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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014