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Optimizing Gastrointestinal Procedure Appointments

Primary Purpose

Gastrointestinal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
An Enhanced Reminder
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gastrointestinal Disease

Eligibility Criteria

21 Years - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kaiser Permanente

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

An Enhanced Reminder

Control

Arm Description

Members randomized to this arm of the study will receive an enhanced reminder protocol, which will include multiple reminders, multiple modalities, and motivational messages. The timing of reminders will depend on the wait time between the date the appointment is made and the date of the appointment. An email reminder will be sent to all members who have provided their personal email information. Members will receive up to two text messages that "roll over" to an IVR automated phone call if the text cannot be delivered. Members scheduled for colonoscopy will also receive a single IVR-T reminder to begin their bowel prep the morning of the calendar day prior to the procedure.

Members randomized to this arm of the study will receive a single text message that "rolls over" to an IVR automated phone call if the text cannot be delivered. This message will be delivered 7 business days prior to the appointment. This replicates the current protocol for GI procedures. Of note, members who schedule appointments within 7 days of the procedure currently receive no reminders.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The Boston Bowel Preparation Measure
A secondary outcome will be the assessment of the adequacy of the bowel preparation for colonoscopy only.

Full Information

First Posted
March 8, 2019
Last Updated
February 18, 2022
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT03879616
Brief Title
Optimizing Gastrointestinal Procedure Appointments
Official Title
Optimizing the Use of Reminders for Gastrointestinal Procedure Appointments
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
September 8, 2019 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15974 (Actual)

8. Arms, Groups, and Interventions

Arm Title
An Enhanced Reminder
Arm Type
Experimental
Arm Description
Members randomized to this arm of the study will receive an enhanced reminder protocol, which will include multiple reminders, multiple modalities, and motivational messages. The timing of reminders will depend on the wait time between the date the appointment is made and the date of the appointment. An email reminder will be sent to all members who have provided their personal email information. Members will receive up to two text messages that "roll over" to an IVR automated phone call if the text cannot be delivered. Members scheduled for colonoscopy will also receive a single IVR-T reminder to begin their bowel prep the morning of the calendar day prior to the procedure.
Arm Title
Control
Arm Type
Other
Arm Description
Members randomized to this arm of the study will receive a single text message that "rolls over" to an IVR automated phone call if the text cannot be delivered. This message will be delivered 7 business days prior to the appointment. This replicates the current protocol for GI procedures. Of note, members who schedule appointments within 7 days of the procedure currently receive no reminders.
Intervention Type
Behavioral
Intervention Name(s)
An Enhanced Reminder
Intervention 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. 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.
Primary Outcome Measure Information:
Title
Rate of Cancellation and Rate of Missed Appointments
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The Boston Bowel Preparation Measure
Description
A secondary outcome will be the assessment of the adequacy of the bowel preparation for colonoscopy only.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Steiner, MD, MPH
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimizing Gastrointestinal Procedure Appointments

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