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Effectiveness of a Pain Assessment and Management Program for Respite Workers Supporting Children With Disabilities

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ClinicalTrials.gov Identifier: NCT03421795
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : May 7, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Society of Pediatric Psychology
Schulich School of Medicine & Dentistry, Western University
Information provided by (Responsible Party):
Meghan McMurtry, University of Guelph

Brief Summary:
This study investigates the impact of pain training delivery for respite care providers who support children with developmental disabilities on (a) pain assessment and management-related knowledge, (b) participant self-rated perceptions of the feasibility, confidence and skill in pain assessment and management, and (c) strategy use. Half of the participants will receive the pain training, while half will receive the training about family-centered care, and be offered the pain training after completion of the follow-up.

Condition or disease Intervention/treatment Phase
Pain Other: Let's Talk About Pain Training Other: Family Centered Care Training Not Applicable

Detailed Description:

Background Information: Everyday pain is common in children with intellectual/developmental disabilities (I/DD). Inadequately managed pain in this population is a common problem, and this is likely due to these children's inability to communicate pain effectively. Unfortunately, many of these children are unable to accurately self-report or effectively communicate the pain experience. Thus, caregivers are often responsible for assessing their pain. Research has focused on professionals and parents, but it is also common for children with I/DD to receive care from others including respite workers. The investigators recently found a difference between pain beliefs held by respite workers and individuals with little to no experience with this population. Specifically, respite workers believed that a significantly larger percentage of children with severe I/DD sensed less pain than typically developing children. This is contrary to research suggesting that children with I/DD have similar pain perception but communicate it differently (e.g., through idiosyncratic behaviours). Thus, it is possible that respite workers miss critical cues when children with I/DD are in pain. As such, the investigators have developed and successfully piloted a pain training program targeted to respite workers who support children with I/DD. This program demonstrated initial success in improving respite workers' pain-related knowledge, as well as their perceptions of the feasibility of and their own confidence and skill in pain assessment and management with this population of children.

Within a randomized control trial, the objectives of this study are to further test the effectiveness of the Let's Talk About Pain respite worker training program on respite workers' (a) pain-related knowledge, (b) self-rated perceptions of the feasibility of and their own confidence and skill in pain assessment and management, and (c) use of pain assessment and management strategies specific to children with I/DD in respite settings. Participants will complete questionnaires immediately before and after provision of a pain training (or control training). Approximately one month after the training, participants will complete these questionnaires for a third time and participate in a focus group regarding their pain assessment and management strategy use.

The long term objectives of this line of research are to: 1) increase pain assessment and management abilities of respite workers, and, consequently, 2) decrease levels of suffering and ill-managed pain in children with I/DD.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multi-centre clustered parallel RCT with an intervention group (pain training) and control group (control training about family centered care, with an option to receive pain training after follow-up).
Masking: None (Open Label)
Masking Description: Organizations will not be made explicitly aware of whether they have been allocated as part of the control or experimental conditions. Organizations will be told, however, that if they are not assigned to the experimental group, they will be given the option to also have an additional training about pain in children with DD at the end of the study. They will also know about the topics of both training programs and the purpose of the study. Participants will only be told that the purpose of the study is to learn about the impact that training programs can have on respite workers' knowledge about caring for children with DD. However, given some of the information in the consent form (e.g., study title is "Let's Talk about Pain"), it is likely that the treatment condition is clear to participants.
Primary Purpose: Other
Official Title: Let's Talk About Pain: A Randomized Controlled Trial Testing the Effectiveness of a Pain Assessment and Management Training Program for Respite Workers Supporting Children With Intellectual and Developmental Disabilities
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : July 3, 2018
Actual Study Completion Date : August 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Let's Talk About Pain Training
Participants complete pre-, post- and follow-up measures, and receive a pain training program. The pain assessment and management training will be based on a training previously developed and piloted by Genik et al. (2017). The training will be facilitated by the same researcher (L.G.) throughout the study.
Other: Let's Talk About Pain Training
See arm/group descriptions.

Sham Comparator: Family Centered Care Training
Participants complete all of the same measures as those in the intervention, but receive a training about family centered care. This training will be facilitated by Andrea Cross (PhD Candidate) from CanChild and will be related to the F-words of childhood disability (function, family, fitness, fun, friends, future; Rosenbaum & Gorter, 2012) .
Other: Family Centered Care Training
See arm/group descriptions.




Primary Outcome Measures :
  1. Within intervention group change from baseline in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised [ Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training) ]
    Pain-related knowledge assessment

  2. Within intervention group change (i.e., maintenance) from post in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised [ Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training) ]
    Pain-related knowledge assessment

  3. Between group difference in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised [ Time Frame: Post (within 30 minutes after completion of training) ]
    Pain-related knowledge assessment

  4. Between group difference in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised [ Time Frame: Follow-Up (approximately one month after training) ]
    Pain-related knowledge assessment


