Clinical trial NCT02236949: Sustainability of a Knowledge Translation Intervention to Improve Paediatric Pain
Official title: Sustainability of a Multidimensional Knowledge Translation Intervention to Improve Paediatric Pain Practices and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pediatric pain
intervention sustainability
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 3907
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research study is to evaluate the effectiveness of short refresher sessions. "Pain Practice Change Boosters" given at regular intervals to sustain improved pain process (assessment and management) and clinical outcomes (pain intensity) achieved during a 15 month knowledge translation intervention, Evidence-based Practice for Improving Quality (EPIQ), in 8 children's hospitals in Canada; and to determine the factors that affect that sustainability. The CIHR Team in Children's Pain (2006-2011) evaluated the effectiveness of the EPIQ intervention in 32 hospital units (4 units at each hospital site). 16 hospital units were allocated to the intervention group and 16 units continued with standard care. The current study focuses on the 16 hospital units that implemented the EPIQ intervention only.

Detailed description: This is an 8 hospital repeated measures Randomized Controlled Trial design using a centrally controlled cluster random allocation of units with stratification by hospital. The sample consisted of the 16 hospital units that implemented the EPIQ intervention in the CIHR Team in Children's Pain study. Randomization was restricted so there was one intervention unit and one standard care unit at each site. Outcomes were measured at 3 time points:12 months after the completion of the EPIQ intervention: Baseline (Time 1); 12 months following the implementation of the Booster intervention (Time 2); and 36 months following the implementation of the Booster intervention (Time 3), including the frequency and proportion of children receiving pain assessment and management strategies, children's pain intensity during painful procedures, and health care professionals' perceptions of the context of sustainability.

Eligibility criteria: Inclusion Criteria:

Hospitals met the following inclusion criteria in at least four patient care units:

* distinct geographic location and administrative structure;
* minimum of 15 beds per unit;
* care for children exposed to painful procedures for diagnostic or therapeutic purposes; and
* implementation of pharmacological and non-pharmacological interventions to manage pain.

The 16 participating hospital units had implemented the EPIQ intervention in the CIHR Team in Children's Pain study. Patients in the participating hospital units were eligible to be included in the determination of the pain practice and clinical outcomes if they:

* were between 32 weeks gestational age at birth and 18 years;
* received skin breaking procedures; and
* were admitted to the unit for \>24 hours.

Surveys used to determine factors influencing sustainability were administered to health care professionals in all participating units, who had at least 1 year of professional experience, had worked on the unit for at least 6 months, and spoke English or French.

Primary outcomes:
measure: Pain Process Outcomes (pain assessment)
timeFrame: T1 (Baseline)
measure: Factors Influencing Sustainability: The Alberta Context Tool (ACT)
timeFrame: T1 (Baseline)
measure: Pain Process Outcomes (pain assessment)
timeFrame: T2 (12 months following the implementation of the Booster)
measure: Pain Process Outcomes (pain assessment)
timeFrame: T3 (24 months following the implementation of the Booster)
measure: Factors Influencing Sustainability: The Alberta Context Tool (ACT)
timeFrame: T2 (12 months following the implementation of the Booster)
measure: Factors Influencing Sustainability: The Alberta Context Tool (ACT)
timeFrame: T3 (24 months following the implementation of the Booster)
measure: Pain Process Outcomes (pain management)
timeFrame: T1 (Baseline)
measure: Pain Process Outcomes (pain management)
timeFrame: T2 (12 months following the implementation of the Booster)
measure: Pain Process Outcomes (pain management)
timeFrame: T3 (24 months following the implementation of the Booster)
Secondary outcomes:
measure: Clinical Pain Outcome: Pain Intensity
timeFrame: T1 (Baseline)
measure: Clinical Pain Outcome: Pain Intensity
timeFrame: T2 (12 months following the implementation of the Booster)
measure: Clinical Pain Outcome: Pain Intensity
timeFrame: T3 (24 months following the implementation of the Booster)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Chidlren's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Children's Hospital Winnipeg
state: Manitoba
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Montreal
country: Canada
facility: CHU St. Justine
state: Quebec
Study officials:
affiliation: The Hospital for Sick Children
name: Bonnie Stevens, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stevens BJ, Yamada J, Estabrooks CA, Stinson J, Campbell F, Scott SD, Cummings G; CIHR Team in Children's Pain. Pain in hospitalized children: Effect of a multidimensional knowledge translation strategy on pain process and clinical outcomes. Pain. 2014 Jan;155(1):60-68. doi: 10.1016/j.pain.2013.09.007. Epub 2013 Sep 8.
citation: Stevens BJ, Harrison D, Rashotte J, Yamada J, Abbott LK, Coburn G, Stinson J, Le May S; CIHR Team in Children's Pain. Pain assessment and intensity in hospitalized children in Canada. J Pain. 2012 Sep;13(9):857-65. doi: 10.1016/j.jpain.2012.05.010.
citation: Stevens BJ, Abbott LK, Yamada J, Harrison D, Stinson J, Taddio A, Barwick M, Latimer M, Scott SD, Rashotte J, Campbell F, Finley GA; CIHR Team in Children's Pain. Epidemiology and management of painful procedures in children in Canadian hospitals. CMAJ. 2011 Apr 19;183(7):E403-10. doi: 10.1503/cmaj.101341. Epub 2011 Apr 4.
citation: Estabrooks CA, Squires JE, Hutchinson AM, Scott S, Cummings GG, Kang SH, Midodzi WK, Stevens B. Assessment of variation in the Alberta Context Tool: the contribution of unit level contextual factors and specialty in Canadian pediatric acute care settings. BMC Health Serv Res. 2011 Oct 4;11:251. doi: 10.1186/1472-6963-11-251.
citation: Stevens BJ, Yamada J, Promislow S, Barwick M, Pinard M; CIHR Team in Children's Pain. Pain Assessment and Management After a Knowledge Translation Booster Intervention. Pediatrics. 2016 Oct;138(4):e20153468. doi: 10.1542/peds.2015-3468. Epub 2016 Sep 1.