Sustainable mobile technology to improve public health service, medication adherence and cost effectiveness: VDOT

State: TX Type: Promising Practice Year: 2016

About HCPHES HCPHES is the county health department for Harris County, Texas – the third most populous county in the United States – providing comprehensive public health services to the community through an annual budget of over $80 million and a workforce of over 700 public health professionals. The HCPHES jurisdiction includes approximately 2.2 million people within Harris County’s unincorporated areas and over 30 other municipalities located in Harris County (not including the city of Houston). For certain public health services such as mosquito/vector control, Ryan White/Part A HIV funding and refugee health screening, the HCPHES jurisdiction encompasses the entirety of the county including the city of Houston, thus providing services to over 4 million people. Public Health Issue In 2014, the rate of TB disease in Harris County was 7.4 cases per 100,000 population, almost 60% higher than the Texas rate, and more than double that of the U.S.  These numbers are even higher in vulnerable populations such as the homeless, low income, uninsured, refugee and immigrant populations – all of which are found in large numbers in Harris County. Because we are a heavily populated and diverse region, respiratory diseases such as TB can easily spread unless significant effort is expended to diagnose and treat all infected individuals. This only occurs with robust public health measure to educate the public, provide testing and treatment, and appropriately isolate infectious individuals to prevent further transmission. The HCPHES TB program utilizes Directly Observed Therapy (DOT) to treat active TB cases and Directly Observed Preventive Therapy (DOPT) to treat household contacts with latent infection.  DOT/DOPT is the accepted standard of care for TB treatment, ensuring that patients take each dose on time.  With a high caseload, providing DOT services in Harris County is costly, routinely requiring 6 to 8 caseworkers to drive up to 17,000 miles per month in aggregate, to observe medication doses.   HCPHES fully embraces technological advances that help to streamline service delivery, reduce overhead, and improve client satisfaction.  Improving TB treatment, with its high cost and significant patient burden is thus a key objective of the department.   Goals and Objectives In 2013, HCPHES learned of innovative approaches to care involving smartphones and secure video technology.  Recognizing the advantage of such technology for its TB Program, it assembled a strategy to implement Video Directly Observed Therapy (VDOT). Goal:  To utilize HIPAA-compliant mobile technology to provide VDOT services to TB patients. Objectives: To improve medication adherence and side-effect monitoring. To increase patient autonomy, flexibility, and privacy. To reduce DOT programmatic costs. Tasks: Develop a departmental strategy and working plan to implement VDOT. Formulate an interdisciplinary working team tasked with timeline development, partnership creation, and multi-phase implementation programming. Consult in-house legal team to review program objectives and ensure regulatory compliance. Perform a literature review on VDOT, and review currently available technologies. Partner with a HIPAA compliant software provider to jointly develop an application providing user-friendly VDOT. Partner with a smartphone service provider offering compatible mobile devices for VDOT patients. Develop materials – patient instruction sheets/videos, VDOT consent forms, technology consent forms, and a VDOT Policies and Procedures booklet. Train TB Elimination Program workforce in the use of VDOT technology. Create patient selection criteria for enrollment. Enroll patients using a multi-phase approach. Continuously re-evaluate enrollment and process guidelines. Integrate VDOT into mainstream TB treatment activities. Implementation The first VDOT implementation step was the creation of an interdisciplinary project team, including TB practitioners, a technologist, IT personnel, and departmental leadership.  HCPHES additionally consulted with in-house legal counsel to ensure ongoing compliance with local and state regulations, as well as HIPAA and 21 CFR Part 11. The VDOT team completed tasks as itemized above, piloting two different VDOT technology platforms in order to determine the one most suitable for departmental needs.    Patients were enrolled into Phase I of VDOT implementation using established patient selection and enrollment guidelines. TB staff were trained on VDOT software platforms.  During Phase II, additional patients were enrolled, with the goal of fully operationalizing the program for routine TB patient care.  Phase II ended in September 2015, with VDOT currently being used as a primary treatment modality for all eligible patients requiring DOT. Results/Impact VDOT implementation was an overwhelming success for the HCPHES TB Elimination Program. Milestones Achieved: Successful Implementation and Operationalization of VDOT Improvement in Patient Adherence, Patient Autonomy, and Flexibility 40-60% Reduction in DOT Programmatic Costs Successful partnerships with two external entities        
Statement of Problem It is quite alarming that in 2015, TB is second only to AIDS as the leading infectious killer in the world. In 2013 there were 9 million TB cases and 1.5 million deaths worldwide (2014 WHO Global TB Report). The World Health Organization has launched its End TB initiative to help TB programs around the world eliminate TB once and for all by the year 2035. Much of this strategy revolves around reducing drug resistance, increasing access to new and innovative treatments, and prioritizing programmatic funding. Part of the WHO global strategy after 2015 involves ensuring high quality treatment is given to all TB patients in a timely manner – and ensuring that they complete the medication regimen. This strategy involves commitment by EVERY country – to support innovative approaches aimed at therapy completion, with concomitant reduction of antibiotic resistance, and disease transmission. In 2014, 9,421 TB cases were reported in the U.S. (a rate of 2.96 cases per 100,000 people). 51% of these cases occurred in only 4 states - California, Texas, New York, and Florida. Although the number of U.S. cases has been declining annually since peaking in 1992, 2014 marked the smallest decline in over a decade (1.5%). 21 states actually saw their TB case numbers rise. Two-thirds of all new TB cases occur in individuals born abroad – with over half of these hailing from Mexico, the Philippines, India, Vietnam, and China. Asians represent the largest ethnic group affected (32% of all cases, 17.8 case rate), followed closely by persons of Hispanic origin (29%, rate 5.0). African Americans and Caucasians represent 21% (rate 5.1) and 13% (rate 0.7) of the total, respectively. Amongst U.S.