The Pediatric Intermed: A New Clinical Decision Making Tool

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Children's Hospital of Eastern Ontario
Sponsor:
Collaborator:
Janssen Inc.
Information provided by (Responsible Party):
Janice S.Cohen, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT01781481
First received: January 23, 2013
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

The investigators have recently developed a paediatric adaptation of the Intermed tool (PIM) to address the unique developmental and social contexts of children and youth. The PIM 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 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 37-PIM items. To examine the construct validity of each of the PIM 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.


Condition
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Pediatric Intermed: A New Clinical Decision Making Tool for Proactive Evaluation of Psychosocial Stress in Children With IBD.

Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • IMPACT III- A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ] [ Designated as safety issue: No ]
    Impact III: A Quality of Life Questionnaire for children with Inflammatory Bowel Disease: (Otley, Griffiths, Hale et al., 2006). This is a self-report measure for assessing quality of life in children with Inflammatory Bowel Disease. It consists of 35 questions which are rated on a 5-point scale. The measure is appropriate for use with children age 8 and older. The measure yields a total quality of life score, as well as scores for the following domains: bowel, systemic, emotional, social/functional, body image and tests/treatment. Studies with the measure have indicated that scores vary with disease severity. Research with regard to the psychometric properties and correlates of this measure is ongoing.

  • Disease Activity Indices [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ] [ Designated as safety issue: No ]

    Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005). This measure assesses Crohn's Disease severity, based on subjective items (e.g, patients's report of abdominal pain, stooling pattern, general well-being) and objective data (e.g., physical examination findings, laboratory tests, weight and height). The scales includes both continuous and categorical (inactive, mild, moderate/severe) severity scores. The GI physician completes the measure.

    Pediatric Ulcerative Colitis Activity Index (PUCAI): (Turner, Otley, Mack et al., 2007). This measure assesses Ulcerative Colitis severity as evaluated by physicians.


  • Health Care Utilization [ Time Frame: Data collected through chart review with respect to the three month period prior to Day 1 (date that patient's participation in Pediatric Intermed interview) ] [ Designated as safety issue: No ]
    • Number of hospital services involved in patents' care
    • Number of telephone calls to the IBD Clinic Nurse
    • Number of extra appointments with the IBD Team (unscheduled/unplanned)
    • Number of visits to the emergency department
    • Number of admissions to hospital


Secondary Outcome Measures:
  • Children's Depression Inventory - CDI [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ] [ Designated as safety issue: No ]
    Children's Depression Inventory: (CDI: Kovacs, 1981). The CDI is a self-report measure of depressive symptoms in children and adolescents aged 7 to 17 years. The measure is comprised of 27 items that factor into five sub-scales (i.e. negative mood, ineffectiveness, negative self-esteem, interpersonal problems and anhedonia). The child or adolescent is instructed to fill out the form based on the preceding two weeks. Test-retest reliabilities vary depending on the time interval between assessments. Overall, the CDI demonstrates acceptable levels of stability (2 weeks .82; 3 weeks .74 to .83). This measure is well validated with good explanatory and predictive value. Concurrent validity has repeatedly been demonstrated through strong correlations with related constructs (Kovacs, 1992).

  • Multidimensional Anxiety Scale for Children [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ] [ Designated as safety issue: No ]
    Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a paediatric self-report scale measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) "never true about me" to (3) "often true about me". Overall the MASC provides a reliable and valid portrayal of anxiety within a paediatric population. Test-retest reliability demonstrated a mean score of .78 at 3 weeks and .93 at 3 months. Validity has been established through correlations with similar constructs (March et al., 1977).

  • Child Behaviour Checklist [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ] [ Designated as safety issue: No ]
    Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. The psychometric properties of this instrument are well-established and satisfactory. Eight days test-retest reliability of the large scales range from .91 to .93 collapsed over age and gender. Inter-parent agreement, as a function of age and gender was .72 and .85 for the large scales. Clinical cutpoints on the scale scores have been shown to significantly discriminate between demographically matched referred and non-referred youth (Achenbach & Rescorla, 2001).

