NCT03879616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,974

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

March 8, 2019

Last Update Submit

February 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Boston Bowel Preparation Measure

    6 months

Study Arms (2)

An Enhanced Reminder

EXPERIMENTAL

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.

Behavioral: An Enhanced Reminder

Control

OTHER

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.

Behavioral: An Enhanced Reminder

Interventions

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.

An Enhanced ReminderControl

Eligibility Criteria

Age21 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente

Aurora, Colorado, 80014, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • John Steiner, MD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 19, 2019

Study Start

March 8, 2019

Primary Completion

September 8, 2019

Study Completion

December 31, 2021

Last Updated

February 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations