Motivational Interview Intervention to Help Patients Formulate Their Goals for Medical Care in the Emergency Department
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
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Intervention Arm
This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Number of Patients Who Found the Intervention Acceptable and Provided Suggestions for Improvement
時間枠:Immediately following the intervention in the emergency department.
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The investigator will measure quantitatively and qualitatively whether patients found this intervention acceptable and provided suggestions for its improvement.
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Immediately following the intervention in the emergency department.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Acceptability of the Intervention by Administering Clinicians.
時間枠:Immediately following the intervention in the emergency department.
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The investigators will ask the emergency department clinicians who administered the intervention to report the intervention acceptability using a Likert scale survey.
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Immediately following the intervention in the emergency department.
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Patient's Quality of Life
時間枠:At baseline (in-person) and 1 month after (over the phone) the intervention.
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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.
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At baseline (in-person) and 1 month after (over the phone) the intervention.
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Advance Care Planning Engagement Behavior
時間枠:At baseline (in-person) and 1 month after (over the phone) the intervention.
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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).
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At baseline (in-person) and 1 month after (over the phone) the intervention.
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Patient Empowerment
時間枠:At baseline (in-person) and 1 month after (over the phone) the intervention.
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The investigators will measure patient empowerment by using a validated survey measure (Patient Activation Measure, PAM™) at baseline and after the intervention.
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At baseline (in-person) and 1 month after (over the phone) the intervention.
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Patient Distress
時間枠:Within 7 days after the intervention.
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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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協力者と研究者
捜査官
- 主任研究者:Kei Ouchi, MD, MPH、Brigham and Women's Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Brief motivational interview interventionの臨床試験
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Washington State UniversityNational Institute on Drug Abuse (NIDA)完了