Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis
Conditions
Keywords
telemedicine, remote consultation, telehealth, ehealth, image archiving, inflammatory bowel disease
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.
Interventions
DEVICECollaborative Imaging
Hardware and software communication tools to provide clinical care from a distance.
Sponsors
VA Palo Alto Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (\> 18 years old) outpatient IBD patients in the Veterans Affairs medical system
Exclusion criteria
* VA patients without IBD * Hospitalized IBD patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Clinical Experience | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinic Appointment Duration | Clinic Visit | The investigators recorded appointment duration in minutes. |
| Clinic Appointment Wait Time | Clinic Visit | The investigators recorded clinic appointment wait time duration in minutes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Encounter Standard in-house clinical visit between patient and physician. | 19 |
| Telemedicine Encounter Remote clinical appointment between patient and physician. | 15 |
| Total | 34 |
Baseline characteristics
| Characteristic | Telemedicine Encounter | Standard Encounter | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 15 Participants | 24 Participants |
| Age, Continuous | 62.8 years STANDARD_DEVIATION 11.5 | 58.5 years STANDARD_DEVIATION 9.6 | 60.4 years STANDARD_DEVIATION 10.5 |
| Gender Female | 2 Participants | 6 Participants | 8 Participants |
| Gender Male | 13 Participants | 13 Participants | 26 Participants |
| Region of Enrollment United States | 15 participants | 19 participants | 34 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 15 |
| serious Total, serious adverse events | 0 / 19 | 0 / 15 |
Outcome results
Primary
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.
Time frame: Clinic Visit
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemedicine | Patient Clinical Experience | 1.2 units on a scale | Standard Deviation 0.4 |
| Standard | Patient Clinical Experience | 1.3 units on a scale | Standard Deviation 0.5 |
p-value: <0.05t-test, 2 sided
Secondary
Clinic Appointment Duration
The investigators recorded appointment duration in minutes.
Time frame: Clinic Visit
Population: Pilot.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemedicine | Clinic Appointment Duration | 59 Minutes | Standard Deviation 18 |
| Standard | Clinic Appointment Duration | 60 Minutes | Standard Deviation 25 |
Secondary
Clinic Appointment Wait Time
The investigators recorded clinic appointment wait time duration in minutes
Time frame: Clinic Visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemedicine | Clinic Appointment Wait Time | 18 minutes | Standard Deviation 14.5 |
| Standard | Clinic Appointment Wait Time | 25 minutes | Standard Deviation 25 |