Clinical trial NCT01781481: The Pediatric Intermed: A New Clinical Decision Making Tool
Official title: The Pediatric Intermed: A New Clinical Decision Making Tool for Proactive Evaluation of Psychosocial Stress in Children With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Keywords: Psychosocial Stress and Adjustment
Pediatric Chronic Illness
Decision-support tool
Integrated Health Care
Case Complexity
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Janssen Inc.
First posted: 2013-02-01
Enrollment: 148
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
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.

Brief 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.

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:

Primary outcomes:
measure: Pediatric INTERMED- Complexity Index
timeFrame: Time of Study Participation (Completion of Pediatric INTERMED tool)
measure: Correlations Between Pediatric INTERMED Domain Scores
timeFrame: Pediatric INTERMED scores at time of study participation
measure: Pediatric INTERMED Items
timeFrame: Day 1 (At time of Pediatric Intermed Interview)
measure: IBD Disease Severity
timeFrame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
measure: Time Since IBD Diagnosis
timeFrame: Data collected through chart review at time of Pediatric INTERMED interview.
measure: Disease Course and Treatment
timeFrame: Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview)
measure: IBD Treatment With Immunomodulators or Anti-TNFa Medications
timeFrame: Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview).
measure: Functional Disability Inventory
timeFrame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
measure: Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease.
timeFrame: Day 1 (At time of Pediatric Intermed Interview)
measure: Child Behaviour Checklist
timeFrame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
measure: Children's Depression Inventory
timeFrame: Administered at study entry
measure: Multidimensional Anxiety Scale for Children
timeFrame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
measure: Pediatric Inventory for Parents- Difficulty Score
timeFrame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
measure: Family Inventory of Life Events and Changes
timeFrame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
measure: Family Inventory of Resources for Management
timeFrame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
measure: Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning
timeFrame: Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis
measure: Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning.
timeFrame: Day 1 (Time of Study Participation)
measure: 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.
timeFrame: Day 1 (At time of Pediatric Intermed Interview)
measure: 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.
timeFrame: Day 1 (At time of Pediatric Intermed Interview)
measure: 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.
timeFrame: Day 1 (At time of Pediatric Intermed Interview)
measure: 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.
timeFrame: Day 1 (At time of Pediatric Intermed Interview)
measure: Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators
timeFrame: Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis
measure: Total Number of Hospital Services Involved in Child's Care.
timeFrame: 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)
measure: Number of Calls to IBD Nurse
timeFrame: 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)
measure: Number of Extra Appointments With the IBD Team
timeFrame: 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)
measure: Number of Visits to the Hospital Emergency Department
timeFrame: 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)
measure: Number of Inpatient Hospital Admissions
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Janice S Cohen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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