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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00310362
Acronym
GIVER
Enrollment
3610
Registered
2006-04-03
Start date
2007-07-31
Completion date
2009-02-28
Last updated
2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

telephone, telemedicine, mass screening, patient education, Patient compliance

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

Interventions

BEHAVIORALUse 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
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 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.

Design outcomes

Primary

MeasureTime frameDescription
Appointment Nonadherence-colonoscopy3 monthsNonattendance was defined as canceling the colonoscopy appointment or not attending the appointment

Secondary

MeasureTime frameDescription
Nonattendance-flexible Sigmoidoscopy3 monthsNonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment
Preparation Nonadherence-colonoscopy3 monthsPreparation nonadherence assessed whether patients had adequately prepared their bowels to complete the colonoscopy procedure.
Preparation Non-adherence-flexible Sigmoidoscopy3 monthsPreparation nonadherence assessed whether patients had adequately prepared their bowels to complete the flexible sigmoidoscopy procedure.

Countries

United States

Participant flow

Participants by arm

ArmCount
Usual Care
Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
1,199
IVR3
Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures..
1,205
IVR7
Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
1,206
Total3,610

Baseline characteristics

CharacteristicUsual CareIVR3IVR7Total
Age, Continuous62.6 years
STANDARD_DEVIATION 9.9
62.8 years
STANDARD_DEVIATION 10.2
62.5 years
STANDARD_DEVIATION 10.2
62.6 years
STANDARD_DEVIATION 10.1
Region of Enrollment
United States
1199 participants1205 participants1206 participants3610 participants
Sex: Female, Male
Female
50 Participants54 Participants50 Participants154 Participants
Sex: Female, Male
Male
1149 Participants1151 Participants1156 Participants3456 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

Appointment Nonadherence-colonoscopy

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

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareAppointment Nonadherence-colonoscopy348 Participants
IVR3Appointment Nonadherence-colonoscopy333 Participants
IVR7Appointment Nonadherence-colonoscopy303 Participants
Secondary

Nonattendance-flexible Sigmoidoscopy

Nonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNonattendance-flexible Sigmoidoscopy155 Participants
IVR3Nonattendance-flexible Sigmoidoscopy169 Participants
IVR7Nonattendance-flexible Sigmoidoscopy164 Participants
Secondary

Preparation Nonadherence-colonoscopy

Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the colonoscopy procedure.

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CarePreparation Nonadherence-colonoscopy348 Participants
IVR3Preparation Nonadherence-colonoscopy349 Participants
IVR7Preparation Nonadherence-colonoscopy319 Participants
Secondary

Preparation Non-adherence-flexible Sigmoidoscopy

Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the flexible sigmoidoscopy procedure.

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CarePreparation Non-adherence-flexible Sigmoidoscopy164 Participants
IVR3Preparation Non-adherence-flexible Sigmoidoscopy173 Participants
IVR7Preparation Non-adherence-flexible Sigmoidoscopy168 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026