Clinical trial NCT05052021: The South African Collaborative Surgical Outcomes Study (SACSOS)
Official title: A Prospective Observational Cohort Study of Patient-reported Outcomes After Surgery Using a Digital Health Platform
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Complications
Keywords: Outcome measures
Peri-operative care
Patient-centered care
Lead sponsor: Sefako Makgatho Health Sciences University
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
name: University of Cape Town
First posted: 2021-09-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To enable a patient-centred approach, patients will be invited to participate in the study by a member of the clinical team responsible for their care. 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.

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To describe the relationship between preoperative and 6-month postoperative health-related quality of life in South African surgical patients.
timeFrame: 6 Months post-operatively
Secondary outcomes:
measure: To describe the relationship between patient comorbidities, surgical characteristics and postoperative patient- reported outcomes measures (quality of recovery, health-related quality of life).
timeFrame: 24-48 hours postoperatively
measure: To assess data quality (accuracy) of the adapted patient-reported POMS by comparison with completed provider POMS.
timeFrame: 5 days postoperatively
measure: To compare data quality (completeness) for patient-reported outcomes and provider POMS between public and private sector settings.
timeFrame: 5-7 days postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: University of Cape Town
name: Bruce Biccard, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sefako Makgatho Health Sciences University
name: Hyla-Louise Kluyts, DMed
role: PRINCIPAL_INVESTIGATOR
References: