Commission use of the Find and Treat Video Observed Therapy on the SureAdhere platform to support tuberculosis treatment completion

LTP Priority: Better Care For Health Conditions: Tuberculosis treatment

Population Intervention Triangle: Segments (link to Section 1 PHE PBA): Service

Type of Interventions: Commission use of the Find and Treat Video Observed Therapy on the SureAdhere platform to support tuberculosis (TB) treatment completion.

Major driver of health inequalities in your area of work

Most people with tuberculosis (TB) are curable by an affordable course of treatment, although this treatment currently takes a minimum of 6 months to complete and 2 years or longer for multi-resistant tuberculosis (Companion handbook to the WHO guidelines for the programmatic management of drug-resistant tuberculosis. WHO). Treatment interruption increases the risk for acquired drug resistance, treatment failure, disease progression, relapse and death, and prolongs transmissibility (Sagbakken M, Frich JC, Bjune GA, Porter JD. Ethical aspects of directly observed treatment for tuberculosis: a cross-cultural comparison. BMC Med Ethics. 2013 Jul 2;14:25).  Innovative approaches have been piloted which bridge the gap between caregiver and patient and limit the cost and stress of frequent travel to the TB clinic for directly observed therapy (DOT) and reduce the need for the health care worker to travel to the patient. However, DOT can place an undue burden on individuals who already face many challenges completing treatment and might offer little added benefit for many. Recently, a video-based approach to DOT (termed VOT) an innovative new way of delivering treatment is being used to treat populations at greater risk of not completing their treatment .

Treatment completion

  • Among people with drug sensitive TB notified in 2016, treatment completion at last recorded outcome was lower for those with a Social Risk Factor (SRF) (80.0%, 420/525) compared to people without a SRF (87.7%, 3,762/4,292). Social risk factors being a history of homelessness, alcohol or drug misuse or imprisonment (Tuberculosis in England 2018: Public Health England).
  • The proportion of people that had died at their last recorded outcome was 2.5 times higher in those with alcohol misuse (11.6%, 21/181) compared to those with no alcohol misuse (4.7%, 229/4,890) (Tuberculosis in England 2018: Public Health England).
  • In a recent randomised control trial, VOT enabled higher levels of treatment observation for patients with tuberculosis, both over the first 2 months of treatment and throughout treatment, than DOT. VOT also supported daily dosing, was effective for socially complex populations, and had a lower dropout rate than DOT. The absence of face-to-face contact did not reduce the identification of adverse events or lead (Story A, Aldridge RW, Smith CM, Garber E, Hall J. et al Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial. Lancet. 2019 Mar 23;393(10177):1216-1224).

Target groups

Deprivation. Inclusion health group.

Intervention

Commission use of the Find and Treat Video Observed Therapy on the SureAdhere platform to support TB treatment completion.

Description

Commission Video Observed Therapy targeted at those considered to be at higher risk of poor adherence or having clinically complex TB. This could be commissioned for individual cases or over a wider population, in order to be cost effective. Electronic remote technologies have been developed to securely & remotely monitor TB patients taking their medication, either in real time or recorded, referred to as video (virtually) observed therapy (VOT).  VOT usually requires patients to film themselves taking medications on a computer or mobile device and then transmit these images to a remote observer via the internet.

Evidence

WHO has recommended the use of additional adherence interventions to ensure good treatment outcomes. Video observed treatment (VOT) can replace DOT when the video communication technology is available and can be appropriately organized and operated by health-care providers and patients (Conditional recommendation, very low certainty in the evidence) (Guidelines for treatment of drug-susceptible tuberculosis and patient care, 2017 update).

Delivery of VOT

There is considerable variation in the structure of TB services across England, with provision of specialist TB services, TB clinical nurse specialists (TB CNS) and outreach/directly observed therapy (DOT) workers, variable; in addition to a mixture of acute and community provision.. In keeping with the Collaborative TB Strategy for England goal of supporting improved treatment completion, implementation of VOT provides better treatment completion and so reduces the development of drug-resistant TB and improves TB control (Tuberculosis (TB): collaborative strategy for England [Internet]. gov.uk).

VOT usually requires patients to film themselves taking medications on a computer or mobile device and then transmit these images to a remote observer via the internet. Video technology has been available for more than a decade, but the increasing availability of smartphones and broadband internet is making VOT practical to implement even in resource-constrained settings (Wade VA, Karnon J, Eliott JA, Hiller JE. Home Videophones Improve Direct Observation in Tuberculosis Treatment: A Mixed Methods Evaluation. PLOS ONE. 2012 Nov 30;7(11):e50155).

Synchronous and asynchronous DOT

Synchronous’ VDOT involves the review of transmitted images in real time by health care workers. In contrast, ‘asynchronous’ VDOT allows videos to be recorded, uploaded and reviewed at a later time – providing greater flexibility to patients and clinical staff. The differences between the DOT, and Synchronous and Asynchronous observed treatments are summarised in Table 1.

Table 1: Procedures and Requirements of DOT, Synchronous VOT and Asynchronous VOT.

HCW and patient Directly Observed Treatment Synchronous Video Observed Treatment   Asynchronous Video Observed Treatment
Timing Occurs in real time (synchronous) Occurs in real time (synchronous) Does not occur in real-time
Location Health care worker (HCW) must be physically present at the same time to observe the patient ingesting medication HCW virtually observes (via live-video) the patient ingesting medication Patient records a video ingesting medication and sends it to HCW to observe at a later time.
Travel Requires either the patient or HCW to physically travel Does not require the HCW and patient to travel (unless physical check-up required i.e. usually once a month) Does not require patient and / HCW to travel (unless physical check-ins are required)
Schedule of treatment regimen Treatment regimen of patient must fit to the patient and HCW schedule Treatment regimen must fit to the patient and HCW’s schedule Treatment regimen fits to both patient and HCW’s schedule
Technology required Does not require technological equipment or a cellular / Wi-Fi connection Requires a smartphone and a cellular / Wi-Fi connection Requires a smartphone and a cellular / Wi-Fi connection

Adapted from Centre for Connected Health Policy. Using Telehealth for Directly Observed Therapy for Treating Tuberculosis. 2015 Apr.

Potential advantages of VOT

  • VOT is based on patient centred care, respecting the patients’ autonomy and individual preferences, and promoting a more holistic approach to the care of patients.
  • The intervention is expected to make savings for the patients in time, cost and physical exertion to travel to the clinic, often among patients with a chaotic lifestyle.
  • For the patient, it is likely to reduce stigma for patients visiting the clinic or a nurse coming to their homes regularly.

Challenges of VOT

  • All medicines can cause side effects, and the risk varies from person to person. Monitoring reactions to medication is a potential concern. Patients at risk of side effects are instructed to look for symptoms associated with the most common and serious reactions to the medications.
  • In a study of districts in California the primary problem were interruption of video and audio connectivity (Garfein RS, Liu L, Cuevas-Mota J, Collins K, Muñoz F, Catanzaro DG, et al. Tuberculosis Treatment Monitoring by Video Directly Observed Therapy in 5 Health Districts, California, USA. Emerg Infect Dis. 2018 Oct;24(10):1806–15).

Feasibility and acceptability of VOT

VOT was first used for TB in 2007 in several clinical programmes in London, as an alternative to in-person treatment observation (Story A, Garfein RS, Hayward A, Rusovich V, Dadu A, Soltan V, et al. Monitoring Therapy Adherence of Tuberculosis Patients by using Video-Enabled Electronic Devices. Emerg Infect Dis. 2016 Mar;22(3):538–40.) VOT has also been piloted and evaluated  in studies in Vietnam(Nguyen TA, Pham MT, Nguyen TL, Nguyen VN, Pham DC, Nguyen BH, et al. Video Directly Observed Therapy to support adherence with treatment for tuberculosis in Vietnam: A prospective cohort study. Int J Infect Dis IJID Off Publ Int Soc Infect Dis. 2017 Dec;65:85–9.), India (Majumdar A, Sujiv A, Palanivel C. Video Directly Observed Treatment: How Effective Will it be in Indian Setting? J Fam Med Prim Care. 2015;4(1):152–3.), Australia, the USA(Mirsaeidi M, Farshidpour M, Banks-Tripp D, Hashmi S, Kujoth C, Schraufnagel D. Video directly observed therapy for treatment of tuberculosis is patient-oriented and cost-effective. Eur Respir J. 2015 Mar 18;ERJ-00110-2015 and Garfein RS, Liu L, Cuevas-Mota J, Collins K, Muñoz F, Catanzaro DG, et al. Tuberculosis Treatment Monitoring by Video Directly Observed Therapy in 5 Health Districts, California, USA. Emerg Infect Dis. 2018 Oct;24(10):1806–15.) were it as considered feasible and resulted in higher rates of treatment adherence. Studies from US and Mexico (Garfein RS, Collins K, Muñoz F, Moser K, Cerecer-Callu P, Raab F, et al. Feasibility of Tuberculosis Treatment Monitoring by Video Directly Observed Therapy: A Binational Pilot Study. Int J Tuberc Lung Dis Off J Int Union Tuberc Lung Dis. 2015 Sep;19(9):1057–64.) show that smart phone VOT is acceptable, can save resources and improve patient commitment to treatment even in highly mobile populations. Use of VOT in tuberculosis patients in an eastern European setting with a high level of drug resistance attests the feasibility of VOT under programmatic conditions and shows good acceptability among a diverse mix of tuberculosis patients and among staff (Sinkou H, Hurevich H, Rusovich V, Zhylevich L, Falzon D, de Colombani P, et al. Video-observed treatment for tuberculosis patients in Belarus: findings from the first programmatic experience. Eur Respir J [Internet]. 2017 Mar 23;49(3)).

