The Hepatitis Testing and Linkage-to-Care Data Review Process: An Approach to Ensuring the Quality of Program Data

Abstract

Objective

CDC's 2012 Hepatitis Testing and Linkage to Care (HepTLC) initiative was a nationally coordinated effort to conduct hepatitis B and hepatitis C screening, posttest counseling, and linkage to care at 34 U.S. sites. This project provided support for data management and monthly data reviews between awardees and a data manager, which facilitated monitoring of awardee progress and regular program improvement opportunities.

Methods

CDC provided technical assistance to awardees for testing processes and program improvement, including Internet-based data submission, reporting software and data management to awardees, offering assistance with submitting, and reviewing data in real time. We describe how one awardee, AIDS Resource Center of Wisconsin (ARCW), used the data management process to improve data quality, inform testing processes and implementation, and measure and report missing variables from an online database.

Results

From October 2012 through July 2014, ARCW performed 2,255 HCV antibody (anti-HCV) tests and 244 HCV ribonucleic acid (RNA) tests as part of the HepTLC initiative. Participants who tested HCV RNA positive (n=189) were referred to medical care. At the end of the study, no records were missing for the anti-HCV test result or HCV RNA test result variables, and only one record was missing for those who were referred to medical care.

Conclusion

Regular data review and monitoring by awardees and CDC-supported data managers provided opportunities for data quality and program improvement. Through regular data review, ARCW reduced the amount of missing data and promoted timely follow-up with participants testing positive for HCV to ensure receipt of results and linkage to care. Other programs can adopt a similar data management model.

In response to the U.S. Department of Health and Human Services' 2011 national action plan¹ to combat viral hepatitis, the Centers for Disease Control and Prevention (CDC) launched the Hepatitis Testing and Linkage to Care (HepTLC) initiative aimed at increasing early identification of individuals with chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) by focusing on medically underserved populations and populations that are disproportionately affected by chronic HBV and HCV.² CDC funded 34 agencies nationwide to implement HepTLC. Funding covered HBV and HCV testing, which comprised test administration, pretest and posttest counseling and educational information, follow-up testing activities, and linkage to care.

The 34 awardees reported testing data on key variables using EvaluationWeb^®,³ an Internet-based data collection and reporting system used by CDC's Division of HIV/AIDS Prevention since 2010 to collect and house human immunodeficiency virus (HIV) testing and prevention intervention data provided by health departments. CDC's Division of Viral Hepatitis selected this system for the HepTLC initiative to allow awardees to easily report data such as participant demographics, laboratory test results, hepatitis vaccination history, receipt of posttest counseling, referral to medical care, reporting of HBV/HCV-positive cases to surveillance, and patients' risk factors for viral hepatitis.

In this article, we describe the data management process used to assist HepTLC awardees in reporting data required for the initiative and highlight how one HepTLC awardee, AIDS Resource Center of Wisconsin (ARCW), used this process to improve data quality, inform testing implementation, and measure and report missing variables from EvaluationWeb. We also present lessons learned by HepTLC data managers about data collection and reporting.

METHODS

HepTLC data management and data submission process

Preparation for data entry and submission.

CDC supported monitoring activities for HepTLC by providing awardees with access to EvaluationWeb within six months of receiving the HepTLC funding, plus technical assistance regarding data collection, submission, and reporting. In preparation for HepTLC's EvaluationWeb launch in March 2013, a support team assisted awardees in understanding the data variables to collect and report, provided assistance with collecting data via hard-copy forms or through their agency's data collection system, and readied agency staff members to use EvaluationWeb. All users were required to complete a security clearance process through CDC, known as eAuthentication, which involved submitting a request and registering users' information in CDC's Secure Access Management Services Partner Portal. After staff members' identities were verified and access was granted, all HepTLC awardee staff members attended an EvaluationWeb training webinar, which included an introduction to HepTLC and a guided walk-through of the data entry process.

Data entry.

