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Completed

NCT Number: NCT03434561

Comparing Different Methods for Collection of Comorbidity Data Per the 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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Assess the accuracy of predicting HCT outcomes and resource utilization (e.g., hospitalization) between the three methods of scoring

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2018
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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