Quality Improvement Care Bundles for Premature Birth

(ABC-QI Trial)

Recruiting at 11 trial locations

Overseen By Mahesha Bandara, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Congenital anomalies, Chromosomal abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

9500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods for caring for babies born slightly early, between 32 and 36 weeks, in specialized baby care units in Alberta. It uses proven methods, such as standardized care bundles for nutritional and respiratory care, to enhance nutrition and breathing support, aiming to shorten hospital stays so babies can go home sooner. Two groups participate: one continues with current care, while the other tries the new strategies. Families with babies born between 32 and 36 weeks in specific Alberta hospitals are well-suited for this trial. As an unphased trial, it offers families the chance to help improve care practices for premature babies.

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 prior data suggests that these quality improvement strategies are safe for premature infants?

Research has shown that quality improvement (QI) strategies are safe for newborn care. These strategies identify key areas to enhance care and increase healthcare providers' knowledge. Previous studies with similar QI programs have focused on improving newborn health without causing harm.

QI strategies often include team building, education, and mentoring. They have been linked to better health outcomes for babies, with no reports of serious side effects. Programs like those in the ABC-QI trial do not involve new medications or invasive procedures, reducing the risk of negative effects. Therefore, they are generally well-tolerated and considered safe in hospital settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a new way of improving care for premature babies through a collaborative quality improvement (QI) approach. Unlike traditional methods that focus on individual interventions, this trial emphasizes team building, education, and mentoring to implement standardized care bundles for both nutritional and respiratory care. This method aims to create a supportive network and consistent practices across NICUs, potentially leading to better outcomes for premature infants by enhancing overall care quality.

What evidence suggests that this trial's treatments could be effective for premature birth?

This trial will compare current management practices with a collaborative quality improvement approach. Research has shown that teamwork-based improvement strategies, which participants in the intervention arm of this trial will receive, can benefit preterm infants. In past studies, these strategies helped make hospital care more consistent, leading to better outcomes for babies born between 32-36 weeks. These strategies include evidence-based care bundles, which are sets of best practices. They have shortened hospital stays by focusing on important areas like nutrition and breathing care. This approach has successfully improved the care and health of newborns in various settings. ^{1 3 5 6 7}

Who Is on the Research Team?

Jennifer Toye, MD

Principal Investigator

University of Alberta

Ayman Abou Mehrem, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intervention Arm- Collaborative Quality implementation Strategies Experimental Treatment 6 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 management Active Control 1 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

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+

Published Research Related to This Trial

The implementation of a respiratory care bundle in a study of 1,050 infants born before 30 weeks gestation led to a significant reduction in the incidence of bronchopulmonary dysplasia (BPD) from 51.2% to 29.9% during the third time period (T3) compared to the first (T1).

Although the respiratory bundle improved outcomes such as BPD-free survival and reduced oxygen requirements at 28 days of life, these benefits were not sustained in the following time period (T4), indicating that while the intervention was effective initially, long-term improvements in BPD rates were not achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NICU bedside caregivers sustain process improvement and decrease incidence of bronchopulmonary dysplasia in infants Mola, SJ., Annibale, DJ., Wagner, CL., et al.[2018]

A nutrition care bundle significantly improved weight gain in premature infants with a birth weight of ≤1000 g, as shown in a study of 584 infants over an 11-year period.

The study found that later epochs of nutritional support were positive predictors of weight gain, indicating that enhanced nutrition practices over time contributed to better growth outcomes in these vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Nutrition Care Bundle and Improved Weight Gain of Extremely Preterm Infants to 36 Weeks Postmenstrual Age. McKinley, LT., Przystac, L., Tucker, R., et al.[2023]

The implementation of a ventilator care bundle in critical care has been shown to significantly reduce the incidence of ventilator-associated pneumonia, improving the quality of care for mechanically ventilated patients.