Pilot single arm VOT studies in the USA, Mexico and Belarus suggest that treatment outcomes were comparable to those with in-person DOT, with markedly reduced health system costs (Garfein RS, Collins K, Muñoz F, Moser K, Cerecer-Callu P, Raab F, et al. Feasibility of Tuberculosis Treatment Monitoring by Video Directly Observed Therapy: A Binational Pilot Study. Int J Tuberc Lung Dis Off J Int Union Tuberc Lung Dis. 2015 Sep;19(9):1057–64 and Sinkou H, Hurevich H, Rusovich V, Zhylevich L, Falzon D, de Colombani P, et al. Video-observed treatment for tuberculosis patients in Belarus: findings from the first programmatic experience. Eur Respir J [Internet]. 2017 Mar 23;49(3)). The New York City reported treatment completion with VDOT was similar to that with in person DOT (96% vs 97%, p=0.63)(Sinkou H, Hurevich H, Rusovich V, Zhylevich L, Falzon D, de Colombani P, et al. Video-observed treatment for tuberculosis patients in Belarus: findings from the first programmatic experience. Eur Respir J [Internet]. 2017 Mar 23;49(3)). Another study with asynchronous VDOT showed more expected medication doses observed than patients onDOT. Though some patients returned to DOT, most were effectively monitored to completion by using VDOT. An Australian study reported a higher proportion of observed treatment doses with VOT compared to in-person DOT, but the effect on treatment completion rates was not statistically significant (Wade VA, Karnon J, Eliott JA, Hiller JE. Home Videophones Improve Direct Observation in Tuberculosis Treatment: A Mixed Methods Evaluation. PLOS ONE. 2012 Nov 30;7(11):e50155). These studies compared VOT to high functioning DOT programmes; there was no difference in adherence, which suggests that comparably high adherence can be obtained using digital technologies for digital support. However, implementation of VDOT resulted in successful anti-tuberculosis treatment outcomes while maximizing resources.

A recent multicentred, randomised control trial in 22 clinics in England showed that VOT enabled higher levels of treatment observation for patients with tuberculosis, both over the first 2 months of treatment and throughout treatment than DOT (Story A, Aldridge RW, Smith CM, Garber E, Hall J, Ferenando G, Possas L, Hemming S, Wurie F, Luchenski S, Abubakar I, McHugh TD, White PJ, Watson JM, Lipman M, Garfein R, Hayward AC. Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial. Lancet. 2019 Mar 23;393(10177):1216-1224). The study also demonstrated that VOT also supported daily dosing, was effective for socially complex populations, and had lower dropout rate than DOT.

VOT Options in the UK

In England DOT is targeted at those considered to be high risk of poor adherence and clinically complex patients. A number of techniques are currently being used. The first randomised controlled trial of asynchronous smartphone enabled video observation of treatment (VOT) using SecureApp for active TB compared to DOT found VOT to be a more effective and cheaper approach to observation of tuberculosis treatment then clinic or community based DOT (Story A, Aldridge R, Smith C, Garber E, Hall J, Fernandez G, et al. S29 A randomised controlled trial comparing smartphone enabled remote video observation with direct observation of treatment for tuberculosis. Thorax. 2017 Dec 1;72(Suppl 3):A21–A21). VOT patients sustained high observation of six-month course of treatment, this declined rapidly in DOT patients. An exploratory study to understand the attitudes and perspectives of patients with MDR tuberculosis supervised with VOT suggests that it is practical and acceptable to patients with MDR tuberculosis, provided they receive effective training and continuing support (Philip Windish, Serena Luchenski, Joe Hall, Yasmin Appleby, Lucia Possas, Sara Hemming, Alistair Story. Video observed therapy for multidrug-resistant tuberculosis: a qualitative study of patient perspectives. November 13 2015 Lancet Abstr Meet) the investigators will observe participants taking their TB tablets three times per week using a mobile phone, iPod or computer with camera facilities in the participants home environment. Based on the experience of the recent trial, VOT is being used routinely by the Find and Treat Service. Most patients with MDR TB in London are now treated using VOT, and many of the patients multiple daily dosing (Story A, Aldridge RW, Smith CM, Garber E, Hall J, Ferenando G, Possas L, Hemming S, Wurie F, Luchenski S, Abubakar I, McHugh TD, White PJ, Watson JM, Lipman M, Garfein R, Hayward AC. Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial. Lancet. 2019 Mar 23;393(10177):1216-1224).

VOT is likely to be preferable to DOT for many patients across a broad range of settings, providing a more acceptable, effective and cheaper option for supervision of daily and multiple daily doses than DOT (Story A, Aldridge RW, Smith CM, Garber E, Hall J, Ferenando G, Possas L, Hemming S, Wurie F, Luchenski S, Abubakar I, McHugh TD, White PJ, Watson JM, Lipman M, Garfein R, Hayward AC. Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial. Lancet. 2019 Mar 23;393(10177):1216-1224). 

Governance, strengths and weakness of SureAdhere App used by the London Find and Treat team

Governance

  • End to end encryption with pass word protection
  • Fully GDPR compliant

Strengths

  • Provision for flexibility, allowing medication to be recorded at all times of the day.
  • This is especially useful for patients who are on MDR /XDR treatment.
  • The app allows for inter-observer reliability and multiple review. The app also provides an option for digital shredding.
  • Saves time, money to the service and maximises efficiency.
  • Can be used efficiently in areas of low prevalence of TB.

Weaknesses

  • Patient does not personally know the person viewing the video, which may cause some issues for the patients.