-born cases, African-Americans make up 37% of the total TB burden. Drug Resistance and Coinfection: Approximately 10% of U.S. TB cases in 2014 were resistant to at least INH, representing an all-time high. 1.3% (91) of all cases were primary MDR (multi-drug resistant), with resistance to both INH and Rifampin. In addition, there were 2 cases of XDR TB (resistance to INH, Rifampin, one fluoroquinolone, and 1 injectable TB agent). HIV coinfection rates continue to decline, (approximately 6% currently), although TB continues to be one of the leading causes of death for HIV-infected individuals globally, responsible for a quarter of all HIV deaths. DOT and Completion Rates: Directly Observed therapy remains the mainstay of treatment modalities for U.S. TB patients. Of all U.S. TB Cases in 2012, approximately 91% received DOT for a portion of their treatment, with 95% of individuals completing their TB treatment regimens, up from 92% in 1998. 89% of these cases completed treatment within 1 year. TB in Texas and Harris County In 2014, Texas ranked 4th in the nation in TB case burden. Texas reported 1,269 cases of TB, with a rate of 4.7 cases per 100,000 population. With a high overall burden of TB, Texas’s TB incidence rate is over 50% higher than the national rate  Close to two-thirds of Texas’s TB patients diagnosed in 2014 were foreign-born, and over 20% had diabetes. 55% of TB cases occurred in persons of Hispanic origin, 18% in Asians, 18% African American, and 9% in Caucasians. TB is a disease of great public health concern in Harris County, the third most populous county in the nation. The rate of TB disease in Harris County was 7.4 cases per 100,000 population in 2014, almost 60% higher than the Texas rate, and more than double that of the U.S. These numbers are even higher in vulnerable populations such as the homeless, low income, uninsured, refugee and immigrant populations – all of which are found in large numbers in Harris County. Burden of TB Care Provision With the highest rate of TB in the state, and with a geographic area larger than that of Rhode Island, providing TB care in Harris County is a costly endeavor, routinely requiring outreach workers to drive up to 17,000 miles per month delivering and observing medication doses. Target Population HCPHES provides TB care for individuals living in unincorporated areas of Harris County lying outside of the city of Houston, as well as in over 30 small surrounding municipalities. In 2014, HCPHES treated 125 patients with active TB, including 1 patient with MDR TB, providing directly observed therapy (DOT) to all cases, as well as 38 TB suspects ultimately not found to have active disease. 75% of these cases have completed treatment as of September 2015, with 13% still in treatment (8% expired, 2% moved, and 1% were lost to follow up). Prophylactic treatment was started on 402 Latent TB Infection (LTBI) patients, with 70% finishing the regimen as of September 2015. Almost three quarters (72%) of HCPHES’s TB patients in 2014 were foreign-born, 66% were male, 17% had extra-pulmonary disease, and 2.4% were co-infected with HIV. Many were uninsured, medically indigent, or on Medicaid. Approximately 45% of cases identified as Hispanic, 30% as Asian, 13% Black, and 13% white. Approximately 1/3 of patients were between the ages of 44 and 64, and over one quarter were elderly (>65yrs). Currently, HCPHES TB staff provide DOT and directly observed preventive therapy (DOPT) to 163 patients, contacts, and suspects each week. Almost all of those who are provided prophylactic treatment against active TB disease are close contacts to active TB cases, or new immigrants settling in Harris County with latent TB or abnormal Chest X-ray. The VDOT target population includes the entire population of active TB cases, TB case suspects, and individuals identified as having latent infection requiring prophylactic therapy. Past Practice/Current Practice Value Traditionally, DOT Outreach Workers (ORW) travel to patients’ homes to observe each dose of TB medication to ensure compliance and decrease rates of TB resistance/recurrence.  This is a costly approach due to travel expenses, travel safety concerns, ORW time, and is often viewed as an invasion of privacy for patients and their loved ones.  Traditional DOT also restricts a patient’s ability to take medications at times convenient for their schedule, and often inhibits travel.  Treatment for active TB disease is lengthy and requires at least 6-9 months of antibiotics. Antibiotic resistance can extend treatment to two years or more. The state of Texas requires Directly Observed Therapy (DOT) to treat all TB cases and suspects, which is the mainstay and gold-standard of TB treatment delivery throughout the world. DOT helps to ensure compliance with the long and grueling treatment regimen required for cure. However, it is quite costly. DOT requires that a health worker travel to a patient’s home to observe each medication dose, usually occurring multiple times per week, and sometimes daily. Public health departments located in more rural areas or sprawling metropolises such as Harris County incur significant costs. Innovative/Evidence Based Practice VDOT is an innovative technology that leads the way towards eliminating TB disease. Several research centers and health departments have previously piloted and researched the use of video technology in the treatment of TB in less populous jurisdictions.  The HCPHES VDOT Program has taken the technology a step further - full operationalization of VDOT within its mainstream TB care, in a manner that is both HIPAA-compliant, and scalable within a large population with a high disease burden.  Because Harris County is the 3rd largest county in the nation with one of the highest TB caseloads, the HCPHES multi-phase implementation of its successful VDOT program revolutionizes care given to myriad individuals.  This year, with full integration, HCPHES plans to provide VDOT services to all eligible patients. Patients enrolled into the HCPHES VDOT Program have benefited from improved medication adherence, faster treatment completion times due to ability to count doses occurring during travel or late-night dosing, greater flexibility, increased autonomy, and privacy. Significant cost savings have allowed for a shifting of the program’s limited resources towards improving detection of latent TB infection in Harris County’s high-risk communities. The result is maximized public health resources, patient centered care and improved confidentiality. A few quotes offered by patients enrolled in HCPHES’s VDOT Program are as follows: VDOT gives me privacy; I’m no longer questioned by neighbors asking why the county car comes to my house and visits me every week. VDOT is convenient for me; it allows me to go to work without having to meet someone outside of my job; it gives me flexibility to take my pills at different times. I live in a close-knit community that is curious when my outreach worker comes to visit. VDOT has given me discretion to take my medicine without any questions from others, and it gives me freedom to move around the city without waiting for her visit.  
