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Better Health Outcomes Through Mentoring and Assessment (BHOMA) (BHOMA)

12 de abril de 2017 actualizado por: University of North Carolina, Chapel Hill

CIDRZ 1229- Better Health Outcomes Through Mentoring and Assessment (BHOMA)

BHOMA Interventions

The purpose of this study is to assess the impact of the BHOMA intervention on health in 3 rural districts of Zambia.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The BHOMA study includes systematic program implementation designed to contribute to generalizable knowledge and evaluation of this program. The program aims to improve primary health care through an integrated package of interventions, at both health facility and community level, centered on improving the patient -provider interface which is considered to be key to improving health outcomes. The primary objective of this research is to assess the impact of the BHOMA intervention on health in three rural districts of Zambia.

Objectives include: to understand the causal pathways of the BHOMA interventions by analyzing inputs, processes, outputs, and outcomes; to measure the cost of the BHOMA interventions; and to measure whether the health system has been strengthened by the BHOMA interventions. The endpoints of the study will be measured by a combination of facility surveys, facility health worker and community health worker interviews, quality assessments, qualitative studies and community surveys.

The study involves 7 stepped introduction of the programme in 48 facilities. A step typically involves initiation of a set of selected health facilities and the communities they serve. On average, 6 randomly selected sites are involved in a step. Facility workers are trained; community health workers, clinic support worker and traditional birth attendants are identified and trained through a month-long Ministry of Health (MOH) approved course. Equipment for data collection and electronic capture are set up, filing systems established and the study begins when the tools get implemented. Close supervision is provided for at least a month following initiation; there after regular supervisory visits are done by six quality improvement teams.

Clinic Intervention, implemented by the Centre for Infectious Disease Research in Zambia (CIDRZ) BHOMA program:

The clinic intervention consists of the following 5 components: 1) the implementation of clinical care forms and accompanying job aids, 2) resources, to includes equipment, supplies, staffing and infrastructure, 3) clinic implementation, which involves a quality improvement team working at the clinic to introduce the new patient flow system and to improve the skills of clinic staff, 4) the use of electronic information for performance assessment, which involves implementing an electronic data entry system within the clinics and 5) supportive mentoring, which will involve the Quality Improvement (QI) team reviewing patient charts for appropriate screening, diagnostics, treatment or follow-up, attending patient visits, identifying equipment or infrastructure issues, and reviewing clinic performance reports and updating the clinic's quality improvement strategy.

Community Intervention, implemented by the CIDRZ BHOMA program:

The community intervention aims to expand the availability of community-based health services and improve the quality of these services with the use of three groups:

Community Health Workers:

The investigators will engage one community health worker (CHW) per Neighborhood Health Committee to conduct patient follow-up and household assessments. The CHWs will use two forms - patient follow-up form and a household assessment form, and will be trained to assess which patients need referral to the clinic or hospital.

Traditional Birth Attendants:

The investigators will offer training for traditional birth attendants (TBAs) working near the implementation clinics. The training will review the goals of facility delivery and introduce a pregnancy referral form for TBAs. The investigators will encourage the TBA to help the patient arrive at the clinic, and provide incentives for the TBAs for clinic referrals. The investigators will also train the TBAs to follow up all pregnancies in the first month to assess the infant and teach the mother about when it is appropriate to bring the infant to the clinic. TBAs will complete infant follow-up forms.

Neighborhood Heath Committees (NHC):

These committees will complete a community health event register, during which they will capture information about serious sicknesses and deaths that are not recorded at the clinics. Each NHC will visit households and return their register to the clinic.

These activities will continue throughout the duration of the funded project.

Tipo de estudio

Intervencionista

Inscripción (Actual)

207517

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Lusaka, Zambia
        • Center for Infectious Disease Research in Zambia

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Intervention Sites The intervention will involve all of the health facilities in the Chongwe, Kafue and Luangwa districts.

Exclusion Criteria Hospitals will be excluded from the intervention as they do not have discrete catchment populations. The intervention will be implemented by 6 teams each of which will use 1 facility as a pilot site to test out the intervention. The pilot sites will be excluded from the evaluation. Health facilities with catchment populations exclusively serving the armed forces will be excluded.

Inclusion Criteria

  • All enumerated adults who are able to give written, informed consent. If an adult is illiterate they may be asked to give consent providing the information is read to them and it is established that they fully understand its contents and there is a witness available to witness the understanding of the information and the fingerprinting of the consent form.
  • All adolescents 10-17 years and children 5 years or less who have a parent or responsible guardian who is able to give written, informed consent. If the parent or guardian is illiterate they may be asked to give consent providing the information is read to them and it is established that they fully understand its contents and there is a witness available to witness the understanding of the information and the fingerprinting of the consent form.

Exclusion Criteria

  • Any adult who is unable to give informed consent due to mental or other disability
  • Any adolescent or child who has no responsible parent or guardian
  • Any household member who has been absent from the house for more than 72 hours

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Usual Care
Care is delivered according to baseline standard practice
Experimental: BHOMA
Care is delivered according to the BHOMA intervention
A complex health systems, clinical care, and community intervention to improve outcomes

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Age standardized mortality rates in those aged <60 years.
Periodo de tiempo: 4 years
The sample size is based on a mortality rate for those aged<60 years of 20/1000 person years, each of 3 cross sectional surveys recruits 150 households of whom 6 members are aged <60 years, and births and deaths within the household in the last 12 months are ascertained. For a values of k between 0.2 and 0.3 there is at least 90% power to detect a 35% reduction in mortality, and for k=0.35 there is approximately 87% power.
4 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mortality in those aged <5 years.
Periodo de tiempo: 4 years
The sample size is based on a mortality rate for those aged<5 years of 35/1000 person years (equivalent to under-5 mortality of 168/1000), each of 3 cross sectional surveys recruits 150 households of whom 2 members are aged <5 years, and births and deaths within the household in the last 12 months are ascertained. For a values of k between 0.2 and 0.3 there is at least 90% power to detect a 35% reduction in mortality, and for k=0.35 there is approximately 84% power.
4 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Jeffrey Stringer, MD, UNC at Chapel Hill

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2011

Finalización primaria (Actual)

1 de agosto de 2016

Finalización del estudio (Actual)

1 de agosto de 2016

Fechas de registro del estudio

Enviado por primera vez

10 de septiembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

12 de septiembre de 2013

Publicado por primera vez (Estimar)

13 de septiembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de abril de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

12 de abril de 2017

Última verificación

1 de febrero de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • CIDRZ 1229

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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