Some awardee staff members collected data via hard-copy forms and manually entered the data into EvaluationWeb. Others submitted data through the upload process using a Microsoft^® Excel^® flat file template. The data entered in the flat file had to match the required HepTLC data variables and response options. Agencies with existing data collection systems, such as electronic health record or electronic medical record systems, could export data from their existing systems into the HepTLC flat file template. Data entered through direct data entry were available immediately for reporting, while uploaded data were available within 24 hours. EvaluationWeb conducted real-time data validation checks as each record was entered into the system; error and/or warning messages appeared immediately if data issues were present in any records entered. Errors referred to instances in which data were not provided for mandatory or required variables, or when an invalid response code was entered (e.g., testing year entered as 2031 instead of 2013). Errors had to be corrected before data could be submitted. The system allowed for some data to be missing from patient records if only a portion of a patient's testing experience was available for entry. A portion of the testing sequence might have been missing if awardees were waiting to receive test results from a laboratory or if participants had not attended their follow-up appointment.

Data review and update.

Data managers reviewed -HepTLC awardees' data monthly, checking for errors and data warnings. Awardees then corrected records that contained errors and warnings in EvaluationWeb. Data managers reviewed each awardee's monthly data and produced an individualized data quality report for each awardee, which included information about whether or not entered data were completed in accordance with the rules around HepTLC data entry and submission. These reports were reviewed during a monthly data review telephone call with the awardee.

As part of the CDC cooperative agreement, awardees submitted a testing goal, and their progress toward meeting that goal was reviewed during the monthly data review telephone call. Data managers and CDC project officers worked closely with awardees to develop strategies that would increase testing and follow-up activities so they could reach their goals. After the data review telephone calls took place, agencies were asked to update any missing or incongruent data. Typically, awardees updated their data within two weeks of their data review telephone calls or by the next monthly submission. In addition to using EvaluationWeb to enter data, system users could create reports using the EvaluationWeb Reflexx Report Builder, an ad-hoc report-building tool.

AIDS RESOURCE CENTER OF WISCONSIN

ARCW was one of 34 HepTLC awardees that received HepTLC funding. ARCW is a leading provider of HIV health care in Wisconsin and provides medical, dental, mental health, and social services for people with HIV. As part of the HepTLC cooperative agreement, ARCW broadened the services offered to participants and conducted HCV tests on people who inject drugs as well as provided HCV counseling and referral services to HCV medical care for people chronically infected with HCV.

ARCW has nine locations throughout Wisconsin and employs 27 prevention services staff members who provide rapid HCV counseling and testing services. ARCW also offers HCV testing through mobile services, alcohol and drug treatment facilities, and detention centers. For the HepTLC initiative, injection drug users were the primary target population for HCV testing and linkage-to-care services. ARCW staff members offered rapid anti-HCV tests and HCV RNA tests (or a referral for this test) to participants whose rapid test was reactive. Recruitment for this project occurred at all ARCW offices through walk-in needle exchange services. Recruitment also occurred at outside venues where ARCW staff members were already providing HIV and HCV educational sessions; other community-based programs also made referrals to ARCW regularly.

RESULTS

From October 2012 through July 2014, ARCW conducted 2,255 anti-HCV tests and 244 HCV RNA tests (Table). During this testing period, a total of 45 anti-HCV test results and 25 HCV RNA test results were missing from the data submitted to EvaluationWeb and reviewed by the data manager to ensure data were clean and complete. Between October 2012 and March 2013, before awardees were provided access to EvaluationWeb and prior to the start of data quality activities, ARCW conducted 278 anti-HCV tests and 26 HCV RNA tests. Three of the anti-HCV test results were missing from the dataset, whereas no HCV RNA test results were missing. Of the 26 HCV RNA tests conducted, 20 individuals were referred to medical care. ARCW was missing data on referral to care on two individuals for this time period.

Table.

