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View on ClinicalTrials.gov

Comparing QI Team Building with QI education for length of stay

Official title: Alberta Collaborative QI Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI Trial)

Alberta (AB) Collaborative Quality Improvement Strategies to Improve Outcomes of Preterm Infants 32 - 36 Weeks' Gestation: A Stepped-Wedge Cluster Randomized Trial

Condition: Length of StaySponsor: University of CalgaryTarget enrollment: 9500
  • 2 groups
  • Sites in Calgary, Edmonton and 3 more cities
  • Recruiting
Peter Lougheed Centre, Calgary, AlbertaFoothills Medical Centre, Calgary, AlbertaRockyview General Hospital, Calgary, AlbertaSouth Health Campus, Calgary, AlbertaGrande Prairie Regional Hospital, Calgary, AlbertaRoyal Alexandra Hospital, Edmonton, AlbertaMisericordia Community Hospital, Edmonton, AlbertaGrey Nuns Community Hospital, Edmonton, AlbertaSturgeon Community Hospital, Edmonton, AlbertaChinook Regional Hospital, Lethbridge, AlbertaMedicine Hat Regional Hospital, Medicine Hat, AlbertaRed Deer Regional Hospital, Red Deer, Alberta

Interventions (7)

  • Behavioural therapy

    QI Team Building

    Each NICU will create a core QI team composed of 6-8 multidisciplinary members including a parent advisor, when feasible. This team will lead the QI activities and education, and champion the culture and practice change in the unit.

  • Behavioural therapy

    QI education

    Each NICU QI team will receive standardized QI education using the 6-hour EPIQ Workshop which involves hands-on approach to enable teams to successfully implement QI projects together. EPIQ 10 Steps and QI Tools will be used to build the team's understanding of QI using realistic improvement opportunities based on the standardized care bundles identified in the trial.

  • Other intervention

    Standardized care bundle- respiratory care

    A care bundle is a small, simple set (3-5 elements) of evidence-based practices that, when performed collectively and reliably, will result in improved patient outcomes. This bundle will aim to implement best practices for stabilization and respiratory care in moderate and late preterm infants (MLPIs) including 1. establishing effective ventilation in the delivery room 2. prevention of hypothermia 3. early diagnosis and management of respiratory distress with continuous positive airway pressure (CPAP) 4. standardized approach for surfactant indications and administration 5. standardized approach for early extubation.

Canadian Sites (12)

12 of 12 recruiting

  • Peter Lougheed Centre

    Calgary, Alberta

    Recruiting
  • Foothills Medical Centre

    Calgary, Alberta

    Recruiting
  • Rockyview General Hospital

    Calgary, Alberta

    Recruiting

Eligibility Criteria

See who this study is looking for7 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Preterm Infants: Infants born at 32 to 36 weeks' gestation and admitted to the participating NICUs or postpartum units.
  • +Quality Improvement Implementation Survey version 2 (QIIS-II) and semi-structured interview participants: Management staff, nurses, nurse practitioners, physicians, and allied health staff employed in participating NICUs.

Exclusion

  • Preterm Infants:
  • Major congenital anomalies or chromosomal abnormalities.
  • Primary admission to a surgical NICU: Alberta Children's Hospital or Stollery Children's Hospital.
  • Infants born in or transferred to a NICU outside Alberta.
  • Patients who have imposed confidentiality restrictions on accessing their health records.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is looking at how care is delivered and organised, rather than at a treatment itself.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A, the comparison group, receives Current practice- standard of careStandard of careThe treatment normally given for a condition outside a study.Read more →.

Registry label: A: Control Arm- Current management

Group B receives one or more of: QI Team Building, QI education, Standardized care bundle- respiratory care, Standardized care bundle- nutritional care, QI mentoring and Collaborative networking.

Registry label: B: Intervention Arm- Collaborative Quality implementation Strategies

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 32 weeks to 36 weeks.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 9,500 people.

The study is currently expected to finish around August 2027.

The main measurement is taken over: Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Length of Stay — measured over Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05231200 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About QI Team BuildingBehavioural

Each NICU will create a core QI team composed of 6-8 multidisciplinary members including a parent advisor, when feasible. This team will lead the QI activities and education, and champion the culture and practice change in the unit.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

About QI educationBehavioural

Each NICU QI team will receive standardized QI education using the 6-hour EPIQ Workshop which involves hands-on approach to enable teams to successfully implement QI projects together. EPIQ 10 Steps and QI Tools will be used to build the team's understanding of QI using realistic improvement opportunities based on the standardized care bundles identified in the trial.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

About Standardized care bundle- respiratory careOther

A care bundle is a small, simple set (3-5 elements) of evidence-based practices that, when performed collectively and reliably, will result in improved patient outcomes. This bundle will aim to implement best practices for stabilization and respiratory care in moderate and late preterm infants (MLPIs) including 1. establishing effective ventilation in the delivery room 2. prevention of hypothermia 3. early diagnosis and management of respiratory distress with continuous positive airway pressure (CPAP) 4. standardized approach for surfactant indications and administration 5. standardized approach for early extubation.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About Standardized care bundle- nutritional careOther

A care bundle is a small, simple set (3-5 elements) of evidence-based practices that, when performed collectively and reliably, will result in improved patient outcomes. This bundle will aim to implement best practices for nutritional support in MLPIs including 1. early initiation of enteral or parenteral nutrition; 2. standardized tables for feeding initiation and progression 3. optimizing breastfeeding and use of mother's own milk 4. standardized approach for a transition from enteral nutrition via tube feeds to oral feeds.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About QI mentoringBehavioural

Each NICU in the intervention arm will have one or more assigned members of the study team who are experienced in collaborative QI and EPIQ methods. The mentors will help local QI teams to engage frontline staff in QI and navigate the unit-specific challenges.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

About Collaborative networkingBehavioural

The study team will conduct virtual meetings every 2 months for the NICUs in intervention arm allowing local QI teams to discuss progress, and share data. The investigators will arrange annual in-person or virtual meetings for the NICUs in the intervention arm to present projects, successes, and lessons learned. These NICUs will have continuing access to the data and will receive quarterly reports using statistical process control charts outlining the unit's performance compared to other units and to the group average.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

About Current practice- standard of careOther

All participating NICUs will be in the control arm during the first year prior to randomization to create a baseline of the current practices and between-units variation. NICUs in the control arm can continue conducting QI activities relevant to current practice, but without receiving the interventions outlined above until they transition to the intervention arm. The investigators will capture these activities and account for them in the analysis.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 32 weeks to 36 weeks.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 32 weeks to 36 weeks.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date)..

The study as a whole is currently expected to finish around 2027-08-30.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 9,500 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 5 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Lethbridge, Alberta, Canada; Medicine Hat, Alberta, Canada; Red Deer, Alberta, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About 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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.