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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief motivational interview intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Patient's Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kei Ouchi, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30770207 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2018 |
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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. |
| 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. |
| 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. |
| 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Immediately following the intervention in the emergency department. |
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| 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. | The clinicians administrating the intervention are part of the research team and are not subjects of the clinical trial per NIH definition because they are not prospectively assigned to an intervention (they are the intervention itself), and the outcomes assessed from them were not health-related. The mean acceptability using a Likert scale (0 not acceptable, 1-4 somewhat unacceptable, 6-9 somewhat acceptable, and 10 completely acceptable). | Posted | Mean | Standard Deviation | score on a scale | Immediately following the intervention in the emergency department. |
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| 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. | Patients found this survey too long to complete when they just left the emergency department after acute health decline. Further, the questions were making patients think more about the end of life, which may skew our aim. Therefore, we decided to stop collecting this outcome after the first 9 patients. Only 3 out of those 9 participants completed their 1-month QUAL-E assessment. | Posted | Mean | Standard Deviation | score on a scale | At baseline (in-person) and 1 month after (over the phone) the intervention. |
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| 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). | Posted | Mean | Standard Deviation | score on a scale | At baseline (in-person) and 1 month after (over the phone) the intervention. |
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| 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. | We did not collect this outcome as the "advance care planning engagement survey" was felt to be better suited for this study. | Posted | At baseline (in-person) and 1 month after (over the phone) the intervention. |
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| 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 | We stopped collecting this outcome after the first 8 patients because patients did not express any clinically meaningful anxiety/distress due to our intervention. Furthermore, a much more traumatic event for these patients seemed to be the recent emergency department visit or hospitalization, which made this scale not appliable. | Posted | Mean | Standard Deviation | score on a scale | Within 7 days after the intervention. |
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AEs were collected up to the 3 months after the intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention. 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. | 5 | 75 | 0 | 75 | 0 | 75 |
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We did not collect some pre-specified outcomes because initial data suggested that they may not be clinically relevant.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kei Ouchi, MD, MPH | Brigham and Women's Hospital | (617) 732-5640 | kei_ouchi@dfci.harvard.edu |
| Dec 2, 2020 |
| Prot_SAP_007.pdf |
| ICF | No | No | Yes | Informed Consent Form: Study Information Sheet for Patients | May 3, 2018 | Dec 2, 2020 | ICF_008.pdf |
| ICF | No | No | Yes | Informed Consent Form: Study Information Sheet for Clinicians | May 24, 2017 | Jan 26, 2021 | ICF_009.pdf |
| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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