The Pediatric Intermed: A New Clinical Decision Making Tool
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

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.
    

Detailed description: 
      Inflammatory Bowel Disease (Crohn's disease/ulcerative colitis) manifests itself in children
      and adolescents in up to 1/3 of those that will eventually develop these conditions. It is
      fast becoming an increasing problem with a 50% increase in Crohn's disease diagnosed in young
      children in the last decade. The patient's chronic symptoms can be both due to and result in
      increased child and family psychosocial stress. Similarly, treatments may add to psychosocial
      stress. Failure to address these psychosocial issues can lead to greater risk for poor
      treatment adherence, higher utilization of health care, and increased psychiatric
      co-morbidity. As such, improvement in health care providers' capacity to identify factors
      contributing to case complexity offers significant potential for improving outcomes.

      Assessment of biological, psychological, social and health delivery of children's chronic
      illness has not been consistently integrated into the health care system. Physical and mental
      health services are often disconnected. Identifying those who would benefit from a mental
      health referral typically rests on the primary care physician or specialist and is often
      triggered by crises. There is also variability in physician education and comfort level in
      assessing psychosocial issues and especially in children with chronic illnesses in which
      symptoms of physical disease and mental health can overlap. Oftentimes this leaves the most
      responsible physician wanting for a simple assessment tool to try and determine who might be
      at risk and benefit from mental health intervention.

      The adult INTERMED is a clinical decision-support tool that provides indicators of
      biological, psychological, social, heath care needs, as well as an overall index of case
      complexity. The tool is efficient to administer and has been successfully used by varied
      health care professionals in diverse medical settings to detect psychosocial needs,
      facilitate referral to effective services and improve health practices and outcomes. However,
      there is no comparable validated tool for use with children/youth.

      The investigators have recently developed a pediatric adaptation of the adult INTERMED to
      address the unique developmental and social contexts of children and youth. A Delphi group of
      international experts in the field of pediatric chronic illness has reviewed the instrument
      to ensure clinical relevance, utility and communication clarity. Initial pilot data has
      demonstrated the Pediatric INTERMED has very good item inter-rater reliability. The focus of
      the current study is to examine the usefulness of this tool to identify biopsychosocial needs
      in IBD children/youth. Canada has a very high IBD incidence and prevalence. Given the facts
      that children with IBD face an unpredictable disease course, complex symptoms and difficult
      management regimens that can significantly impact their lives, it is not surprising that
      patients with this chronic incurable condition are highly vulnerable to mental health
      comorbidities. The development of this new tool will have significant importance if it proves
      to be useful in this population. The current study will examine a sizeable cohort of patients
      with regards to the relations between Pediatric INTERMED domains and other measures of
      children's disease, mood, behaviour, quality of life, family stress and strengths, and health
      services utilization. Both ulcerative colitis and Crohn's disease in children and youth lend
      themselves very well to this study because of the validated measures of disease severity that
      have been developed already.

      Implementation of the novel Pediatric INTERMED n clinical practice will provide a new way to
      assist IBD Teams in screening their patients to be proactive in referral to mental health
      resources, and facilitate case management which targets patient needs. Clearly, clinicians
      are well aware that compliance, anxiety and depression will affect disease outcomes and too
      often these are only dealt with at times of crisis that has led to disease flare or reports
      that medicines are no longer effective. Use of this structured assessment tool begins to
      realize the potential of developing a truly integrated biopsychosocial approach to this
      chronic disease. The ease of use and objective nature of the tool will enhance communication
      among primary and tertiary providers and contribute to best practice approaches in the
      provision of integrated physical and mental health care. It will also assist in monitoring
      the impact of childhood chronic illness, identify factors linked to optimal health outcomes
      and inform program planning and resource allocations.

