Clinical trial NCT03099252: Caring for Babies: A Study of Ontario Maternal-Newborn Hospitals on the Implementation of Parent-targeted Education
Official title: Caring for Babies: A Study of Ontario Maternal-Newborn Hospitals on the Implementation of Parent-targeted Education (ONesiE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Ontario Child Health Support Unit (OCHSU)
name: Better Outcomes Registry & Network Ontario
name: Dalhousie University
name: Ottawa Hospital Research Institute
name: University of Calgary
name: McGill University
name: The Hospital for Sick Children
name: Headwaters Health Care Centre
name: Champlain Maternal Newborn Regional Program
name: St Thomas Elgin General Hospital
name: Baby Friendly Hospital Initiative
First posted: 2017-04-04
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Background: 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-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.

Objectives: To conduct a process evaluation to understand during the 6-month intervention period; (1) to what extent did HCPs implement the BSweet2Babies video in their setting; (2) What were the barriers and facilitators encountered in implementing the BSweet2Babies video; (3) What were the barriers and facilitators encountered in implementing the evidence shown in the BSweet2babies video (i.e. breastfeeding, skin-to-skin care, sucrose).

Study design and methods: Sequential exploratory mixed methods study. The mixed methods implementation study includes process evaluation, exploration of facilitators and barriers to implementation of the video and uptake of the demonstrated recommended pain management of BF, SSC or sucrose during initial blood sampling by heel prick.

Data Analysis: Directed content analysis will be used to analyse the qualitative data (i.e. monthly phone calls and bi-monthly community of practice teleconferences). Interview data will be transcribed verbatim with consent. A deductive and inductive approach will be used to code the qualitative data with codes developed apriori based on the Theoretical Domains Framework. Any concepts that do not fit within the framework will be assigned a new code.

Process evaluation will be described and summarized according to the process evaluation of complex intervention guide.

BORN Ontario data analysts in consultation with CoI Taljaard will conduct analysis using descriptive statistics to compare characteristics of participating sites and births including unit type (Level 1 compared to Level 2), birth volume, infant sex, and parity. In addition, BIS pain data will be reported as baseline and following the 6- month implementation period.

Eligibility criteria: Inclusion criteria for hospitals include:

* 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

Primary outcomes:
measure: Process Evaluation
timeFrame: 7 months.
measure: BORN BIS Pain Data
timeFrame: Six months prior to study launch date.
measure: BORN BIS Pain Data
timeFrame: Six months following completion of the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Denise Harrison, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: