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A Semi-structured Interview PACIENTE Improves Communication With Family Members at the Intensive Care Unit (PACIENTE)

Result of an Intervention for the Group of Physicians Responsible for Providing Information on the Satisfaction of the Relatives of Patients Hospitalized in an Intensive Care Unit

The purpose of this study is to assess whether a formal training strategy using an interview PACIENTE may improve physician's skills and quality of communication with family members at the ICU.

調査の概要

状態

完了

介入・治療

詳細な説明

Introduction: Effective communication with physicians is an important factor for families at intensive care unit. Although physicians should have adequate communication skills, training programs are not available that would enable them to enhance this competence. Formal training using a semi-structured interview to improve skills and quality of communication was provided to physicians in charge of supplying information to families at the intensive care unit (ICU).

Objective: To assess whether a formal training strategy using an interview PACIENTE may improve physician's skills and quality of communication with family members at the ICU.

Methods: A pre- and post- intervention study was designed for a university hospital mixed ICU (medical and surgical). Training was provided to 34 resident physicians in charge of giving information to families at the ICU using interview PACIENTE. The interview was done conjointly with participation in simulated difficult clinical cases with actors posing as family members.

Patient registries: Family satisfaction was assessed with a validated survey, FS-ICU 24, in 122 and 123 family members pre- and post-intervention training, respectively, on the fourth day after patient admission to the ICU. The surveys were identified with consecutive numbers and not collected data that would allow subsequent identification of patients or their families. After the intervention, structures of interviews were monitored with checklists designed for this purpose. The meetings were always in the same place for this activity.

The surveys were answered on paper and the data included in an SPSS database by one of the researchers. Single questions in the 24-FS-ICU survey were analyzed according to the author's suggestions with minor modifications. Scores from items 1-6 in the published survey were transformed to scores from 0 to 100. The Mann-Whitney U test was used to determine any score differences between pre- and post-interventions. Differences of P<0.05 were considered statistically significant.

The sample size was calculated to be 122 participants for pre-intervention and 122 participants for post-intervention to detect α coefficient of 0.05 and with a power of 0.90. The survey was performed in the waiting room and questionnaires were collected immediately; thus, there were no missing questionnaires.

研究の種類

介入

入学 (実際)

245

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • That consented to participate in the satisfaction survey
  • That whom had been in the ICU for 72 h.

Exclusion Criteria:

  • Family members with language barriers (requiring assistance to answer a question in writing)
  • Previous ICU admission within the study period
  • Patient's death by the fourth day of admission
  • Proved reasons for risk of judicial proceedings.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:非ランダム化
  • 介入モデル:並列代入
  • 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
介入なし:Pre-intervention
Family members of patients admitted to the ICU from August to December 2013 that consented to participate in the satisfaction survey and had been in the ICU for 72 h.
実験的:Post-intervention
Family members of patients admitted to the ICU from March to August 2014 that consented to participate in the satisfaction survey and had been in the ICU for 72 h.
The final training was provided to a group of 34 residents --from internal medicine, anesthesiology, gynecology, and intensive care-- in charge of giving information to the patient's family members in the ICU. They were trained in the semi-structured interview PACIENTE (Present oneself and greet, Attend and listen, Call diagnosis, Inform treatment, Expose prognosis, Name introductory phrases to bad news, Take time to provide empathetic comfort, Explain an action plan involving the family) conjointly while participating in simulated difficult clinical cases with family members-actors. Four training programs were performed from February to September 2014.

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
Comprehension of the information, measured with the instrument FS-ICU 24. Third question, second part.
時間枠:Four months
Measured with the instrument FS-ICU 24. Third question, second part.
Four months
Adequate time to address concerns and answer questions, measured with the instrument FS-ICU 24. Tenth question, second part.
時間枠:Four months
Measured with the instrument FS-ICU 24. Tenth question, second part.
Four months

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall satisfaction with care, measured with the instrument FS-ICU 24.
時間枠:Four months
Measured with the instrument FS-ICU 24.
Four months
Overall satisfaction with decision-making measured with the instrument FS-ICU 24.
時間枠:Four months
Measured with the instrument FS-ICU 24.
Four months
Global survey satisfaction measured with the instrument FS-ICU 24.
時間枠:Four months
Measured with the instrument FS-ICU 24.
Four months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Miguel H Coral, MD、Fundación Universitaria de Ciencias de la Salud

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年8月1日

一次修了 (実際)

2014年8月1日

研究の完了 (実際)

2014年8月1日

試験登録日

最初に提出

2015年1月8日

QC基準を満たした最初の提出物

2015年1月12日

最初の投稿 (見積もり)

2015年1月13日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年1月13日

QC基準を満たした最後の更新が送信されました

2015年1月12日

最終確認日

2015年1月1日

詳しくは

本研究に関する用語

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。

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