Goals and Objectives Goal:  To utilize HIPAA-compliant mobile technology to provide VDOT services to TB patients. Objectives: To improve medication adherence and side-effect monitoring. To increase patient autonomy, flexibility, and privacy. To reduce DOT programmatic costs. Implementation Strategy In late 2013, HCPHES learned about the potential to remotely provide DOT services to TB patients utilizing video technology.  The department knew that such a service would require HIPAA compliance, and need to meet certain other regulatory requirements. However, if successful, it could significantly reduce operating costs and overhead, increase patient privacy and satisfaction, and likely enhance regimen adherence. HCPHES began its exploration of remote video technology in 2013 by conducting a literature review on the topic. Based upon this research, a year-long discovery and planning phase commenced. During this year, the department researched the history of VDOT utilization in other U.S. health departments, and interviewed several HIPAA-compliant telemedicine platform providers. Two different platforms were piloted and compared using a created Platform Evaluation Survey tool.  A HCPHES interdisciplinary VDOT Team was established that represented 3 components: clinical, technical and data management.  Outlined below are the three major phases of implementation for the HCPHES VDOT program, with the tasks involved in each phase: Planning Literature Review VDOT Interdisciplinary Team Construction Creation of a Process Flow Map Interview Platform Providers Interview Smartphone Service Providers Set Enrollment Goals Train TB staff Create Instruction Guides/Consent Forms Phase I – Initial Pilot Enroll 30 patients Troubleshoot Identified Technology and Process Issues Make modifications to software platform as necessary Acquire and Implement Patient Feedback Phase II – Integration into mainstream TB Care Enroll 45 patients Establish a VDOT Champion amongst TB outreach worker staff Continue Troubleshooting Continue Platform Modifications Expand eligibility criteria based on current patient and staff experiences Begin VDOT program effectiveness evaluation Disseminate Results A Smart Phone for Each Enrolled Patient Realizing that some patients may have limited access to smartphone technology, cellular service providers were interviewed with the goal of obtaining low-cost smartphones and service plans. The VDOT team ultimately contracted with a smartphone service provider offering free phones, with an agreement that HCPHES would pay monthly service fees only for phones actively in use with patients. Although admittedly there were some concerns regarding patient misuse or loss of borrowed phones, this fear has largely been overcome by the reality that most patients exhibited only the utmost care for their smartphones, and used them solely for the purpose of submitting VDOT videos. The following list outlines some of the requirements HCPHES had when searching for a VDOT Smartphone service and equipment provider: Ability to enable/block international calls, texts, and roaming Hot spot capability Ability to monitor monthly voice, data, text usage Ability to Block Access to Inappropriate mobile applications or websites Preparing Outreach Worker Staff HCPHES Outreach workers (ORW) were trained to operate the VDOT phone application, including the Client Management System (CMS, or “back-end” of the application). A number of training sessions were held with the outreach workers, with post-training surveys issued to participants to assess their comfort with various tasks Phase I – Pilot Nurse Case Managers (NCM) identified thirty patients to enroll into the pilot, based upon pre-determined selection criteria (See Patient Selection Criteria Section). Patients were educated in use of the technology, and signed consents for VDOT participation and smartphone use (See Appendix B, VDOT Participation Agreement and Smartphone Agreement). Phase II – Full Implementation Initial patient selection criteria were modified based upon pilot-phase experiences. A total of 45 additional patients were enrolled onto VDOT, and technology platform modifications were made to streamline video-capture and medication adherence calculations embedded into the software. Patient feedback was continually evaluated. Towards the end of this phase, the program initiated analysis of the cost-effectiveness and overall utility of VDOT as a treatment modality. Platform Selection HCPHES requested proposals from several qualified remote telemedicine software providers to provide a system capable of remote treatment of TB patients.  An award was made to the vendor whose proposal fit departmental needs the best. The HCPHES TB program developed a list of criteria for its VDOT software platform.  These criteria are listed below: A customizable turn-key system Easy-to-use patient-facing application Easy-to-use Client Management System enabling remote video viewing and acceptance. Security – HIPAA and 21 CFR Part 11 compliance, encryption, PHI Android/IOS system compatibility Platform integration into EMR Future expansion capability Readily available Product Support Company billing infrastructure Staff Education All TB program staff were trained on Smartphone and VDOT application software. Staff training modules focused on the following goals: Setting up a phone for usage Downloading the VDOT software onto the phone, Reviewing and explaining consent forms with patients Ensuring Patient Signature and ability to consent Training patients on taking medications during video recording Video recording technique VDOT video submission. In addition, other appropriate clinical staff were trained on the following items: Navigation of Client Management System (CMS, or “back-end” of application) Initiating a patient onto VDOT in the CMS Viewing and accepting (or declining) submitted videos Calculation of Adherence on the CMS Outreach Workers were trained to appropriately document video submissions, and communicate with their Nurse Case Manager (NCM) about any issues or concerns with patient video submission. Criteria for Patient Selection Through the process of VDOT implementation, a set of criteria were developed, allowing for successful patient selection.  Most importantly, the patient or his/her guardian must be able to consent to participate. Furthermore, the patient must NOT be considered at risk for poor adherence (e.g. homeless, history of substance abuse, prior TB treatment, psychiatric illness, or memory impairment). Other Issues to be considered: Patient’s Overall Medical Condition and Stability Patient motivation towards his/her current TB Treatment Drug-Resistance – may confer additional worries about compliance Whether or not the person has achieved sputum conversion Patient ability to open medication packets and identify each medication Skill in operating phone technology and VDOT software Environment conducive to recording and submitting confidential videos Ability to securely store up to 30 days of TB medications in the home environment Sometimes, it is appropriate to remove a patient from enrollment on VDOT.  