Clinical Implementation of a Pictographic Constipation Action Plan for Children With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Constipation is a common disorder that globally affects 0.7% to 29.6% of children. The
      majority of these children receive the diagnosis of functional constipation. Functional
      Constipation can be challenging to diagnose and treat. The ROME IV criteria provides
      structure in the approach to Functional Constipation by standardizing diagnosis criteria.
      Functional Constipation should be suspected when a child has at least two symptoms per week
      for the last month consisting of: two or fewer defecations in the toilet per week, greater
      than or equal to 1 episode of fecal incontinence per week, history of retentive posturing or
      excessive volitional stool retention, history of painful or hard bowel movements, presence of
      a large fecal mass in the rectum, or history of large diameter stools that can obstruct the
      toilet.

      Written action plans and similar self-management tools have been associated with improved
      clinical and patient-reported outcomes for several pediatric chronic disease processes
      including anaphylaxis, asthma, and atopic dermatitis. These tools have been shown to improve
      patient/caregiver confidence in disease self-management at home, to increase adherence to
      pharmacotherapy regimens, and ultimately to enhance patient-centered outcomes. The impact of
      a Constipation Action Plan on Functional Constipation clinical and patient-related outcomes
      has not been investigated. The aim of this project was to implement and to evaluate the
      effectiveness of the Uniformed Services Constipation Action Plan in the management of
      children with Functional Constipation in a pediatric gastroenterology clinic.
    

Detailed description: 
      Bakcground

      Worldwide, it is estimated that constipation affects 0.7% to 29.6% of children. Constipation
      accounts for 3% to 10% of general pediatric outpatient visits and up to 25% of visits to
      pediatric gastroenterologists. Constipation is often associated with infrequent and/or
      painful defecation, fecal incontinence, and abdominal pain. Furthermore, it may result in
      significant distress to the child and family, and has a significant impact on health care
      cost, school absenteeism, and parental workdays missed. While there are concerning organic
      causes of constipation, - the diagnosis for the 90% of pediatric constipation complaints is
      not attributable to an organic etiology and is thus classified as functional.

      When a child meets these criteria, the diagnosis of functional constipation can be made when,
      after appropriate evaluation is performed, the patient's symptoms cannot be fully explained
      by another medical condition.

      Multiple research investigations have demonstrated the negative effects on quality of life of
      pediatric patients with functional constipation as well as the negative effect of this
      diagnosis on their parents and other caregivers. This impaired health related quality of life
      (HRQoL) exhibited by children with constipation is lower not only than those of healthy
      controls, but also lower than children with other significant gastrointestinal diseases such
      as inflammatory bowel disease or gastroesophageal reflux disease.

      In 2014, the pediatric gastroenterology team from Boston Children's Hospital began to
      advocate for a new "Shared Care" model which implemented of a collaborative quality
      improvement plan by coordinating a special education program for surrounding primary care
      managers (PCM) with a focus on the diagnosis and management of functional constipation in
      children. After developing a constipation management algorithm, The Boston Children's team
      would conduct digital education with PCMs to discuss constipation pathophysiology as well as
      the application of the Boston Children's constipation management algorithm. Post-intervention
      analysis revealed decreased referrals to the pediatric gastroenterology service, which was
      attributed to improved provider education.

      Beyond empowering providers in the chronic care of children, there are multiple examples of
      other novel interventions to empower patients and parents to better manage chronic
      conditions, when away from the Patient Centered Medical Home.

      Specifically, clinical symptom action plans including those for constipation, asthma,
      anaphylaxis, and eczema have all been used in the clinical arena. These plans are tailored
      specifically to the medical needs of the have demonstrated the ability to decrease hospital
      admissions, decrease emergency department visits, and improve satisfaction for home care by
      parents. Of note, investigators at the Albert Einstein Colle of Medicine have shown that the
      implementation of an asthma action plan program decreases hospital admissions, decreases
      emergency department visits, and decreases medical resource cost.

      While appropriate pharmacotherapy and the use of constipation action plans have demonstrated
      varying scientific rigor within the literature, current clinical practice guidelines and
      available evidence fail to address the root of the constipation problem in children- which
      include lifestyle factors such as diets low in fiber, inadequate hydration, poor posturing
      and other maladaptive behaviors. Direct patient education is key to help address and overcome
      these obstacles. Most recently a clinical questionnaire for children has placed an emphasis
      on the clinical impact of behaviors and posturing with the release of the Rome IV
      Questionnaire for Pediatric Functional gastrointestinal Disorders.

      Prior to this, however, current clinical practice guidelines and action plans for
      constipation have failed to address what many gastroenterologists would consider the root of
      the constipation problem- poor posturing. The effect of inappropriate straight posturing on
      the puborectalis angle and the detrimental effect it can have on defecation. The puborectalis
      muscles acts like a sling encircling the lower colon. When the back is straight and the knees
      are below the level of the abdomen, the puborectalis muscle contracts causing the colon to
      kink, thereby impeding the evacuation of stool. When the angle is changed by lifting the
      knees higher, an angle of 35 degrees can be attained which has been associated with decreased
      constipation in adults. As a standard of care, posture modification has been made possible
      through the use of a Defecation Posture Modification Device (DPMD). As a minimal-cost,
      non-pharmacologic means of therapy, the DPMD is postured to enact real change on the care of
      constipation in children by serving as a stool for children to prop their feet on and achieve
      the desired 35 degree angle. This along with other behavioral modifications included in the
      standard of care: sticker charts, scheduled toilet time, and rewards systems may capture the
      psychological aspect of functional constipation management which warrants additional
      investigation.

