Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roy Soetikno, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT01296841
First received: February 15, 2011
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Inflammatory Bowel Disease
Ulcerative Colitis
Crohn's Disease
Device: Collaborative Imaging
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Pilot: Use of Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care

Resource links provided by NLM:


Further study details as provided by VA Palo Alto Health Care System:

Primary Outcome Measures:
  • Patient Clinical Experience [ Time Frame: Clinic Visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: Clinic Visit ] [ Designated as safety issue: No ]
    The investigators recorded appointment duration in minutes.

  • Clinic Appointment Wait Time [ Time Frame: Clinic Visit ] [ Designated as safety issue: No ]
    The investigators recorded clinic appointment wait time duration in minutes


Enrollment: 34
Study Start Date: October 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Telemedicine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296841

Locations
United States, California
Veterans Affairs Palo Alto
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
Investigators
Principal Investigator: Tonya Kaltenbach, MD MS VA Palo Alto Health Care System
  More Information

Additional Information:
Publications:

Responsible Party: Roy Soetikno, Clinical Professor, Chief of Endoscopy, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01296841     History of Changes
Other Study ID Numbers: TELEMED PA
Study First Received: February 15, 2011
Results First Received: January 15, 2012
Last Updated: February 6, 2013
Health Authority: United States: Federal Government

Keywords provided by VA Palo Alto Health Care System:
telemedicine
remote consultation
telehealth
ehealth
image archiving
inflammatory bowel disease

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014