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Sustainability of a Knowledge Translation Intervention to Improve Paediatric Pain

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ClinicalTrials.gov Identifier: NCT02236949
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Bonnie Stevens, The Hospital for Sick Children

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
Pain Behavioral: Pain Practice Change Booster Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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.



Primary Outcome Measures :
  1. Pain Process Outcomes (pain assessment) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236949


Locations
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Canada, Alberta
Stollery Chidlren's Hospital
Edmonton, Alberta, Canada, T6G 2G3
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
Children's Hospital Winnipeg
Winnipeg, Manitoba, Canada, R3A 1S1
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3H 3J5
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
CHU St. Justine
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Bonnie Stevens, RN, PhD The Hospital for Sick Children
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: September 11, 2014    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015
Keywords provided by Bonnie Stevens, The Hospital for Sick Children:
pediatric pain
intervention sustainability