Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care

Ulcerative Colitis Clinical Trial

Official title:

A Randomized Controlled Pilot: Use of Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296841
• Other study ID #: TELEMED PA
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2011
• Last updated: February 6, 2013
• Start date: October 2009
• Est. completion date: June 2010

Study information

• Verified date: February 2013
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that outpatient clinical care of Inflammatory Bowel Disease patients may be provided using a new computerized system over standard network - called Collaborative Imaging - with similar patient experience compared to a conventional clinic visit.

Description:

Significant advances in gastroenterology have led the field to grow into a number of advanced subspecialties: inflammatory bowel disease (IBD), motility, therapeutic endoscopy, and transplant hepatology. Telemedicine, the application of information technology in support of health care delivery from a distance, has been employed with good success in various chronic conditions with excellent patient satisfaction.

Primary Aim: Our primary study endpoint was measuring patient clinical experience between two groups: A telemedicine remote clinic visit and a standard "in-house" visit.

Secondary Aim: To compare standard clinic metrics including clinic wait time, patient throughput, and appointment time between the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (> 18 years old) outpatient IBD patients in the Veterans Affairs medical system

Exclusion Criteria:

• VA patients without IBD

• Hospitalized IBD patients

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Device:
• Collaborative Imaging
Hardware and software communication tools to provide clinical care from a distance.

Locations

Country	Name	City	State
United States	Veterans Affairs Palo Alto	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (7)

Dorsey ER, Deuel LM, Voss TS, Finnigan K, George BP, Eason S, Miller D, Reminick JI, Appler A, Polanowicz J, Viti L, Smith S, Joseph A, Biglan KM. Increasing access to specialty care: a pilot, randomized controlled trial of telemedicine for Parkinson's disease. Mov Disord. 2010 Aug 15;25(11):1652-9. doi: 10.1002/mds.23145. — View Citation

Fisher ES, Welch HG. The future of the Department of Veterans Affairs health care system. JAMA. 1995 Feb 22;273(8):651-5. — View Citation

Grogan-Johnson S, Alvares R, Rowan L, Creaghead N. A pilot study comparing the effectiveness of speech language therapy provided by telemedicine with conventional on-site therapy. J Telemed Telecare. 2010;16(3):134-9. doi: 10.1258/jtt.2009.090608. Epub 2010 Mar 2. — View Citation

Telleman H, Burger TF, Mulder CJ. Evolution of gastroenterology training. World J Gastroenterol. 2009 Apr 21;15(15):1793-8. — View Citation

van der Heijden JP, Spuls PI, Voorbraak FP, de Keizer NF, Witkamp L, Bos JD. Tertiary teledermatology: a systematic review. Telemed J E Health. 2010 Jan-Feb;16(1):56-62. doi: 10.1089/tmj.2009.0020. Review. — View Citation

Verhoeven F, Tanja-Dijkstra K, Nijland N, Eysenbach G, van Gemert-Pijnen L. Asynchronous and synchronous teleconsultation for diabetes care: a systematic literature review. J Diabetes Sci Technol. 2010 May 1;4(3):666-84. Review. — View Citation

Wallace P, Haines A, Harrison R, Barber JA, Thompson S, Roberts J, Jacklin PB, Lewis L, Wainwright P; Virtual Outreach Project Group. Design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations [ISRCTN54264250]. BMC Fam Pract. 2002 Jan 11;3:1. Epub 2002 Jan 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Clinical Experience	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.	Clinic Visit	No
Secondary	Clinic Appointment Duration	The investigators recorded appointment duration in minutes.	Clinic Visit	No
Secondary	Clinic Appointment Wait Time	The investigators recorded clinic appointment wait time duration in minutes	Clinic Visit	No

External Links

•   telemedicine cameras
•   telemedicine headset
•   telemedicine personal computer
•   telemedicine personal computer
•   Telemedicine server software