Optimizing Gastrointestinal Procedure Appointments

Gastrointestinal Disease Clinical Trial

Official title:

Optimizing the Use of Reminders for Gastrointestinal Procedure Appointments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879616
• Other study ID #: GI2019
• Status: Completed
• Phase: N/A
• Start date: March 8, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project will address the question:

Does an "enhanced" IVR-T protocol differ in effectiveness from the standard IVR-T protocol in reducing missed appointments and late cancellations for GI endoscopy? Hypothesis: The enhanced IVR-T protocol will be more effective.

Description:

This study will be a randomized trial over a 6-month period (March 8 through September 7, 2019) in 3 GI endoscopy clinics (Franklin, Rock Creek, and Lone Tree). All members currently receive a text reminder 7 days prior to their procedure, which rolls over to a telephone reminder if the text cannot be delivered or the member's phone is not text-enabled. Members will be randomized either to receive this standard IVR-T protocol (control) or to receive an enhanced reminder (intervention) protocol.

Randomization: Beginning in March 8, 2019, a randomization algorithm will be used in the Structured Query Language program that manages the IVR relational database to assign each visit for a procedure at all three sites to control or intervention. Since members with multiple procedures on different days during the study period could receive control or intervention for different visits, the statistical analysis will be limited to the first randomized appointment during the project period. Randomization will be stratified by clinic site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15974
• Est. completion date: December 31, 2021
• Est. primary completion date: September 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 120 Years

Eligibility

Inclusion criteria:

• Members scheduled for any GI procedure (upper endoscopy, colonoscopy, or both), with or without anesthesia, at all three clinical sites (Franklin, Rock Creek, Lone Tree) will be included if their procedure is scheduled = 2 days prior to the procedure. The IVR-T protocol will be adapted based on the wait time between appointment scheduling and the date of the procedure.

• Members with all clinical indications (screening, diagnosis, or surveillance), will be included.

Exclusion criteria:

• KPCO members who request not to participate in research or not to receive IVR-T or email outreach

• KPCO members in the "break the glass" or "code pink" protocols.

• Members whose procedure is scheduled < 2 days prior to the procedure.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

Behavioral:
• An Enhanced Reminder
This study will be a randomized trial over a 6-month period (March 8 through September 7, 2019) in 3 GI endoscopy clinics (Franklin, Rock Creek, and Lone Tree). All members currently receive a text reminder 7 days prior to their procedure, which rolls over to a telephone reminder if the text cannot be delivered or the member's phone is not text-enabled. Members will be randomized either to receive this standard IVR-T protocol (control) or to receive an enhanced reminder (intervention) protocol. Data from the randomized trial, for both intervention and control participants, will be analyzed to develop a statistical prediction rule that identifies members at highest risk of missing their procedure.

Locations

Country	Name	City	State
United States	Kaiser Permanente	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Cancellation and Rate of Missed Appointments	The primary outcome for the study will be "appointment loss," defined by GI leaders as the combined rate of prior day cancellations, same-day cancellations, and missed clinic appointments ("no shows"). The rationale for this outcome definition is that it is difficult to schedule new procedures within this time frame.	6 months
Secondary	The Boston Bowel Preparation Measure	A secondary outcome will be the assessment of the adequacy of the bowel preparation for colonoscopy only.	6 months