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Infant Special Program for In Hospital Resuscitation Education in the Delivery Room (INSPIRE-D)

2016년 9월 30일 업데이트: Theresa Mariero Olasveengen, Oslo University Hospital

Infant Special Program for In Hospital Resuscitation Education in the Delivery Room - INSPIRE-D

The overall objective is to determine whether a bundled In-hospital Newborn Resuscitation Edu-cation intervention (INSPIRE-D) improves process of care associated with improved newborn survival and neurologic outcomes.

연구 개요

상세 설명

This prospective interventional trial will be conducted in the delivery unit at OUS. The planned studies consist of five distinct phases with step-wise interventions; 1) baseline data collection, 2) introducing educational debriefing, 3) intensive run-in/rolling-refresher phase, 4) INSPIRE-D phase and lastly 5) evaluation phase.

Phase 1: The baseline data collection phase

  1. Needs assessment/questionnaires from participating healthcare providers will be collected which include demographic data such as sex, age, education, and work experience, as well as exposure to resuscitation training, simulation, self-perceived confidence and suggestions for further training/educational topics.
  2. Observations of the newborn in the resuscitation bays will be done by video recordings and supplemented by resuscitation records, hospital quality improvement data and medical records. Data points to be collected of the newborn are demographics, gestational age, physiological parameters such as heart rate and respirations/oxygenation, Apgar score, interventions performed, and outcomes during and at discharge from hospital.
  3. The healthcare providers adherence to guidelines in neonatal resuscitation (both technical and non-technical skills like team collaboration) will be evaluated by examining the video recordings and scored by validated scoring systems formerly tested with good intra- and inter-rater reliability. The scoring systems is adapted to guidelines from the Norwegian Council of Resuscitation and retested for intra- and inter-rater reliability.

Phase 2: Intervention Phase with Educational Debriefings

  1. Educational debriefings of healthcare providers involved in clinical situations with newborn resuscitation: Selected resuscitation events will be debriefed facilitated by a study team member with special competence in facilitation and an instructor in neonatal resuscitation. The debriefing will be held depending on clinical schedule and availability, to discuss process of care, performance, and provide education to multidisciplinary staff with advocacy/inquiry debriefing techniques.
  2. For healthcare providers; cont¬inued needs assessment and prospective observations by video-recordings in resuscitation bays to document quality of care.
  3. Baseline skills assessment will be collected using a novel manikin, the Newborn Lung Simulator. Healthcare providers will be presented for a mini-simulation with a compromised newborn and asked to perform high quality resuscitation. The performance and adherence to guidelines will be evaluated and retested after the intervention.

Phase 3 - Intensive run-in of high frequency training and team reflection: "The rolling refresher phase"

  1. In this phase training triggers are identified at the start of each day shift. A careful consideration of perinatal factors of both mother and infant will identify "high risk" deliveries with babies who may need resuscitation. If no risk deliveries are identified, a random Healthcare Provider team among the present staff will be selected.
  2. "Just-in-time" and "just-in-place" training; the novel "Rolling refresher", will be introduced (target >80% of staff) at the beginning of day shifts. Health Care Providers caring for labouring mothers with training triggers will be identified and exposed to "low dose" simulation-based "just-in-time" and "just-in-place" skills training. The short training session (<10 minutes) will take place on-site in the resuscitation bay with relevant topics such as; timely assessment of need for intervention, effective assisted ventilations on a Newborn Lung Simulator. We will use observations from the video-films to target training with focus on rapid evaluation of respiratory distress, correct ventilation technique and use of pulse oximetry.
  3. Continued simulation training will be based on problem areas identified from baseline. Performance during simulation training will be evaluated and registered.
  4. Educational debriefings will continue, as in Phase 2
  5. Continued needs assessment and prospective observations in resuscitation bays to document provider confidence, simulation performance and quality of care during implementation of the INSPIRE-D bundle described above.

Phase 4: Continued INSPIRE-D bundle. After successful implementation defined as >80% of staff having been through at least one "just-in-time and just in place" training session, all interventions above (phase 2 and 3) will continue on routine basis. Continued needs assessment of confidence and performance are repeated as described above.

Phase 5: Evaluation. Evaluation of the INSPIRE-D bundle to identify and define key factors and processes that we prove necessary to ensure timely and effective neonatal resuscitation associated with improved newly born survival and neurologic outcomes.

연구 유형

중재적

등록 (실제)

435

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Oslo, 노르웨이, 0405
        • Oslo University Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Neonates that require stabilisation and/or resuscitation such as ventilatory support, medications and/or chest compressions.

Exclusion Criteria:

  • Parent or health care provider reserved against study participation.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Control period
Assessment of resuscitation quality and clinical outcomes prior to educational intervention
실험적: Educational intervention
Assessment of resuscitation quality and clinical outcomes after educational intervention consisting of debriefing and rolling refreshers.
Educational Debriefings and High frequency training and team reflection

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Quality of neonatal resuscitation (Validated performance score assessed by video analysis)
기간: 12 months
Validated performance score assessed by video analysis
12 months

2차 결과 측정

결과 측정
기간
Clinical outcome - Time to effective respiration
기간: 12 months
12 months
Clinical outcome - Time to heart rate > 100
기간: 12 months
12 months
Clinical outcome - Admission to intensive care
기간: 12 months
12 months
Health care providers adherence to guidelines and behaviour markers - Self-reported score
기간: 12 months
12 months
Health care providers adherence to guidelines and behaviour markers - Simulation score
기간: 12 months
12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Theresa M Olasveengen, MD PhD, Oslo University Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 1월 1일

기본 완료 (실제)

2015년 1월 1일

연구 완료 (실제)

2016년 5월 1일

연구 등록 날짜

최초 제출

2015년 1월 12일

QC 기준을 충족하는 최초 제출

2015년 1월 26일

처음 게시됨 (추정)

2015년 1월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 10월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 9월 30일

마지막으로 확인됨

2016년 9월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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