9500 Participants Needed

Quality Improvement Care Bundles for Premature Birth

(ABC-QI Trial)

Recruiting at 11 trial locations
DP
AA
MB
Overseen ByMahesha Bandara, MSc
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Quality Improvement Care Bundles for Premature Birth?

Research shows that using care bundles, which are sets of practices done together, can improve patient outcomes. For example, a nutrition care bundle helped premature infants gain weight better, and care bundles in intensive care units have reduced infections. This suggests that care bundles can be effective in improving care quality in various settings.12345

Is the Quality Improvement Care Bundle generally safe for humans?

The studies on care bundles, including those for respiratory and nutritional care in infants, focus on improving care quality and outcomes without reporting any specific safety concerns, suggesting they are generally safe when implemented correctly.46789

What makes the Quality Improvement Care Bundles for Premature Birth unique compared to other treatments?

The Quality Improvement Care Bundles for Premature Birth are unique because they use standardized sets of care practices, focusing on nutrition and respiratory support, to improve outcomes in premature infants. These bundles are evidence-based and aim to reduce complications like bronchopulmonary dysplasia (a lung condition) and improve growth, which is different from traditional treatments that may not use such comprehensive, structured approaches.246810

What is the purpose of this trial?

The ABC-QI Trial aims to implement collaborative quality improvement (QI) strategies to standardize care for 32-36 week infants in Level 2 and 3 Neonatal intensive care units (NICUs) across the province of Alberta. The investigators want to know if using validated quality improvement methods and evidence-based care bundles will decrease the duration of hospital stay and get babies home as quickly as possible.

Research Team

JT

Jennifer Toye, MD

Principal Investigator

University of Alberta

AA

Ayman Abou Mehrem, MD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for preterm infants born between 32 to 36 weeks' gestation in Alberta's NICUs, as well as the healthcare staff working there. Infants with major birth defects or those needing surgery, and babies treated outside Alberta are excluded.

Inclusion Criteria

My baby was born between 32 and 36 weeks and is in the NICU or postpartum unit.
Management staff, nurses, nurse practitioners, physicians, and allied health staff employed in participating NICUs for Quality Improvement Implementation Survey version 2 (QIIS-II) and semi-structured interview participants

Exclusion Criteria

My baby was born early and has a major birth defect or genetic issue.
Preterm Infants with primary admission to a surgical NICU at Alberta Children's Hospital or Stollery Children's Hospital
Infants born in or transferred to a NICU outside Alberta.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Arm

NICUs in the control arm conduct QI activities relevant to current practice without receiving the interventions

1 year

Intervention Arm

NICUs transition to the intervention arm and implement collaborative QI strategies including QI Team Building, QI Education, and care bundles

1 year

Follow-up

Participants are monitored for safety and effectiveness after discharge, including emergency room visits and rehospitalizations

6 months

Treatment Details

Interventions

  • Collaborative networking
  • Current practice- standard of care
  • QI education
  • QI mentoring
  • QI Team Building
  • Standardized care bundle- nutritional care
  • Standardized care bundle- respiratory care
Trial Overview The ABC-QI Trial tests if quality improvement strategies and care bundles for respiratory and nutritional support can shorten hospital stays for moderately late preterm infants in Level 2 and 3 NICUs.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Arm- Collaborative Quality implementation StrategiesExperimental Treatment6 Interventions
The study intervention is a constellation of collaborative QI strategies: 1) QI Team Building; 2) QI Education; 3) Implementation of 2 standardized practice care bundles (Respiratory Care, and Nutritional Care); 4) QI mentoring; and 5) Collaborative networking.
Group II: Control Arm- Current managementActive Control1 Intervention
NICUs in the control arm can continue conducting QI activities relevant to current practice and current standard of care, but without receiving the interventions until they transition to the intervention arm.

Standardized care bundle- nutritional care is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as Standardized Nutritional Care for:
  • Care for moderate and late preterm infants in Level 2 and 3 NICUs

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Covenant Health, Canada

Collaborator

Trials
3
Recruited
2,300+

University of Alberta

Collaborator

Trials
957
Recruited
437,000+

Covenant Health

Collaborator

Trials
7
Recruited
14,100+

Alberta Health services

Collaborator

Trials
168
Recruited
658,000+

Findings from Research

Malnutrition in hospitals is a serious issue that can lead to increased risks of infections, longer hospital stays, and higher healthcare costs, highlighting the need for better detection and treatment.
The implementation of a comprehensive nutrition care bundle, which includes six key components for assessing and providing nutritional support, can significantly improve patient outcomes by ensuring adequate nutrition during hospital stays.
New Nutrition Guidelines: Promoting Enteral Nutrition via a Nutrition Bundle.VanBlarcom, A., McCoy, MA.[2018]
Healthcare professionals found that care bundles for COPD improved the standardization of care practices and facilitated smoother transitions for patients between different care settings, enhancing the overall process of care delivery.
The successful implementation of these care bundles was influenced by the presence of clinical champions and system-based initiatives, but challenges in accurately diagnosing COPD sometimes limited their effectiveness, indicating areas for improvement in care delivery.
Using and implementing care bundles for patients with acute admission for COPD: qualitative study of healthcare professionals' experience in four hospitals in England.Shaw, A., Morton, K., King, A., et al.[2021]
The introduction of sepsis care bundles has been shown to significantly reduce the risk of sepsis, with a relative risk reduction exceeding 25% and an absolute risk reduction of over 9%, indicating a strong potential for improving patient outcomes.
Care bundles, particularly in the context of preventing infections like ventilator-associated pneumonia and catheter-associated bloodstream infections, have demonstrated effectiveness in multicenter studies, suggesting they can enhance the reliability of evidence-based care delivery.
Care bundles: the holy grail of infectious risk management in hospital?Marwick, C., Davey, P.[2021]

References

New Nutrition Guidelines: Promoting Enteral Nutrition via a Nutrition Bundle. [2018]
Using and implementing care bundles for patients with acute admission for COPD: qualitative study of healthcare professionals' experience in four hospitals in England. [2021]
Care bundles: the holy grail of infectious risk management in hospital? [2021]
Implementation of a Nutrition Care Bundle and Improved Weight Gain of Extremely Preterm Infants to 36 Weeks Postmenstrual Age. [2023]
Implementing quality initiatives using a bundled approach. [2016]
NICU bedside caregivers sustain process improvement and decrease incidence of bronchopulmonary dysplasia in infants [2018]
Pressure Ulcer Prevention Care Bundle: A Cross-sectional, Content Validation Study. [2020]
Quality improvement to reduce chronic lung disease rates in very-low birth weight infants: high compliance with a respiratory care bundle in a small NICU. [2019]
Using the WHO safe childbirth checklist to improve essential care delivery as part of the district-wide maternal and newborn health quality improvement initiative, a time series study. [2021]
Effect of ICU care bundles on long-term patient-relevant outcomes: a scoping review. [2023]
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