This dis-enrollment can either be program-initiated, or, more rarely, patient-initiated. Factors to consider for Removing a Patient from VDOT: Any adverse reaction to a TB medication Patient non-compliance with signed agreements – abuse of VDOT equipment Change in patient’s health or mental status Patient non-compliance with medical appointments, treatment regimen, or provider recommendations Patient requests to return to traditional DOT for valid reasons Patient Education and VDOT Initiation Patients selected to participate in the VDOT program are educated on proper use of the smartphone technology as well as on the VDOT software. This education generally takes place in the patient’s home with a trained DOT worker. All questions are answered during these scheduled visits, and the patient’s capacity to perform the operations necessary for successful video creation are continually assessed. 1st VDOT Home Visit The patient and Nurse Case Manager (or Outreach Worker) review and ensure understanding of the conditions and responsibilities defined in the VDOT phone and program agreements.  The patient is instructed about what to do in the event of an emergency, drug side effects, or equipment failure. The patient acknowledges that VDOT participation does not impact his/her public health orders for continued TB treatment, and signs all applicable agreements.  The Nurse Case Manager or Outreach Worker demonstrates proper use of the equipment and software, such as navigation, video submission, side-effect review, and proper cell phone positioning. Finally, the phone is activated, and the first VDOT dose is taken, with in-person observation by the TB program staff member.   During initial patient education (with reminders offered as needed thereafter), the patient follows the following 7 steps to ensure successful video submission: Step 1: Gather all necessary supplies and find a quiet location Step 2: Start VDOT Software Answer Questions When Prompted Step 3: Start Video Capture. Ensure Sufficient Distance between Patient and Phone Step 4: Clearly State Name and Open Medication Packet Step 5: Show Pills that are to be Taken, Providing a Close-Up View Step 6: Swallow Pills in Front of Camera, and then Say “Aaaahh” Step 7: Submit Video to TB Team for Review Multi-lingual staff, materials and documents are made available to patients in English, Spanish and Vietnamese. 2nd VDOT Home Visit At the second home visit, the patient must successfully demonstrate appropriate use of the smartphone and the VDOT software application to the Nurse Case Manager or Outreach Worker.  The patient should be able to demonstrate adequate use, without assistance from program staff.  At the conclusion of this visit, the patient is left with up to a 2-week supply of medications, with instructions to call the VDOT hotline with any concerns or questions. If the patient shows any difficulties during this second visit, a third in-home VDOT visit is offered. Infrequently, the Nurse Case Manager or Outreach Worker may determine that a patient is unable to successfully complete VDOT without assistance and the patient is removed from VDOT and placed on traditional DOT. In a successful VDOT arrangement, the patient and Nurse Case Manager or Outreach Worker mutually agree on the days and times that medications will be taken and recorded. The Nurse Case Manager or Outreach Worker schedules to meets the patient in their home at least once a month, providing up to a one-month supply of medications to the patient. This monthly visit allows for discussion of any clinical or technical issues not already addressed Viewing and Accepting VDOT Videos When VDOT videos are uploaded by patients to the secure server, outreach workers view them using the “back end,” or Client Management System (CMS) of the platform software. This is a secure web-based interface allowing for review of videos on any internet connection. Videos are generally reviewed and accepted by trained outreach workers, however may be accepted by any member of the TB Care team. Video Acceptance requires several key ingredients: Clear audio and good lighting Patient identification with full name, birth date, and today’s date Clear visualization of patient, medication, and glass of water at all times Visualization of all pills being swallowed with verification of no pocketed pills There are a host of reasons a viewer would reject a patient-submitted video: Inadequate visualization of patient leading to doubt as to patient’s identity Inadequate visualization of medications to be taken Inadequate view of liquid or container used to swallow pills Inability to ascertain whether all pills were actually swallowed Unacceptable Videos Too much space between camera and patient - makes it difficult to capture video details Too little space between camera and patient - makes it difficult to see packet of medication and drink HIPAA and Data Security The Health Insurance Portability and Accountability Act (HIPAA) establishes national standards for the privacy of individually identifiable health information and defines a wide range of identifiers, including name, birthdate, phone number, various ID numbers, facial images and others. Successful VDOT implementation, including software, interface, network, protocols and procedures, ensures HIPAA compliance. An array of linked administrative, physical, technical and encryption safeguards are utilized to provide data security and privacy of Protected Health Information. Regulatory and Legal Considerations Each state has its own regulations and statutes regarding the use of technology in the practice of medicine, and some may have statues specific to Video Directly Observed Therapy. HCPHES consulted with Harris County legal counsel prior to initiating VDOT to ensure compliance with local laws as well as accessed the Network for Public Health Law which offers some legal and practical guidance, and maintains a listing of legislation in Western states pertaining to use of VDOT. The “Back-End” of the VDOT Application - Client Management System (CMS) The CMS allows for viewing and acceptance of patient-uploaded videos.  This software also allows for calculation of medication adherence, based on information entered about the patient’s regimen during enrollment onto the CMS.  Additionally, the software allows for quality assurance measures, such as the ability to override video rejections or acceptances.  