Trial Outcomes & Findings for Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care (NCT NCT01296841)

Results Overview

We used a validated Ware Specific Visit Questionnaire to assess patients' satisfaction with their clinic-visit encounter. This is a 14-item questionnaire on doctor-patient interaction including factors such as attention to complaints, technical skills, and personal manner (courtesy,and ease of appointment scheduling and is based on a five-point Likert scale (1 excellent to 5 poor). Patients completed the questionnaire at the time of the visit. The 14 item scores were individually scored and then averaged to provide the final overall value.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Clinic Visit

Results posted on

2017-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Encounter Standard "in-house" clinical visit between patient and physician.	Telemedicine Encounter Remote clinical appointment between patient and physician.
Overall Study STARTED	19	15
Overall Study COMPLETED	19	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Encounter n=19 Participants Standard "in-house" clinical visit between patient and physician.	Telemedicine Encounter n=15 Participants Remote clinical appointment between patient and physician.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=99 Participants	9 Participants n=107 Participants	24 Participants n=206 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants
Age, Continuous	58.5 years STANDARD_DEVIATION 9.6 • n=99 Participants	62.8 years STANDARD_DEVIATION 11.5 • n=107 Participants	60.4 years STANDARD_DEVIATION 10.5 • n=206 Participants
Gender Female	6 Participants n=99 Participants	2 Participants n=107 Participants	8 Participants n=206 Participants
Gender Male	13 Participants n=99 Participants	13 Participants n=107 Participants	26 Participants n=206 Participants
Region of Enrollment United States	19 participants n=99 Participants	15 participants n=107 Participants	34 participants n=206 Participants

PRIMARY outcome

Timeframe: Clinic Visit

Population: per protocol

We used a validated Ware Specific Visit Questionnaire to assess patients' satisfaction with their clinic-visit encounter. This is a 14-item questionnaire on doctor-patient interaction including factors such as attention to complaints, technical skills, and personal manner (courtesy,and ease of appointment scheduling and is based on a five-point Likert scale (1 excellent to 5 poor). Patients completed the questionnaire at the time of the visit. The 14 item scores were individually scored and then averaged to provide the final overall value.

Outcome measures

Outcome measures
Measure	Telemedicine n=15 Participants clinic experience (mean ± SD, 1 excellent, 5 poor)	Standard n=19 Participants clinic experience (mean±SD)
Patient Clinical Experience	1.2 units on a scale Standard Deviation 0.4	1.3 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Clinic Visit

Population: Pilot.

The investigators recorded appointment duration in minutes.

Outcome measures

Outcome measures
Measure	Telemedicine n=19 Participants clinic experience (mean ± SD, 1 excellent, 5 poor)	Standard n=15 Participants clinic experience (mean±SD)
Clinic Appointment Duration	59 Minutes Standard Deviation 18	60 Minutes Standard Deviation 25

SECONDARY outcome

Timeframe: Clinic Visit

The investigators recorded clinic appointment wait time duration in minutes

Outcome measures

Outcome measures
Measure	Telemedicine n=19 Participants clinic experience (mean ± SD, 1 excellent, 5 poor)	Standard n=15 Participants clinic experience (mean±SD)
Clinic Appointment Wait Time	18 minutes Standard Deviation 14.5	25 minutes Standard Deviation 25

Adverse Events

Standard Encounter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Telemedicine Encounter

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

Roy Soetikno

VA Palo Alto

Phone: 650-493-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place