Clinical Implementation of a Pictographic Constipation Action Plan for Children With Functional Constipation

NCT05437523 | Completed DMC

• 1 other identifier: WRNMMC-EDO-2020-0443, 921062
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Constipation

Keywords

clinical action plan

Outcome Measures

Primary Outcomes (6)

• Clinical outcomes- ROME IV Pediatric Diagnostic Questionnaire to diagnose Functional Constipation- Start of Study

  The measure of implementation effectiveness was clinical: whether the subject met the ROME IV criteria for functional constipation based on the Rome IV Diagnostic Questionnaire for Pediatric Gastrointestinal Disorders for Children and Adolescents (ROME IV Pediatric Diagnostic Questionnaire). Scoring instructions for Functional Constipation: Two or more of the following: (C 1) Two or fewer stools per week, OR (C3) painful stool\] OR (C4) Passage of very large stools, OR (C5) Stool retention "once a week" or more often, OR (C6) History of large fecal mass in rectum, OR (C7) Soiling "once a week" or more often.

  At the start of the study

• Clinical outcomes- ROME IV Pediatric Diagnostic Questionnaire to diagnose Functional Constipation- End of Study

  The measure of implementation effectiveness was clinical: whether the subject met the ROME IV criteria for functional constipation based on the Rome IV Diagnostic Questionnaire for Pediatric Gastrointestinal Disorders for Children and Adolescents (ROME IV Pediatric Diagnostic Questionnaire). Scoring instructions for Functional Constipation: Two or more of the following: (C 1) Two or fewer stools per week, OR (C3) painful stool\] OR (C4) Passage of very large stools, OR (C5) Stool retention "once a week" or more often, OR (C6) History of large fecal mass in rectum, OR (C7) Soiling "once a week" or more often.

  At the end of the study (4-months after study start)

• Patient-related outcomes-PedsQL™ Gastrointestinal Symptoms Version 3.0 (PedsGIQL)

  Patient-related outcomes were measured using the PedsQL™ Gastrointestinal Symptoms Version 3.0 (PedsGIQL). The PedsGIQL includes 11 domains (76 questions): stomach pain, stomach upset, food and drink limits, trouble swallowing, heartburn and reflux, gas and bloating, constipation, diarrhea, worry, medicines, and communication. The questions are all graded on 5-point Likert scales (0- Never, 1- Almost Never, 2-Sometimes, 3-Often, 4-Almost Always). Once items were recorded, all items were reverse-scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0) to calculate Total Scale Scores per instructions from Varni (the creator of the tool). Higher Total Scale Scores demonstrated less (fewer) gastrointestinal symptoms and thus higher (better) gastrointestinal-specific healthcare related quality of life.

  start the 4-month study

• Patient-related outcomes-PedsQL™ Gastrointestinal Symptoms Version 3.0 (PedsGIQL)

  Patient-related outcomes were measured using the PedsQL™ Gastrointestinal Symptoms Version 3.0 (PedsGIQL). The PedsGIQL includes 11 domains (76 questions): stomach pain, stomach upset, food and drink limits, trouble swallowing, heartburn and reflux, gas and bloating, constipation, diarrhea, worry, medicines, and communication. The questions are all graded on 5-point Likert scales (0- Never, 1- Almost Never, 2-Sometimes, 3-Often, 4-Almost Always). Once items were recorded, all items were reverse-scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0) to calculate Total Scale Scores per instructions from Varni (the creator of the tool). Higher Total Scale Scores demonstrated less (fewer) gastrointestinal symptoms and thus higher (better) gastrointestinal-specific healthcare related quality of life.

  end of the 4-month study

• Health confidence- Health Confidence Score to measure self-efficacy- Start of Study

  Health confidence for home management of functional constipation was measured using the Health Confidence Score (HCS), a tool with established external validity for chronic disease self-management. The HCS is a low HL health confidence inventory assesses health knowledge, capability to self-manage, access to help, and shared decision-making using a 4-point Likert scale with pictographs (3-strongly agree, 2-agree, 1-neutral, 0-disagree). Higher scores correspond to higher (i.e., better) health confidence.

  measured using validated questionnaire at the start of the 4-month study

• Health confidence- Health Confidence Score to measure self-efficacy- End of Study

  Health confidence for home management of functional constipation was measured using the Health Confidence Score (HCS), a tool with established external validity for chronic disease self-management. The HCS is a low HL health confidence inventory assesses health knowledge, capability to self-manage, access to help, and shared decision-making using a 4-point Likert scale with pictographs (3-strongly agree, 2-agree, 1-neutral, 0-disagree). Higher scores correspond to higher (i.e., better) health confidence.

  measured using validated questionnaire at the End of the 4-month study

Secondary Outcomes (2)

• medication adherence, 1 of 2 outcomes measure for Adherence

  at end of 4-month study

• medication adherence, 2 of 2 outcomes measure for Adherence

  at end of 4-month study

Study Arms (2)

Study group participants received a constipation action plan (USCAP)

EXPERIMENTAL

Received a personalized, pictographic, constipation action plan which detailed the subjects medications to manage functional constipation. The action plan was downloaded from: https://wrnmmc.libguides.com/pediatrics/USAP Watched a study group, specific, education video. Followed up in 4 months.

Other: Constipation Action Plan

Control

ACTIVE COMPARATOR

Received medications to treat functional constipation Did not receive a written action plan. Watched a control group, specific, education video. Followed up in 4 months.

Other: Standard of care without constipation action plan

Interventions

Constipation Action Plan OTHER

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

Study group participants received a constipation action plan (USCAP)

Standard of care without constipation action plan OTHER

Standard of care without constipation action plan

Control

Eligibility Criteria

• Age: 4 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Toilet-trained children aged four years and older
• Participants were diagnosed with functional constipation based on the ROME IV criteria

You may not qualify if:

• Participants diagnosed with an alternative ROME IV diagnosis (e.g., irritable bowel syndrome)
• Participants diagnosed with an alternative etiology (i.e., organic etiology) to be a cause of their constipation.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

• Reeves PT, Kolasinski NT, Yin HS, Alqurashi W, Echelmeyer S, Chumpitazi BP, Rogers PL, Burklow CS, Nylund CM. Development and Assessment of a Pictographic Pediatric Constipation Action Plan. J Pediatr. 2021 Feb;229:118-126.e1. doi: 10.1016/j.jpeds.2020.10.001. Epub 2020 Oct 15.

  PMID: 33068567 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 29, 2022
• Study Start: August 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)