Trial Outcomes & Findings for Use of Telehealth In-home Messaging to Improve GI (Gastrointestinal) Endoscopy Completion Rates (NCT NCT00310362)

NCT ID: NCT00310362

Last Updated: 2020-06-30

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3610 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-06-30

Participant Flow

Participant milestones

Measure	Usual Care Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.	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.	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.
Overall Study STARTED	1199	1205	1206
Overall Study COMPLETED	1199	1205	1206
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Usual Care n=1199 Participants Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.	IVR3 n=1205 Participants 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..	IVR7 n=1206 Participants 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.	Total n=3610 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 9.9 • n=5 Participants	62.8 years STANDARD_DEVIATION 10.2 • n=7 Participants	62.5 years STANDARD_DEVIATION 10.2 • n=5 Participants	62.6 years STANDARD_DEVIATION 10.1 • n=4 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	54 Participants n=7 Participants	50 Participants n=5 Participants	154 Participants n=4 Participants
Sex: Female, Male Male	1149 Participants n=5 Participants	1151 Participants n=7 Participants	1156 Participants n=5 Participants	3456 Participants n=4 Participants
Region of Enrollment United States	1199 participants n=5 Participants	1205 participants n=7 Participants	1206 participants n=5 Participants	3610 participants n=4 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Usual Care n=790 Participants Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.	IVR3 n=794 Participants 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.	IVR7 n=797 Participants 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.
Appointment Nonadherence-colonoscopy	348 Participants	333 Participants	303 Participants

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Usual Care n=409 Participants Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.	IVR3 n=411 Participants 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.	IVR7 n=409 Participants 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.
Nonattendance-flexible Sigmoidoscopy	155 Participants	169 Participants	164 Participants

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Usual Care n=790 Participants Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.	IVR3 n=794 Participants 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.	IVR7 n=797 Participants 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.
Preparation Nonadherence-colonoscopy	348 Participants	349 Participants	319 Participants

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Usual Care n=409 Participants Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.	IVR3 n=411 Participants 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.	IVR7 n=409 Participants 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.
Preparation Non-adherence-flexible Sigmoidoscopy	164 Participants	173 Participants	168 Participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IVR3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IVR7

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joan Griffin

MInneapolis VA Health Care System

Phone: 507-538-1490

Email: griffin.joan@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place