A Prospective Observational Cohort Study of Patient-reported Outcomes After Surgery Using a Digital Health Platform
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- To describe the relationship between preoperative and 6-month postoperative health-related quality of life in South African surgical patients.
研究概览
简要总结
Improving quality of perioperative care depends on reliable measurement of clinically important and patient-centred data, that will allow collaborative decision-making between patient and clinician. The use of digital health tools to share person-centric data with the aim of improving quality of care is encouraged by the World Health Organization Global Strategy on Digital Health. With virtual and online communication becoming a universal feature of modern life, there is a promising opportunity to engage patients and clinicians in perioperative data collection using digital health platforms. The Perioperative Shared Health Record (PSHR), developed by Safe Surgery South Africa, provides the opportunity to capture standardised patient-centric postoperative outcomes measures, like Quality of Recovery (QOR), Health Related Quality of Life (HRQOL), the WHO Disability Assessment Schedule (WHODAS). These are all standardised measures and questionnaires, which have been recommended by working groups focused on the patient's experience after surgery. The PSHR enables sharing of data between the surgical patient and his/her clinical team (surgeons and anaesthetists).
详细描述
SACSOS is a patient-centered prospective observational cohort study.
Initially, clinical teams in the South African private health care sector will be approached. In later phases of the study, recruitment will include eligible patients in the South African public health care sector.
Patient engagement and -participation will be sought during the recruitment process by engaging with the clinical team (surgeon, anaesthetist, hospital clinical manager) for individual patient care (at a micro level); in data collection using a patient-centric platform; and in the follow up after surgery. Data will be collected by patients using a digital platform, the Perioperative Shared Health Record (PSHR). De-identified data will be extracted from the database at predetermined intervals and made available to the principal investigator for analysis.
The PSHR will be updated to optimise health information exchange between the surgical patient and clinical team members during the study.
Participation from health care providers will be in a team-based approach, including surgeon(s) and/or anaesthetist(s) at each specific center. A core group of participating centers will be identified.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients presenting for any surgical procedure at South African hospitals during the specified study period.
排除标准
- •Patients unable to provide consent to participation.
- •Patients whose legal guardian is unable to provide consent to participation (if applicable).
- •Patients unable to nominate next-of-kin, guardian of or a person of their choice, as their representative during follow-up.
结局指标
主要结局
To describe the relationship between preoperative and 6-month postoperative health-related quality of life in South African surgical patients.
时间窗: 6 Months post-operatively
Health Related Quality of Life, measured with the EQ-5D-5L score, preoperatively and at 6 months postoperatively
次要结局
- To describe the relationship between patient comorbidities, surgical characteristics and postoperative patient- reported outcomes measures (quality of recovery, health-related quality of life).(24-48 hours postoperatively)
- To assess data quality (accuracy) of the adapted patient-reported POMS by comparison with completed provider POMS.(5 days postoperatively)
- To compare data quality (completeness) for patient-reported outcomes and provider POMS between public and private sector settings.(5-7 days postoperatively)
研究者
Hyla-Louise Kluyts
Professor
Sefako Makgatho Health Sciences University