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Online Health Assessment to Support Comprehensive Care

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of California, Los Angeles
Northwestern University
Beth Israel Deaconess Medical Center
Harvard Medical School
Information provided by (Responsible Party):
Simon K. Lo, M.D., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT02122302
First received: April 22, 2014
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Altered Gastrointestinal Anatomy
Chronic Pancreatic Disease
Chronic Pancreatic Pain
Device: CarePrep Online Health Assessment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Online Health Assessment to Support Comprehensive Care

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Physician and patient evaluation of validity and feasibility of online patient self-assessment system to support integrated gastrointestinal and biopsychosocial care [ Time Frame: One year ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 80
Study Start Date: May 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Web-based health assessment Device: CarePrep Online Health Assessment
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.
Other Name: Online CarePrep Assessment (OCA)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT02122302

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
University of California, Los Angeles
Northwestern University
Beth Israel Deaconess Medical Center
Harvard Medical School
Investigators
Principal Investigator: Simon K Lo, M.D. Cedars-Sinai Medical Center
Principal Investigator: Stephen J Pandol, M.D. Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Simon K. Lo, M.D., Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02122302     History of Changes
Other Study ID Numbers: Pro00027150, 1R43DK092097
Study First Received: April 22, 2014
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cedars-Sinai Medical Center:
Altered gastrointestinal anatomy
Chronic pancreatic disease
Chronic pancreatic pain
Patient self-assessment
Online assessment

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on November 24, 2014