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Completed

NCT Number: NCT03208530

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.

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Key information

Conditions

Emergency Service, Hospital Advance Care Planning Disease Attributes Emergencies Motivational Interviewing Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  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 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.

  3. Advance Care Planning Engagement Behavior

    Time frame: 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).

  4. Patient Empowerment

    Time frame: 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.

  5. Patient Distress

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2017
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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