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Trial record 2 of 2 for:    MARCH8

Optimizing Gastrointestinal Procedure Appointments

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ClinicalTrials.gov Identifier: NCT03879616
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

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.


Condition or disease Intervention/treatment Phase
Gastrointestinal Disease Behavioral: An Enhanced Reminder Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Optimizing the Use of Reminders for Gastrointestinal Procedure Appointments
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : September 7, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: An Enhanced Reminder

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

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.


Control
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

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 Measures :
  1. Rate of Cancellation and Rate of Missed Appointments [ Time Frame: 6 months ]
    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 :
  1. The Boston Bowel Preparation Measure [ Time Frame: 6 months ]
    A secondary outcome will be the assessment of the adequacy of the bowel preparation for colonoscopy only.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03879616


Contacts
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Contact: John Steiner, MD, MPH 303-636-2908 ext 2908 john.f.steiner@kp.org
Contact: Jennifer Barrow, MSPH 303-636-2487 ext 2487 jennifer.c.barrow@kp.org

Locations
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United States, Colorado
Kaiser Permanente Recruiting
Aurora, Colorado, United States, 80014
Sponsors and Collaborators
Kaiser Permanente
Investigators
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Principal Investigator: John Steiner, MD, MPH Kaiser Permanente
  Study Documents (Full-Text)

Documents provided by Kaiser Permanente:

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03879616     History of Changes
Other Study ID Numbers: GI2019
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases