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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00310362
First received: March 30, 2006
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Colorectal Cancer
Behavioral: Use of IVR system to improve adherene to GI appointments and prep procedures

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Use of Telehealth In-Home Messaging to Improve GI Endoscopy Completion Rates

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Appointment Nonadherence-colonoscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment


Secondary Outcome Measures:
  • Nonattendance-flexible Sigmoidoscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Nonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment

  • Preparation Nonadherence-colonoscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Preparation nonadherence assessed whether patients had adequately prepared to complete the colonoscopy procedure.

  • Preparation Non-adherence-flexible Sigmoidoscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Preparation nonadherence assessed whether patients had adequately prepared to complete the flexible sigmoidoscopy procedure.


Enrollment: 3610
Study Start Date: July 2007
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Usual Care with nurse phone call
Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
Behavioral: Use of IVR system to improve adherene to GI appointments and prep procedures
Interactive voice response system 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.
Experimental: interactive voice response 3 days prior
IVR3-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
Behavioral: Use of IVR system to improve adherene to GI appointments and prep procedures
Interactive voice response system 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.
Experimental: interactive voice response 7 days prior
IVR7-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
Behavioral: Use of IVR system to improve adherene to GI appointments and prep procedures
Interactive voice response system 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.

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310362

Locations
United States, Minnesota
Academy Health Center Departments
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Investigators
Principal Investigator: Joan M. Griffin, PhD Minneapolis VA Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00310362     History of Changes
Other Study ID Numbers: IIR 03-295
Study First Received: March 30, 2006
Results First Received: September 16, 2014
Last Updated: September 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
telephone
telemedicine
mass screening
patient education
Patient compliance

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014