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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
History of Changes

February 15, 2011
February 6, 2013
October 2009
June 2010   (final data collection date for primary outcome measure)
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.
Overall patient satisfaction [ Time Frame: Clinic Visit ] [ Designated as safety issue: No ]
The investigators assessed patient experience using a 14-item Ware Specific visit questionnaire, including overall patient satisfaction. It is based on a 5-point Likert scale (1 excellent - 5 poor).
Complete list of historical versions of study NCT01296841 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • Clinic Patient Number [ Time Frame: Per Clinic Day ] [ Designated as safety issue: No ]
    Investigators recorded the number of patients seen per clinic day in order to compare the clinic throughput and overall operation of the telemedicine versus standard clinic encounter.
Not Provided
Not Provided
 
Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care
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.

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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Inflammatory Bowel Disease
  • Ulcerative Colitis
  • Crohn's Disease
Device: Collaborative Imaging
Hardware and software communication tools to provide clinical care from a distance.
Other Name: Telemedicine
  • No Intervention: Standard encounter
    Standard "in-house" clinical visit between patient and physician.
  • Experimental: Telemedicine Encounter
    Remote clinical appointment between patient and physician.
    Intervention: Device: Collaborative Imaging

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • VA patients without IBD
  • Hospitalized IBD patients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01296841
TELEMED PA
Yes
Roy Soetikno, VA Palo Alto Health Care System
VA Palo Alto Health Care System
Not Provided
Principal Investigator: Tonya Kaltenbach, MD MS VA Palo Alto Health Care System
VA Palo Alto Health Care System
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP