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Completed

NCT Number: NCT02236949

Sustainability of a Knowledge Translation Intervention to Improve Paediatric Pain

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stollery Chidlren's Hospital, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain Practice Change Booster Intervention

Behavioral

See experimental arm for a description of the intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Sustainability of a Multidimensional Knowledge Translation Intervention to Improve Paediatric Pain Practices and Outcomes

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2014
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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