NCT03208530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 25, 2021

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

July 3, 2017

Results QC Date

December 4, 2020

Last Update Submit

January 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Acceptability of the Intervention by Administering Clinicians.

    Immediately following the intervention in the emergency department.

  • Patient's Quality of Life

    At baseline (in-person) and 1 month after (over the phone) the intervention.

  • Advance Care Planning Engagement Behavior

    At baseline (in-person) and 1 month after (over the phone) the intervention.

  • Patient Empowerment

    At baseline (in-person) and 1 month after (over the phone) the intervention.

  • Patient Distress

    Within 7 days after the intervention.

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Behavioral: Brief motivational interview intervention

Interventions

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.

Intervention Arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥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.").

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

We did not collect some pre-specified outcomes because initial data suggested that they may not be clinically relevant.

Results Point of Contact

Title
Kei Ouchi, MD, MPH
Organization
Brigham and Women's Hospital

Study Officials

  • Kei Ouchi, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 5, 2017

Study Start

August 1, 2017

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

January 13, 2022

Results First Posted

February 25, 2021

Record last verified: 2022-01

Locations