SOLICITATION NOTICE
A -- Continued Development of Breast Cancer Screening Surveillance
- Notice Date
- 4/2/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-30039-NG
- Archive Date
- 5/2/2003
- Point of Contact
- Malinda Holdcraft, Purchasing Agent, Phone (301) 402-4509, Fax (301) 402-4513, - Renita Smith, Contract Specialist, Phone 301-496-8612, Fax 301-480-0241,
- E-Mail Address
-
holdcram@exchange.nih.gov, rs442i@nih.gov
- Description
- The National Cancer Institute (NCI), Division of Cancer Control and Population Sciences (DCCPS), Applied Research Program (ARP) plans to procure the services on a sole source basis with Group Health Cooperative of Puget Sound, Center for Health Studies, 1730 Minor Avenue, Suite 100, Seattle, Washington 98101. This request for supplies/services is being prepared in accordance with the format in FAR Part 12. The North American Industry Classification System Code is 541710 and the business size standard is 500 employees. In order to meet the growing need to automate data collection and centralize health information that serves the needs of multiple care providers, NCI supported the development of an automated system that efficiently gathers patient information and allows easy updating of existing data in the course of usual clinical care. The next phase (first phase was performed under purchase order 263-MQ-218301), in evaluating this effort to determine the value of developing NCI initiatives related to this research need is a pilot study to evaluate the usefulness of this tablet version of data related to breast cancer risk in a mammography clinic and validate its usefulness to both patients and staff. For the benefit of the research efforts within the Breast Cancer Surveillance Consortium (BCSC) sites and for women receiving mammography within clinical practice a computer-based tablet system that allows automated completion and collection of accurate data that can be kept confidential but accessible to those who need it was developed. The application exports data from the tablet in a form that can be adapted to a variety of data systems, provides updated data for elements that change over time, and gathers that information efficiently in the course of usual care. It accommodates the needs for a high level of data security that insures protection for individuals, is compliant with Health Insurance Portability and Accountability Act (HIPPA) is structured to add additional elements, and is compatible with other automated data systems to which the information might be exported. Purpose: The goal of this project is to conduct a 6-month pilot study to evaluate the usefulness of this automated version of data related to breast cancer risk in a mammography clinic. This observational study shall be conducted among women at the time of their mammogram appointment at a single clinic within GHC. The long-term goal of this research is to develop an automated tool for use in breast cancer screening centers that reduces burden upon women, facilitates rapid flow of women through the centers, and collects accurate information. The specific aims of this effort are: 1) To test whether women will use an electronic tablet to complete the automated screening tool, 2) To test whether women accept previously completed answers in the current evaluation, 3) To evaluate the impact of the automated tool on clinic flow, 4) To evaluate the usefulness of a data summary to clinical staff as it pertains to the mammogram appointment and diagnostic process, 5) To determine which aspects of the electronic tool could be improved to allow for greater deployment at other screening centers within the Breast Cancer Surveillance Consortium. Period of Performance: It is anticipated that this pilot study to evaluate the usefulness of an automated version of data related to breast cancer risk in a mammography clinic should require 1 month of advance preparation, five months to administer the evaluation (including recruitment), and 1 month to analyze results. Total duration of project with review of final report is approximately 6-8 months. FAR Clause 52.217-8 Option to Extend Services (November 1999) applies. Methods: The evaluation shall include an assessment of patient satisfaction and clinical staff satisfaction to determine acceptance of the automated tool versus a paper tool. Specifically the technical ease of use, physical ease of use, screen display, interruption of normal clinic flow, response time, ability to correct errors, problem reporting, and the acceptance of prepopulated elements with data from previous assessments shall be evaluated. The study design shall address the following issues. Selection of study subjects: Information related to selection of study subjects shall include eligibility criteria related to participation in central mammography screening at GHC between the proposed periods of the study. In order to evaluate data issues, participants must be part of the Breast Cancer Screening Program (BCSP) and eligible to fill out the Breast Screening Recruitment and Reminder (BSRR) form. It is anticipated that women who fit these criteria shall be at least 40 years old and shall not have had another mammogram at GHC within the past 12 months. Because the goal of this pilot is to evaluate the feasibility of the automated tool among a wide variety of patients, older women may be over-selected since it is more likely that younger women will be familiar with computers and more readily accept using the automated tool. Women who have previously answered the current version of the paper instrument shall be targeted since they are the only members of the target population who will have pre-populated data. Identification/recruitment method: The process for identification of women shall be detailed, including period of selection, process for recruitment, timing of recruitment, consent process, and forms needed for participation in the study. Women shall be randomly selected to participate in the evaluation of the electronic tool. Those who are not selected shall be asked to fill out the paper tool and complete an evaluation of the administration process upon completion. The role of project staff in the recruitment process shall be detailed. Anticipated number/response rate: The anticipated number of available women and response rate shall be detailed. This accrual to the study shall be monitored. The offeror shall provide a plan for how to enhance accrual if it