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| ID | Type | Description | Link |
|---|---|---|---|
| 462647 | Other Grant/Funding Number | CIHR |
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| Name | Class |
|---|---|
| University of Alberta | OTHER |
| Alberta Health services | OTHER |
| Covenant Health, Canada | OTHER |
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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.
A stepped-wedge cluster randomized trial will be conducted in 12 NICUs across Alberta (10 Level II and 2 Level III). Each NICU is considered a cluster and will be randomized to transition to the intervention arm at one of three time points.
The planned trial interventions include:
Intervention arm (Collaborative QI Strategies): 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. Based on the randomization, 4 NICUs will transition to the intervention arm at the end of each year.
Control arm (current management): 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm- Current management | Active Comparator | 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. |
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| Intervention Arm- Collaborative Quality implementation Strategies | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QI Team Building | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | The duration of hospitalization until final discharge. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Cost to healthcare system per participant | The investigators will use the Canadian Institute for Health Information Patient Cost Estimator to calculate the daily cost based on the Case Mix Groups for gestational age and birth weight. | 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). |
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Inclusion Criteria:
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 Criteria:
Preterm Infants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahesha Bandara, MSc | Contact | 1-403-944-3753 | mahesha.yatigalpotht@ucalgary.ca | |
| Ayman Abou Mehrem, MD | Contact | 1-403-944-3699 | a.aboumehrem@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ayman Abou Mehrem, MD | University of Calgary | Principal Investigator |
| Jennifer Toye, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter Lougheed Centre | Recruiting | Calgary | Alberta | T1Y 6J4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37130608 | Derived | Abou Mehrem A, Toye J, Aziz K, Benzies K, Alshaikh B, Johnson D, Faris P, Soraisham A, McNeil D, Al Hamarneh YN, Foss K, Foulston C, Johns C, Zimmermann GL, Zein H, Hendson L, Kumaran K, Price D, Singhal N, Shah PS. Alberta Collaborative Quality Improvement Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI) Trial: a protocol for a multicentre, stepped-wedge cluster randomized trial. CMAJ Open. 2023 May 2;11(3):E397-E403. doi: 10.9778/cmajo.20220177. Print 2023 May-Jun. |
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After the study is completed, the de-identified, archived data will be transmitted to and stored at the Federated Research Data Repository (FRDR), for use by other researchers including those outside of the study.
Data will be available after completion of the study and publication of the main manuscript.
Approval from the principle investigator and the ABC-QI Trial Data Management Committee.
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A stepped-wedge cluster randomized trial (SW-CRT) design. Each of the 12 participating NICUs (10 Level II and 2 Level III) are considered clusters and will be randomized to transition to the intervention arm at one of three-time points over a period of four years. The first year will be a baseline period where no clusters are exposed to the intervention. Based on the randomization, four NICUs will transition to the intervention arm at the end of each year. All clusters will have transitioned to the intervention arm by the start of year four.
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| QI education | Behavioral | 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. |
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| Standardized care bundle- respiratory care | Other | 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
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| Standardized care bundle- nutritional care | Other | 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
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| QI mentoring | Behavioral | 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. |
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| Collaborative networking | Behavioral | 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. |
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| Current practice- standard of care | Other | 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. |
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| Number of participants with Hypothermia | Axillary temperature <36.5°C. | Within 1 hour of birth |
| Number of participants with Hypoglycemia | Blood glucose <2.6 mmol/L. | First 24 hours of age |
| Surfactant administration | Date and method of administration | First 168 hours of age. |
| Duration of respiratory support | Total number of days administered | 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). |
| Age at achieving full enteral feeding | Date when the enteral intake reaches 120 ml/kg/day. | 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). |
| Time to regain birth weight | Difference in days between birth date and date when the infants regains or exceeds birth weight after initial weight loss. | 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). |
| Weight in grams | actual values in grams | At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date). |
| Length in centimeters | actual values in centimeters | At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date). |
| Head circumference in centimeters | actual values in centimeters | At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date). |
| Breastmilk use | Defined as number of feeds where infant received breastfeeding or maternal expressed breastmilk | 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). |
| Number of unplanned rehospitalizations per participant | Unplanned readmission to any hospital in Alberta following discharge | Within 30 days after discharge home |
| Number of emergency room visits per participant | Emergency room visits to any hospital in Alberta following discharge | Within 30 days after discharge home |
| Hospital mortality | Proportion of infants who dies before first discharge home | Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date). |
| Infant mortality before 1 year of corrected age | Corrected age = chronological age - days required for an infant to complete postmenstrual age of 40 weeks. | Before 1 year of corrected age |
| Transfer from Level II to Level III NICU | Proportion of infants who require escalation of care and transfer to Level III NICU. | Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date). |
| Staff perception of collaborative QI (EPIQ) implementation. | Semi-structured interviews with selected sample of staff from each NICU | Year 2, 3, and 4 of study |
| Foothills Medical Centre | Recruiting | Calgary | Alberta | T2N 2T9 | Canada |
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| Rockyview General Hospital | Recruiting | Calgary | Alberta | T2V 1P9 | Canada |
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| South Health Campus | Recruiting | Calgary | Alberta | T3M 1M4 | Canada |
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| Grande Prairie Regional Hospital | Recruiting | Calgary | Alberta | T8V 4B1 | Canada |
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| Royal Alexandra Hospital | Recruiting | Edmonton | Alberta | T5H 3V9 | Canada |
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| Misericordia Community Hospital | Recruiting | Edmonton | Alberta | T5R 4H5 | Canada |
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| Grey Nuns Community Hospital | Recruiting | Edmonton | Alberta | T6L 5X8 | Canada |
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| Sturgeon Community Hospital | Recruiting | Edmonton | Alberta | T8N 6C4 | Canada |
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| Chinook Regional Hospital | Recruiting | Lethbridge | Alberta | T1J 1W5 | Canada |
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| Medicine Hat Regional Hospital | Recruiting | Medicine Hat | Alberta | T1A 4H6 | Canada |
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| Red Deer Regional Hospital | Recruiting | Red Deer | Alberta | T4N 4E7 | Canada |
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