Comparing Different Methods for Collection of Comorbidity Data Per the HCT-CI

May 30, 2023 updated by: Fred Hutchinson Cancer Center

Comparing Different Methods for Collection of Comorbidity Data Per the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI)

Comorbidity assessment in the field of HCT might be a burden on the medical team at the clinic or the research staff. This research study aims to explore and validate new methods, Claims-based and patient questionnaire-based, as alternatives to the standard chart-based method in order to facilitate comorbidity coding. The study aims to save time and effort of medical personnel and to ensure the inclusion of comorbidity information in all clinical trials and outcome research studies in order to improve the accuracy of treatment decision-making, patient assignment to appropriate HCT strategy and hence HCT outcomes.

Study Overview

Status

Completed

Conditions

Detailed Description

Studies have shown the importance of pre-transplant comorbidities in predicting mortality after allogeneic HCT.

However, comorbidity assessment might be a burden on the medical team at the clinic or the research staff. This research study aims to explore and validate new methods as alternatives to the standard chart-based method in order to facilitate comorbidity coding. The study aims to save time and effort of medical personnel and to ensure the inclusion of comorbidity information in all clinical trials and outcome research studies in order to improve the accuracy of treatment decision-making, patient assignment to appropriate HCT strategy and hence HCT outcomes.

This study will investigate two parallel approaches aimed at simplifying comorbidity assessment and thereby facilitating wide-spread use of the HCT-CI. Patient questionnaire-based and Claims-based methods will be tested as possible alternative to the Chart-based method. primary outcome is prediction of non-relapse mortality. It is expected that once this method of comorbidity coding is validated, it will benefit physicians in non-academic institutions and community clinics.

Study Type

Observational

Enrollment (Actual)

360

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
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research 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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with hematological malignancies who are being treated with allogeneic hematopoietic cell transplantation (HCT) at the Seattle Cancer Care Alliance

Description

Inclusion Criteria:

  • Patients eligible for autologous or allogeneic HCT.
  • Able to speak and read English.
  • Willing and able to provide informed consent.
  • There is no restriction based on diagnosis, intensity of conditioning regimen, type of donor graft, degree of HLA-matching, or stem cell source.
  • Patients >20 years old
  • Access to a telephone for study-related communications.

Exclusion Criteria:

  • HCT candidates who cannot read, write, or speak English.
  • Patients <20 years old

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the rate of agreement on HCT-CI scores between 3 measures
Time Frame: 2 years
3 measures: the questionnaire-based and the claims-based methods versus the chart-based method.
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the accuracy of predicting HCT outcomes and resource utilization (e.g., hospitalization) between the three methods of scoring
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Mohamed Sorror, MD, Associate Member, Fred Hutch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 22, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2650
  • 4R00HL088021-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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