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Use of Telehealth In-home Messaging to Improve GI (Gastrointestinal) Endoscopy Completion Rates (GIVER)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring telephone, telemedicine, mass screening, patient education, Patient compliance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients with either flexible sigmoidoscopy or colonoscopy appointments scheduled greater than 7 days before their appointment in the GI endoscopy clinic from August 20, 2007 through October 31, 2008. Exclusion Criteria: Patients were not considered eligible for inclusion in the study if, based on a medical record review prior to randomization, they had unreliable means of receiving the intervention or the intervention would have provided inappropriate or inaccurate information. These patients included those who lived in a nursing or group home or homeless shelter; had no listed telephone number; scheduled the appointment less than 8 days in advance; or, had Type 1 diabetes, dementia or Alzheimer's or multiple GI procedures on the same day (such as those with both upper and lower GI procedures). All patients excluded from the study were assigned to usual care.

Sites / Locations

  • Minneapolis VA Health Care System, Minneapolis, MN

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Usual Care with nurse phone call

interactive voice response 3 days prior

interactive voice response 7 days prior

Arm Description

Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.

Interactive voice response system was used to remind patients 3 days before a scheduled appointment and to educate them about preparation procedures for the appointment (IVR3)

Interactive voice response system was used to remind patients 7 days before a scheduled appointment and to educate them about preparation procedures for the appointment (IVR7)

Outcomes

Primary Outcome Measures

Appointment Nonadherence-colonoscopy
Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment

Secondary Outcome Measures

Nonattendance-flexible Sigmoidoscopy
Nonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment
Preparation Nonadherence-colonoscopy
Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the colonoscopy procedure.
Preparation Non-adherence-flexible Sigmoidoscopy
Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the flexible sigmoidoscopy procedure.

Full Information

First Posted
March 30, 2006
Last Updated
June 15, 2020
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00310362
Brief Title
Use of Telehealth In-home Messaging to Improve GI (Gastrointestinal) Endoscopy Completion Rates
Acronym
GIVER
Official Title
Use of Telehealth In-Home Messaging to Improve GI Endoscopy Completion Rates
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Low endoscopy completion rates are a major problem in the VA, causing delay or failure to receive essential care, increased clinic wait times, lost capacity, increased costs, thus limiting endoscopic screening for colorectal cancer. This study tests whether an Interactive Voice Response (IVR) messaging system is equally effective in promoting the completion of flexible sigmoidoscopy and colonoscopy as usual clinical care practices that include phone calls from nurses to patients prior to preparation and procedures. Previous studies have examined the role of scheduling facilitation or patient adherence on endoscopy completion and the use of IVR technology to enhance patient adherence in other medical contexts. This is the first study, however, to evaluate the use of IVR for endoscopy completion and the first to compare it to the effectiveness of phone calls from nurses prior to an endoscopy appointment.
Detailed Description
Background: Low endoscopy completion rates are a major problem nationwide and in the VA. For clinics, delays or failure to complete exams can cause clinic inefficiencies, such as increased wait times for needed procedures, lost capacity, and increased costs. For patients, delays reduce the chance for recommended timely screening consistent with practice guidelines and for diagnostic tests, can cause significant anxiety, delayed treatment and possibly poorer prognosis. This study tests whether an Interactive Voice Response (IVR) messaging system is equally effective in motivating patients to complete a flexible sigmoidoscopy or colonoscopy as usual clinical care practices, which include reminder phone calls from clinic nurses. This is the first study to evaluate the use of IVR for endoscopy completion and the first to compare it to the effectiveness of phone calls from nurses prior to an endoscopy appointment. Objectives: The primary set of objectives was to test whether IVR messaging was equivalent to clinic usual care (UC) practices in motivating patients to attend a scheduled flexible sigmoidoscopy or colonoscopy appointment and to adequately prepare for the exam. Secondary objectives included comparing patient satisfaction with UC and IVR phone calls and assessing if IVR or UC was more effective for sub-groups that may have more difficulty with preparation, including those with poor physical and mental functioning, health literacy, social support and trust in physicians and those with spinal cord injury, paraplegia, PTSD, or with little intention to be tested for colorectal cancer in the future. Methods: This was a stratified 3-arm randomized controlled trial among patients with upcoming flexible sigmoidoscopy or colonoscopy appointments. All patients who had a colonoscopy or flexible sigmoidoscopy appointment scheduled from August 20, 2007 through October 31, 2008 were assessed for inclusion in this study. Patients were not considered eligible if, based on a medical record review prior to randomization, they had unreliable means of receiving the intervention or the intervention would have provided inappropriate or inaccurate information. The three study arms included: 1) UC (nurse phone call 7 days prior to the procedure); 2) IVR7 (call from IVR system 7 days prior to procedure); and, 3) IVR3 (call from IVR system 3 days prior to procedure). One week after the initial appointment self-administered surveys were sent to all participants to assess satisfaction with reminder/motivation calls. Appointment and gastrointestinal (GI) procedure data were extracted from medical record files to assess study outcomes. The principal outcome measures were (1) attendance at the scheduled endoscopy appointment; (2) adequate preparation for the exam; (3) patient satisfaction with reminder/motivation telephone calls. Status: Complete