The bundle approach is adaptable to various intensive care unit environments, but its flexibility can limit comparability across different centers, highlighting the need for multidisciplinary engagement for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing quality initiatives using a bundled approach. Dawson, D., Endacott, R.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care bundles: the holy grail of infectious risk management in hospital? Marwick, C., Davey, P.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Nutrition Guidelines: Promoting Enteral Nutrition via a Nutrition Bundle. VanBlarcom, A., McCoy, MA.[2018]

A systematic review of 2012 records identified 38 studies on care bundles in ICUs, revealing that while sepsis bundles showed a positive effect on patient survival, the overall impact on long-term outcomes like health-related quality of life (HrQoL) and post-intensive care syndrome (PICS) remains inconclusive due to variability in study designs and high risk of bias.

The review highlights the need for further research to better understand the long-term benefits of ICU care bundles, particularly regarding their effects on patients' quality of life and recovery after intensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ICU care bundles on long-term patient-relevant outcomes: a scoping review. Paul, N., Ribet Buse, E., Knauthe, AC., et al.[2023]

A study involving 68 nurses in Turkish ICUs validated a pressure ulcer prevention care bundle, achieving a high content validation score of 3.9 out of 4, indicating its effectiveness and appropriateness for clinical use.

Nurses found the care bundle to be comprehensive and feasible for clinical decision-making, although some expressed concerns about its complexity and implementation, suggesting areas for improvement in future iterations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure Ulcer Prevention Care Bundle: A Cross-sectional, Content Validation Study. Tilmazer, T., Tuzer, H.[2020]

Implementing a standardized respiratory care bundle in a neonatal intensive care unit led to a significant 73% reduction in chronic lung disease rates among very-low birth weight infants, dropping from 43% to 12%.

The study, which included 107 infants, also showed improvements in other health outcomes, such as a decrease in combined rates of chronic lung disease and death from 50% to 20%, and a reduction in severe intraventricular hemorrhage and the need for surgical ligation of patent ductus arteriosus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kubicka, Z., Zahr, E., Rousseau, T., et al.[2019]

Integrating the World Health Organization Safe Childbirth Checklist (WHO-SCC) into a district-wide quality improvement program in Ethiopia significantly improved adherence to essential birth care practices, with adherence rates reaching 86% for the 'On Admission' bundle and 80% for the 'Before Pushing' bundle.

The study highlights the effectiveness of a systems approach in enhancing the delivery of reliable quality care in maternal and newborn health, suggesting that such interventions can lead to sustained improvements in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bitewulign, B., Abdissa, D., Mulissa, Z., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10158756/

Alberta Collaborative Quality Improvement Strategies to ... The ABC-QI trial aims to evaluate the impact of collaborative quality improvement strategies in moderate and late preterm neonates on clinical ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05231200

Alberta Collaborative QI Strategies to Improve Outcomes of ... 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 ...

3. pm.amegroups.org pm.amegroups.org/article/view/5096/html

Improving outcomes for preterm infants in the California ... Specific strategies have included real-time data reports, toolkits of evidence-based practice, dissemination through educational meetings, and ...

4. nichq.org nichq.org/projects/collaborative-improvement-and-innovation-network-to-reduce-infant-mortality-infant-mortality-coiin/

Collaborative Improvement and Innovation Network to ... Opportunities for States to Improve Women's Health and Birth Outcomes through Medicaid Incentives for Effective Contraceptive Use and Postpartum Care. This ...

5. bmjopenquality.bmj.com bmjopenquality.bmj.com/content/12/4/e002443

Quality improvement collaboratives as part of a ... We implemented a QIC as part of a quality improvement intervention package designed to improve newborn survival in Kenya and Uganda.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4162801/

Association of a quality improvement program with neonatal ... In the current study, we assessed the association of Canada-wide implementation of EPIQ with mortality and morbidity among preterm infants less than 29 weeks ...

7. nature.com nature.com/articles/s41372-024-02124-w

The role of QI collaboratives in neonatology We found that the QICs in neonatology play a significant role in identification of target topics, developing best practices, improving provider knowledge, ...