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Implementation fidelity of hospital based directly observed therapy for tuberculosis treatment in Bhutan: mixed-method study.

ABSTRACT: BACKGROUND:Direct observed treatment (DOT) has been implemented in Bhutan since 1997 and currently, it is offered in various model of delivery including a combination of hospital based, home based DOT and ambulatory DOT. Overall, treatment success rate for tuberculosis cases is higher than the global target; however, it is still need to be improved. Evaluation to the implementation fidelity of DOT is important to identify potential rooms for improvement. This study aimed to assess two major components of the program's implementation fidelity: to assess patient's adherence to DOT and explore factors for adherence; to assess provider's compliance with DOT guideline and explore factors for compliance. METHODS:This research used a sequential explanatory mixed method. The conceptual framework of implementation fidelity was adopted to guide this study design. The cross-sectional study of TB patients was enrolled in two hospitals with highest TB load, between September to November 2017 in Bhutan. Interviewer assisted survey was conducted with 139?TB patients who visited the hospital in continuation phase. In-depth interview was then conducted with nine TB patients and four health staffs to explore the barriers and enablers of DOT. RESULTS:Total of 61.9% (86/139) of patients has received DOT at intensive phase. Proportion was higher among MDR-TB cases (100%), and smear sputum positive TB cases (84.7%). In the continuation phase, 5.8% of patients took medicine at hospital, 48.9% at home and the rest 45.3% no longer practiced DOT. More than 90% of patient received correct dosage and standard regimen of anti-TB drugs according to the guideline. The key factors affecting poor adherence to DOT as perceived by patients were; lack of willingness to visit the clinic on daily basis due to long distance, financial implications and family support. However, patient's satisfaction to the quality of TB treatment service delivery was high (98.6%). Providing incentives to the patient was most agreed enabler felt by both health workers and patients. CONCLUSION:In the selected hospital sites, the patient's adherence to DOT and provider's compliance with DOT guideline is partially implemented; the coverage and the duration of DOT is very low, therefore, need to revise and improve DOT model and structure.

SUBMITTER: Dorji K

PROVIDER: S-EPMC7168849 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Implementation fidelity of hospital based directly observed therapy for tuberculosis treatment in Bhutan: mixed-method study.

Dorji Kunzang K Lestari Trisasi T Jamtsho Sonam S Mahendradhata Yodi Y

BMC public health 20200419 1

<h4>Background</h4>Direct observed treatment (DOT) has been implemented in Bhutan since 1997 and currently, it is offered in various model of delivery including a combination of hospital based, home based DOT and ambulatory DOT. Overall, treatment success rate for tuberculosis cases is higher than the global target; however, it is still need to be improved. Evaluation to the implementation fidelity of DOT is important to identify potential rooms for improvement. This study aimed to assess two ma ...[more]

PMID: 32306977

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Project description:Background: Excellent adherence to tuberculosis (TB) treatment is critical to cure TB and avoid the emergence of resistance. Wirelessly observed therapy (WOT) is a novel patient self-management system consisting of an edible ingestion sensor (IS), external wearable patch, and paired mobile device that can detect and digitally record medication ingestions. Our study determined the accuracy of ingestion detection in clinical and home settings using WOT and subsequently compared, in a randomized control trial (RCT), confirmed daily adherence to medication in persons using WOT or directly observed therapy (DOT) during TB treatment.Methods and findings: We evaluated WOT in persons with active Mycobacterium tuberculosis complex disease using IS-enabled combination isoniazid 150 mg/rifampin 300 mg (IS-Rifamate). Seventy-seven participants with drug-susceptible TB in the continuation phase of treatment, prescribed daily isoniazid 300 mg and rifampin 600 mg, used IS-Rifamate. The primary endpoints of the trial were determination of the positive detection accuracy (PDA) of WOT, defined as the percentage of ingestions detected by WOT administered under direct observation, and subsequently the proportion of prescribed doses confirmed by WOT compared to DOT. Initially participants received DOT and WOT simultaneously for 2-3 weeks to allow calculation of WOT PDA, and the 95% confidence interval (CI) was estimated using the bootstrap method with 10,000 samples. Sixty-one participants subsequently participated in an RCT to compare the proportion of prescribed doses confirmed by WOT and DOT. Participants were randomized 2:1 to receive WOT or maximal in-person DOT. In the WOT arm, if ingestions were not remotely confirmed, the participant was contacted within 24 hours by text or cell phone to provide support. The number of doses confirmed was collected, and nonparametric methods were used for group and individual comparisons to estimate the proportions of confirmed doses in each randomized arm with 95% CIs. Sensitivity analyses, not prespecified in the trial registration, were also performed, removing all nonworking (weekend and public holiday) and held-dose days. Participants, recruited from San Diego (SD) and Orange County (OC) Divisions of TB Control and Refugee Health, were 43.1 (range 18-80) years old, 57% male, 42% Asian, and 39% white with 49% Hispanic ethnicity. The PDA of WOT was 99.3% (CI 98.1; 100). Intent-to-treat (ITT) analysis within the RCT showed WOT confirmed 93% versus 63% DOT (p < 0.001) of daily doses prescribed. Secondary analysis removing all nonworking days (weekends and public holidays) and held doses from each arm showed WOT confirmed 95.6% versus 92.7% (p = 0.31); WOT was non-inferior to DOT (difference 2.8% CI [-1.8%, 9.1%]). One hundred percent of participants preferred using WOT. WOT associated adverse events were <10%, consisting of minor skin rash and pruritus associated with the patch. WOT provided longitudinal digital reporting in near real time, supporting patient self-management and allowing rapid remote identification of those who needed more support to maintain adherence. This study was conducted during the continuation phase of TB treatment, limiting its generalizability to the entire TB treatment course.Conclusions: In terms of accuracy, WOT was equivalent to DOT. WOT was superior to DOT in supporting confirmed daily adherence to TB medications during the continuation phase of TB treatment and was overwhelmingly preferred by participants. WOT should be tested in high-burden TB settings, where it may substantially support low- and middle-income country (LMIC) TB programs.Trial registration: ClinicalTrials.gov NCT01960257.

Project description:BackgroundThe health care system in Thailand has struggled to cope with the COVID-19 pandemic, resulting in decreased administration of community-based directly observed therapy (DOT) for tuberculosis (TB). As an alternative to failed DOT, video-observed therapy (VOT) or the Thai asynchronous VOT system, "TH VOT," was devised. We developed a protocol for a study to test the superiority of VOT over DOT in ensuring treatment compliance.ObjectiveWe aim to compare the mean cumulative compliance days of TB patients and their observers under the VOT program with that of individuals under the DOT program during the intensive phase of TB treatment.MethodsA cluster randomized controlled trial of pulmonary TB patients and their observers will be conducted over a 2-month period. This study will be conducted in the Hat Yai and Meuang Songkhla districts of Songkhla Province, Southern Thailand. A total of 38 observers working at 38 primary care units (PCUs) will be randomized equally into VOT and DOT groups. The TH VOT system will be implemented in 19 PCUs in the VOT group while the other 19 PCUs will continue with the traditional DOT program. Approximately 1-5 TB patients will be under observation, depending on the PCU jurisdiction in which the patients reside. The inclusion criteria for TB patients will be as follows: patients diagnosed with newly active pulmonary TB with a positive acid-fast bacilli sputum smear, aged >18 years, own a smartphone, and are able to use the LINE (Line Corporation) app. The exclusion criteria will be patients with a condition that requires the intervention of a specialist, rifampicin resistance according to a cartridge-based nucleic acid amplification test (GeneXpert MTB/RIF), unable to continue the treatment, and/or alcohol dependence. After the 2-month observation period, all sessions and follow-up clinical outcomes recorded will be retrieved. An intention-to-treat analysis will be performed to assess the compliance of both patients undergoing drug administration and their observers.ResultsThe Human Research Ethics Committee, Faculty of Medicine, Prince of Songkla University approved the trial on February 19, 2021 (approval number 64-03618-9). The trial was funded in May 2021. The recruitment period will be from January 2022 to July 2022. The observation is scheduled to end by September 2022.ConclusionsIf the VOT shows superiority in observational compliance among patients and observers, the existing DOT policy will be replaced with VOT.Trial registrationThai Clinical Trials Registry TCTR20210624002; https://www.thaiclinicaltrials.org/show/TCTR20210624002.International registered report identifier (irrid)DERR1-10.2196/38796.

