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

Colorectal Cancer Clinical Trial

— GIVER  

Official title:

Use of Telehealth In-Home Messaging to Improve GI Endoscopy Completion Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310362
• Other study ID #: IIR 03-295
• Status: Completed
• Phase: N/A
• Start date: July 2007
• Est. completion date: February 2009

Study information

• Verified date: June 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3610
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures
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.

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appointment Nonadherence-colonoscopy	Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment	3 months
Secondary	Nonattendance-flexible Sigmoidoscopy	Nonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment	3 months
Secondary	Preparation Nonadherence-colonoscopy	Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the colonoscopy procedure.	3 months
Secondary	Preparation Non-adherence-flexible Sigmoidoscopy	Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the flexible sigmoidoscopy procedure.	3 months