Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care

January 17, 2017 updated by: Roy Soetikno, VA Palo Alto Health Care System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Veterans Affairs Palo Alto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard encounter
Standard "in-house" clinical visit between patient and physician.
Experimental: Telemedicine Encounter
Remote clinical appointment between patient and physician.
Device: Collaborative Imaging
Hardware and software communication tools to provide clinical care from a distance.
Other Names:
  • Telemedicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Clinical Experience
Time Frame: Clinic Visit
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinic Appointment Duration
Time Frame: Clinic Visit
The investigators recorded appointment duration in minutes.
Clinic Visit
Clinic Appointment Wait Time
Time Frame: Clinic Visit
The investigators recorded clinic appointment wait time duration in minutes
Clinic Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Palo Alto Health Care System

Investigators

  • Principal Investigator: Tonya Kaltenbach, MD MS, VA Palo Alto Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 15, 2011

First Submitted That Met QC Criteria

February 15, 2011

First Posted (Estimate)

February 16, 2011

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TELEMED PA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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