The South African Collaborative Surgical Outcomes Study (SACSOS)

Sefako Makgatho Health Sciences University

Status: Not yet enrolling

Conditions: Postoperative Complications

Treatments: Other: Public or Private Sector Patients

Study type: Observational

Funder types: Other

Identifiers

NCT05052021

SMUREC/M/184/2020

Details and patient eligibility

About

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).

Full description

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.

The study will focus on patient participation with the web-based platform as the primary recruitment method. This will reduce the need for clinician input, and promote greater patient-centeredness. Patient participation and data capturing require internet access to the web-based platform.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients presenting for any surgical procedure at South African hospitals during the specified study period.

Exclusion criteria

• 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.

Trial design

1,000 participants in 2 patient groups

Patients within the private healthcare sector

Description:

Patients from private sector hospitals in South Africa accommodating the use of the Bespoke Surgical Institute (BSI) Deep Health clinical data platform.

Treatment:

Other: Public or Private Sector Patients

Patients within the public healthcare sector.

Description:

Patients admitted for surgery at Dr George Mukhari Academic Hospital, Gauteng Department of Health.

Treatment:

Other: Public or Private Sector Patients