Sustainability of a Knowledge Translation Intervention to Improve Paediatric Pain

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Completed
CT.gov ID
NCT02236949
Collaborator
(none)
3,907
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pain Practice Change Booster Intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
3907 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Sustainability of a Multidimensional Knowledge Translation Intervention to Improve Paediatric Pain Practices and Outcomes
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pain Practice Change Booster

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
See experimental arm for a description of the intervention

No Intervention: Usual Care Group

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

Outcome Measures

Primary Outcome Measures

  1. Pain Process Outcomes (pain assessment) [T1 (Baseline)]

    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).

  2. Factors Influencing Sustainability: The Alberta Context Tool (ACT) [T1 (Baseline)]

    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.

  3. Pain Process Outcomes (pain assessment) [T2 (12 months following the implementation of the Booster)]

    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).

  4. Pain Process Outcomes (pain assessment) [T3 (24 months following the implementation of the Booster)]

    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).

  5. Factors Influencing Sustainability: The Alberta Context Tool (ACT) [T2 (12 months following the implementation of the Booster)]

    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.

  6. Factors Influencing Sustainability: The Alberta Context Tool (ACT) [T3 (24 months following the implementation of the Booster)]

    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.

  7. Pain Process Outcomes (pain management) [T1 (Baseline)]

    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).

  8. Pain Process Outcomes (pain management) [T2 (12 months following the implementation of the Booster)]

    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).

  9. Pain Process Outcomes (pain management) [T3 (24 months following the implementation of the Booster)]

    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).

Secondary Outcome Measures

  1. Clinical Pain Outcome: Pain Intensity [T1 (Baseline)]

    Pain intensity was measured through patient observation during routinely scheduled painful procedures at 3 time points, using one of four validated, age-appropriate measures: Premature Infant Pain Profile (PIPP) (Stevens et al., 1996) Faces-Legs-Arms-Cry-Consolability Scale (FLACC) (Merkel et al., 1997), Faces Pain Scale-Revised (FPS-R) (Hicks et al., 2001), and Numerical Rating Scale (NRS) (Jensen et a., 1986). Data were collected by local pain experts, experienced pediatric clinicians, who were trained on the four measures to ensure accurate and standardized use.

  2. Clinical Pain Outcome: Pain Intensity [T2 (12 months following the implementation of the Booster)]

    Pain intensity was measured through patient observation during routinely scheduled painful procedures at 3 time points, using one of four validated, age-appropriate measures: Premature Infant Pain Profile (PIPP) (Stevens et al., 1996) Faces-Legs-Arms-Cry-Consolability Scale (FLACC) (Merkel et al., 1997), Faces Pain Scale-Revised (FPS-R) (Hicks et al., 2001), and Numerical Rating Scale (NRS) (Jensen et a., 1986). Data were collected by local pain experts, experienced pediatric clinicians, who were trained on the four measures to ensure accurate and standardized use.

  3. Clinical Pain Outcome: Pain Intensity [T3 (24 months following the implementation of the Booster)]

    Pain intensity was measured through patient observation during routinely scheduled painful procedures at 3 time points, using one of four validated, age-appropriate measures: Premature Infant Pain Profile (PIPP) (Stevens et al., 1996) Faces-Legs-Arms-Cry-Consolability Scale (FLACC) (Merkel et al., 1997), Faces Pain Scale-Revised (FPS-R) (Hicks et al., 2001), and Numerical Rating Scale (NRS) (Jensen et a., 1986). Data were collected by local pain experts, experienced pediatric clinicians, who were trained on the four measures to ensure accurate and standardized use.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stollery Chidlren's Hospital Edmonton Alberta Canada T6G 2G3
2 BC Children's Hospital Vancouver British Columbia Canada V6H 3V4
3 Children's Hospital Winnipeg Winnipeg Manitoba Canada R3A 1S1
4 IWK Health Centre Halifax Nova Scotia Canada B3H 3J5
5 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
6 Montreal Children's Hospital Montreal Quebec Canada H3H 1P3
7 CHU St. Justine Montreal Quebec Canada H3T 1C5

Sponsors and Collaborators

  • The Hospital for Sick Children

Investigators

  • Principal Investigator: Bonnie Stevens, RN, PhD, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bonnie Stevens, Bonnie Stevens RN PhD, Signy Hildur Eaton Chair in Paediatric Nursing, Associate Chief of Nursing Research, Senior Scientist Research Institute, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT02236949
Other Study ID Numbers:
  • 1000026324
First Posted:
Sep 11, 2014
Last Update Posted:
May 22, 2015
Last Verified:
May 1, 2015
Keywords provided by Bonnie Stevens, Bonnie Stevens RN PhD, Signy Hildur Eaton Chair in Paediatric Nursing, Associate Chief of Nursing Research, Senior Scientist Research Institute, The Hospital for Sick Children

Study Results

No Results Posted as of May 22, 2015