Caring for Babies: A Study of Ontario Maternal-Newborn Hospitals on the Implementation of Parent-targeted Education

NCT03099252 | Unknown

• 1 other identifier: CHEO REB# 17/01CTO
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Newborn infants have blood work procedures for newborn screening and bilirubin testing in their first days of life that cause pain, distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving small amounts of sweet solutions (sucrose or glucose) with or without a pacifier, effectively and safely reduce pain and distress in newborn infants during painful procedures. However, studies of neonatal pain management practices in Ontario and throughout Canada demonstrate inconsistent use of these strategies. There is a clear need for developing and testing acceptable parent-targeted interventions, alongside health care provider (HCP)-targeted knowledge translation (KT) interventions, to support parents' involvement in comforting their infants during painful procedures. To address this knowledge to action (KTA) gap, Denise Harrison's Be Sweet to Babies team developed the BSweet2Babies video, which demonstrates the effectiveness of BF, SSC, and sucrose during infant bloodwork and how parents can use and advocate for these pain management strategies. This project addresses a knowledge to practice gap that is highly relevant to all babies and their families. Thus, this study has the potential to advance health care of all babies and contribute to the science of KT by evaluating the implementation of a parent-targeted and mediated KT strategy in diverse hospital settings. Hospitals were eligible for inclusion if they (1) provide Level 1 or Level 2 maternal/newborn care contributing data to the Better Outcomes Registry \& Network Ontario (BORN) Information Systems (BIS); (2) have a birth volume of at least 50 per year; (3) have \<85% use of pain management (BF,SSC, sucrose) during newborn screening or bilirubin sampling, as per BIS data; and (4) have \< 50% missing data for the pain management data element in the BIS. Participating hospitals will receive a tablet and will offer all parents the 5 minute BSweet2Babies video before newborn bloodwork. BORN Information System (BIS) data will subsequently be analyzed to evaluate the use of BF, SSC and sweet solutions.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• Process Evaluation

  Directed content analysis will be used to analyze data from monthly interview, bi-monthly teleconferences and end of intervention surveys

  7 months.

• BORN BIS Pain Data

  Number of effective pain treatment used during newborn screening.

  Six months prior to study launch date.

• BORN BIS Pain Data

  Number of effective pain treatment used during newborn screening.

  Six months following completion of the intervention.

Study Arms (1)

Enrolled

Participating hospitals will offer the video to all parents on their MBU during the 6 month intervention period (using the preferred delivery methods of the hospital and the parents). The video will be available via multiple means to facilitate optimal parental exposure in diverse settings. This will ensure flexibility of the delivery of the intervention, based on preferences of the nominated nurse leaders and their HCP team, families and available resources. All participating maternal/newborn centres will receive the following tools via the designated nurse unit leader of enrolled sites: 1. Parent-targeted BSweet2Babies video 2. Parent cards- Reminder for parents of video, with Quick Response (QR) code of the video 3. BSweet2Babies Poster-visual reminder for parents and HCP's on the enrolled units 4. Monthly support calls for the nursing leaders of the Mother Baby Units (MBU) 5. Bi-monthly community of practice teleconferences for the nursing leaders of the MBU

Other: Parent-targeted BSweet2Babies video

Interventions

Parent-targeted BSweet2Babies video OTHER

The video portrays three babies having blood tests while being i) BF, ii) held SSC with the mother, and iii) receiving sucrose. The calming effects of these strategies are powerfully portrayed. Voice-over in user-friendly language explains how parents can help their babies by partnering with clinicians to use these strategies. As per the definition of patient-targeted and mediated interventions, this video is: i) patient (parent)-targeted, as it actively engages parents to improve their knowledge, positively affect their experience (during newborn screening), change their behavior and their baby's outcomes; ii) patient-mediated, as the video enables parents to change health professional behavior.

Enrolled

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ontario hospitals that provide Level 1 or Level 2 maternal/newborn care, contributing data to the BORN Information System and meet the eligibility criteria.

You may qualify if:

• Hospitals providing Level 1 and Level 2 maternal/newborn care contributing data to the BIS
• A birth volume of at least 50 per year
• Hospitals will be excluded if they:
• \>85% use of pain management (BF, SSC, sucrose) during newborn screening
• \>50% missing data for the pain management data element in the BIS. element.
• two hospitals that were used as pilot sites will be excluded

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• Ontario Child Health Support Unit (OCHSU): collaborator
• Better Outcomes Registry & Network Ontario: collaborator
• Dalhousie University: collaborator
• Ottawa Hospital Research Institute: collaborator
• University of Calgary: collaborator
• McGill University: collaborator
• The Hospital for Sick Children: collaborator
• Headwaters Health Care Centre: collaborator
• Champlain Maternal Newborn Regional Program: collaborator
• St Thomas Elgin General Hospital: collaborator
• Baby Friendly Hospital Initiative: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Denise Harrison, RN, PhD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair in Nursing Care of Children, Youth and Families

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: September 1, 2018
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)