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

Advance Care Planning Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208530
• Other study ID #: 2016P002637
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: January 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advance Care Planning
• Emergencies
• Emergency Service, Hospital
• Motivational Interviewing

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately following the intervention in the emergency department.
Secondary	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.	Immediately following the intervention in the emergency department.
Secondary	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.	At baseline (in-person) and 1 month after (over the phone) the intervention.
Secondary	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).	At baseline (in-person) and 1 month after (over the phone) the intervention.
Secondary	Patient Empowerment	The investigators will measure patient empowerment by using a validated survey measure (Patient Activation Measure, PAM™) at baseline and after the intervention.	At baseline (in-person) and 1 month after (over the phone) the intervention.
Secondary	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	Within 7 days after the intervention.