跳至主要内容
临床试验/NCT05236452
NCT05236452已完成不适用

Effect of Integrating Traditional Tuberculosis Care With Modern Health Care on Case Detection, Cost, and Client Satisfaction in Amhara Region, Ethiopia

Bahir Dar University2 个研究点 分布在 1 个国家目标入组 918 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
918
试验地点
2
主要终点
Tuberculosis case detection rate

研究概览

简要总结

Although many interventions are implemented to increase TB case detection, decrease diagnosis delay, and avoid catastrophic costs, there are no significant changes and the end TB goal will not be achieved in 2035. Innovative intervention that considers indigenous knowledge and unique culture and religious perspectives because many people go to traditional healers and holy water for healing. Therefore, integrating traditional tuberculosis care with modern care increase case detection, decrease diagnosis delay, and avoid catastrophic costs. There is no literature clearly defining integrating traditional TB care with modern care, but for the purpose of this study, integrating traditional care with modern care is defined as the collaboration of two systems through referral linkage. TB screening and diagnosis services will be done collaboratively in traditional and modern care services. A referral linkage model will be used to detect TB cases in both traditional and modern care services. Health care providers, traditional healers, priests, pastors, and imams will participate in the integration process. TB detection or diagnosis services will be integrated through referral linkage and strengthening capacity-building strategies. Traditional care centers and modern health care services will work collaboratively to improve TB case detection, reduce care costs, and avoid diagnosis delays. The standardized operational procedure of the full interventional package is described below.

There are four steps of the intervention phases. These are the preliminary phase, preparation for implementation and refinement on a small scale phase, administering the intervention, and end-line assessment of outcomes. The intervention will be providing training for traditional and modern care practitioners, patient education, TB screening, and bidirectional referral linkage.

This study hypothesized that integrating traditional care with modern care at the primary care level will increase the TB case detection rate by fifteen percentage points. Integrating traditional care with modern care at the primary care level will decrease TB diagnosis delay by fifteen percentage points. Integrating traditional care with modern care at the primary care level also will decrease the cost of TB care by 15 percentages of points

详细描述

Quantitative description Design: Both qualitative and quantitative methods will be used to answer our research questions. Cluster randomized control trial study design will be used to determine the effectiveness of integrating traditional care into modern care on case detection rate (for the first, second, and third objectives). The explanatory sequential design will be used to determine the effect of integrating traditional care and modern care on patient satisfaction (fourth objective). This explanatory sequential design will follow to obtain substantiate evidence from quantitative data which is used to determine whether it has effects on patient satisfaction on integration between the traditional with modern care. In this design, two phases will be involved. The first phase will be an initial quantitative instrument phase, followed by a qualitative data collection phase, in which the qualitative phase builds directly on the results from the quantitative phase. In this way, the quantitative results will be explained in more detail through the qualitative data.

Study participants: Study participants will be TB suspected individuals (i.e., coughs for more than two weeks, and other constitutional TB signs and symptoms such as fever, chills, night sweats, anorexia, and weight loss).

Intervention: Integration is recognized as a multidimensional concept with no singular purpose. Integrated service delivery can be defined as joining inputs, management, organization, and distribution of health services related to diagnostics, treatment, care, rehabilitation, and health promotion as a means of improving health status, access, quality, and continuity of care, consumer satisfaction, and efficiency. There is no literature clearly defining integrating traditional TB care with modern care, but for this study, integrating traditional care with modern care is defined as the collaboration of two systems through referral linkage. TB screening and diagnosis services will be done collaboratively in traditional and modern care services. A referral linkage model will be used to detect TB cases in both traditional and modern care services. Health care providers, traditional healers, priests, pastors, and imams will participate in the integration process. TB detection or diagnosis services will be integrated through referral linkage and strengthening capacity-building strategies. Traditional care centers and modern health care services will work collaboratively to improve TB case detection, reduce care costs, and avoid diagnosis delays. The standardized operational procedure of the full interventional package is described below.

Phase 1: Preliminary phase A preliminary intervention package is developed by inviting TB experts, and language professionals. The training manual is prepared and will deliver for practitioners to increase their knowledge and skill. Based on the provision of training contents, the knowledge gain and skill acquisition will be evaluated. The fidelity of the intervention is developed to monitor the whole implementation activities of the training manual as planned.

Phase 2: Preparation for implementation and refine on a small scale In this phase, numerous activities related to the intervention will be performed. Experts who can implement the intervention will be recruited based on experts' educational status (who have earned a BSc degree and above in nursing or public health or medical doctor), and have research and working experiences at TB clinic. A pilot test will be implemented outside the study area on 10% of the project sample size which is suggested by Connelly LM (2008)(287). Based on pilot findings and experts' judgment, the intervention package will be refined and enriched. Before the actual intervention is administered, a baseline data collection will be conducted on TB case detection rate and diagnostic delay in both intervention and control sites.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The random allocation process, enrolling participants and participants assigned in the intervention group will be done by statisticians who will not have awareness about the characteristics of the intervention and control groups using the computer random.org website. The study subjects will be unaware of the intervention they received. Laboratory personnel who will be involved in the tuberculosis diagnosis and a person who will assess the outcomes of intervention will be unaware of the group assignment. Intervention outcomes will be assessed by research assistants who are not participating in participant recruitment and they are masked. The study participants, caretakers/attendants, and healthcare providers will be masked at any point.

入排标准

性别
All
接受健康志愿者

入选标准

  • All sick people who come to traditional healers' clinic or holy water with cough for two weeks or more, unintentional weight loss, anorexia, fever, chest pain, chillness, night sweating, and/or fatigues will be included in the study.
  • All TB suspected patients who come to the health facilities with self-referral will be included in the study
  • Health facilities in the study area should have at least a microscope diagnostic service will be included in the study
  • All HEWs, TB focal persons at each level (health centers, hospitals, Woreda, Zone, and regional health bureau), traditional healers, clergy, pastors, Imams, and patients on anti-tuberculosis treatment will be the potential candidates for this study.

排除标准

  • Patients coming from traditional care centers and health facilities outside of the intervention and control area will be excluded from the study.
  • Debtera and Witch (Tinquaye) were excluded from this study because they have no known structure. In addition, people go to witch and Debtera secretly because they fear stigma and discrimination by society.

结局指标

主要结局

Tuberculosis case detection rate

时间窗: The outcome will be measured at 12 months

The case detection rate is calculated as the number of cases notified divided by the number of cases estimated for that year, expressed as a percentage. Tuberculosis case detection is diagnosed in a patient and is reported within the national surveillance system, and then to WHO. The case detection rate is expressed as the number of cases notified divided by the number of cases estimated for that year, expressed as a percentage.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Desalegne Amare

Associate professor

Bahir Dar University

研究点 (2)

Loading locations...

相似试验