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
telephone, telemedicine, mass screening, patient education, Patient compliance

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3610 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care with nurse phone call
Arm Type
Experimental
Arm Description
Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
Arm Title
interactive voice response 3 days prior
Arm Type
Experimental
Arm Description
Interactive voice response system was used to remind patients 3 days before a scheduled appointment and to educate them about preparation procedures for the appointment (IVR3)
Arm Title
interactive voice response 7 days prior
Arm Type
Experimental
Arm Description
Interactive voice response system was used to remind patients 7 days before a scheduled appointment and to educate them about preparation procedures for the appointment (IVR7)
Intervention Type
Behavioral
Intervention Name(s)
Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures
Intervention Description
Interactive voice response system (IVR) calls patients 7 or 3 days prior to their appointment. Information available in the IVR system is based on the same template nurses use in usual care and includes an appointment reminder, preparation instructions, basic information about the procedure, and answers to commonly asked questions.
Primary Outcome Measure Information:
Title
Appointment Nonadherence-colonoscopy
Description
Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Nonattendance-flexible Sigmoidoscopy
Description
Nonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment
Time Frame
3 months
Title
Preparation Nonadherence-colonoscopy
Description
Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the colonoscopy procedure.
Time Frame
3 months
Title
Preparation Non-adherence-flexible Sigmoidoscopy
Description
Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the flexible sigmoidoscopy procedure.
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with either flexible sigmoidoscopy or colonoscopy appointments scheduled greater than 7 days before their appointment in the GI endoscopy clinic from August 20, 2007 through October 31, 2008. Exclusion Criteria: Patients were not considered eligible for inclusion in the study if, based on a medical record review prior to randomization, they had unreliable means of receiving the intervention or the intervention would have provided inappropriate or inaccurate information. These patients included those who lived in a nursing or group home or homeless shelter; had no listed telephone number; scheduled the appointment less than 8 days in advance; or, had Type 1 diabetes, dementia or Alzheimer's or multiple GI procedures on the same day (such as those with both upper and lower GI procedures). All patients excluded from the study were assigned to usual care.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan M. Griffin, PhD
Organizational Affiliation
Minneapolis VA Health Care System, Minneapolis, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21504256
Citation
Griffin JM, Hulbert EM, Vernon SW, Nelson D, Hagel EM, Nugent S, Baines Simon A, Bangerter A, van Ryn M. Improving endoscopy completion: effectiveness of an interactive voice response system. Am J Manag Care. 2011 Mar;17(3):199-208.
Results Reference
result

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Use of Telehealth In-home Messaging to Improve GI (Gastrointestinal) Endoscopy Completion Rates

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