Resetting the Default: Improving Provider-patient Communication to Reduce Antibiotic Misuse
調査の概要
詳細な説明
Significance: Antibiotic overuse and misuse contribute to the development of antibiotic resistant infections that kill at least 23,000 Americans and cause an additional 2 million infections annually. If left unchecked, antibiotic resistant infections are estimated to cause 10 million deaths worldwide by 2050. Antibiotic associated adverse drug reactions (e.g., rash, diarrhea, nausea, and vomiting) also result in over 140,000 Emergency Department visits annually.
The majority of all antibiotic prescribing occurs in outpatient settings where children receive 49 million prescriptions annually. Over 70% of these are for respiratory infections and nearly 8.5 million of these prescriptions are inappropriate (i.e., either an unnecessary broad-spectrum antibiotic or to treat a viral illness). There are many factors that lead to overprescribing, but chief among them is inadequate parent-provider communication.
Innovation: This study is the first US multi-site randomized controlled trial comparing the effectiveness an education vs. communication skills provider intervention to stimulate high quality parent-provider communication and judicious use of antibiotics.
Approach: 1,600 eligible parents (or caregivers) of children between the ages of 1 and 5 will be enrolled and exposed to one of the interventions based on the provider they see for their visit. English and Spanish speaking parents will be recruited from the Children's Mercy Hospital Primary Care Clinic (CMH PCC) in Kansas City, Missouri and the Heartland Primary Care Clinics in Kansas City, KS and Lenexa, KS. Parents in both arms will receive identical brief negatively behavioral framed antibiotic education via tablet computers. Providers will be randomized to the parent-provider education or communication skills intervention arm and trained accordingly. The primary outcome is rate of inappropriate antibiotic prescribing. Secondary outcomes are parental ratings of shared decision-making and satisfaction, re-visits and adverse drug reactions. Data will be collected via a tablet computer administered RedCap survey administered in the exam room prior and immediately following the child's visit. Additional data will be garnered from the medical record (antibiotic prescribing) and a 2-week follow-up telephone call with parents (re-visits and adverse drug reactions).
Public Health Impact: This study could have significant public health implications and meet the goals outlined in the 2014 Executive Order on Combating Antibiotic Resistance, which seeks to slow the emergence of resistant bacteria and prevent the spread of resistant infections through the judicious and appropriate use of antibiotics.
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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Kansas
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Kansas City、Kansas、アメリカ、66109
- Heartland Primary Care
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Lenexa、Kansas、アメリカ、66227
- Heartland Primary Care
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Missouri
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Kansas City、Missouri、アメリカ、64111
- Children's Mercy Pediatric Care Clinic
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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: \
- Parent or guardian of a child 1-5 years of age with suspected respiratory tract infection who are English or Spanish speaking
Exclusion Criteria:
- Parents of children who require hospitalization
- Received antibiotics in the last 30 days
- Have concurrent bacterial infection, an immune compromising condition or chronic medical condition
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:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Education
All providers will receive identical training on the appropriate prescribing of antibiotics for ARTIs in a 20 minute presentation.
Follow up refresher video clips will also be available for all providers to view at their convenience throughout the study.
Parents in both arms will receive identical high quality education on the pros and cons of antibiotics and tips for communicating with their provider.
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The first intervention is an educational intervention regarding appropriate diagnosis and treatment of common respiratory infections.
This education will be delivered in an interactive lecture format for providers with follow up short informational video clips available over the course of the project.
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アクティブコンパレータ:Communication Skills
Providers randomized to the communication intervention will receive additional training on communication skills in a 40 minute communication skills training session.
This training session will include good and bad communication examples, training on positive and negative behavioral framing, and education regarding key drivers of patient satisfaction.
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The second intervention is an education plus communication skills training intervention.
This training session will include identical antibiotic education training, good and bad communication examples, training on negative behavioral framing, and education regarding key drivers of patient satisfaction.
Additionally providers will be informed of parent's desire for antibiotics rating prior to their consultation with the patient.
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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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Inappropriate antibiotic use
時間枠:18 months
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Patient medical records will be reviewed 2 weeks after the visit to determine the clinical diagnosis and whether or not antibiotics were given.
Determination will be made regarding the appropriateness of the diagnosis and prescribing using current clinical practice guidelines.
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18 months
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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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Revisits
時間枠:18 months
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All parents will be called 2 weeks following the initial visit to determine if any revisits to the same office or to another health care facility were made after the initial visit for either clinical worsening or lack of clinical improvement, or due to an adverse drug reaction.
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18 months
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Adverse drug reactions
時間枠:18 months
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All parents will be called 2 weeks following the visit to determine if the patient developed an adverse drug reaction to antibiotics.
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18 months
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Shared decision-making
時間枠:18 months
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Parents will rate the quality of the shared decision-making using validated survey instruments
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18 months
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Parent Satisfaction with visit
時間枠:18 months
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Parents will rate the their satisfaction with the visit using validated measures.
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18 months
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協力者と研究者
協力者
捜査官
- 主任研究者:Jason G. Newland, MD、Washington University School of Medicine
- 主任研究者:Kathy Goggin, PhD、Childrens Mercy Hospital
出版物と役立つリンク
一般刊行物
- Goggin K, Hurley EA, Bradley-Ewing A, Bickford C, Lee BR, Pina K, De Miranda ED, Mackenzie A, Yu D, Weltmer K, Linnemayr S, Butler CC, Miller M, Newland JG, Myers AL. Reductions in Parent Interest in Receiving Antibiotics following a 90-Second Video Intervention in Outpatient Pediatric Clinics. J Pediatr. 2020 Oct;225:138-145.e1. doi: 10.1016/j.jpeds.2020.06.027. Epub 2020 Jun 15.
- Goggin K, Bradley-Ewing A, Myers AL, Lee BR, Hurley EA, Delay KB, Schlachter S, Ramphal A, Pina K, Yu D, Weltmer K, Linnemayr S, Butler CC, Newland JG. Protocol for a randomised trial of higher versus lower intensity patient-provider communication interventions to reduce antibiotic misuse in two paediatric ambulatory clinics in the USA. BMJ Open. 2018 May 9;8(5):e020981. doi: 10.1136/bmjopen-2017-020981.
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 (見積もり)
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
本研究に関する用語
その他の研究ID番号
- PCORI150731759
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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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