Clinical trial NCT03421795: Effectiveness of a Pain Assessment and Management Program for Respite Workers Supporting Children With Disabilities
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain assessment/management
developmental disabilities
children
education
respite workers
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Society of Pediatric Psychology
name: Western University
First posted: 2018-02-05
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Within intervention group change from baseline in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised
timeFrame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
measure: Within intervention group change (i.e., maintenance) from post in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised
timeFrame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
measure: Between group difference in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised
timeFrame: Post (within 30 minutes after completion of training)
measure: Between group difference in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised
timeFrame: Follow-Up (approximately one month after training)
Secondary outcomes:
measure: Between group difference in ratings of the feasibility of pain assessment
timeFrame: Post (within 30 minutes after completion of training)
measure: Between group difference in ratings of the feasibility of pain assessment
timeFrame: Follow-Up (approximately one month after training)
measure: Between group difference ratings of the feasibility of pain management
timeFrame: Post (within 30 minutes after completion of training)
measure: Between group difference ratings of the feasibility of pain management
timeFrame: Follow-Up (approximately one month after training)
measure: Between group difference ratings of perceived confidence in pain assessment abilities
timeFrame: Post (within 30 minutes after completion of training)
measure: Between group difference ratings of perceived confidence in pain assessment abilities
timeFrame: Follow-Up (approximately one month after training)
measure: Between group difference ratings of perceived confidence in pain management abilities
timeFrame: Post (within 30 minutes after completion of training)
measure: Between group difference ratings of perceived confidence in pain management abilities
timeFrame: Follow-Up (approximately one month after training)
measure: Between group difference ratings of perceived skill in pain assessment
timeFrame: Post (within 30 minutes after completion of training)
measure: Between group difference ratings of perceived skill in pain assessment
timeFrame: Follow-Up (approximately one month after training)
measure: Between group difference ratings of perceived skill in pain management
timeFrame: Post (within 30 minutes after completion of training)
measure: Between group difference ratings of perceived skill in pain management
timeFrame: Follow-Up (approximately one month after training)
measure: Within intervention group change from baseline in ratings of the feasibility of pain assessment
timeFrame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
measure: Within intervention group change from baseline in ratings of the feasibility of pain management
timeFrame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
measure: Within intervention group change from baseline in ratings of perceived confidence in pain assessment
timeFrame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
measure: Within intervention group change from baseline in ratings of perceived confidence in pain management
timeFrame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
measure: Within intervention group change from baseline in ratings of perceived skill in pain assessment
timeFrame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
measure: Within intervention group change from baseline in ratings of perceived skill in pain management
timeFrame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
measure: Within intervention group change (i.e., maintenance) from post in ratings of the feasibility of pain assessment
timeFrame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
measure: Within intervention group change (i.e., maintenance) from post in ratings of the feasibility of pain management
timeFrame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
measure: Within intervention group change (i.e., maintenance) from post in ratings of perceived confidence in pain assessment
timeFrame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
measure: Within intervention group change (i.e., maintenance) from post in ratings of perceived confidence in pain management
timeFrame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
measure: Within intervention group change (i.e., maintenance) from post in ratings of perceived skill in pain assessment
timeFrame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
measure: Within intervention group change (i.e., maintenance) from post in ratings of perceived skill in pain management
timeFrame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
Other outcomes:
measure: Between group difference in use of evidence-based pain assessment and management strategies as indicated on a researcher-generated questionnaire and in focus groups
timeFrame: Follow-Up (approximately one month after training)
measure: Within intervention group change from baseline in use of evidence-based pain assessment and management strategies as indicated on a researcher-generated questionnaire
timeFrame: Baseline (within 30 minutes prior to start of training), Follow-Up (approximately one month after training)
measure: Within intervention group descriptive ratings of training
timeFrame: Post (within 30 minutes after completion of training)
Locations:
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
Study officials:
References:
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.
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.
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.
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.
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.
citation: 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. doi: 10.1097/00002508-200311000-00001.
citation: Genik LM, McMurtry CM, Barata PC, Barney CC, Lewis SP. Study protocol for a multi-centre parallel two-group randomized controlled trial evaluating the effectiveness and impact of a pain assessment and management program for respite workers supporting children with disabilities. Paediatr Neonatal Pain. 2020 Apr 26;2(1):7-13. doi: 10.1002/pne2.12014. eCollection 2020 Mar.