Trial Outcomes & Findings for Child Health Improvement Through Computer Automation of Constipation Management in Primary Care (NCT NCT02354820)
NCT ID: NCT02354820
Last Updated: 2022-09-14
Results Overview
Parents are asked if constipation is still present at a subsequent visit within 6 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16264 participants
Primary outcome timeframe
All visits within 6 months of initial constipation complaint.
Results posted on
2022-09-14
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
9667
|
6597
|
|
Overall Study
COMPLETED
|
9667
|
6597
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Child Health Improvement Through Computer Automation of Constipation Management in Primary Care
Baseline characteristics by cohort
| Measure |
Control
n=9667 Participants
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.
|
Experimental
n=6597 Participants
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
|
Total
n=16264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9667 Participants
n=5 Participants
|
6597 Participants
n=7 Participants
|
16264 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6 years
n=5 Participants
|
6 years
n=7 Participants
|
6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4752 Participants
n=5 Participants
|
3283 Participants
n=7 Participants
|
8035 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4915 Participants
n=5 Participants
|
3314 Participants
n=7 Participants
|
8229 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4431 Participants
n=5 Participants
|
3447 Participants
n=7 Participants
|
7878 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
907 Participants
n=5 Participants
|
683 Participants
n=7 Participants
|
1590 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4329 Participants
n=5 Participants
|
2467 Participants
n=7 Participants
|
6796 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Symptoms of constipation
|
612 participants
n=5 Participants
|
432 participants
n=7 Participants
|
1044 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: All visits within 6 months of initial constipation complaint.Parents are asked if constipation is still present at a subsequent visit within 6 months.
Outcome measures
| Measure |
Control
n=4324 Participants
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.
|
Experimental
n=3153 Participants
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
|
|---|---|---|
|
Number of Patients With Persistent Constipation Within 6 Months
|
325 participants with persistent symptoms
|
224 participants with persistent symptoms
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
William E. Bennett, Jr. Principal Investigator
Indiana University School of Medicine
Phone: 3172786928
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place