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

Completed

• Conditions: Hematopoietic Malignancy

• Registration Number: NCT03434561
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2013-03-22
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-15
• Status Verified: 2018-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States