Activate Tennessee: A CHW-Supported Program for Patient Activation

Обзор

The research project will involve community health workers (CHWs) that will help participants to better understand their medical conditions and to responsibly manage their medical needs. The project will focus on participants with the greatest medical needs and those that have many different illnesses at the same time. CHWs will help guide participants in focusing on improving their knowledge and confidence to manage their health conditions and to improve their ability to understand how the healthcare system works. This will give participants the opportunity to take charge of their illnesses and possibly improve their health conditions over time. The CHWs will work together with participants to develop a health plan focused on their specific health needs.

Подробное описание

Medically underserved persons living with at least two chronic conditions will be recruited for the study.

Participants assigned to the intervention group will receive strategic and intentional outreach and support from a CHW for 9 months to carry out the patient activation intervention. CHWs will work with participants in the intervention group to develop an Individual Patient Health Activation Plan (IHAP) that is informed by the participants individual health conditions and responses to survey questions. CHWs will actively engage in outreach with participants at a minimum of once a month to see how they are doing and to update or modify the IHAP, as needed. They will assist the participant in understanding medical advice, developing chronic disease self-management skills, accessing health care, making appointments, and addressing challenges arising from social determinants of health. CHWs will also utilize motivational interviewing to assist participants in making progress on their activation goals. CHWs will follow up with the study participant monthly but remain available to participants as frequently as participants communicate the need and interest. Beyond the minimum frequency of monthly, the length and frequency of visits will be determined collaboratively based on participant needs and goals. Fidelity will be measured by completion of participant's IHAP and monthly completion of CHW documentation including documented use of at least two patient activation interventions.

Participants in the comparator group will receive support to complete an IHAP and access to an interactive community resource website. CHWs will remain available to comparator group participants in response to communicated need and interest but will not provide active outreach to participants.

Both groups s will meet with the CHWs four times (Baseline, 3 months, 6 months, and 9 months) to complete study surveys and questionnaires, including the patient activation, the primary study outcome.

Вмешательства

• Поведенческое Intervention
  Persons assigned to the intervention group will receive strategic and intentional outreach and support from a CHW for 9 months to carry out the patient activation intervention. CHWs will work with persons in the intervention group to develop an Individual Patient Health Activation Plan (IHAP) that is informed by the participants individual health conditions. The IHAP will address priorities and barriers to obtaining optimal health, access to care, and adherence to a health care plan. CHWs will a
• Поведенческое Control Group
  Persons in the comparator group will receive support to complete an IHAP and access to an interactive community resource website. CHWs will remain available to comparator group participants in response to communicated need and interest but will not provide active outreach to participants.

Первичные конечные точки

• Patient Activation Measure [Срок оценки: From enrollment to end of 9 months]

Критерии участия

Критерии включения

• 18 years and older,
• Able to speak and understand English
• Have been told by a health care provider that they have two or more, chronic health conditions
• Are classified as medically underserved or socially vulnerable person

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 24. Association of State and Territorial Health Officials. (n.d.). Community health workers: evidence of their effectiveness. Association of State and Territorial Health Officials. Accessed on April 10, 2025: https://www.astho.org/globalassets/pdf/community-health-workers-summary-evidence.pdf
• Kangovi S, Mitra N, Turr L, Huo H, Grande D, Long JA. A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol. Contemp Clin Trials. 2017 Feb;53:115-121. doi: 10.1016/j.cct.2016.12.009. Epub 2016 Dec 10. PMID 27965180
• Crespo R, Christiansen M, Tieman K, Wittberg R. An Emerging Model for Community Health Worker-Based Chronic Care Management for Patients With High Health Care Costs in Rural Appalachia. Prev Chronic Dis. 2020 Feb 13;17:E13. doi: 10.5888/pcd17.190316. PMID 32053481
• 21. Patel MI, Kapphahn K, Salava D, et al. The effect of a multilevel community health worker-led intervention on health-related quality of life, patient activation, acute care use, and total costs of care: A randomized controlled trial. Journal of Clinical Oncology. 2022;40(16_suppl):6500-6500.
• Jana S, Basu I, Rotheram-Borus MJ, Newman PA. The Sonagachi Project: a sustainable community intervention program. AIDS Educ Prev. 2004 Oct;16(5):405-14. doi: 10.1521/aeap.16.5.405.48734. PMID 15491952
• Liebman AK, Juarez PM, Leyva C, Corona A. A pilot program using promotoras de salud to educate farmworker families about the risk from pesticide exposure. J Agromedicine. 2007;12(2):33-43. doi: 10.1300/J096v12n02_04. PMID 18086652
• Morgan K, Lee J, Sebar B. Community health workers: a bridge to healthcare for people who inject drugs. Int J Drug Policy. 2015 Apr;26(4):380-7. doi: 10.1016/j.drugpo.2014.11.001. Epub 2014 Nov 13. PMID 25477284
• Stupplebeen DA, Barnett-Sherrill AT, Sentell TL. Community Health Workers in Hawai'i: A Scoping Review and Framework Analysis of Existing Evidence. Hawaii J Med Public Health. 2019 Jun;78(6 Suppl 1):6-14. PMID 31285962

Идентификаторы

NCT: NCT07279415 · TR72217X5599 · OT2HL158287

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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