N/A N=148

The Pediatric Intermed: A New Clinical Decision Making Tool

Inflammatory Bowel Disease

Bottom Line

View on ClinicalTrials.gov: NCT01781481 ↗

Enrolled (actual)

148

Serious AEs

0.0%

Results posted

Jul 2016

Primary outcome: Primary: Pediatric INTERMED- Complexity Index — 24; 9.0; 4.0; 4.0 scores on a scale

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric · 8+ yrs
Sex: All
Sponsor: Children's Hospital of Eastern Ontario
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Pediatric INTERMED- Complexity Index	24; 9.0; 4.0; 4.0; 4.0; 3.0	—
PRIMARY Correlations Between Pediatric INTERMED Domain Scores	1; .29; .34; .32; .19; .29	<0.05 sig
PRIMARY Pediatric INTERMED Items	.7; 1.4; 98; .7; 20.9; 78.4	—
PRIMARY IBD Disease Severity	62.8; 25.7; 8.1; 3.4; 4.3; 25.7	—
PRIMARY Time Since IBD Diagnosis	15.5; 34.5; 32.4; 17.6	—
PRIMARY Disease Course and Treatment	1; 0; 1	—
PRIMARY IBD Treatment With Immunomodulators or Anti-TNFa Medications	55.4; 42.6	—
PRIMARY Functional Disability Inventory	4; 2	—
PRIMARY Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease.	45; 22; 57	—
PRIMARY Child Behaviour Checklist	54; 46; 45; 48; 50	—
PRIMARY Children's Depression Inventory	42	—
PRIMARY Multidimensional Anxiety Scale for Children	50.00	—
PRIMARY Pediatric Inventory for Parents- Difficulty Score	82	—
PRIMARY Family Inventory of Life Events and Changes	7	—
PRIMARY Family Inventory of Resources for Management	127; 36	—
PRIMARY Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning	-.06; .06; -.12; .09; -.15; .04	>0.05
PRIMARY Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning.	.56; .46; .46; .52; .42; .38	<0.01 sig
PRIMARY Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range.	4; 10; 6; 125	—
PRIMARY Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range.	3; 11; 4; 125	—
PRIMARY Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range.	8; 5; 22; 100	—
PRIMARY Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range.	5; 8; 3; 119	—
PRIMARY Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators	.26; .08; .25; .37; .20; .15	<0.01 sig
PRIMARY Total Number of Hospital Services Involved in Child's Care.	2.00	<0.01 sig
PRIMARY Number of Calls to IBD Nurse	—	<0.01 sig
PRIMARY Number of Extra Appointments With the IBD Team	—	<0.01 sig
PRIMARY Number of Visits to the Hospital Emergency Department	—	<0.05 sig
PRIMARY Number of Inpatient Hospital Admissions	—	<0.01 sig

Summary

The investigators have recently developed a paediatric adaptation of the INTERMED tool to address the unique developmental and social contexts of children and youth. The Pediatric INTERMED adopts a life-chart methodology to structure and organize complex case material in time, colour-coding domains to facilitate identification of areas of high need and risk for each patient. The focus of the present study is to examine the characteristics and usefulness of the tool in identifying psychosocial stress in children/youth diagnosed with Inflammatory Bowel Disease (IBD), as well as identifying overall case complexity. Children and parents will participate in a semi-structured structured interview with a clinical nurse who will then rate the 34-PIM items. To examine the construct validity of each of the Pediatric INTERMED domains (biological, psychological, social, caregiver/family, health care system) participants will complete questionnaires assessing social and psychological functioning, parent and family stress, quality of life and adaptive functioning. Information about disease status, and health care utilization will be obtained from medical chart review. It is hypothesized that greater case complexity will be predictive of more complex disease course/treatment, poorer quality of life, and increased health care utilization.

Eligibility Criteria

Inclusion Criteria

diagnosis of IBD (Crohn's or Ulcerative Colitis)
fluency in English or French
between the ages of 8 and 17
residing in the CHEO catchment area.

Exclusion Criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01781481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.