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Improving Communication During Pediatric Visits for Acute Respiratory Illness

2010年7月21日 更新者:University of Washington

The excessive use of outpatient antibiotics in the pediatric population has contributed to the rapid development of resistance in many strains of Streptococcus pneumoniae. Research has shown that community-based interventions may have a modest impact on reducing the injudicious use of antibiotics in children. However, since the actual prescribing of antibiotics is done by physicians and research has shown that physician-parent communication patterns during pediatric visits for acute respiratory tract infections (ARTI) strongly influence antibiotic prescription rate, it is crucial to develop effective interventions aimed specifically at them.

The overall goal of this study is to improve physician-parent communication patterns during visits for pediatric ARTI and, ultimately, to decrease rates of antibiotic prescribing for these illnesses in children.

調査の概要

状態

完了

詳細な説明

The overall goal of this study is to test a novel communication-based intervention aimed at decreasing rates of prescribing antibiotics for ARTI in children. We propose a randomized controlled trial involving a sample of 34 primary care pediatricians drawn from 8 practices in the Puget Sound Pediatric Research Network (PSPRN). Our research design incorporates a novel physician intervention that teaches the importance of specific physician communication behaviors. The primary physician outcomes for the study will be changes in the utilization of communication behaviors as reported by parents, and antibiotic prescribing rates for children presenting with ARTI symptoms. The primary parent outcome measure for the study will be satisfaction with care. Changes in the primary outcomes for the intervention physicians will be compared to changes in these outcomes for control physicians. The trial has five specific aims and five major hypotheses.

  1. To evaluate the effectiveness of the proposed intervention in achieving its stated goals of changing physician communication behaviors.

    • We hypothesize that physicians in the intervention group will have increased reported use of desirable communication behaviors and decreased reported use of undesirable communication behaviors relative to control group physicians.
  2. To determine the antibiotic prescribing rates for children aged 6 months to 10 years presenting with ARTI symptoms and assess how these rates change as a function of the intervention.

    • We hypothesize that physicians in the intervention group will decrease antibiotic prescribing rates for ARTI relative to the control group physicians.
  3. To determine visit-specific satisfaction levels for parents of children seen by study physicians and assess how satisfaction levels change as a function of the intervention.

    • We hypothesize that parents who take their children to physicians in the intervention group will report increased satisfaction with care, relative to control group physicians.
  4. To identify the factors (e.g., physician communication behaviors) that mediate the relationships between physicians being in the intervention group, decreased antibiotic prescribing, and increased parent satisfaction with care.

    • We hypothesize that increased use of desirable communication behaviors and decreased use of undesirable communication behaviors will partially mediate the relationships between being an intervention group physician, decreased inappropriate prescribing, and increased parent satisfaction with care.
  5. To perform a validation study of the Physician Communication Behavior Inventory (PCBI) survey items. Using a standardized approach, specific physician communication behaviors will be coded through review of 100 video taped physician-parent encounters. The behaviors coded will be compared to parent responses on the PCBI surveys from these encounters.

    • We hypothesize that parent reports of physician communication behaviors on the PCBI will be highly correlated with actual physician communication behaviors coded from video tape data.

研究の種類

介入

入学 (実際)

1313

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

19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:

  • Parents: the parent must present with a child between the ages of 6 months and 10 years old, who has not received antibiotics for any reason in the prior two weeks and who has any of the following symptoms: cough, runny nose/congestion, sore throat, ear pain, or ear tugging. Parents must be able to read English or Spanish; the visit must occur during one of the three data collection periods for the participating physician; and parents must have not previously participated in teh study.
  • Physicians: physician must be a member of Puget Sound Pediatric research Network (PSPRN).

Exclusion Criteria:

  • Parents: parents who are 18 years of age or less
  • Physicians: physicians who are not members of PSPRN

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: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
実験的:介入
Physicians that were assigned to the intervention group attended a 3.5 hour intervention workshop where they were trained in skills to communicate information about physical examination findings, treatment, and follow-up that will ultimately facilitate appropriate antibiotic prescribing and increase parent satisfaction with care.
介入なし:コントロール

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
Effectiveness of intervention in changing physician communication behaviors
時間枠:12 months
To evaluate the effectiveness of the proposed intervention in achieving its stated goals of changing physician communication behavoirs
12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Antibiotic prescribing rates as a function of the intervention
時間枠:12 months
To determine the antibiotic prescribing rates for children aged 6 months to 10 years presenting with ARTI symptoms and assess how these rates change as a function of the intervention
12 months
Satisfaction levels for parents as a function of the intervention
時間枠:12 months
To determine visit-specific satisfaction levels for parents of children seen by study physicians and assess how satisfaction levels change as a function of the intervention
12 months
Factor identification
時間枠:12 months
To identify the factors (e.g., physician communication behaviors) that mediate the relationships between physicians being in the intervention group, decreased antibiotic prescribing, and increased parent satisfaction with care
12 months
Validation study of the PCBI
時間枠:12 months
To perform a validation study of the Physician Communication Behavior Inventory (PCBI) survey items. Using a standardized approach, specific physician communication behaviors will be coded through review of 100 video taped physician-parent encounters. The behaviors coded will be compared to parent responses on the PCBI surveys from these encounters.
12 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。

スポンサー

捜査官

  • 主任研究者:Rita Mangione-Smith, MD, MPH、University of Washington/ Seattle Children's Hospital
  • 主任研究者:James A Taylor, MD, MPH、University of Washington

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

2007年9月1日

一次修了 (実際)

2009年4月1日

研究の完了 (実際)

2009年4月1日

試験登録日

最初に提出

2010年7月21日

QC基準を満たした最初の提出物

2010年7月21日

最初の投稿 (見積もり)

2010年7月23日

学習記録の更新

投稿された最後の更新 (見積もり)

2010年7月23日

QC基準を満たした最後の更新が送信されました

2010年7月21日

最終確認日

2010年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 32542-A
  • 61-5957 (その他の識別子:Children's IRB application number)

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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