This built-in quality measure helps to assure fairness in administration of VDOT, and also allows for effective oversight by program leadership. Other Public Health Applications of VDOT Technology HCPHES is exploring the utilization of the VDOT mobile platform for other public health needs such as temperature monitoring in passengers from Ebola-affected countries, Refugee Health Screening follow-up, HIV treatment adherence, and other types of infectious disease monitoring. Practice Timeframe HCPHES has been involved in its VDOT implementation for the last two years.  The program implementation timeframe is outlined below: October 2013 – June 2014: Planning Phase – Research, Literature Review, Team Formation, Strategy July 2014 - September 2014:  Phase 1 – Pilot, Patient Enrollment, Refinement of Process and Technology, 30 Enrollees October 2014 – September 2015: Phase 2 – Full Implementation and Integration into TB program, 47 Enrollees October 2015 – September 2016: Phase 3 – Further Integration of VDOT into TB Program, expanded access, 13 Enrollees to date Stakeholders   HCPHES’s successful VDOT implementation requires recognition of a handful of key stakeholders, both internal and external to the department: HCPHES Clinical Team: The clinical team implemented VDOT according to the team’s set protocols and also participated in programmatic goal-setting and decision-making. The team consisted of: Disease Control & Clinical Prevention Division Director - Physician Chief of Disease Control and Medical Epidemiology - Physician TB Nurse Practitioner VDOT champion and outreach worker VDOT case registry assistant VDOT outreach worker HCPHES VDOT Administrative Team: This team provided program oversight, assisted in program design and implementation, and ensured compliance with guidelines and regulations, including HIPAA compliance. They also assisted in the continuous evaluation of operational efficiency and cost effectiveness.  The team consisted of the following individuals: Interim TB program Manager and VDOT Manager 1115 Waiver/DSRIP Project Manager 1115 Waiver/DSRIP Administrator DCME Support Services Administrator Financial analyst In-house Lead Technologist In-house IT Expert HCPHES Executive Leadership: HCPHES Executive leadership provided vision and direction with regards to offering support and structure for the implementation of VDOT into the TB Elimination program.  The department fully supports all efforts to incorporate technology into routine health department operations, and has included this in its Strategic Plan, which is publicly available on the departmental website: .  Departmental Leadership Includes: HCPHES Executive Director HCPHES Deputy Director and Director of Operations and Finance HCPHES In-House Legal Counsel TB Patients: TB disease still carries significant stigma for patients, which is only exacerbated by a public health worker’s arrival at one’s doorstep on a daily basis to administer medications.  Traditional DOT also disrupts a patient’s lifestyle, often requiring a patient to take medications during the workday or other inconvenient time.  VDOT offers increased patient privacy and autonomy, allowing the patient to upload a video in the privacy of their own home or office, at a time that is most convenient.  It also allows patients to travel, including internationally, while still counting doses towards completion of their TB regimens.  Previously, any unobserved doses were not able to be counted, and the treatment regimen had to be extended by the number of unobserved doses. Technology Providers: VDOT implementation requires partnership with a software platform provider.  The HCPHES partnership with its chosen platform provider allowed for joint development of software that was useful to the TB program, and provided patients with easy-to-use features that allowed for successful video submission.  HCPHES’s software platform provider benefitted from involvement in the VDOT implementation process by being at the cutting edge of the practical use of their software, improved application functionality, and national recognition as a reputable provider of HIPAA-secure VDOT software. Additionally, HCPHES chose to partner with a smartphone service provider to provide free phones and cellular service to patients.  This helped reduce barriers for patients who did not already possess smartphone technology or home internet service.  Our smartphone service provider benefited through its compensation for service provision, and through its partnership with a local health department employing cutting-edge technology, which it touts in its community service advertisements.  In future, patients will be able to download and use VDOT using their own smartphones, increasing the number of patients able to use VDOT, and reducing smartphone service costs for HCPHES. Local Public Health Department and Local Community Public health clinicians, workers, and leadership all have a vested interest in TB care delivery improvements, reduction in spending, and reducing the TB burden in the local community.  Improved adherence rates and compliance reduce the burden on public health workers, and reduce the chance of failed treatment and need for re-treatment. Improved compliance also reduces further disease transmission.  Furthermore, VDOT improves worker safety due to reduced driving and time on the road.   Reduced travel costs for costly DOT allows reallocation of limited public health resources towards other public health goals such as targeted TB testing in high risk communities. Larger National and International Public Health Community The larger national and international public health community benefits from similar gains in improved TB adherence rates and reduction in spending.  With improved compliance rates and treatment success, fewer cases will mean progress to the world public health goal complete TB elimination.  Costs and Funding VDOT implementation at HCPHES began with a grant-funded initiative through the Delivery System Reform Incentive Payment (DSRIP) program. HCPHES spent approximately $600,000 on implementation, most of which was spent on technology development and VDOT program staff salaries.  A VDOT Program Manager was hired to oversee implementation and enrollment, a VDOT nurse case manager was hired to manage enrollees and all clinical concerns, and additional outreach workers were hired to specifically handle video submissions, patient enrollment, and assist in TB staff training.   Now that VDOT has been integrated into the HCPHES TB Elimination program, some VDOT staff positions can be phased out.  Most current VDOT costs are associated with smartphone service, new staff training, ongoing technology modifications, software licensing, and software platform maintenance.    
