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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

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE March 8, 2019
Estimated Primary Completion Date September 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing Gastrointestinal Procedure Appointments
Official Title  ICMJE Optimizing the Use of Reminders for Gastrointestinal Procedure Appointments
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Gastrointestinal Disease
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: An Enhanced Reminder
  • 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.
    Intervention: Behavioral: An Enhanced Reminder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
13000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date September 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03879616
Other Study ID Numbers  ICMJE GI2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Steiner, MD, MPH Kaiser Permanente
PRS Account Kaiser Permanente
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP