.
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
Outcome measures
| Measure |
Intervention Arm
n=8 Participants
This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.
Brief motivational interview intervention: 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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|---|---|
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Patient Distress
Total Score
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0.66 score on a scale
Standard Deviation 0.63
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Patient Distress
Subscale - Intrusion
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0.70 score on a scale
Standard Deviation 0.61
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Patient Distress
Subscale - Avoidance
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0.86 score on a scale
Standard Deviation 1.19
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Patient Distress
Subscale - Hyperarousal
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0.33 score on a scale
Standard Deviation 0.31
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Adverse Events
Intervention Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place