Advance Care Planning, Emergency Service, Hospital, Motivational Interviewing
Conditions
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.
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.
Interventions
BEHAVIORALBrief 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.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Found the Intervention Acceptable and Provided Suggestions for Improvement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the Intervention by Administering Clinicians. | 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. |
| Patient's Quality of Life | At baseline (in-person) and 1 month 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, 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. |
| Advance Care Planning Engagement Behavior | At baseline (in-person) and 1 month 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, 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). |
| Patient Empowerment | At baseline (in-person) and 1 month 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. |
| Patient Distress | Within 7 days after the intervention. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Intervention Arm |
|---|---|
| Age, Continuous | 72.68 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Region of Enrollment United States | 75 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 75 |
| other Total, other adverse events | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 |
Outcome results
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.
Time frame: Immediately following the intervention in the emergency department.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Number of Patients Who Found the Intervention Acceptable and Provided Suggestions for Improvement | 48 Participants |
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.
Time frame: Immediately following the intervention in the emergency department.
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Acceptability of the Intervention by Administering Clinicians. | 7 score on a scale | Standard Deviation 1 |
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).
Time frame: At baseline (in-person) and 1 month after (over the phone) the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Advance Care Planning Engagement Behavior | Post-intervention (3 month) | 4.3 score on a scale | Standard Deviation 0.9 |
| Intervention Arm | Advance Care Planning Engagement Behavior | Baseline | 3.8 score on a scale | Standard Deviation 0.8 |
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
Time frame: Within 7 days after the intervention.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Patient Distress | Subscale - Intrusion | 0.70 score on a scale | Standard Deviation 0.61 |
| Intervention Arm | Patient Distress | Subscale - Avoidance | 0.86 score on a scale | Standard Deviation 1.19 |
| Intervention Arm | Patient Distress | Total Score | 0.66 score on a scale | Standard Deviation 0.63 |
| Intervention Arm | Patient Distress | Subscale - Hyperarousal | 0.33 score on a scale | Standard Deviation 0.31 |
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.
Time frame: At baseline (in-person) and 1 month after (over the phone) the intervention.
Population: We did not collect this outcome as the advance care planning engagement survey was felt to be better suited for this study.
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.
Time frame: At baseline (in-person) and 1 month after (over the phone) the intervention.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Patient's Quality of Life | Baseline Overall Score (Mean) | 3.69 score on a scale | Standard Deviation 0.28 |
| Intervention Arm | Patient's Quality of Life | 1-month Overall Score (Mean) | 3.72 score on a scale | Standard Deviation 0.2 |
| Intervention Arm | Patient's Quality of Life | Baseline Symptoms Impact Subscale (Mean) | 3.70 score on a scale | Standard Deviation 0.14 |
| Intervention Arm | Patient's Quality of Life | 1-month Symptoms Impact Subscale (Mean) | 3.00 score on a scale | Standard Deviation 0.98 |
| Intervention Arm | Patient's Quality of Life | Baseline Relationship with Healthcare Provider Subscale (Mean) | 4.00 score on a scale | Standard Deviation 0.71 |
| Intervention Arm | Patient's Quality of Life | 1-month Relationship with Healthcare Provider Subscale (Mean) | 4.40 score on a scale | Standard Deviation 0.6 |
| Intervention Arm | Patient's Quality of Life | Baseline Preparation for the End of Life Subscale (Mean) | 2.60 score on a scale | Standard Deviation 0.31 |
| Intervention Arm | Patient's Quality of Life | 1-month Preparation for the End of Life Subscale (Mean) | 2.58 score on a scale | Standard Deviation 0.96 |
| Intervention Arm | Patient's Quality of Life | Baseline Life Completion Subscale (Mean) | 4.00 score on a scale | Standard Deviation 0.33 |
| Intervention Arm | Patient's Quality of Life | 1-month Life Completion Subscale (Mean) | 4.14 score on a scale | Standard Deviation 0.5 |