To date, several qualitative and quantitative methods have been utilized to evaluate VDOT program outcomes. Analysis is still ongoing with the recent completion of Phase II of VDOT implementation. Preliminary results, however, indicate that TB patients can be successfully treated remotely with VDOT with improved side-effect monitoring. Routine Use of VDOT demonstrated significant cost savings when compared to traditional DOT. The following discussion will review preliminary and expected outcomes of the HCPHES VDOT Implementation Program with respect to its stated goals and objectives for the program. VDOT Implementation Goal:  To utilize HIPAA-compliant mobile technology to provide VDOT services to TB patients. HCPHES has been successful in providing VDOT services to currently ~ 100 individuals, aggregated over the three phases of implementation.  The software that is utilized by the VDOT program is HIPAA-compliant, and there have been no known breeches in confidentiality.  The VDOT software application has worked very well with few glitches, offering patients an eagerly awaited alternative to traditional DOT services.  Any encountered glitches have been addressed and modified, with the help of the software platform vendor.  Phase II VDOT Patient Outcomes (October 2014 – September 2015) Of 47 Enrollees: 15 discontinued VDOT use for various reasons (32%) 6 were removed due to missed/forgotten doses (13%) 3 had cellular service reception issues precluding VDOT use (6%) 2 were not able to effectively use technology (4%) 2 moved out of jurisdiction into another TB treatment program not using VDOT (4%) 1 refused Latent TB treatment entirely (who had been using VDOT) (2%) 1 was removed due to failure to abide by equipment use guidelines (2%) 19 have completed TB/LTBI treatment while using VDOT (40%, as of Oct 2015) 13 currently receive TB/LTBI treatment and are expected to complete treatment on VDOT (28%) As noted from the above statistics, almost one third of patients discontinued use of VDOT during treatment, for various reasons.  25% of enrollees discontinued use due to factors that may be modifiable, however, such as forgotten doses, inability to use technology effectively, cellular reception issues, or failure to abide by equipment use guidelines.  We anticipate discontinuance to diminish as the program matures. Future modifications, including automated reminders sent from the software application, improved training on the software, and allowing patients to use their own smartphones for VDOT (using service-providers best suited to their locations) should reduce some of this attrition.  HCHPES anticipates continued use of VDOT, and expanded access to individuals who were not initial targets of the implementation program, such as new immigrants and other patients with latent infection who are not close contacts to active TB cases. Factors leading to Success of the HCPHES VDOT Implementation In analysis of the overall implementation of VDOT within the health department, there were several factors that clearly contributed to the success of the program.   Some of these factors are listed below: Establishment of Clear Initial Objectives and an organized Timeline Creation and adherence to a VDOT Process flow map, Creation of a Software Platform Evaluation Survey Having a Dedicated VDOT Implementation Team composed of individuals with diverse professional backgrounds Having In-house legal counsel to assist with regulatory compliance and to review agreements. Broad Stakeholder Support and Participation, both internal and external to the department Constant Communication between Involved Parties, both internal and external Well-chosen Collaborative Partners with a vested interest in VDOT implementation success Strong and Effective Leadership with vision and commitment to project goals Other factors contributing to the success were related to the implementation process, and also worthy of mention: Availability of Multi-lingual Staff and Program Materials, which assisted in easy integration of VDOT into the patient’s care plan Selection of a VDOT Champion, an Outreach Worker tasked with general technical troubleshooting and training of existing and new TB program staff. Weekly VDOT “Tag-Up” Meetings to Assess Progress towards stated Goals and Objectives. Challenges to VDOT Implementation and Use: During the implementation phase, HCPHES did encounter several challenges, some of which have been overcome.  Some of these challenges were: Poor smartphone signal strength in one neighborhood (close to an airport), which limited ability to upload videos.  This was overcome by ensuring good signal prior to taking the video, which minimized lost videos.  For three patients with recurrently poor signal, and no access to home wi-fi services, VDOT had to be discontinued (3/47 Phase II enrollees discontinued, 6%). Ability of the VDOT software platform to receive upgrades via internet, especially in locations/countries that do not allow free access to web services.  This issue was encountered by a patient traveling in an Asian country with firewalls preventing automatic software upgrades that were necessary for the application to function.  This was overcome through sending the upgrade to the patient via email for manual upload. More frequently rejected videos in very young and elderly patients. There appeared to be a trend towards poor video quality in this group, precluding ability to count these doses towards TB treatment regimen completion.  This challenge was mitigated by asking that all newly enrolled children and elderly have a family member or friend assist in the video-capture process during each medication dose, to ensure proper video capture technique and submission. Forgotten doses without the reminder of a physically present DOT worker. Some patients on VDOT forgot to take medication doses, especially when their regimen required only intermittent dosing such as twice or thrice-weekly dosing.  This has been somewhat overcome by phone call reminders to patients, and the program is in the process of formalizing a reminder system with the ability to send text reminders directly from the VDOT software application.  