A Revolutionary Approach to Managing Functional Constipation in Children Using Digital Education Videos, and Personalized Constipation Action Plans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Health confidence- Health Confidence Score to measure self-efficacy- Start of Study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Toilet-trained children aged four years and older
- •Participants were diagnosed with functional constipation based on the ROME IV criteria
排除标准
- •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.
研究组 & 干预措施
Study group participants received a constipation action plan (USCAP)
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.
干预措施: Constipation Action Plan (Other)
Control
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.
干预措施: Standard of care without constipation action plan (Other)
结局指标
主要结局
Health confidence- Health Confidence Score to measure self-efficacy- Start of Study
时间窗: measured using validated questionnaire at the start of the 4-month 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.
Health confidence- Health Confidence Score to measure self-efficacy- End of Study
时间窗: measured using validated questionnaire at the End of the 4-month 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.
Clinical outcomes- ROME IV Pediatric Diagnostic Questionnaire to diagnose Functional Constipation- Start of Study
时间窗: At the start of the 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.
Clinical outcomes- ROME IV Pediatric Diagnostic Questionnaire to diagnose Functional Constipation- End of Study
时间窗: At the end of the study (4-months after study start)
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.
Patient-related outcomes-PedsQL™ Gastrointestinal Symptoms Version 3.0 (PedsGIQL)
时间窗: end of the 4-month study
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.
Patient-related outcomes-PedsQL™ Gastrointestinal Symptoms Version 3.0 (PedsGIQL)
时间窗: start the 4-month study
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.
次要结局
- 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)