Online Health Assessment to Support Comprehensive Care

December 11, 2017 updated by: Simon K. Lo, M.D., Cedars-Sinai Medical Center
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Online CarePrep Assessment (OCA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

Harvard Medical School (HMS and HSDM)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, Los Angeles
Northwestern University
Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Simon K Lo, M.D., Cedars-Sinai Medical Center
  • Principal Investigator: Stephen J Pandol, M.D., Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 31, 2016

Study Completion (Actual)

May 31, 2016

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00027150
  • 1R43DK092097 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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