      In summary, investigators seek to create a program which combines improved patient/ provider
      education, incorporates constipation action plans, to shift the care paradigm to rely more
      intentionally on written clinical action plans to address low health literacy and improve
      outcomes.

      Methods Investigators measured clinical and patient-related outcomes during this quality
      improvement project.

      At the time of enrollment, participants (or a parent proxy) responded to a health literacy
      questionnaire: The Newest Vital Sign. This enrollment survey also offered use of a defecation
      posture modification device (DPMD) to participants at no cost. The remainder of the
      enrollment survey gathered baseline measurements using validated instruments developed for
      clinical, patient-related, and health confidence outcomes which would be trended over time to
      grade USCAP effectiveness. These instruments are discussed in greater detail below. Four
      months later, participants responded to a second survey which repeated these clinical,
      patient-related, and health confidence measures.

      The 4-month study period was selected based on our institutional practice pattern and to
      capture recurrences in constipation that can occur after the discontinuation of
      pharmacotherapy following shorter treatment durations outlined in the North American Society
      for Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN) clinical practice
      guideline. Survey 2 used common, real-world, clinically relevant questions to assess for
      pharmacotherapy adherence. Investigators used two questions adapted from the Self-Report
      Measure for Medication Adherence from Wilson et al. In order to assess adherence both
      qualitatively and quantitatively, participants were asked, "How often does the patient take
      his/her constipation medicine in the way he/she is supposed to?" using the 5-point Likert
      scale (0- Never, 1- Almost Never, 2-Sometimes, 3-Often, 4-Almost Always). Next, participants
      responded to the question, "How many months did the patient take their constipation medicines
      for?" using a continuous rating from 0 to 4 months. Finally, participants were asked if they
      used a DPMD with every bowel movement.

      Measurements of Implementation Effectiveness Investigators evaluated the effectiveness of the
      USCAP through multiple approaches. These include clinical, adherence, patient-related, and
      health confidence outcomes. Toilet-trained subjects, aged ≥4 years, who met the ROME IV
      criteria for FC were block randomized to receive either the USCAP or control. All discharge
      instructions were to continue pharmacotherapy for 4 months. Investigators measured subjects
      at enrollment and 4 months. Metrics included: clinical outcomes using the ROME IV Pediatric
      Diagnostic Questionnaire, patient-related outcomes using the PedsQL™ Gastrointestinal
      Symptoms Module [PedsGIQL] (a 5-point Likert scale: 0- Never, 1- Almost Never, 2- Sometimes,
      3-Often, 4-Almost Always). The PedsGIQL was administered to participants on at the start of
      the project after the clinic visit concluded, and 4 months after initial visit. The goal was
      to demonstrate an improvement in HRQoL. HRQoL responses were stratified by calculating Total
      Scale Scores. Higher Total Scale Scores demonstrated less (fewer) gastrointestinal symptoms
      and thus higher (better) gastrointestinal-specific HRQoL. Total Scale Scores were calculated
      by taking the sum of the reverse-scored items and then dividing by the number of items
      responded to. Finally, self-efficacy using the Health Confidence Score [HCS] (4-point Likert
      scale: 3-strongly agree, 2-agree, 1-neutral, 0-disagree).

      DATA ANALYSIS Treatment success rates of the treatment and control groups (i.e., the
      proportion of each group which no longer met the definition of functional constipation) were
      compared at project conclusion. Investigators also performed an analysis to determine the
      proportion of subjects with self/parent-proxy reported Pediatric Bristol Stool Form Scale
      (PBSFS) 3 or 4 achieved at the close of the project and the changes in rates of fecal
      incontinence (FI). Investigators compared Total Scale Scores from the PedsGIQL between
      treatment and control groups to determine whether significant change occurred during the
      project. Changes in HCS were analyzed to compare whether the USCAP is associated with higher,
      sustained health-confidence compared to control. Univariate analyses were conducted using the
      Kolmogorov-Smirnov test to investigate potential outliers and normality of the data. When
      continuous variables were found to be normally distributed, values were summarized using
      means and standard deviations (SD). When data were found to be skewed or non-normal data were
      summarized with medians and interquartile ranges (IQR). When comparing continuous variables
      between groups either a Student's t-test or Wilcoxon rank sum tests were used. Frequency data
      were reported as counts and percentages. Chi-square was used for all categorical comparisons.
      When any condition had N ≤5, a Fisher's Exact Test was applied. A P-value <0.05 was
      considered statistically significant. SAS 9.4 (SAS Institute, Cary, NC) was used for all
      analyses.
    

Intervention name(s): Constipation Action Plan; Standard of care without constipation action plan
Intervention type(s): Other; Other
Intervention description(s): The author team previously developed and assessed this constipation action plan using the universal precautions approach to produce a tool which could optimize knowledge transfer from clinicians to patients, and support stepwise home self-management of functional constipation. The Uniformed Services Constipation Action Plan can be freely downloaded at the following web link: https://wrnmmc.libguides.com/pediatrics/USAP; Standard of care without constipation action plan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Toilet-trained children aged four years and older were enrolled if they were evaluated in our institution's pediatric gastroenterology clinic and were diagnosed with functional constipation based on the ROME IV criteria.
Children were excluded if they were expected to have alternative ROME IV diagnoses (e.g., irritable bowel syndrome), or if an alternative etiology was suspected to be a cause of their constipation.
Subjects were then block randomized to either receive a constipation action plan or the standard of care (control)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clinical action plan