Online Health Assessment to Support Comprehensive Care
Primary Purpose
Chronic Pancreatitis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CarePrep Online Health Assessment
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Pancreatitis focused on measuring Altered gastrointestinal anatomy, Chronic pancreatic disease, Chronic pancreatic pain, Patient self-assessment, Online assessment
Eligibility Criteria
Inclusion Criteria:
- Be a current or future patient of the Cedars-Sinai Medical Center's Pancreaticobiliary clinic
- Read English
- Have access to a computer or touch-screen tablet to complete the online assessment
Exclusion Criteria:
- Patients unable or unwilling to complete the online assessment at home or in clinic
Sites / Locations
- Cedars-Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Web-based health assessment
Arm Description
Outcomes
Primary Outcome Measures
Physician and patient evaluation of validity and feasibility of online patient self-assessment system to support integrated gastrointestinal and biopsychosocial care
Feedback via cognitive and structured interviews will assess validity: Cognitive interviews will probe for CarePrep comprehension and ease of use and will measure patients' rationale for selecting their online responses; structured interviews will include a block of standardized questions mirroring the online CarePrep assessment; patients' interview responses will be compared to data from their online session to assess the sensitivity of CarePrep screening questions; patients' ratings of CarePrep's accuracy will be collected to improve and validate system design; and experts and clinicians will review relevant sections of the CarePrep report for accuracy in order to address the utility and accuracy of reported data..
Physician and patient self-reports will assess feasibility and utility: After the refinement and validation phases have been completed, patients and clinicians will score the usefulness of Careprep in routine clinic use via brief self-reports.
Secondary Outcome Measures
Full Information
NCT ID
NCT02122302
First Posted
April 22, 2014
Last Updated
December 11, 2017
Sponsor
Cedars-Sinai Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Los Angeles, Northwestern University, Beth Israel Deaconess Medical Center, Harvard Medical School (HMS and HSDM)
1. Study Identification
Unique Protocol Identification Number
NCT02122302
Brief Title
Online Health Assessment to Support Comprehensive Care
Official Title
Online Health Assessment to Support Comprehensive Care
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study was terminated due to unsuccessful accrual.
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 31, 2016 (Actual)
Study Completion Date
May 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Los Angeles, Northwestern University, Beth Israel Deaconess Medical Center, Harvard Medical School (HMS and HSDM)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This investigation develops an online, patient self-assessment system, called "CarePrep" to support the care and clinical research of patients with chronic pancreatic disease and chronic pancreatic pain. This web-based assessment presents patients with questions that address medical, psychological, social, behavioral, and quality-of-life issues that are relevant to pancreatic disease. Patients will be given the opportunity to enter and track their symptoms over the Internet from home or clinic. The system is also designed to gather clues to identify neuropathic pain, which occurs when the nervous system fails to properly regulate pain signals. Any of these factors can contribute to chronic pain and may point the way to more effective treatment. The broad objective of this study is to extend CarePrep to cover a full range of topics that are relevant to chronic pancreatic disease. The study team will refine this content based on the system's accuracy in real clinical settings and direct efforts to maximize its feasibility.
Detailed Description
The following aims will be addressed:
Aim 1: Refine and extend CarePrep content for targeted disorders.
Working with experts at our sites, the study team will review CarePrep content in association with current literature and established instruments. Applying this data, a comprehensive pain assessment will be developed and content to target chronic pancreatic pain (CPP) will be prioritized. During Phase 1 of the study, the system will be deployed, patient testing begun, and feedback gathered to guide refinement. Patients will be asked to complete their online CarePrep assessment before their scheduled clinic visit; the report will be delivered to their attending physician prior to the clinic encounter. Patients who are unable to complete their assessment at home will have access to electronic tablets which will be provided in clinic.
Aim 2: Test with patients, gather feedback, and conduct cognitive and structured interviews to assess validity.
Research staff will conduct individual patient interviews to assess CarePrep validity, via the following ways: Cognitive interviews probing for CarePrep comprehension and ease of use, as well as measuring patients' rationale for selecting their online responses; structured interviews that will include a block of standardized questions that mirror the online CarePrep assessment (patients' interview responses will be compared to data from their online session to assess the sensitivity of CarePrep screening questions); and patients' ratings of CarePrep's accuracy will be collected to improve and validate system design.
Aim 3: Assess feasibility.
In Phase II of the study, physician and patient self-reports will be used to assess feasibility and utility. The objective of this phase is to deliver a system that supports a comprehensive health assessment and facilitates physician-patient communication so that physicians will adopt the system for routine care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
Keywords
Altered gastrointestinal anatomy, Chronic pancreatic disease, Chronic pancreatic pain, Patient self-assessment, Online assessment
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Web-based health assessment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CarePrep Online Health Assessment
Other Intervention Name(s)
Online CarePrep Assessment (OCA)
Intervention Description
Patients can utilize a web-based self-assessment system to answer questions that address medical, psychological, social, behavioral, and quality-of-life issues that are relevant to pancreatic disease. Patients can enter and track their symptoms over the Internet from home or clinic. The system is also designed to gather clues to identify neuropathic pain, which occurs when the nervous system fails to properly regulate pain signals.
Primary Outcome Measure Information:
Title
Physician and patient evaluation of validity and feasibility of online patient self-assessment system to support integrated gastrointestinal and biopsychosocial care
Description
Feedback via cognitive and structured interviews will assess validity: Cognitive interviews will probe for CarePrep comprehension and ease of use and will measure patients' rationale for selecting their online responses; structured interviews will include a block of standardized questions mirroring the online CarePrep assessment; patients' interview responses will be compared to data from their online session to assess the sensitivity of CarePrep screening questions; patients' ratings of CarePrep's accuracy will be collected to improve and validate system design; and experts and clinicians will review relevant sections of the CarePrep report for accuracy in order to address the utility and accuracy of reported data..
Physician and patient self-reports will assess feasibility and utility: After the refinement and validation phases have been completed, patients and clinicians will score the usefulness of Careprep in routine clinic use via brief self-reports.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be a current or future patient of the Cedars-Sinai Medical Center's Pancreaticobiliary clinic
Read English
Have access to a computer or touch-screen tablet to complete the online assessment
Exclusion Criteria:
Patients unable or unwilling to complete the online assessment at home or in clinic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon K Lo, M.D.
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen J Pandol, M.D.
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Online Health Assessment to Support Comprehensive Care
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