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Motivational Interview Intervention to Help Patients Formulate Their Goals for Medical Care in the Emergency Department

Primary Purpose

Emergency Service, Hospital, Motivational Interviewing, Advance Care Planning

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief motivational interview intervention
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Emergency Service, Hospital

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.

Outcomes

Primary Outcome Measures

Number of Patients Who Found the Intervention Acceptable and Provided Suggestions for Improvement
The investigator will measure quantitatively and qualitatively whether patients found this intervention acceptable and provided suggestions for its improvement.

Secondary Outcome Measures

Acceptability of the Intervention by Administering Clinicians.
The investigators will ask the emergency department clinicians who administered the intervention to report the intervention acceptability using a Likert scale survey.
Patient's Quality of Life
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.
Advance Care Planning Engagement Behavior
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).
Patient Empowerment
The investigators will measure patient empowerment by using a validated survey measure (Patient Activation Measure, PAM™) at baseline and after the intervention.
Patient Distress
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

Full Information

First Posted
July 3, 2017
Last Updated
January 11, 2022
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03208530
Brief Title
Motivational Interview Intervention to Help Patients Formulate Their Goals for Medical Care in the Emergency Department
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Test the acceptability and feasibility of a brief motivational interview intervention to facilitate advance care planning (ACP) conversations for older adults with serious co-morbid illness being discharged from the emergency department (ED). The investigators will interview the participants to understand their perception of the intervention and collect patient-reported outcomes data after leaving the ED.
Detailed Description
This study is designed to engage seriously ill older adults in conversations about their goals of care. Our intervention is intended to help these patients understand the significance of ED visits in the course of their illnesses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Service, Hospital, Motivational Interviewing, Advance Care Planning

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.
Intervention Type
Behavioral
Intervention Name(s)
Brief motivational interview intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients Who Found the Intervention Acceptable and Provided Suggestions for Improvement
Description
The investigator will measure quantitatively and qualitatively whether patients found this intervention acceptable and provided suggestions for its improvement.
Time Frame
Immediately following the intervention in the emergency department.
Secondary Outcome Measure Information:
Title
Acceptability of the Intervention by Administering Clinicians.
Description
The investigators will ask the emergency department clinicians who administered the intervention to report the intervention acceptability using a Likert scale survey.
Time Frame
Immediately following the intervention in the emergency department.
Title
Patient's Quality of Life
Description
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.
Time Frame
At baseline (in-person) and 1 month after (over the phone) the intervention.
Title
Advance Care Planning Engagement Behavior
Description
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).
Time Frame
At baseline (in-person) and 1 month after (over the phone) the intervention.
Title
Patient Empowerment
Description
The investigators will measure patient empowerment by using a validated survey measure (Patient Activation Measure, PAM™) at baseline and after the intervention.
Time Frame
At baseline (in-person) and 1 month after (over the phone) the intervention.
Title
Patient Distress
Description
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
Time Frame
Within 7 days after the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kei Ouchi, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30770207
Citation
Ouchi K, George N, Schuur JD, Aaronson EL, Lindvall C, Bernstein E, Sudore RL, Schonberg MA, Block SD, Tulsky JA. Goals-of-Care Conversations for Older Adults With Serious Illness in the Emergency Department: Challenges and Opportunities. Ann Emerg Med. 2019 Aug;74(2):276-284. doi: 10.1016/j.annemergmed.2019.01.003. Epub 2019 Feb 13.
Results Reference
derived

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Motivational Interview Intervention to Help Patients Formulate Their Goals for Medical Care in the Emergency Department

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