Cancer Clinical Trial
— RISGIMOfficial title:
Refining Information Technology Support for Genetics in Medicine
The clinical use of genetic testing is expanding and, as a result, the number of variants identified in patients is growing. Knowledge of the clinical impact of these variants improves over time. However, the combination of more testing and the rapid evolution of genetic knowledge make it impossible for clinicians to fully account for the latest implications of their patients' genetic profiles as patient care decisions are made. This proposed study plans to enhance and evaluate IT infrastructure developed to provide timely genetic variant updates and patient search functionality to clinicians to assist in optimizing patient care.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | December 2014 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Study subjects selected from Partners HealthCare and non-Partners study sites include: - treating clinicians - geneticists - genetic counselors - pathologists Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Fred A. Litwin Centre for Clinical Genetics and Genomic Medicine | Toronto | Ontario |
United States | University of Michigan Cardiovascular Center | Ann Arbor | Michigan |
United States | Brigham and Women's Hospital Cardiovascular Genetics Center | Boston | Massachusetts |
United States | Children's Hospital Boston's Cardiovascular Genetics Clinic | Boston | Massachusetts |
United States | Children's Hospital Boston's Ear, Nose, and Throat Clinic | Boston | Massachusetts |
United States | Massachusetts General Hospital Division of Pulmonary Oncology | Boston | Massachusetts |
United States | Massachusetts General Hospital's Diagnostic Molecular Pathology Laboratory | Boston | Massachusetts |
United States | Massachusetts General Hospital's Hypertrophic Cardiomyopathy Clinic | Boston | Massachusetts |
United States | Massachusetts General Hospital's Medical Genetics Clinic | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | National Institutes of Health (NIH), National Library of Medicine (NLM) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficiency of Obtaining Updated Genetic Variant Information | Phone and email logging procedures will be implemented before study onset to establish a solid baseline. Laboratory staff will log each time they receive a phone call or email requesting updated information on a genetic variant. These logs will be maintained throughout the study period even once the GIC tool becomes available. System auditing processes will capture data on when genetic variants are updated, when alerts are sent, and clinician accesses to online screens. Centralized system data will be evaluated to track usage of the GIC patient search functions, using a flagging approach. |
Continuous across 21 months | No |
Secondary | Perception of Impact of Variant Update Significance Level Alerting on Clinician Workload | Surveys will be constructed that ask treating clinicians about their experience with using the GIC and its perceived impact on workload. The surveys will be distributed both pre and post implementation of the GIC system to provide comparative data. Interviews will also be conducted, transcribed, coded for themes, and open-ended comments will be classified to reflect issues relating to clinician experience with the GIC. Call logs and centralized system audit information which can track time spent using the tool will be used to determine time and effort required to get updated information. | Continuous Across 21 months | No |
Secondary | Perception of Impact of Variant Update Significance Level Alerting on Clinician Satisfaction | Surveys will be constructed that ask treating clinicians about their satisfaction with using the GIC. The surveys will be distributed both pre and post implementation of the GIC system to provide comparative data. Interviews will also be conducted, transcribed, coded for themes, and open-ended comments will be classified to reflect issues relating to clinician experience with the GIC. Call logs and centralized system audit information which can track time spent using the tool will be used to determine time and effort required to get updated information. | Continuous Across 21 months | No |
Secondary | Perception of Impact of Variant Update Significance Level Alerting on Clinical Care | Surveys will be constructed that ask treating clinicians about their experiences with using the GIC and its perceived impact on clinical care. The surveys will be distributed Both pre and post implementation of the GIC system to provide comparative data. Interviews will also be conducted, and those along with open-ended comments will be classified to reflect issues relating to clinician experience with the GIC. Call logs and centralized system audit information which can track time spent using the tool will be used to determine time and effort required to get updated information. | Continuous Across 21 months | No |
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