Selected hepatitis C virus testing variables missing from database, by month and year, during the Hepatitis Testing and Linkage to Care (HepTLC) initiative, AIDS Resource Center of Wisconsin, October 2012–July 2014^a

^aThe HepTLC initiative promoted viral hepatitis B and hepatitis C screening, posttest counseling, and linkage to care at 34 U.S. sites during 2012–2014.

AIDS = acquired immunodeficiency syndrome

anti-HCV = hepatitis C virus antibody

HCV = hepatitis C virus

RNA = ribonucleic acid

In July 2014, after more than a year of working with CDC-supported staff members on data quality, ARCW conducted and recorded data for 108 anti-HCV tests. Three individuals who required follow-up HCV RNA tests received them and were referred to medical care. At the end of the month, ARCW determined that one individual had not yet attended his or her first medical appointment.

During the project period, 189 individuals received HCV RNA-positive test results and were referred to medical care. At the end of the testing period, only one missing record for this variable remained, and ARCW determined that this individual was lost to follow-up.

DISCUSSION

Lessons learned

The monthly data review telephone calls between the data manager and ARCW, which began in May 2013, were useful to ARCW supervisory staff members in improving the data collection and submission process. For example, supervisors were informed of each record that contained missing data and what data were missing, and were able to link the missing data to the staff member who conducted the testing session. ARCW program supervisors identified several testing data challenges. For example, sometimes staff members were unsure which fields should be completed. Supervisors and staff members worked together to improve data collection and entry processes. Over time, staff members made fewer mistakes. By the end of July 2014, the only missing result in the different variable fields was one missing record for referral to medical care. Through the data review process and by identifying the records with missing referral data, staff members were able to explain each missing data point. The most common reasons staff members reported missing data were that participants were in the process of following up and other participants were lost to follow-up (e.g., unable to be located, moved, or left the facility where they were originally tested). To help correct this problem, staff members used multiple methods for communications with participants, including participant telephone numbers, home addresses, e-mail addresses, and telephone numbers of family members or friends. If a lack of transportation prevented participants from returning to the office for their test results, staff members provided them with gas cards.

An additional challenge was the loss of participants because of the lag time between anti-HCV and HCV RNA tests. ARCW identified several solutions to increase their ability to complete the follow-up and linkage-to-care process. One solution was to train staff members to draw blood on-site, which eliminated the need for individuals to return for another appointment. In some ARCW locations, an on-site medical provider, such as a phlebotomist or nurse, assisted in the blood draws. For patients with difficult blood draws, ARCW established relationships with local health department nurses to have them assist as needed. Another challenge arose in providing HCV RNA test results to injection drug users. The blood collected was sent to the Wisconsin State Laboratory of Hygiene for testing, and individuals were asked to return to the office within two weeks to obtain their final results. However, it was challenging to reach participants who were tested at treatment facilities or detention centers and were released in that time frame.

PRACTICE IMPLICATIONS

The data management process resulted in the collection of high-quality data, which allowed HepTLC awardees to continue program monitoring and improvement. For example, HepTLC agencies regularly tracked progress toward meeting their testing goals through monthly data discussions with awardee staff members and data managers. The data review telephone calls allowed for regular goal tracking and development of strategies if an awardee was unable to reach its testing goal. HepTLC awardees and data managers reviewed and developed solutions for reaching participants to conduct follow-up testing and linkage to care. Strategies included partnership development with community health departments, onsite blood draws, follow-up with family members, and helping participants pay for transportation to keep their follow-up appointments. These processes have helped inform best practices related to the provision of HCV education, linkage to care, and prevention services for use in future projects. The combination of high-quality data and best practices allowed CDC to identify effective strategies to ensure people living with chronic hepatitis B and C were aware of their status, report on hepatitis B and C prevention efforts, and inform policy and program planning at the national level.

CONCLUSION

This model provided access to real-time data and informed program monitoring and evaluation. Program managers used the data collected to monitor program goals and objectives and troubleshoot programmatic or data-related issues as they arose, rather than waiting to address them at the program's conclusion.