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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421795
• Other study ID #: REB16-12-696
• Status: Completed
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: August 2, 2018

Study information

• Verified date: May 2019
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: August 2, 2018
• Est. primary completion date: July 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Developmental Disabilities
• Pain

Intervention

Other:
• Let's Talk About Pain Training
See arm/group descriptions.
• Family Centered Care Training
See arm/group descriptions.

Locations

Country	Name	City	State
Canada	University of Guelph	Guelph	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University of Guelph	Canadian Institutes of Health Research (CIHR), Schulich School of Medicine & Dentistry, Western University, Society of Pediatric Psychology

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Breau LM, MacLaren J, McGrath PJ, Camfield CS, Finley GA. Caregivers' beliefs regarding pain in children with cognitive impairment: relation between pain sensation and reaction increases with severity of impairment. Clin J Pain. 2003 Nov-Dec;19(6):335-44. — View Citation

Chen-Lim ML, Zarnowsky C, Green R, Shaffer S, Holtzer B, Ely E. Optimizing the assessment of pain in children who are cognitively impaired through the quality improvement process. J Pediatr Nurs. 2012 Dec;27(6):750-9. doi: 10.1016/j.pedn.2012.03.023. Epub 2012 Apr 10. Review. — View Citation

Dubois A, Capdevila X, Bringuier S, Pry R. Pain expression in children with an intellectual disability. Eur J Pain. 2010 Jul;14(6):654-60. doi: 10.1016/j.ejpain.2009.10.013. Epub 2009 Dec 5. — View Citation

Genik LM, McMurtry CM, Breau LM, Lewis SP, Freedman-Kalchman T. Pain in Children With Developmental Disabilities: Development and Preliminary Effectiveness of a Pain Training Workshop for Respite Workers. Clin J Pain. 2018 May;34(5):428-437. doi: 10.1097/AJP.0000000000000554. — View Citation

Genik LM, McMurtry CM, Breau LM. Caring for children with intellectual disabilities part 1: Experience with the population, pain-related beliefs, and care decisions. Res Dev Disabil. 2017 Mar;62:197-208. doi: 10.1016/j.ridd.2017.01.020. Epub 2017 Feb 14. — View Citation

Twycross A, Williams A. Establishing the validity and reliability of a pediatric pain knowledge and attitudes questionnaire. Pain Manag Nurs. 2013 Sep;14(3):e47-53. doi: 10.1016/j.pmn.2011.03.001. Epub 2011 Apr 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Between group difference in use of evidence-based pain assessment and management strategies as indicated on a researcher-generated questionnaire and in focus groups	Assessment of use of evidence-based pain assessment and management strategies (researcher generated questionnaire with open-ended responses and focus groups)	Follow-Up (approximately one month after training)
Other	Within intervention group change from baseline in use of evidence-based pain assessment and management strategies as indicated on a researcher-generated questionnaire	Assessment of use of evidence-based pain assessment and management strategies (researcher generated questionnaire)	Baseline (within 30 minutes prior to start of training), Follow-Up (approximately one month after training)
Other	Within intervention group descriptive ratings of training	Assessment of training program endorsement	Post (within 30 minutes after completion of training)
Primary	Within intervention group change from baseline in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised	Pain-related knowledge assessment	Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
Primary	Within intervention group change (i.e., maintenance) from post in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised	Pain-related knowledge assessment	Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
Primary	Between group difference in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised	Pain-related knowledge assessment	Post (within 30 minutes after completion of training)
Primary	Between group difference in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised	Pain-related knowledge assessment	Follow-Up (approximately one month after training)
Secondary	Between group difference in ratings of the feasibility of pain assessment	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.	Post (within 30 minutes after completion of training)
Secondary	Between group difference in ratings of the feasibility of pain assessment	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.	Follow-Up (approximately one month after training)
Secondary	Between group difference ratings of the feasibility of pain management	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.	Post (within 30 minutes after completion of training)
Secondary	Between group difference ratings of the feasibility of pain management	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.	Follow-Up (approximately one month after training)
Secondary	Between group difference ratings of perceived confidence in pain assessment abilities	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.	Post (within 30 minutes after completion of training)
Secondary	Between group difference ratings of perceived confidence in pain assessment abilities	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.	Follow-Up (approximately one month after training)
Secondary	Between group difference ratings of perceived confidence in pain management abilities	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.	Post (within 30 minutes after completion of training)
Secondary	Between group difference ratings of perceived confidence in pain management abilities	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.	Follow-Up (approximately one month after training)
Secondary	Between group difference ratings of perceived skill in pain assessment	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.	Post (within 30 minutes after completion of training)
Secondary	Between group difference ratings of perceived skill in pain assessment	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.	Follow-Up (approximately one month after training)
Secondary	Between group difference ratings of perceived skill in pain management	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.	Post (within 30 minutes after completion of training)
Secondary	Between group difference ratings of perceived skill in pain management	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.	Follow-Up (approximately one month after training)
Secondary	Within intervention group change from baseline in ratings of the feasibility of pain assessment	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.	Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
Secondary	Within intervention group change from baseline in ratings of the feasibility of pain management	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.	Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
Secondary	Within intervention group change from baseline in ratings of perceived confidence in pain assessment	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.	Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
Secondary	Within intervention group change from baseline in ratings of perceived confidence in pain management	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.	Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
Secondary	Within intervention group change from baseline in ratings of perceived skill in pain assessment	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.	Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
Secondary	Within intervention group change from baseline in ratings of perceived skill in pain management	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.	Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
Secondary	Within intervention group change (i.e., maintenance) from post in ratings of the feasibility of pain assessment	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.	Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
Secondary	Within intervention group change (i.e., maintenance) from post in ratings of the feasibility of pain management	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.	Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
Secondary	Within intervention group change (i.e., maintenance) from post in ratings of perceived confidence in pain assessment	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.	Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
Secondary	Within intervention group change (i.e., maintenance) from post in ratings of perceived confidence in pain management	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.	Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
Secondary	Within intervention group change (i.e., maintenance) from post in ratings of perceived skill in pain assessment	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.	Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
Secondary	Within intervention group change (i.e., maintenance) from post in ratings of perceived skill in pain management	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.	Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)