Official Title: “Use of Telehealth in-Home Messaging to Improve GI Endoscopy Completion Rates”

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.

Study Type: Interventional

Study Design: Other, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: November 2008

Background:

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. This is the first study to evaluate the use of IVR for appointment reminders and to inform patients of steps to adequately prepare for flexible sigmoidoscopy and colonoscopy. It is also the first to compare the effectiveness of IVR and phone calls from nurses prior to an endoscopy appointment.

Objectives:

1) To test the equivalence of IVR messaging and usual clinical care in promoting completion rates of flexible sigmoidoscopy and colonoscopy. 2) To test the timing of the IVR messages to see if messages are more salient immediately before preparation for the appointment or one week before. 3) To test for differences in patient satisfaction with both systems.

Methods:

We will use a three-arm randomized trial: 1) Usual care. Usual care (UC) at the Minneapolis VAMC consists of a mailed appointment notification letter after an appointment has been made and a personal reminder call from a clinic nurse 7 days prior to the veteran's appointment.

Nurses use a computerized template to guide them through the call. They remind patients of their appointment date and time, thoroughly review preparation instructions, provide basic information about the procedure, and answer any questions patients may have. One day prior to the scheduled appointment, veterans receive a generic automated reminder call that informs them that they have an appointment scheduled at the Minneapolis VAMC. 2) Intervention 1 (IVR-7). The IVR system calls patients 7 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. One day prior to the scheduled appointment, veterans receive a generic automated reminder call that informs them that they have an appointment scheduled at the Minneapolis VAMC. 3) Intervention 2 (IVR-3).

Identical to Intervention 1, but IVR system calls patients 3 days prior to their appointment, instead of 7 days.

For 15 months all patients scheduled for colonoscopy or flexible sigmoidoscopy in the GI clinic will be randomized into one of the three groups.

The principal outcome measures will be (1) percent of colonoscopies completed; (2) percent of flexible sigmoidoscopies completed; (3) percent of no shows and patient cancellations for colonoscopy; (4) percent of no shows or patient cancellations for flexible sigmoidoscopy.

Surveys will be sent to all individuals who made an appointment in the GI clinic to assess satisfaction within each arm. In addition, survey information will be collected to assess possible reasons why some patients do not show for their appointment or do not adequately prepare for the procedure.

Status:

Data collection began July 2007. We expect data collection to continue through November 2008.

Intervention(s) in this Clinical Trial

• Behavioral: Educational messages using IVR system
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Usual Care

Primary Measures

• Endoscopic completion rates
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

• Cancellation and No-show rates
  • Time Frame: 3 months
    Safety Issue?: No

Inclusion Criteria:

• All patients with either flexible sigmoidoscopy or colonoscopy appointments scheduled greater than 7 days before their appointment in the GI endoscopy clinic.

Exclusion Criteria:

• None for trial. Patients living in nursing homes or homeless shelters will be included in usual care. Patients with both upper and lower GI procedures scheduled for the same day will be included in usual care. Patients who make appointments within 7 days of their appointments will be included in usual care.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Department of Veterans Affairs

Overall Clinical Trial Officials and Contacts

Joan M. Griffin, PhD Principal Investigator Department of Veterans Affairs  

Overall Contact: Jill E Ronco, MPA (612) 467-4282 jill.ronco@va.gov

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00310362

Study ID Number: IIR 03-295

ClinicalTrials.gov Identifier: NCT00310362

Health Authority: United States: Federal Government