Objective 1:  To improve medication adherence and side-effect monitoring. Medication adherence has improved through the use of VDOT, in that patients are able to count doses previously unable to be counted towards their treatment completion.  Previously, when a patient would miss an in-person DOT session, they were asked to take the medications on their own, but the dose was not counted towards completion, extending the duration of their therapy.  With VDOT, however, individuals who miss their usually scheduled dose can take the dose at an alternate time, or on the following day (in patients on biweekly or triweekly regimens), without losing a day of treatment.  The VDOT application jointly developed with the software provider uniquely asks patients whether or not they are experiencing any side effects such as nausea, jaundice, or rash, prior to allowing the patient to start the video capture process. This side effect monitoring feature enables TB clinical staff to ensure that doses are not being taken while a patient is experiencing side effects.  If a patient experiences a side effect, they are instructed not to take their medication dose and to immediately call the TB nurse case manager to discuss further plans. Objective 2:  To increase patient autonomy, flexibility, and privacy. Patients using VDOT continually state that they enjoy the flexibility offered by the technology.  Some patients work in fields such as construction, or truck-driving, and must take their medicines very early in the morning or late at night.  They find it difficult to maintain compliance with traditional DOT which requires dosing during working hours.  VDOT allows these patients to take medications on their own schedules, and travel if need be.  In addition, they enjoy the privacy of taking their doses without having an outreach worker physically present. A phone survey was completed at the conclusion of Phase II (September/October 2015) to gather patient feedback regarding patient VDOT experiences.  24 of the 47 Phase II VDOT patients (51% yield) were reached and completed the survey.  Patients were questioned on a variety of topics, such as: Level of satisfaction using VDOT Identified Positive aspects of VDOT?  Privacy, Travel ability, Convenience, etc. Limitations or challenges using VDOT; Remembering to take dose, need for more training, etc. Whether or not a phone reminder system for doses would be helpful Comfort with VDOT phone application; Not comfortable, Comfortable, Very comfortable. Whether patient would recommend VDOT to others; Not likely, Likely, Very likely. Satisfaction with VDOT Training Sessions; Not satisfied; Satisfied; Very satisfied. Knowledge of outreach worker performing the VDOT training session Ability of training outreach worker to connect to the patient. Whether patient needed to stop taking medications for any reason during VDOT use Survey analysis is currently ongoing.  Preliminary results reveal that 23 of 24 individuals surveyed (96%) were “Very satisfied” with their VDOT experience, and only 1 patient (4%) reported serious concern about technical glitches reducing the number of doses counting towards final TB completion numbers.  It should be noted that this 1 patient did successfully finish treatment using VDOT.  A few quotes offered by patients enrolled in HCPHES’s VDOT Program are as follows: VDOT gives me privacy; I’m no longer questioned by neighbors asking why the county car comes to my house and visits me every week. VDOT is convenient for me; it allows me to go to work without having to meet someone outside of my job; it gives me flexibility to take my pills at different times. I live in a close-knit community that is curious when my outreach worker comes to visit. VDOT has given me discretion to take my medicine without any questions from others, and it gives me freedom to move around the city without waiting for her visit. Objective 3:  To reduce DOT programmatic costs. Preliminary analysis of DOT cost reductions was completed using data from 46 of the 47 Phase II enrollees.  A rudimentary and incomplete estimate of mileage cost savings shows that up to $10 may have been saved for each VDOT dose taken by these 46 patients (using current mileage reimbursement rates of 52.5c per mile), factoring in outreach worker visits made to the patient’s home for training and medication drop-off, etc.  This cost savings does not include savings on worker time and salary expense, which are also considerable, but not yet analyzed.  This number likely underestimates the true cost savings in that it includes all of the inefficiencies that existed during Phase II of VDOT implementation, with regards to technological glitches requiring additional visits by outreach workers, training inadequacies and technology changes resulting in increased visits, and an overall lack of experience with the technology.  Additionally, many Phase II patients were started on VDOT towards the end of their treatment regimens, lowering their actual cost savings, as savings generally accrue over time through avoidance of traditional DOT visits. Using the cost savings analysis based on Phase II patients, a typical uncomplicated TB patient may save the HCPHES TB program up to $500 in mileage alone, if started on VDOT at the start of the continuation phase of treatment.  (Assuming a 2 month initiation phase, 4 month continuation phase, and a thrice-weekly medication dosing regimen during the continuation phase).  The continuation phase would usually require 48 in-person DOT visits using the traditional model of care.  Given an average of 2-4 monthly outreach worker visits made to patients while on VDOT, and 2 VDOT training sessions, at least 30 in-person visits are avoided by using VDOT.   Because the HCPHES TB program treats over 100 active TB and 400 LTBI patients annually, significant savings are anticipated with regards to mileage, and worker time/salary, not to mention savings that accrue due to decreased vehicular accidents and time taken off for workplace injuries.  In general, HCPHES estimates a 40-60% cost savings when using VDOT when compared to traditional DOT.  This savings is expected to increase with improved efficiency in using the technology.        
