Emergency Service, HospitalNCT03208530
Motivational Interview Intervention to Help Patients Formulate Their Goals for Medical Care in the Emergency Department
A study testing Brief motivational interview intervention in people with Emergency Service, Hospital and Motivational Interviewing, run by Brigham and Women's Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Emergency Service, Hospital, Motivational Interviewing, Advance Care Planning
- What is being tested?
- Brief motivational interview intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 31 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥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.").
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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
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.
Read the 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.
- Being tested
- Brief motivational interview intervention
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief motivational interview interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention. Receives: Behavioral: Brief motivational interview intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately following the intervention in the emergency department.
Secondary outcomes (5)
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.
Measured: Immediately following the intervention in the emergency department.
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.
Measured: At baseline (in-person) and 1 month after (over the phone) 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).
Measured: At baseline (in-person) and 1 month after (over the phone) the intervention.
Patient Empowerment
The investigators will measure patient empowerment by using a validated survey measure (Patient Activation Measure, PAM™) at baseline and after the intervention.
Measured: At baseline (in-person) and 1 month after (over the phone) 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
Measured: Within 7 days after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Aug 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency Service, HospitalStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kei Ouchi, Brigham and Women's Hospital
- Investigators
- Kei Ouchi, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208530
- Sponsor's protocol ID
- 2016P002637
- Status last verified
- Jan 2022
- First submitted
- 3 Jul 2017
- Last updated
- 13 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30770207
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03208530
- Acronym / sponsor ID
- 2016P002637
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Brief motivational interview interventionThis is a single arm study with all enrolled patients receiving the same brief motivational interview intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- ≥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.").
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief motivational interview interventionA brief (<7minutes) interview by an emergency department clinician to empower patients to formulate and communicate their goals for medical care with patients' outpatient clinicians. | Behavioural | Intervention Arm |
Primary outcome
Number of Patients Who Found the Intervention Acceptable and Provided Suggestions for Improvement
Time frame: 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.
5 secondary outcomes
Acceptability of the Intervention by Administering Clinicians.
Time frame: Immediately following the intervention in the emergency department.
Patient's Quality of Life
Time frame: At baseline (in-person) and 1 month after (over the phone) the intervention.
Advance Care Planning Engagement Behavior
Time frame: At baseline (in-person) and 1 month after (over the phone) the intervention.
Patient Empowerment
Time frame: At baseline (in-person) and 1 month after (over the phone) the intervention.
Patient Distress
Time frame: Within 7 days after the intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30770207Ouchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kei Ouchi, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief motivational interview intervention in people with Emergency Service, Hospital and Motivational Interviewing, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Found the Intervention Acceptable and Provided Suggestions for Improvement (time frame: Immediately following the intervention in the emergency department.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03208530, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.