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

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ClinicalTrials.gov Identifier: NCT03208530
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Kei Ouchi, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Emergency Service, Hospital Motivational Interviewing Advance Care Planning Behavioral: Brief motivational interview intervention Not Applicable

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Study Type : Interventional
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Intervention Arm
This is a single arm study with all enrolled patients receiving the same brief motivational interview 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.




Primary Outcome Measures :
  1. Acceptability of the intervention by patients. [ Time Frame: Immediately following the intervention in the emergency department. ]
    The investigators will qualitatively measure how patients perceived the intervention by conducting qualitative interviews and identifying recurrent themes.


Secondary Outcome Measures :
  1. Acceptability of the intervention by administering clinicians. [ Time Frame: Immediately following the intervention in the emergency department. ]
    The investigators will ask the emergency department clinicians who administered the intervention to report the intervention acceptability using a Likert scale survey.

  2. Patient's Quality of life [ Time Frame: At baseline (in-person) and 3 months after (over the phone) the intervention. ]
    The investigators will measure patient's quality of life using a validated survey measure (Quality of life at the end of life, QUAL-E) at baseline and after the intervention.

  3. Advance care planning engagement behavior [ Time Frame: At baseline (in-person) and 3 months 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) at baseline and after the intervention.

  4. Patient empowerment [ Time Frame: At baseline (in-person) and 3 months after (over the phone) the intervention. ]
    The investigators will measure patient empowerment by using a validated survey measure (Patient Activation Measure, PAM™) at baseline and after the intervention.

  5. Patient distress [ Time Frame: Immediately following the intervention in the emergency department. ]
    The investigators will measure patient anxiety/distress by using a validated survey measure (Impact of Event Scale - Revised, IES-R) after the intervention.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208530


Contacts
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Contact: Kei Ouchi, MD, MPH 617-732-5640 kouchi@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kei Ouchi, MD, MPH    617-732-5640    kouchi@bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Kei Ouchi, Brigham and Women's Hospital:
Study Protocol  [PDF] July 6, 2017


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Responsible Party: Kei Ouchi, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03208530     History of Changes
Other Study ID Numbers: 2016P002637
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes