跳至主要内容
临床试验/NCT02886364
NCT02886364已完成不适用

Evaluation of the Adapted Safe Childbirth Checklist and Respectful Care in Rural Community Hospitals and Maternity Centers in Chiapas, Mexico: A Mixed Methods Convergent Intervention Study

Brigham and Women's Hospital0 个研究点目标入组 575 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
575
主要终点
Adherence with evidence-based practices in the checklist

研究概览

简要总结

The purpose of this mixed methods study is to evaluate the implementation of an adapted Safe Childbirth Checklist in a rural hospital in Chiapas, Mexico. The study aims are:

  1. To evaluate the implementation of the adapted Safe Childbirth Checklist using quality of care indicators and the perspectives of providers and patients;
  2. To examine changes in the perceptions of disrespectful and respectful practices around childbirth among providers before and after a quality improvement program.
  3. To understand how postpartum women and their male partners perceive the care they received at the hospitals in Ángel Albino Corzo and Revolución with regard to disrespectful and respectful practices, and how, if at all, these experiences compare with prior birth experiences in other settings.
  4. To examine trends in proportion of facility-based births in the catchment area of the hospital after the implementation of the adapted Safe Childbirth Checklist

详细描述

This is a mixed methods convergent intervention study design. Quantitative and qualitative data will be collected and integrated to answer the specific aims above. There are 3 groups of people who will be approached to participate in this study:

  1. Obstetric providers at the maternity center in Revolución (approximately 7-15 people)
  2. Pregnant women who come to the maternity center or hospitals in Ángel Albino Corzo or Revolución to give birth from September 2016 - June 2017 (approximately 300 women, age >15 years old)
  3. Postpartum women who delivered in the maternity center or hospitals after September 2016 (approximately 30-40 women, age >15 years old) and their male partners (approximately 30-40 men, age >15 years old) who live in Partners In Health-affiliated communities

The quality improvement training program will center on coaching around the adapted Safe Childbirth Checklist. This document contains reminders for evidence-based practices during childbirth, and it has been adapted to the context in Mexico. Only standard of care practices will be taught and employed at the maternity center. The quality improvement program has no additional intervention that would change diagnoses or management during peripartum care.

Risks to subjects are minimized by ensuring privacy in all research encounters. Additionally, research staff will not provide any clinical care to subjects, thereby dissociating participation in research from receiving clinical care.

There are no anticipated harms to the participants of this study that would compromise their safety because our quality improvement program does not introduce a new diagnostic test or treatment modality. The only foreseeable risk is emotional distress from discussing a potentially traumatic birth experience, which could occur with both healthcare providers and patients. The research team will undergo sensitization training in identifying signs of distress that may arise during the survey, interview, or focus group. They will be instructed to provide the appropriate mental health referrals if necessary. Partners In Health has a growing mental health program that can provide appropriate clinical accompaniment if required.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Women who delivered at Ángel Albino Corzo Hospital between September 2016 and June 2017
  • Women who live in Partners In Health-affiliated communities

排除标准

  • Index pregnancy that ended in miscarriage or stillbirth
  • Non-Spanish speaking

研究组 & 干预措施

Women delivered at AAC Hospital

Other

The intervention is only being implemented at the Ángel Albino Corzo Hospital due to limited funding. The site was selected by the Ministry of Health in Chiapas as a hospital that would benefit from improved quality of care around childbirth. There are no other arms in this study.

干预措施: Adapted Safe Childbirth Checklist (Behavioral)

结局指标

主要结局

Adherence with evidence-based practices in the checklist

时间窗: 10 months

Quantitative data will be collected through key indicators in the checklist to capture uptake of best practices over time.

Number of facility-based childbirths within Partners In Health-affiliated communities in the catchment area of hospital

时间窗: 10 months

The proportions of facility-based births vs. home births will be compared pre- and post-implementation of the adapted Safe Childbirth Checklist.

Perceptions of patient safety and quality of care from providers and patients

时间窗: 10 months

Qualitative data will be collected through interviews of providers, postpartum women and their partners regarding their childbirth experiences in the district hospital where the adapted Safe Childbirth Checklist was implemented.

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

Daniel Palazuelos

Associate Physician

Brigham and Women's Hospital

相似试验