Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06431867 |
| Other study ID # |
BTHFT2918 |
| Secondary ID |
NIHR205378 |
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2024 |
| Est. completion date |
September 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Bradford Institute for Health Research |
| Contact |
Anne Heaven, MPhil |
| Phone |
+44 1274382815 |
| Email |
anne.heaven[@]bthft.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The Investigators aim to improve primary-care for older women with osteoporosis.
Older women they spoke with previously felt unseen, unimportant, unheard and uninformed.
These women felt that bone/joint health was an important issue for women aged 70+.
Osteoporosis is a disease that makes bones more breakable and can lead to significant pain,
disability and death, costing approximately £4.4 billion a year in the United Kingdom.
Women are four times more likely to have osteoporosis than men and suffer fractures earlier.
Osteoporosis care is poor in primary care even though good guidelines are available.
The Investigators will work with older women and healthcare professionals to help guide the
research. They have already looked at published research and will build on this. They will
identify what is important for both older women and professionals to inform the first
interview questions. The Investigators will ask older women and healthcare professionals
about the diagnosis and treatment of osteoporosis. They will also ask them how they manage
osteoporosis as a patient or care provider.
At regular intervals, the Investigators will look at the interview findings first and then
share their thoughts with older women and professionals. Together they will explore what the
interviews mean. These discussions may change the questions asked and who is interviewed
next.
The Investigators will combine all the information from interviews to identify what works
well and less well in osteoporosis care. They will check these findings against the
guidelines. They will continue to work with older women and healthcare professionals to
develop recommendations for improving care. The Investigators will also identify areas of
further work.
They will share recommendations with healthcare commissioners and produce a summary for a
variety of professional networks. They will also publish papers in journals aimed at
healthcare professionals and produce a summary document and advice for older women to use.
Description:
RESEARCH QUESTION How can older women and primary healthcare professionals be empowered to
improve osteoporosis care?
BACKGROUND The Women's Health Strategy for England highlights the lack of focus on older
women's needs and experiences. The Investigators talked to 32 older women across five public
engagement workshops. These women felt unseen, unimportant, unheard and uninformed. They also
felt bone/joint health and osteoporosis were important issues for older women (aged 70+).
Osteoporosis leads to around 180,000 fractures per year causing significant pain, disability
and death. The related cost, in the United Kingdom, is estimated at £4.4 billion a year.
Women are four times more likely to suffer with osteoporosis than men and tend to suffer
fractures earlier. Despite comprehensive guidelines being available, evidence suggests that
osteoporosis care is lacking in primary care.
AIMS AND OBJECTIVES To develop strategies to improve osteoporosis care using insights from
the experience of primary healthcare professionals and older women.
METHODS Ethnographic meta-analysis literature review, in-depth interviews and co-production
workshops. An information specialist will update the preliminary literature review. The
Investigators will synthesise evidence from older women and healthcare professionals to
identify new theoretical constructs. Findings will be reviewed in co-production workshops and
used to focus initial lines of enquiry. The Investigators will purposively sample 30 older
women, from across England, aged 70+ to interview. They will also elicit the views of
healthcare professionals in primary care. Interviews will explore the process of diagnosis,
treatment and management of osteoporosis. Information from interviews will initially be
reviewed by the Investigators.
Following a Constructivist Grounded Theory approach, the Investigators will take initial
findings to co-production workshops on a regular basis throughout fieldwork. Workshops will
facilitate iterative analysis and identify theoretical sampling gaps. This process may change
the types of questions asked or who is interviewed. The Investigators will combine
information from all interviews to identify barriers and facilitators for older women's
osteoporosis care, and cross-reference this with existing guidelines. Professional 'expert
witnesses' will join the workshops when required. Finally, recommendations for improving
osteoporosis care will be co-produced . Areas of further work that would improve osteoporosis
care in the future will also be identified.
PATIENT AND PUBLIC INVOLVEMENT Lay members will be involved in co-production workshops
throughout the research. The Investigators will also work with an expert patient co-applicant
in overall management of the project.
TIMELINES FOR DELIVERY Following 3 months of pre-award set-up, the Investigators will conduct
the literature review and develop the interview schedule in months 1-3. Interviews and
workshops will happen in months 4-11. A final analysis and report will be available in month
18.
IMPACT AND DISSEMINATION Findings will be sent to Integrated Care Boards responsible for
local commissioning to facilitate 'better fit' services. The Investigators will also produce
dissemination products for wide distribution through a variety of professional networks.
Academic papers will be published in journals targeted at healthcare professionals. Summary
information and advice, for older women, will be disseminated via national and community
networks and presentations nationwide. These outputs will be aimed at supporting successful
implementation of the All Party Parliamentary Group recommendations for better diagnosis,
treatment and management.
