POSITIVE OUTCOMES: Improving Quality

King's College London

Status

Not yet enrolling

Conditions

HIV

Treatments

Other: POSITIVE OUTCOMES

Study type

Observational

Funder types

Other

Identifiers

NCT07229326

IN-UK-985-6892

Details and patient eligibility

About

People Living with HIV (PLWH) in the UK have a high burden of mental health, social and spiritual concerns, physical symptoms, and poorer health-related quality of life than the general population. PLWH feel that routine clinical appointments do not routinely address the things that matter to them, with implications for their engagement and outcomes of treatment and care. Contrastingly, good psychosocial care and communication with HIV professionals are associated with improvements in clinical outcomes, adherence and retention in care. Although HIV service structures, processes and outputs are routinely audited, it is person-centred patient-reported outcomes that define quality care. We have established a stakeholder project team, conducted community consultation and undertaken careful research-led development of a PROM for PLWH (called "POSITIVE OUTCOMES". This PROM has been developed in 2 European countries and validated in 5 European countries, using best scientific principles of psychometrics. We have established face and content validity, conducted cognitive interviews, and demonstrated validity and reliability in a sample of N=1,705 PLWH who completed at least 2 data points (manuscript in preparation). This was conducted alongside a national consultation to develop the new iteration of HIV care standards that includes a standard on "person-centred care" https://www.bhiva.org/file/KrfaFqLZRlBhg/BHIVA-Standards-of-Care-2018.pdf.

To meet the requirements in delivering and auditing person-centred care within those standards, we need to answer the following questions:

What are optimal methods for routine implementation of the PROM from the perspectives of stakeholders
What are locally-relevant components of a Decision Support Tool to provide clinicians with appropriate evidence-based clinical responses to patient PROM scores
What is an implementable Quality Improvement Programme to improve person-centred outcomes, informing (inter)national roll out with existing registry data?

The aim of this proposal is to develop a five-site demonstration patient-centred quality improvement programme determining feasibility, optimal implementation methods and data usage, and to deliver a framework for (inter)national adoption.

The objectives are:

To develop a quality improvement team within each of our three demonstration sites and identify site-specific challenges and potential solutions (including IT) for PROM implementation.
To develop an evidence-based Decision Support Tool (DST) specifying clinical responses to real-time PROM data from PLWH that are feasible within local resources, a PROM training programme for clinicians and a PLWH "mentor" for patients in each site
Hold a quality improvement launch meeting to train on POSITIVE OUTCOMES and DST implementation.
Implement the Positive Outcomes PROM in three demonstration sites
Test impact on outcomes using annual quality improvement cycles at facility level Determine stakeholder (PLWH, clinician) views on the quality improvement mechanisms, impact and areas for further refinement.
Develop and disseminate a national manual on implementation of the POSITIVE OUTCOMES quality improvement programme.

The project is working with 5 clinics across the UK and the US:

King's College Hospital NHS Foundation Trust (London, UK)
Chelsea and Westminster Hospital (London, UK)
Brighton and Sussex University Hospitals NHS Trust (Brighton, UK)
HOWARD BROWN Health Clinic (Chicago, US)
CAN SUPPORT Community Health Center (Miami, US)

The observational model for the project is a quality improvement programme.

Enrollment

17,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult (aged at least 18 years) attending outpatient HIV care at one of the UK recruitment sites
able to consent to participate in the study
able to communicate in English or a language provided by NHS translation services
purposively sampled by age, gender, ethnicity, sexual orientation, and time since HIV diagnosis

Exclusion criteria