      Study Design

      Children/youth (ages of 8-17) followed in the IBD Clinic at the Children's Hospital of
      Eastern Ontario (CHEO) with confirmed diagnoses of IBD (Crohn's disease or ulcerative
      colitis) are eligible for the study. A clinical nurse will complete the Pediatric INTERMED
      for all study participants: based on information obtained from a review of the patients'
      hospital chart and a semi-structured interview conducted with the child/youth and primary
      caregivers), Following the Pediatric INTERMED interview, children/youth and parents
      participating in the project will complete a battery of self-report instruments to provide
      assessments of patients' social and psychological functioning, parent/family stresses,
      adjustment and resources. In addition, information will be obtained from the patients' charts
      about aspects of their diagnoses, treatment regimens, disease activity and complications, and
      health care utilization in the 3 months prior to their participation in the study.

      Primary Hypotheses/Objectives and Statistical Rationale

        1. Demonstrate that the Pediatric INTERMED is a reliable tool for use in IBD children (good
           inter-rater reliability and internal consistency). 40 interviews with the clinical
           research nurse will be videotaped so that a second health care professional trained in
           the use of the PIM, can also complete the PIM tool, in order to examine inter-rater
           reliability. Agreement between raters will be measured by means of intraclass
           correlations. Items within each domain will be examined to confirm that they meet
           internal consistency criteria (Cronbach's Alpha of .80).

        2. Demonstrate that the Pediatric INTERMED domains successfully identify patient needs.
           Concurrent validity of the Pediatric INTERMED will be examined by looking at the
           Spearman rank, Pearson correlations, as appropriate, between each domain score and the
           measures hypothesized to be conceptually linked to the domain. To assess aspects of the
           Psychological Domain, the patients will complete the Children's Depression Inventory,
           the Multidimensional Anxiety Scale for Children and parents will complete the Child
           Behaviour Checklist (CBCL). Measures linked to the Social Domain of the PIM, include The
           Functional Disability Inventory, which taps the child's involvement in daily activities,
           and CBCL Competence Scores (Social, School, Activities), and the IMPACT-III, an IBD
           specific quality of life measure. To examine constructs linked to the Caregiver/Family
           Domain parents will complete the Pediatric Inventory for Parents, an index of childhood
           illness-related parenting stress, the Family Inventory of Life Events and Changes and
           the Family Inventory of Resources for Management. Disease/treatment and health care data
           gathered will be used to validate the Biological and Health System Domains.

        3. Demonstrate that Pediatric INTERMED Complexity score is predictive of increased health
           care utilization. A general linear approach will be used to study the relation of the
           Pediatric INTERMED to health service utilization. Multivariate models will also be
           tested including potential covariates such as disease severity, time since diagnosis.

      Statistical Power Calculations

      The CHEO GI clinic sees 40 to 60 new patients diagnosed with IBD per year. In 2007 the clinic
      actively followed 265 children with IBD. Once diagnosed children are followed on an ongoing
      basis. The frequency of follow-up appointments varies depending on the nature and course of a
      child's disease, but the children/youth are seen at minimum three times each year. In
      general, participation rates in studies of children/youth with chronic illness are typically
      in the vicinity of 80-90% or better and this figure is consistent with the experience of the
      CHEO IBD clinic in the recruitment of patients into various knowledge generation studies. The
      PIM involves 5 domains of information inclusive of various components. To achieve
      significance with the various domains the investigators estimated that a total of 140-150
      children will need to be enrolled. This sample size is sufficient to ensure that there are a
      sufficient number of observations per variable to conduct multivariate analyses. Tabachnick
      and Fidell (2007) and others indicated that 4 is the absolute minimum number of observations
      per variable to conduct multivariate analyses. A subject size of 140-150 would be sufficient
      to provide 4 observations per variable. Further, the anticipated sample size is sufficient to
      conduct all proposed analyses. Further corrections for multiple testing will be applied on a
      per-analysis basis.
    

Observational model: Cohort
Time perspective: Cross-Sectional
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.
      
Keywords: Psychosocial Stress and Adjustment; Pediatric Chronic Illness; Decision-support tool; Integrated Health Care; Case Complexity