POSITIVE OUTCOMES: Improving Quality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

17000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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People Living with HIV

POSITIVE OUTCOMES

Intervention Type OTHER

POSITIVE OUTCOMES is a validated patient-reported outcome measure

Interventions

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POSITIVE OUTCOMES

POSITIVE OUTCOMES is a validated patient-reported outcome measure

Intervention Type OTHER

Eligibility Criteria

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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

* Aged under 18
* not attending care at one of the recruitment sites
* not able to consent to participate in the study
* speaks a language not available through NHS translation services

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No