NCT00310362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,610

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

September 25, 2014

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

1.5 years

First QC Date

March 30, 2006

Results QC Date

September 16, 2014

Last Update Submit

June 15, 2020

Conditions

Keywords

telephonetelemedicinemass screeningpatient educationPatient compliance

Outcome Measures

Primary Outcomes (1)

  • Appointment Nonadherence-colonoscopy

    Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment

    3 months

Secondary Outcomes (3)

  • Nonattendance-flexible Sigmoidoscopy

    3 months

  • Preparation Nonadherence-colonoscopy

    3 months

  • Preparation Non-adherence-flexible Sigmoidoscopy

    3 months

Study Arms (3)

Usual Care with nurse phone call

EXPERIMENTAL

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 Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures

interactive voice response 3 days prior

EXPERIMENTAL

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)

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

interactive voice response 7 days prior

EXPERIMENTAL

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)

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

Interventions

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.

Usual Care with nurse phone callinteractive voice response 3 days priorinteractive voice response 7 days prior

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Related 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.

MeSH Terms

Conditions

Colorectal NeoplasmsPatient Compliance

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr. Joan Griffin
Organization
MInneapolis VA Health Care System

Study Officials

  • Joan M. Griffin, PhD

    Minneapolis VA Health Care System, Minneapolis, MN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2006

First Posted

April 3, 2006

Study Start

July 1, 2007

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

June 30, 2020

Results First Posted

September 25, 2014

Record last verified: 2020-06

Locations