  • Functional Disability Inventory [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ] [ Designated as safety issue: No ]
    Functional Disability Inventory: (FDI); Walker & Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) "no trouble" to "(4) "impossible". The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p<.001) between the FDI and an objective index of disability (Walker & Greene, 1991).

  • Pediatric Inventory for Parents [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ] [ Designated as safety issue: No ]
    Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The PIP measures four domains of stress and adjustment; Communication (with child and health-care team); Emotional Distress (e.g., feeling helpless, seeing child sad); Medical Care (e.g., making decisions, bring child to the clinic); and Role Function (e.g., being unable to go to work, being in the hospital). Items related to each area are measured along two dimensions: Frequency and Difficulty. The internal consistency reliability for the PIP is high (Cronbach's alpha range .80-.90) and the measure has been found to have very good construct validity.

  • Family Inventory of Life Events and Changes [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ] [ Designated as safety issue: No ]
    Family Inventory of Life Events and Changes (FILE): (McCubbin & Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity.

  • Family Inventory of Resources for Management [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ] [ Designated as safety issue: No ]
    Family Inventory of Resources for Management (FIRM): (McCubbin & Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The FIRM has four subscales: Family Strengths I, Family Strengths II, Extended Family Support Scale III, and the Financial Well-being Scale IV, as was as a total resource score. The scale is comprised of 69 items, which are responded to using a Likert scale format. The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children.


Other Outcome Measures:
  • Disease Course, Treatment and Complications [ Time Frame: Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview) ] [ Designated as safety issue: No ]
    Number of hospitalizations, medication adverse events, disease adverse events (refers to known complications with IBD), number of surgeries, number of concommitant conditions.

  • Information about Diagnosis [ Time Frame: Data collected through chart review with respect to the three month period prior to Day 1 (date that patient's participation in Pediatric Intermed interview) ] [ Designated as safety issue: No ]
    Age at diagnosis, time since diagnosis, activity score at diagnosis (PCDAI/PUCAI), family history of IBD in 1st degree relatives, family history of IBD in 2nd degree relatives, time from onset of symptoms until diagnosis, Montreal Classification of Disease Location.


Estimated Enrollment: 150
Study Start Date: April 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children and youth with IBD
Children/youth (ages 8-17) with confirmed diagnoses of IBD.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All children between the ages of 8 and 17 who are followed in the CHEO GI Clinic and who have been diagnosed with an Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitus). Once diagnosed, children are followed on an ongoing basis in the clinic for management of their chronic illness, with the frequency of follow-up appointments varying depending on the nature and course of a child's disease. Both parents of the subjects will be invited to participate in the study, although if only one parent is present only they will be included. If a child/youth is in foster placement, consent will be obtained from child protection officials to have the caregiver (s) most involved with the child/youth participate in the interview.

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:

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781481

Contacts
Contact: Janice S Cohen, Ph.D. 613-737-7600 ext 2497 cohen@cheo.on.ca
Contact: David R Mack, MD, FRCPC 613-737-7600 ext 2516 dmack@cheo.on.ca

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Janice S Cohen, Ph.D.    613-737-7600 ext 2497    cohen@cheo.on.ca   
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Janssen Inc.
Investigators
Principal Investigator: Janice S Cohen, Ph.D. Children's Hospital of Eastern Ontario
  More Information

Publications:

Responsible Party: Janice S.Cohen, Psychologist, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT01781481     History of Changes
Other Study ID Numbers: 09/32E
Study First Received: January 23, 2013
Last Updated: January 30, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Children's Hospital of Eastern Ontario:
Psychosocial Stress and Adjustment
Pediatric Chronic Illness
Decision-support tool
Integrated Health Care
Case Complexity

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 26, 2014