Project description:IntroductionDecentralization of Directly Observed Treatment (DOT) for tuberculosis (TB) to the community (home-based DOT) has improved the coverage of TB treatment and reduced the burden to the health care facilities (facility-based DOT). We aimed to compare TB treatment outcomes in home-based and facility-based DOT under programmatic conditions in an urban setting with a high TB burden.MethodologyA retrospective analysis of a cohort of adult TB patients (?15 years) routinely notified between 2010 and 2013 in two representative TB sub-districts in the Temeke district, Dar es Salaam, Tanzania. We assessed differences in treatment outcomes by calculating Risk Ratios (RRs). We used logistic regression to assess the association between DOT and treatment outcomes.ResultsData of 4,835 adult TB patients were analyzed, with a median age of 35 years, 2,943 (60.9%) were men and TB/HIV co-infection prevalence of 39.9%. A total of 3,593 (74.3%) patients were treated under home-based DOT. Patients on home-based DOT were more likely to die compared to patients on facility-based DOT (RR 2.04, 95% Confidence Interval [95% CI]: 1.52-2.73), and more likely to complete TB treatment (RR 1.14, 95% CI: 1.06-1.23), but less likely to have a successful treatment outcome (RR 0.94, 95% CI: 0.92-0.97). Home-based DOT was preferred by women (adjusted Odds Ratio [aOR] 1.55, 95% CI: 1.34-1.80, p<0.001), older people (aOR 1.01 for each year increase, 95% CI: 1.00-1.02, p = 0.001) and patients with extra-pulmonary TB (aOR 1.45, 95% CI: 1.16-1.81, p = 0.001), but less frequently by patients on a retreatment regimen (aOR 0.12, 95% CI: 0.08-0.19, p<0.001).Conclusions/significanceTB patients under home-based DOT had more frequently risk factors of death such as older age, HIV infection and sputum smear-negative TB, and had higher mortality compared to patients under facility-based DOT. Further operational research is needed to monitor the implementation of DOT under programmatic conditions.

Project description:BackgroundTuberculosis is a major public health concern resulting in high rates of morbidity and mortality worldwide, particularly in low- and middle-income countries. Tuberculosis requires a long and intensive course of treatment. Thus, various approaches, including patient empowerment, education and counselling sessions, and involvement of family members and community workers, have been suggested for improving treatment adherence and outcome. The current randomized controlled trial aims to evaluate the effectiveness over usual care of an innovative multicomponent people-centered tuberculosis-care strategy in Armenia.Methods/designInnovative Approach to Tuberculosis care in Armenia is an open-label, stratified cluster randomized controlled trial with two parallel arms. Tuberculosis outpatient centers are the clusters assigned to intervention and control arms. Drug-sensitive tuberculosis patients in the continuation phase of treatment in the intervention arm and their family members participate in a short educational and counselling session to raise their knowledge, decrease tuberculosis-related stigma, and enhance treatment adherence. Patients receive the required medications for one week during the weekly visits to the tuberculosis outpatient centers. Additionally, patients receive daily Short Message Service (SMS) reminders to take their medications and daily phone calls to assure adherence and monitoring of treatment potential side effects. Control-arm patients follow the World Health Organization--recommended directly observed treatment strategy, including daily visits to tuberculosis outpatient centers for drug-intake. The primary outcome is physician-reported treatment outcome. Patients' knowledge, depression, quality of life, within-family tuberculosis-related stigma, family social support, and self-reported adherence to tuberculosis treatment are secondary outcomes.DiscussionImproved adherence and tuberculosis treatment outcomes can strengthen tuberculosis control and thereby forestall tuberculosis and multidrug resistant tuberculosis epidemics. Positive findings on effectiveness of this innovative tuberculosis treatment people-centered approach will support its adoption in countries with similar healthcare and economic profiles.Trial registrationClinicalTrials.gov registration number: NCT02082340. Date of registration: 4 March 2014.

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Implementation fidelity of hospital based directly observed therapy for tuberculosis treatment in Bhutan: mixed-method study.

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Implementation fidelity of hospital based directly observed therapy for tuberculosis treatment in Bhutan: mixed-method study.

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