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Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial
BACKGROUND: Hypertension is the most common cardiovascular disease in Nigeria and contributes to a large non-communicable disease burden. Our aim was to implement and evaluate a large-scale hypertension treatment and control program, adapted from the Kaiser Permanent Northern California and World He...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9344662/ https://www.ncbi.nlm.nih.gov/pubmed/35918703 http://dx.doi.org/10.1186/s43058-022-00328-9 |
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author | Baldridge, Abigail S. Aluka-Omitiran, Kasarachi Orji, Ikechukwu A. Shedul, Gabriel L. Ojo, Tunde M. Eze, Helen Shedul, Grace Ugwuneji, Eugenia N. Egenti, Nonye B. Okoli, Rosemary C. B. Ale, Boni M. Nwankwo, Ada Osagie, Samuel Ye, Jiancheng Chopra, Aashima Sanuade, Olutobi A. Tripathi, Priya Kandula, Namratha R. Hirschhorn, Lisa R. Huffman, Mark D. Ojji, Dike B. |
author_facet | Baldridge, Abigail S. Aluka-Omitiran, Kasarachi Orji, Ikechukwu A. Shedul, Gabriel L. Ojo, Tunde M. Eze, Helen Shedul, Grace Ugwuneji, Eugenia N. Egenti, Nonye B. Okoli, Rosemary C. B. Ale, Boni M. Nwankwo, Ada Osagie, Samuel Ye, Jiancheng Chopra, Aashima Sanuade, Olutobi A. Tripathi, Priya Kandula, Namratha R. Hirschhorn, Lisa R. Huffman, Mark D. Ojji, Dike B. |
author_sort | Baldridge, Abigail S. |
collection | PubMed |
description | BACKGROUND: Hypertension is the most common cardiovascular disease in Nigeria and contributes to a large non-communicable disease burden. Our aim was to implement and evaluate a large-scale hypertension treatment and control program, adapted from the Kaiser Permanent Northern California and World Health Organization HEARTS models, within public primary healthcare centers in the Federal Capital Territory, Nigeria. METHODS: A type 2 hybrid, interrupted time series design was used to generate novel information on large-scale implementation and effectiveness of a multi-level hypertension control program within 60 primary healthcare centers in the Federal Capital Territory, Nigeria. During the formative phase, baseline qualitative assessments were held with patients, health workers, and administrators to inform implementation package adaptation. The package includes a hypertension patient registry with empanelment, performance and quality reporting, simplified treatment guideline emphasizing fixed-dose combination therapy, reliable access to quality essential medicines and technology, team-based care, and health coaching and home blood pressure monitoring. Strategies to implement and adapt the package were identified based on barriers and facilitators mapped in the formative phase, previous implementation experience, mid-term qualitative evaluation, and ongoing stakeholder and site feedback. The control phase included 11 months of sequential registration of hypertensive patients at participating primary healthcare centers, followed by implementation of the remainder of the package components and evaluation over 37 subsequent, consecutive months of the intervention phase. The formative phase was completed between April 2019 and August 2019, followed by initiation of the control phase in January 2020. The control phase included 11 months (January 2020 to November 2020) of sequential registration and empanelment of hypertensive patients at participating primary healthcare centers. After completion of the control phase in November 2020, the intervention phase commenced in December 2020 and will be completed in December 2023. DISCUSSION: This trial will provide robust evidence for implementation and effectiveness of a multi-level implementation package more broadly throughout the Federal Capital Territory, which may inform hypertension systems of care throughout Nigeria and in other low- and middle-income countries. Implementation outcome results will be important to understand what system-, site-, personnel-, and patient-level factors are necessary for successful implementation of this intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT04158154. The trial was prospectively registered on November 8, 2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s43058-022-00328-9. |
format | Online Article Text |
id | pubmed-9344662 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-93446622022-08-03 Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial Baldridge, Abigail S. Aluka-Omitiran, Kasarachi Orji, Ikechukwu A. Shedul, Gabriel L. Ojo, Tunde M. Eze, Helen Shedul, Grace Ugwuneji, Eugenia N. Egenti, Nonye B. Okoli, Rosemary C. B. Ale, Boni M. Nwankwo, Ada Osagie, Samuel Ye, Jiancheng Chopra, Aashima Sanuade, Olutobi A. Tripathi, Priya Kandula, Namratha R. Hirschhorn, Lisa R. Huffman, Mark D. Ojji, Dike B. Implement Sci Commun Study Protocol BACKGROUND: Hypertension is the most common cardiovascular disease in Nigeria and contributes to a large non-communicable disease burden. Our aim was to implement and evaluate a large-scale hypertension treatment and control program, adapted from the Kaiser Permanent Northern California and World Health Organization HEARTS models, within public primary healthcare centers in the Federal Capital Territory, Nigeria. METHODS: A type 2 hybrid, interrupted time series design was used to generate novel information on large-scale implementation and effectiveness of a multi-level hypertension control program within 60 primary healthcare centers in the Federal Capital Territory, Nigeria. During the formative phase, baseline qualitative assessments were held with patients, health workers, and administrators to inform implementation package adaptation. The package includes a hypertension patient registry with empanelment, performance and quality reporting, simplified treatment guideline emphasizing fixed-dose combination therapy, reliable access to quality essential medicines and technology, team-based care, and health coaching and home blood pressure monitoring. Strategies to implement and adapt the package were identified based on barriers and facilitators mapped in the formative phase, previous implementation experience, mid-term qualitative evaluation, and ongoing stakeholder and site feedback. The control phase included 11 months of sequential registration of hypertensive patients at participating primary healthcare centers, followed by implementation of the remainder of the package components and evaluation over 37 subsequent, consecutive months of the intervention phase. The formative phase was completed between April 2019 and August 2019, followed by initiation of the control phase in January 2020. The control phase included 11 months (January 2020 to November 2020) of sequential registration and empanelment of hypertensive patients at participating primary healthcare centers. After completion of the control phase in November 2020, the intervention phase commenced in December 2020 and will be completed in December 2023. DISCUSSION: This trial will provide robust evidence for implementation and effectiveness of a multi-level implementation package more broadly throughout the Federal Capital Territory, which may inform hypertension systems of care throughout Nigeria and in other low- and middle-income countries. Implementation outcome results will be important to understand what system-, site-, personnel-, and patient-level factors are necessary for successful implementation of this intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT04158154. The trial was prospectively registered on November 8, 2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s43058-022-00328-9. BioMed Central 2022-08-02 /pmc/articles/PMC9344662/ /pubmed/35918703 http://dx.doi.org/10.1186/s43058-022-00328-9 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Baldridge, Abigail S. Aluka-Omitiran, Kasarachi Orji, Ikechukwu A. Shedul, Gabriel L. Ojo, Tunde M. Eze, Helen Shedul, Grace Ugwuneji, Eugenia N. Egenti, Nonye B. Okoli, Rosemary C. B. Ale, Boni M. Nwankwo, Ada Osagie, Samuel Ye, Jiancheng Chopra, Aashima Sanuade, Olutobi A. Tripathi, Priya Kandula, Namratha R. Hirschhorn, Lisa R. Huffman, Mark D. Ojji, Dike B. Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial |
title | Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial |
title_full | Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial |
title_fullStr | Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial |
title_full_unstemmed | Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial |
title_short | Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial |
title_sort | hypertension treatment in nigeria (htn) program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9344662/ https://www.ncbi.nlm.nih.gov/pubmed/35918703 http://dx.doi.org/10.1186/s43058-022-00328-9 |
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