Constipation, Encopresis
Conditions
Brief summary
This project seeks to expand an existing computerized decision support system used in pediatric primary care. The expanded system will add a module that helps clinicians recognize constipated children and then provides evidence-based reminders for constipation management, as well as automates patient educational materials. The current system is deployed across multiple sites, and the constipation module will be randomized to deployment in different sites. The difference in constipation management and patient outcomes will then be compared between sites receiving the intervention and sites not receiving the intervention over a 12 month period.
Interventions
OTHEREvidence Based Constipation Reminders
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
William E. Bennett, Jr.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Patients presenting to one of 5 primary care clinics in the Eskenazi Health system in Indianapolis, IN. * Patients given a pre-screener form as part of the existing CHICA decision support system. * Age between 2 years and 12 years, inclusive.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Persistent Constipation Within 6 Months | All visits within 6 months of initial constipation complaint. | Parents are asked if constipation is still present at a subsequent visit within 6 months. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Patients are identified by the pre-screener form given to parents as having constipation or encopresis. No intervention is given to providers to help them with constipation management. | 9,667 |
| Experimental Patients are identified by the pre-screener form given to parents as having constipation or encopresis. Evidence based reminders and patient educational materials are given to providers to help them with constipation management.
Evidence Based Constipation Reminders | 6,597 |
| Total | 16,264 |
Baseline characteristics
| Characteristic | Experimental | Total | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 6597 Participants | 16264 Participants | 9667 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6 years | 6 years | 6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3447 Participants | 7878 Participants | 4431 Participants |
| Race (NIH/OMB) More than one race | 2467 Participants | 6796 Participants | 4329 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 683 Participants | 1590 Participants | 907 Participants |
| Sex: Female, Male Female | 3283 Participants | 8035 Participants | 4752 Participants |
| Sex: Female, Male Male | 3314 Participants | 8229 Participants | 4915 Participants |
| Symptoms of constipation | 432 participants | 1044 participants | 612 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9,667 | 0 / 6,597 |
| serious Total, serious adverse events | 0 / 9,667 | 0 / 6,597 |
Outcome results
Primary
Number of Patients With Persistent Constipation Within 6 Months
Parents are asked if constipation is still present at a subsequent visit within 6 months.
Time frame: All visits within 6 months of initial constipation complaint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Patients With Persistent Constipation Within 6 Months | 325 participants with persistent symptoms |
| Experimental | Number of Patients With Persistent Constipation Within 6 Months | 224 participants with persistent symptoms |