Secondary Outcome Measures :
  1. Between group difference in ratings of the feasibility of pain assessment [ Time Frame: Post (within 30 minutes after completion of training) ]
    Researcher generated scale measuring participants' perceptions of the feasibility of pain assessment; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  2. Between group difference in ratings of the feasibility of pain assessment [ Time Frame: Follow-Up (approximately one month after training) ]
    Researcher generated scale measuring participants' perceptions of the feasibility of pain assessment; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  3. Between group difference ratings of the feasibility of pain management [ Time Frame: Post (within 30 minutes after completion of training) ]
    Researcher generated scale measuring participants' perceptions of the feasibility of pain management; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  4. Between group difference ratings of the feasibility of pain management [ Time Frame: Follow-Up (approximately one month after training) ]
    Researcher generated scale measuring participants' perceptions of the feasibility of pain management; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  5. Between group difference ratings of perceived confidence in pain assessment abilities [ Time Frame: Post (within 30 minutes after completion of training) ]
    Researcher generated scale measuring participants' perceptions of their own confidence in their pain assessment abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  6. Between group difference ratings of perceived confidence in pain assessment abilities [ Time Frame: Follow-Up (approximately one month after training) ]
    Researcher generated scale measuring participants' perceptions of their own confidence in their pain assessment abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  7. Between group difference ratings of perceived confidence in pain management abilities [ Time Frame: Post (within 30 minutes after completion of training) ]
    Researcher generated scale measuring participants' perceptions of their own confidence in their pain management abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  8. Between group difference ratings of perceived confidence in pain management abilities [ Time Frame: Follow-Up (approximately one month after training) ]
    Researcher generated scale measuring participants' perceptions of their own confidence in their pain management abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  9. Between group difference ratings of perceived skill in pain assessment [ Time Frame: Post (within 30 minutes after completion of training) ]
    Researcher generated scale measuring participants' perceptions of their own skill in pain assessment; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  10. Between group difference ratings of perceived skill in pain assessment [ Time Frame: Follow-Up (approximately one month after training) ]
    Researcher generated scale measuring participants' perceptions of their own skill in pain assessment; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  11. Between group difference ratings of perceived skill in pain management [ Time Frame: Post (within 30 minutes after completion of training) ]
    Researcher generated scale measuring participants' perceptions of their own skill in pain management; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  12. Between group difference ratings of perceived skill in pain management [ Time Frame: Follow-Up (approximately one month after training) ]
    Researcher generated scale measuring participants' perceptions of their own skill in pain management; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  13. Within intervention group change from baseline in ratings of the feasibility of pain assessment [ Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training) ]
    Researcher generated scale measuring participants' perceptions of the feasibility of pain assessment; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  14. Within intervention group change from baseline in ratings of the feasibility of pain management [ Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training) ]
    Researcher generated scale measuring participants' perceptions of the feasibility of pain management; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  15. Within intervention group change from baseline in ratings of perceived confidence in pain assessment [ Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training) ]
    Researcher generated scale measuring participants' perceptions of their own confidence in their pain assessment abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  16. Within intervention group change from baseline in ratings of perceived confidence in pain management [ Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training) ]
    Researcher generated scale measuring participants' perceptions of their own confidence in their pain management abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  17. Within intervention group change from baseline in ratings of perceived skill in pain assessment [ Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training) ]
    Researcher generated scale measuring participants' perceptions of their own skill in pain assessment; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  18. Within intervention group change from baseline in ratings of perceived skill in pain management [ Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training) ]
    Researcher generated scale measuring participants' perceptions of their own skill in pain management; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  19. Within intervention group change (i.e., maintenance) from post in ratings of the feasibility of pain assessment [ Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training) ]
    Researcher generated scale measuring participants' perceptions of the feasibility of pain assessment; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  20. Within intervention group change (i.e., maintenance) from post in ratings of the feasibility of pain management [ Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training) ]
    Researcher generated scale measuring participants' perceptions of the feasibility of pain management; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  21. Within intervention group change (i.e., maintenance) from post in ratings of perceived confidence in pain assessment [ Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training) ]
    Researcher generated scale measuring participants' perceptions of their own confidence in their pain assessment abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  22. Within intervention group change (i.e., maintenance) from post in ratings of perceived confidence in pain management [ Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training) ]
    Researcher generated scale measuring participants' perceptions of their own confidence in their pain management abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  23. Within intervention group change (i.e., maintenance) from post in ratings of perceived skill in pain assessment [ Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training) ]
    Researcher generated scale measuring participants' perceptions of their own skill in pain assessment; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  24. Within intervention group change (i.e., maintenance) from post in ratings of perceived skill in pain management [ Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training) ]
    Researcher generated scale measuring participants' perceptions of their own skill in pain management; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.


Other Outcome Measures:
  1. Between group difference in use of evidence-based pain assessment and management strategies as indicated on a researcher-generated questionnaire and in focus groups [ Time Frame: Follow-Up (approximately one month after training) ]
    Assessment of use of evidence-based pain assessment and management strategies (researcher generated questionnaire with open-ended responses and focus groups)

  2. Within intervention group change from baseline in use of evidence-based pain assessment and management strategies as indicated on a researcher-generated questionnaire [ Time Frame: Baseline (within 30 minutes prior to start of training), Follow-Up (approximately one month after training) ]
    Assessment of use of evidence-based pain assessment and management strategies (researcher generated questionnaire)

  3. Within intervention group descriptive ratings of training [ Time Frame: Post (within 30 minutes after completion of training) ]
    Assessment of training program endorsement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Over the age of 18
  • Proficient in the English language
  • Active respite worker who provides respite care to children (age 0 - 18) with developmental disabilities

Exclusion Criteria:

  • n/a

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): NCT03421795


Locations
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Canada, Ontario
University of Guelph
Guelph, Ontario, Canada, N1G2W1
Sponsors and Collaborators
University of Guelph
Canadian Institutes of Health Research (CIHR)
Society of Pediatric Psychology
Schulich School of Medicine & Dentistry, Western University

Publications:
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Responsible Party: Meghan McMurtry, Associate Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT03421795     History of Changes
Other Study ID Numbers: REB16-12-696
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meghan McMurtry, University of Guelph:
pain assessment/management
developmental disabilities
children
education
respite workers
Additional relevant MeSH terms:
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Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders