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PainNCT02236949

Sustainability of a Knowledge Translation Intervention to Improve Paediatric Pain

A study testing Pain Practice Change Booster Intervention in people with Pain, run by The Hospital for Sick Children at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Pain Practice Change Booster Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,907 participants
Where
7 sitesCanada
Study dates
Sep 2011to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites
  • Stollery Chidlren's Hospital

    Edmonton, Alberta, T6G 2G3

  • IWK Health Centre

    Halifax, Nova Scotia, B3H 3J5

  • Montreal Children's Hospital

    Montreal, Quebec, H3H 1P3

  • CHU St. Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • BC Children's Hospital

    Vancouver, British Columbia, V6H 3V4

  • Children's Hospital Winnipeg

    Winnipeg, Manitoba, R3A 1S1

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Pain
Being tested
Pain Practice Change Booster Intervention
Keywords
pediatric pain, intervention sustainability
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain Practice Change Booster InterventionBehavioural

    See experimental arm for a description of the intervention

Study groups in NCT02236949
Study groupRoleWhat they receive
Pain Practice Change BoosterExperimentalPain 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.
Receives: Behavioral: Pain Practice Change Booster Intervention
Usual Care GroupNo interventionNo interventions associated with the study were conducted on these units.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: T1 (Baseline)

  2. 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.

    Measured: T1 (Baseline)

  3. 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).

    Measured: T2 (12 months following the implementation of the Booster)

  4. 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).

    Measured: T3 (24 months following the implementation of the Booster)

  5. 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.

    Measured: T2 (12 months following the implementation of the Booster)

  6. 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.

    Measured: T3 (24 months following the implementation of the Booster)

  7. 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).

    Measured: T1 (Baseline)

  8. 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).

    Measured: T2 (12 months following the implementation of the Booster)

  9. 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).

    Measured: T3 (24 months following the implementation of the Booster)

Secondary outcomes (3)
  1. Clinical Pain Outcome: Pain Intensity

    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.

    Measured: T1 (Baseline)

  2. Clinical Pain Outcome: Pain Intensity

    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.

    Measured: T2 (12 months following the implementation of the Booster)

  3. Clinical Pain Outcome: Pain Intensity

    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.

    Measured: T3 (24 months following the implementation of the Booster)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2014 (estimated)
  2. Study startSep 2011
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,907 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02236949
Sponsor's protocol ID
1000026324
Status last verified
May 2015
First submitted
5 Sep 2014
Last updated
22 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24021861
  • 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.

    PubMed 22958873
  • 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.

    PubMed 21464171
  • 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.

    PubMed 21970404
  • 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.

    PubMed 27587614

Questions about this trial

What is this clinical trial studying?

A study testing Pain Practice Change Booster Intervention in people with Pain, run by The Hospital for Sick Children at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Process Outcomes (pain assessment) (time frame: T1 (Baseline)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02236949, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.

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