NCT02236949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,907

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable pain

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

2.8 years

First QC Date

September 5, 2014

Last Update Submit

May 21, 2015

Conditions

Keywords

pediatric painintervention sustainability

Outcome Measures

Primary Outcomes (9)

  • Pain Process Outcomes (pain assessment)

    Pain process outcomes included the proportion of children per unit whose pain was assessed and whether a validated pain measure was used. Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).

    T1 (Baseline)

  • Factors Influencing Sustainability: The Alberta Context Tool (ACT)

    The Alberta Context Tool (ACT) (Estabrooks, 2011) was used to determine the factors that influence sustainability in each of the 16 participating hospital units, including organizational culture, leadership, readiness to change, organizational complexity, professional autonomy and support within the workplace. The ACT measures health care professionals' perceptions of these contextual factors at the unit and institutional levels. The tool was administered in survey form to staff on the participating units at 3 time points.

    T1 (Baseline)

  • Pain Process Outcomes (pain assessment)

    Pain process outcomes included the proportion of children per unit whose pain was assessed and whether a validated pain measure was used. Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).

    T2 (12 months following the implementation of the Booster)

  • Pain Process Outcomes (pain assessment)

    Pain process outcomes included the proportion of children per unit whose pain was assessed and whether a validated pain measure was used. Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).

    T3 (24 months following the implementation of the Booster)

  • Factors Influencing Sustainability: The Alberta Context Tool (ACT)

    The Alberta Context Tool (ACT) was used to determine the factors that influence sustainability in each of the 16 participating hospital units, including organizational culture, leadership, readiness to change, organizational complexity, professional autonomy and support within the workplace. The ACT measures health care professionals' perceptions of these contextual factors at the unit and institutional levels. The tool was administered in survey form to staff on the participating units at 3 time points.

    T2 (12 months following the implementation of the Booster)

  • Factors Influencing Sustainability: The Alberta Context Tool (ACT)

    The Alberta Context Tool (ACT) was used to determine the factors that influence sustainability in each of the 16 participating hospital units, including organizational culture, leadership, readiness to change, organizational complexity, professional autonomy and support within the workplace. The ACT measures health care professionals' perceptions of these contextual factors at the unit and institutional levels. The tool was administered in survey form to staff on the participating units at 3 time points.

    T3 (24 months following the implementation of the Booster)

  • Pain Process Outcomes (pain management)

    Pain process outcomes included the proportion of children per unit who had painful procedures: (i) without pain management interventions, (ii) with pharmacological interventions, and (iii) with non-pharmacological interventions (i.e., physical or psychological). Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).

    T1 (Baseline)

  • Pain Process Outcomes (pain management)

    Pain process outcomes included the proportion of children per unit who had painful procedures: (i) without pain management interventions, (ii) with pharmacological interventions, and (iii) with non-pharmacological interventions (i.e., physical or psychological). Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).

    T2 (12 months following the implementation of the Booster)

  • Pain Process Outcomes (pain management)

    Pain process outcomes included the proportion of children per unit who had painful procedures: (i) without pain management interventions, (ii) with pharmacological interventions, and (iii) with non-pharmacological interventions (i.e., physical or psychological). Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).

    T3 (24 months following the implementation of the Booster)

Secondary Outcomes (3)

  • Clinical Pain Outcome: Pain Intensity

    T1 (Baseline)

  • Clinical Pain Outcome: Pain Intensity

    T2 (12 months following the implementation of the Booster)

  • Clinical Pain Outcome: Pain Intensity

    T3 (24 months following the implementation of the Booster)

Study Arms (2)

Pain Practice Change Booster

EXPERIMENTAL

Pain Practice Change Booster Intervention: 12 months after the EPIQ intervention, and every 4 months for 2 years, a 30-60 minute standardized booster session was delivered to a small group of champions in each hospital unit randomized to the intervention group. Two co-facilitators familiar with the EPIQ intervention conducted all booster sessions via teleconference. Booster sessions included reviewing the effectiveness knowledge translation strategies champions implemented over the past four months to sustain and improve targeted pain practices; determining the sustainability of the pain practice changes, developing a commitment to change plan of action for the next four months.

Behavioral: Pain Practice Change Booster Intervention

Usual Care Group

NO INTERVENTION

No interventions associated with the study were conducted on these units.

Interventions

See experimental arm for a description of the intervention

Pain Practice Change Booster

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Stollery Chidlren's Hospital

Edmonton, Alberta, T6G 2G3, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Children's Hospital Winnipeg

Winnipeg, Manitoba, R3A 1S1, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3H 3J5, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

CHU St. Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (5)

  • 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.

    PMID: 24021861BACKGROUND
  • 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.

    PMID: 22958873BACKGROUND
  • 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.

    PMID: 21464171BACKGROUND
  • 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.

    PMID: 21970404BACKGROUND
  • 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.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bonnie Stevens, RN, PhD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bonnie Stevens RN PhD, Signy Hildur Eaton Chair in Paediatric Nursing, Associate Chief of Nursing Research, Senior Scientist Research Institute

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 11, 2014

Study Start

September 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations