The Pediatric Intermed: A New Clinical Decision Making Tool

This study has been completed.
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: July 22, 2016
Last verified: July 2016
  Purpose
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.

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 Inflammatory Bowel Disease

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

Primary Outcome Measures:
  • Pediatric INTERMED- Complexity Index [ Time Frame: Time of Study Participation (Completion of Pediatric INTERMED tool) ] [ Designated as safety issue: No ]

    34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action).

    Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains:

    Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity).

    Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity).

    Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity).

    Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity).

    Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity).


  • Correlations Between Pediatric INTERMED Domain Scores [ Time Frame: Pediatric INTERMED scores at time of study participation ] [ Designated as safety issue: No ]
    Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores.

  • Pediatric INTERMED Items [ Time Frame: Day 1 (At time of Pediatric Intermed Interview) ] [ Designated as safety issue: No ]
    Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items.

  • IBD Disease Severity [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ] [ Designated as safety issue: No ]
    IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe.

  • Time Since IBD Diagnosis [ Time Frame: Data collected through chart review at time of Pediatric INTERMED interview. ] [ Designated as safety issue: No ]
    Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in "months since date of diagnosis", with a range from 1 - 131 months.

  • Disease Course and Treatment [ 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 since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record).

  • IBD Treatment With Immunomodulators or Anti-TNFa Medications [ Time Frame: Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview). ] [ Designated as safety issue: No ]
    Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2).

  • 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 minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. 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).

  • Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease. [ Time Frame: Day 1 (At time of Pediatric Intermed Interview) ] [ Designated as safety issue: No ]
    35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008).

  • 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. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores.

  • Children's Depression Inventory [ Time Frame: Administered at study entry ] [ Designated as safety issue: No ]
    27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences.

  • 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 pediatric self-report scale that 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". Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences.

  • Pediatric Inventory for Parents- Difficulty Score [ 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 Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater "perceived difficulty".

  • 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. Scores can range from 0-71, with higher scores indicating greater family stress.

  • 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 scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). 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. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources.

  • Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning [ Time Frame: Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis ] [ Designated as safety issue: No ]
    Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire.

  • Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. [ Time Frame: Day 1 (Time of Study Participation) ] [ Designated as safety issue: No ]
    Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9).

  • 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. [ Time Frame: Day 1 (At time of Pediatric Intermed Interview) ] [ Designated as safety issue: No ]
    This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range.

  • 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. [ Time Frame: Day 1 (At time of Pediatric Intermed Interview) ] [ Designated as safety issue: No ]
    This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range.

  • 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. [ Time Frame: Day 1 (At time of Pediatric Intermed Interview) ] [ Designated as safety issue: No ]
    This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range.

  • 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. [ Time Frame: Day 1 (At time of Pediatric Intermed Interview) ] [ Designated as safety issue: No ]
    This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range.

  • Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators [ Time Frame: Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis ] [ Designated as safety issue: No ]
    Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management.

  • Total Number of Hospital Services Involved in Child's Care. [ Time Frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) ] [ Designated as safety issue: No ]
    Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview.

  • Number of Calls to IBD Nurse [ Time Frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) ] [ Designated as safety issue: No ]
    Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview

  • Number of Extra Appointments With the IBD Team [ Time Frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) ] [ Designated as safety issue: No ]
    Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview.

  • Number of Visits to the Hospital Emergency Department [ Time Frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) ] [ Designated as safety issue: No ]
    Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview.

  • Number of Inpatient Hospital Admissions [ Time Frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) ] [ Designated as safety issue: No ]
    Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview.


Enrollment: 148
Study Start Date: April 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (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   (Child)
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

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
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:
Lyons, JS. Communimetrics. A communication theory of measurement for human services. New York: Springer, 2009.
Han, C, Zhao N, Blank M, Gasink, C. Impact of psychiatric disorders on patients with crohn's disease: An analysis based on a healthcare claims database. Gastroenterology-Supplements 2010; 138(5), S-9.
Kathol, R.G., Perez, R., Cohen, J.S., (2010). The Integrated Case Management Model: Assisting Complex Patients Regain Physical and Mental Health, Springer Publishing Co. N,Y,.
Achenbach TM, Rescorla LA. Manual for ASEBA School-Age Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families. 2001.
McCubbin H, Patterson J. Family Inventory of Life Events and changes. In McCubbin H, Thompson A, eds. Family assessment inventories for research and practice, pp 81-100. Madison.: University of Wisconsin, 1991.
McCubbin H, Comeau J. Family Inventory of Resources for Management. In McCubbin H, Thompson A, eds. Family assessment inventories for research and practice, pp. 81-100. Madison: University of Wisconsin, 1991.

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
Results First Received: July 15, 2016
Last Updated: July 22, 2016
Health Authority: Canada: Ethics Review Committee
Individual Participant Data  
Plan to Share IPD: No

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:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on August 28, 2016