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Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care

Primary Purpose

Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Collaborative Imaging
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Inflammatory Bowel Disease focused on measuring telemedicine, remote consultation, telehealth, ehealth, image archiving, inflammatory bowel disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • VA patients without IBD
  • Hospitalized IBD patients

Sites / Locations

  • Veterans Affairs Palo Alto

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard encounter

Telemedicine Encounter

Arm Description

Standard "in-house" clinical visit between patient and physician.

Remote clinical appointment between patient and physician.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinic Appointment Duration
The investigators recorded appointment duration in minutes.
Clinic Appointment Wait Time
The investigators recorded clinic appointment wait time duration in minutes

Full Information

First Posted
February 15, 2011
Last Updated
January 17, 2017
Sponsor
VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01296841
Brief Title
Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care
Official Title
A Randomized Controlled Pilot: Use of Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease
Keywords
telemedicine, remote consultation, telehealth, ehealth, image archiving, inflammatory bowel disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard encounter
Arm Type
No Intervention
Arm Description
Standard "in-house" clinical visit between patient and physician.
Arm Title
Telemedicine Encounter
Arm Type
Experimental
Arm Description
Remote clinical appointment between patient and physician.
Intervention Type
Device
Intervention Name(s)
Collaborative Imaging
Other Intervention Name(s)
Telemedicine
Intervention Description
Hardware and software communication tools to provide clinical care from a distance.
Primary Outcome Measure Information:
Title
Patient Clinical Experience
Description
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.
Time Frame
Clinic Visit
Secondary Outcome Measure Information:
Title
Clinic Appointment Duration
Description
The investigators recorded appointment duration in minutes.
Time Frame
Clinic Visit
Title
Clinic Appointment Wait Time
Description
The investigators recorded clinic appointment wait time duration in minutes
Time Frame
Clinic Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (> 18 years old) outpatient IBD patients in the Veterans Affairs medical system Exclusion Criteria: VA patients without IBD Hospitalized IBD patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tonya Kaltenbach, MD MS
Organizational Affiliation
VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19370773
Citation
Telleman H, Burger TF, Mulder CJ. Evolution of gastroenterology training. World J Gastroenterol. 2009 Apr 21;15(15):1793-8. doi: 10.3748/wjg.15.1793.
Results Reference
background
PubMed Identifier
7844876
Citation
Fisher ES, Welch HG. The future of the Department of Veterans Affairs health care system. JAMA. 1995 Feb 22;273(8):651-5. No abstract available.
Results Reference
background
PubMed Identifier
20533449
Citation
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.
Results Reference
background
PubMed Identifier
20513335
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. doi: 10.1177/193229681000400323.
Results Reference
background
PubMed Identifier
20197354
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.
Results Reference
background
PubMed Identifier
20064068
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.
Results Reference
background
PubMed Identifier
11835692
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. doi: 10.1186/1471-2296-3-1. Epub 2002 Jan 11.
Results Reference
background
Links:
URL
http://www.apple.com/imac/
Description
telemedicine personal computer
URL
http://www.apple.com/macpro/
Description
telemedicine personal computer

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Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care

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