ISE to Support Constipation Management

NCT ID: NCT02977858

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-30

Study Completion Date

2020-02-05

Brief Summary

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This study is a single site prospective controlled trial assessing two educational interventions designed to educate local pediatric Primary Care Physicians (PCP) and nurses on collaboratively developed treatment guidelines for pediatric constipation. The study aims to assess the impact of an Spaced Education game to aid the implementation of the management guideline. PCP adherence to recommended treatment will be assessed in addition to PCP satisfaction with the educational methods, constipation knowledge and patient outcomes.

Detailed Description

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Primary care practices in the Greater Cincinnati region, that are part of the Ohio Valley Pediatric Care Association (OVPCA) will be recruited to take part in the study. It is estimated that approximately 170 providers in 40 practices will take part overall. The study participants will be the PCPs and nurses in their practices.

Prior to the educational intervention (described below), participating PCPs and nurses will be asked to complete Constipation Action Plan (CAP) forms detailing the treatments they prescribed to each patient with constipation symptoms at each new visit and the subsequent follow up visits for constipation. The CAP form will contain a section to describe the patient's symptoms as well as fields to be checked for each treatment the PCP instructed the patient to follow.

Practices will be clustered by size (number of providers) and randomly assigned to 1 of 2 educational interventions (Dissemination or Dissemination +Interactive Spaced Education).

Dissemination will include webinars and e-mail distribution of the Constipation Management Guideline and a slide set containing the evidence-based rationale as well as clinical tips for advanced management of functional constipation. All PCPs will receive the guideline and slide set and be offered an opportunity to ask questions of a gastroenterologist.

Participating PCPs and nurses randomized to the Interactive Spaced Education (ISE) arm will complete an online ISE course assessing their understanding of the constipation guidelines.

Constipation knowledge will be tested via quiz in multiple choice format. Online surveys to assess satisfaction with the educational intervention, likelihood to change practice, ease of participation in the SE course (if applicable) and feedback for ways to improve future educational efforts will be administered at three time-points.

Conditions

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Constipation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Dissemination

Educational practice for HCPs,Dissemination only - Practices who will participate in education for constipation management guidelines via dissemination of webinar alone.

Educational practice for HCPs,Dissemination only

Intervention Type OTHER

Study participants are health care professionals (HCPs) who will be provided educational material and complete knowledge assessments

Dissemination + ISE

Educational practice for HCPs,Spaced Education - Practices who will participate in education for constipation management guidelines via dissemination of webinar along with a web-based format referred to as Interactive Spaced Education.

Educational practice for HCPs,Dissemination only

Intervention Type OTHER

Study participants are health care professionals (HCPs) who will be provided educational material and complete knowledge assessments

Educational practice for HCPs,Spaced Education

Intervention Type OTHER

Study participants are health care professionals (HCPs) who will be provided educational material via a Spaced Education program; participants will subsequently complete knowledge assessments

Interventions

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Educational practice for HCPs,Dissemination only

Study participants are health care professionals (HCPs) who will be provided educational material and complete knowledge assessments

Intervention Type OTHER

Educational practice for HCPs,Spaced Education

Study participants are health care professionals (HCPs) who will be provided educational material via a Spaced Education program; participants will subsequently complete knowledge assessments

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* PCPs and nurses who are willing and able to complete the education intervention throughout the study time-frame, as outlined in the protocol (education intervention does not need to be completed prior to taking part in the study)
* PCPs and nurses who are willing to complete Constipation Action Plans and submit them in a timely fashion to the CCHMC Quality Improvement program staff

Exclusion Criteria

* PCPs or nurses who are unwilling and/or unable to follow protocol requirements.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Mallon, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Mallon D, Fei L, Farrell M, Anderson JB, Klein M. Randomized Controlled Trial of Interactive Spaced Education to Support Constipation Management by Pediatric Primary Care Providers. J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):568-574. doi: 10.1097/MPG.0000000000003405.

Reference Type DERIVED
PMID: 35149642 (View on PubMed)

Other Identifiers

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2015-9317

Identifier Type: -

Identifier Source: org_study_id

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