lags behind projected accrual. The final number of women required to address the specific aims shall be detailed. Description of intervention(s): The evaluation shall be completely described, including the roles of the patient participants and the project staff. Samples of the actual script that staff members will use to explain to the patient how to use the device and answer any elements that the patient might have shall be provided. The proposal shall provide detail on the instrument that will be used to ascertain the woman's experience with the automated tool once she has completed her form and mammogram appointment. It is anticipated that this interview shall consist of both close-ended satisfaction elements and open-ended elements to elucidate information about the functionality, ease of use, trouble shooting, and overall opinion of the device, the software, and administration of the tool. A control group of women who are not selected to fill out the automated tool shall also be interviewed after completion of the paper instrument. In addition, an approach for obtaining relevant demographic information such as age, ethnicity, education, and socioeconomic factors already in the Group Health database for purposes of further characterizing women in this evaluation should be provided. An evaluation of staff perception of this process shall also be performed in a similar manner with close-ended satisfaction elements, and additional open-ended elements that target the flow of the clinic and the ease of use for clinical staff. A sample of this evaluation tool shall be provided. Data collection: Data sources and key information obtained from each: Data sources shall be detailed and are anticipated to include mammography patients and clinic staff, consisting of mammogram technologists and radiologists. The focus of the patient evaluation shall be patient satisfaction with the automated device. Specifically, elements shall target ease of use, screen display, instructions/terminology, error correction, response time, the input device, prepopulation of data, and overall system usefulness. Patients shall be asked about their previous experience with technology including ATM usage, calculators, video recorders, etc. In addition, open-ended elements shall be included that request comment on women's experience with the device including problems that arose during the intervention, aspects of the device that they felt were beneficial, and any improvements they thought could be made. Mammogram technologists shall be asked elements about the ease of use of the device to obtain information needed during the exam, any interruption in clinic flow that was observed, and their preference for the automated version compared to the paper version. Radiologists shall be asked elements regarding the ease of use of the device in terms of a summary page that is printed out and faxed to the clinic at the end of the day. They shall be asked to compare this data summary with that obtained using the paper tool, and to report any problems that arose during the study or suggestions they might have to improve the automated process. Data collection protocol for a typical subject: The patient shall be asked to fill out an evaluation form after completing the automated tool at the end of her mammogram appointment. The evaluation shall consist of a few close-ended elements asking patients to rate their satisfaction with the device for each of the categories listed above. The patient shall be provided with an opportunity to give open-ended comments on her experience with the device, including both positive and negative comments and suggestions for improving the device. It is anticipated that the evaluation should be short and take no longer than 10 minutes. The contractor shall present a plan that details the following: 1) Project timeline that details the study design, recruitment of subjects, data collection methods, and analysis plan, 2) Interim progress plan with statistics on recruitment, non-response, and status of patient acceptance of the automated tool and, 3) Final report with descriptive analysis of the pilot study including hardware performance, troubleshooting report, patient acceptance, and clinical staff acceptance. Contractor Requirements: The contractor shall provide adequate and appropriate staff, equipment, supplies, and space facilities necessary for carrying out the requirements of this procurement. The study design issues relevant to easy collection and exporting of the data shall be done with appropriate consultation with other BCSC experts and national experts on related research. Changing variables at this time will interrupt correct interpretation of current experiment in progress. Group Health Cooperative of Puget Sound is the only source known to the NCI that offers this unique type of service and is uniquely qualified to conduct this evaluation because it is a member of the BCSC; has a computer-based tablet system that allows automated completion and collection of accurate data elements which can be kept confidential and accessible to those who need it; has a data system infrastructure with pre-populated patient information; and has a long history of using data to both assist with clinical care and facilitate reminders to women due for mammograms. This notice of intent is not a request for competitive quotation. However, if any interested party believes it can meet the above requirements, it may submit a statement of capabilities. The capability statement and any other furnished information must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can fully meet the requirements herein. Capability statements must be received in the contracting office by 1:00 PM EST (local Washington DC time) on April 17, 2003. If you have any questions, please submit them in writing via electronic mail to Malinda Holdcraft, Purchasing Agent on holdcram@exchange.nih.gov or by fax 301-402-4513. A determination by the Government not to compete this proposed requirement based on responses to this notice is solely within the discretion of the Government. Information received shall be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted.
- Place of Performance
- Address: NIH/NCI, 9000 Rockville Pike, Bethesda, MD
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN00293734-W 20030404/030402231049 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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