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Online Health Assessment to Support Comprehensive Care

Cedars-Sinai Medical Center logo

Cedars-Sinai Medical Center

Status

Withdrawn

Conditions

Chronic Pancreatitis

Treatments

Device: CarePrep Online Health Assessment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02122302
1R43DK092097 (U.S. NIH Grant/Contract)
Pro00027150

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Web-based health assessment
Experimental group
Treatment:
Device: CarePrep Online Health Assessment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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