Lessons Learned The HCPHES TB Elimination Program learned several lessons that are worthy of mention related to various challenging issues encountered during VDOT Implementation.  These are outlined below. Troubleshooting Smartphone Technology after Patient Complaint or Missed/Unacceptable Videos: Problem: Connecting enrolled patients to an outreach worker capable of troubleshootin Solution: Assigning VDOT Champion to address all technical troubleshooting until all staff were appropriately trained Enrolling a Diverse Range of Patients onto VDOT Problem: Elderly and Very Young Patients had difficulty using technology Solution: Establishing (from enrollment) a responsible and committed family member to ensure proper video technique and smartphone usage. This member was trained along with the patient on how to use software and smartphone. Some patients lacking this support were ultimately removed from VDOT and returned to traditional DOT. Connectivity Issues Affecting Video Transmission Problem: Some areas of the county experienced poor cellular reception, resulting in videos not being uploaded onto serves Solution: All enrolled patients living in these identified areas (i.e. near airports or other “dead zones”) were placed on high alert by VDOT team to maintain active communication and ensure adequate cellular reception prior to video submission. VDOT software provider worked to make sure smartphones were downloading all available software updates. Some patients were required to return to traditional DOT. Staff Communication Regarding Missed Videos Problem: Outreach workers did not always notify Nurse Case Managers that patients were missing videos, or submitted unacceptable videos, leading to inaccurate adherence calculations and misinformed clinical staff.  Solution: VDOT Team established a protocol for notification of missed/unacceptable videos. Outreach Worker who viewed an unacceptable video, or noticed a missing video immediately contacted the patient’s Nurse Case Manager for notification. Outreach worker would contact the patient to troubleshoot reason for missed/inadequate dose, and retrain patient on correct video recording if needed Sustainability HCPHES is committed to continuing its use of VDOT as a novel approach to increase TB medication adherence, improve regimen completion rates, improve patient satisfaction, and reduce departmental programmatic costs.  VDOT has become an integral component of the HCPHES TB Elimination Program.  With the significant cost savings attributable to the technology, the sustainability of VDOT as an integral part of the HCPHES TB Elimination program is expected.  Below are outlined some sustainability-related issues, and how they are being addressed by the HCPHES TB Elimination program Future Technological Needs  HCPHES anticipates future technological costs related to VDOT application software modifications, annual software licensing, and smartphone service plans.  With an anticipated increase in the number of patients that will become eligible to use VDOT, HCPHES may need to acquire additional smartphones from our contract provider, which should remain free to the program, minus the monthly service plan costs.  These costs should be mitigated, however, by enabling VDOT enrollees to download the software onto their own smartphones, eliminating the need to provide smartphone equipment (and service plans) to patients.  This feature permitting patients to use their own smartphones for VDOT should be enabled by the end of 2015. Some aspects of the technological sustainability of the HCPHES VDOT program are uniquely different from standard enterprise software systems due to the cutting-edge nature of the technology.  Users of more established enterprise systems pay significant customization fees to vendors.  However, since HCPHES is the first user to ever operationalize the deployment of VDOT software, HCPHES subject matter experts are working closely with the developer to inform needed updates and customizations to the system.  Hence, HCPHES benefits from its early adopter status by not only receiving these customizations and updates at greatly reduced costs (often for free), but also establishing the benchmark for future VDOT systems. Future VDOT-related Staffing The HCPHES VDOT program has already begun to phase out some of the initial staffing requirements utilized to implement the program.  With full integration into the TB Elimination Program, HCPHES anticipates fewer traditional DOT workers being needed to do in-person visits, and a shifting of resources towards sustaining VDOT needs, such as viewing submitted videos, technology troubleshooting, and patient/staff VDOT training. Regulatory considerations/Use of Telemedicine/Billing The regulatory landscape with respect to telemedicine and VDOT, in particular, is ever-changing in the United States, and in Texas.  HCPHES continues to remain abreast of any regulatory changes, with respect to the ability to engage in telemedicine-type practices, and with respect to billing needs.  HCPHES has remained engaged on a state level with the Texas state health department, as well as with state legislators, providing education regarding the benefits of using VDOT with patients.  With regards to billing, reduced funding appropriated to TB programs nationwide has “pushed” TB programs to consider billing for their public health services.  This includes billing for DOT visits.  VDOT visits cannot currently be billed for, however.  Despite the current lack of ability to bill for VDOT, HCPHES continues to support legislation and policy supporting such billing, while also recognizing that VDOT is such a cost-saving initiative that even without the ability to bill for its use, is worth the investment. VDOT as the ONLY Sustainable model for DOT In the state of Texas, Directly Observed Therapy (DOT) is mandatory for active TB patients and persons suspected of having TB disease.  Reduced funding for TB programs, as well as pressures to provide more services with less money, mean that unless more efficient means of providing DOT are attempted, TB care, in general, is unsustainable.  It is only with technological advances such as VDOT that the nation will be able to sustain continued care of its TB population.  HCPHES anticipates that reduced spending on traditional DOT services will allow its TB Elimination program to focus on other program objectives such as increased targeted TB testing and prophylactic treatment in high-risk communities.  Allocating funds towards this important goal will allow Harris County, the nation, and the world to more quickly realize its goal of eliminating TB once and for all. National and International Sustainability As a partner in the worldwide goal towards TB eradication, the HCPHES TB Elimination Program has created a VDOT Implementation Guide that it hopes will promote not only the sustainability of VDOT as a technological tool, but the sustainability of TB patient care worldwide.   This VDOT Implementation Guide is available free of charge on the following website:, and may be used by other health departments as they consider use of the technology to meet their needs.  HCPHES has additionally promoted and shared its experiences with VDOT at the following 2015 conferences:  National Association of County and City Health Officials (NACCHO), Texas Association of City and County Health Officials (TACCHO), and the American Public Health Association (APHA) Annual Meeting.  HCPHES looks forward to continuing to support the use of VDOT as a sustainable model for continued high-quality TB care. Ventures Outside of Tuberculosis HCPHES is exploring the utilization of VDOT for other public health needs such as temperature monitoring in passengers arriving from Ebola-affected countries, Refugee Health Screening follow-up consultations, and various types of infectious disease monitoring and patient support.  In sum, HCPHES believes that VDOT is here to stay.  It has become a vital part of the department’s efforts to embrace technology to the advantage of the public whose health it serves to protect.    
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