N599 Module 4 assignment: capstone project design and methods, a full sample

How the Project Was Built: Design and Methods for Testing Phone-Verified Weekly Dosing Against Dropout From Preventive Tuberculosis Therapy

Student Name

Master of Science in Nursing Program, Aspen University

N599: Nursing Capstone

Instructor Name

Month Day, Year

How the Project Was Built: Design and Methods for Testing Phone-Verified Weekly Dosing Against Dropout From Preventive Tuberculosis Therapy

The capstone project asks whether more patients finish preventive treatment when the county's tuberculosis clinic replaces four months of unsupervised daily rifampin and monthly appointments with a three-month weekly combination of rifapentine and isoniazid, each dose filmed by the patient and checked by a nurse. This section describes the project's design, setting and participants, the intervention, the measures and data sources, ethical safeguards and the plan for analysis. The methods are reported following the order set out in SQUIRE 2.0, the standard checklist for improvement reports (Ogrinc et al., 2016).

Design and Setting

The project uses a pre-post quality improvement design comparing a six-month implementation period with the twelve months before it. The setting is the tuberculosis clinic of a county health department serving a mid-sized city, staffed by two public health nurses, a part-time physician, an outreach worker and contracted interpreters. The clinic evaluates and treats about 14 new patients with latent infection each month, most referred through refugee health screening, immigration examinations and contact investigations. A pre-post design cannot exclude the influence of other changes during the period, so any concurrent changes, such as staffing or referral patterns, will be documented and considered in interpretation.

Participants

All adults aged 18 and older who start treatment for latent tuberculosis infection during the implementation period are included in the evaluation. All are offered the weekly regimen unless it is contraindicated, for example by pregnancy, certain drug interactions such as some antiretroviral combinations, or known intolerance, consistent with national guidance naming the three-month combination as a preferred option (Sterling et al., 2020). Patients who accept the weekly regimen and have a smartphone are offered video-observed dosing; those without a smartphone or who decline video are offered weekly in-person or self-administered dosing with weekly phone contact. Patients who prefer daily rifampin continue to receive it. Including every patient who starts treatment, whatever their choice, allows the project to measure the effect of the new approach on the clinic as a whole rather than only on those who choose it.

The Intervention

At the treatment visit, a public health nurse teaches the patient through an interpreter, using a simple picture of how much treatment reduces the chance of later active disease, and helps the patient install a secure video-observed therapy application on their phone. The patient takes the first dose in the clinic while recording a practice video. Each week, the patient records themselves swallowing the dose, the application uploads the video, and a nurse reviews it within one business day, replying with a short message and asking about side effects. If no video arrives within 24 hours of the scheduled day, the nurse sends a reminder; after 48 hours, the nurse or outreach worker calls. Missed doses are rescheduled within the window allowed by clinic protocol. Monthly clinic visits are replaced by a telephone check at weeks four and eight and an in-person visit only if symptoms or side effects require it.

Measures and Data Sources

The primary outcome is treatment completion. For the weekly regimen, completion is defined as 11 or more doses taken within 16 weeks, the definition used in the major trial of self-administered versus observed weekly treatment (Belknap et al., 2017). For daily rifampin, completion follows the clinic's existing definition of 120 doses within six months, allowing comparison with the baseline period. Secondary measures include the proportion of patients choosing each option, the proportion of scheduled weekly videos received on time, reasons for stopping treatment, adverse events leading to discontinuation, and nursing time per patient, recorded in a simple log. Data come from the electronic health record, the video platform's dose report and the nursing log, and are extracted into a spreadsheet with no names, using study numbers.

Before implementation, the capstone student and one of the clinic nurses independently extracted completion status for a random sample of 20 baseline charts to check that the completion definition could be applied consistently. They agreed on 19 of the 20 charts, and the single disagreement, involving a patient who transferred care to another county, was resolved by adding a rule that transferred patients are counted by their status at the receiving clinic when that information is available and are otherwise excluded from both periods.

Ethical Considerations

The health department's review process judged the work to be a local improvement effort that did not need research review, because it implements an evidence-based practice to improve local care and uses data collected in routine practice. Patients nonetheless receive a clear explanation of the video option and may decline it without any effect on their care. The video platform is a secure system approved by the health department, videos are stored only until reviewed and then deleted according to policy, and nurses view them only on department devices. Because many patients are recent immigrants, the nurses explain that the videos and records are not shared with immigration authorities, as consistent with department policy, since fear of such sharing could deter participation.

Analysis Plan

The primary analysis compares the proportion of patients completing treatment during the implementation period with the 58% baseline, using a chi-square test, treating p below 0.05 as significant. Because the number of patients is modest, perhaps 80 in six months, the confidence interval around the new completion rate will be reported alongside the test, and the result will be interpreted in terms of practical importance as well as statistical significance. A run chart plotting, month by month, the share of each new group of starters who finish, beginning with the baseline year, will show whether any change is sustained. Completion will also be reported separately by regimen and observation method, recognizing that these subgroups reflect patients' choices and are not randomized. Secondary measures will be summarized descriptively.

Conclusion

The project's methods are designed to answer a practical question with data the clinic already collects: whether weekly dosing confirmed by nurses over video raises completion of latent tuberculosis treatment. A pre-post design, an inclusive participant definition, operational outcome definitions consistent with published trials and the clinic's baseline, protection of patients' privacy and a combined statistical and run chart analysis together provide a realistic, defensible basis for judging whether the change worked. The next section reports the results.

References

Belknap, R., Holland, D., Feng, P.-J., Millet, J.-P., Caylà, J. A., Martinson, N. A., Wright, A., Chen, M. P., Moro, R. N., Scott, N. A., Arevalo, B., Miró, J. M., Villarino, M. E., Weiner, M., & Borisov, A. S. (2017). Self-administered versus directly observed once-weekly isoniazid and rifapentine treatment of latent tuberculosis infection: A randomized trial. Annals of Internal Medicine, 167(10), 689-697. https://doi.org/10.7326/M17-1150

Ogrinc, G., Davies, L., Goodman, D., Batalden, P., Davidoff, F., & Stevens, D. (2016). SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): Revised publication guidelines from a detailed consensus process. BMJ Quality & Safety, 25(12), 986-992. https://doi.org/10.1136/bmjqs-2015-004411

Sterling, T. R., Njie, G., Zenner, D., Cohn, D. L., Reves, R., Ahmed, A., Menzies, D., Horsburgh, C. R., Crane, C. M., Burgos, M., LoBue, P., Winston, C. A., & Belknap, R. (2020). Guidelines for the treatment of latent tuberculosis infection: Recommendations from the National Tuberculosis Controllers Association and CDC, 2020. MMWR Recommendations and Reports, 69(1), 1-11. https://doi.org/10.15585/mmwr.rr6901a1