POSITIVE OUTCOMES: Improving Quality
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: POSITIVE OUTCOMES.
- Who it may be relevant to
- Registry conditions: HIV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
POSITIVE OUTCOMES: Driving up the Quality of HIV Outpatient Care Through the Routine Implementation of a PROM to Promote Patient-centredness
Overview
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.
Interventions
- Other POSITIVE OUTCOMES
POSITIVE OUTCOMES is a validated patient-reported outcome measure
Primary outcome measures
- Stakeholder views [Time frame: 6-24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Harding R, Clucas C, Lampe FC, Date HL, Fisher M, Johnson M, Edwards S, Anderson J, Sherr L. What factors are associated with patient self-reported health status among HIV outpatients? A multi-centre UK study of biomedical and psychosocial factors. AIDS Care. 2012;24(8):963-71. doi: 10.1080/09540121.2012.668175. Epub 2012 Apr 23. PMID 22519889
- Bristowe K, Clift P, James R, Josh J, Platt M, Whetham J, Nixon E, Post FA, McQuillan K, Ni Cheallaigh C, Murtagh F, Anderson J, Sullivan AK, Harding R. Towards person-centred care for people living with HIV: what core outcomes matter, and how might we assess them? A cross-national multi-centre qualitative study with key stakeholders. HIV Med. 2019 Sep;20(8):542-554. doi: 10.1111/hiv.12758. Epub 2 PMID 31162817
- Bristowe K, Murtagh FEM, Clift P, James R, Josh J, Platt M, Whetham J, Nixon E, Post FA, McQuillan K, Cheallaigh CN, Kall M, Anderson J, Sullivan AK, Harding R. The development and cognitive testing of the positive outcomes HIV PROM: a brief novel patient-reported outcome measure for adults living with HIV. Health Qual Life Outcomes. 2020 Jul 6;18(1):214. doi: 10.1186/s12955-020-01462-5. PMID 32631444
- Harding R, Jones CI, Bremner S, Bristowe K, West B, Siegert RJ, O'Brien KK, Whetham J; EMERGE Consortium, Horizon 2020. Positive Outcomes: Validity, reliability and responsiveness of a novel person-centred outcome measure for people with HIV. HIV Med. 2022 Jul;23(6):673-683. doi: 10.1111/hiv.13224. Epub 2022 Jan 11. PMID 35014143
Identifiers
NCT: NCT07229326 · IN-UK-985-6892