Old AgeCHAFFINCHNCT06947915
Co-producing a Novel Model an Outcome Framework for the Implementation of Falls Management in Care Home Settings.
An observational study of Old Age and Long Term Care Facility, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
AIM: To co-produce a novel model for implementation of falls management for older people living in care homes SECONDARY OBJECTIVES Component One Objectives: Primary :To co-produce a novel model for the implementation of falls management in care homes Secondary To facilitate a series of co-production workshops with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Old Age, Long Term Care Facility, Fall Prevention
- What is being tested?
- Co-design workshop, Survey and Interview
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2023to 18 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Care home staff, residents and ICS stakeholders
Who may be able to join
- Key stakeholders within an ICS system including: carers, registered health professionals, managers and owners/executives from care homes commissioners, health care professionals and regulators involved in care home and falls management pathways, residents living in care homes relatives of residents living in care homes
- 18 years and over (no upper age limit)
- Any member of staff working in the 10 case study care homes in Nottinghamshire
Who cannot join
- Unable to read and understand written English
- Lack of capacity to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
AIM: To co-produce a novel model for implementation of falls management for older people living in care homes
SECONDARY OBJECTIVES
Read more
Component One Objectives:
Primary :To co-produce a novel model for the implementation of falls management in care homes Secondary
- To facilitate a series of co-production workshops with representation of key stakeholders
- To co-produce a novel implementation model for falls management
- To co-produce an outcomes framework to evaluate the implementation model
- To explore the feasibility of delivering the model and using the outcomes framework across Nottingham and Nottinghamshire Integrated Care Systems (ICSs)
Component Two Objectives:
- To evaluate how and the extent to which co-production occurs during the process of developing a novel model and an outcomes framework for the implementation for falls management in care homes
- To reflect on challenges and facilitators of using co-production approaches in this context
- To evaluate how care home residents can be supported to voice their priorities within the process.
Read the detailed description
Component One: Co-production of the implementation model and outcomes framework A series of co-production workshops will be undertaken using a systemic action research methodology to develop and explore the feasibility of a novel implementation model and outcomes framework. This will involve three small workshop groups consisting of residents and relatives, care home staff only, and representatives from ICS partner organisations. All participants will be invited to attend a multi-stakeholder workshop in the later stages of the process to share ideas. Data collected for component one will be collected by the PI and PhD student. The novel model will be co-produced as part of this project but may include activities such as a care home audit programme, a reporting process, training and education and a community of practice. Following co-production of the model it will be delivered across Nottinghamshire ICB and refined in line with the systemic action research process.
Component Two: Evaluating the co-production process A process evaluation will be undertaken to explore how and the extent to which co-production occurs in component one, including reflection on challenges and facilitators, and how resident involvement is supported. Data collected for component two will be collected by the PhD student.
- Conditions
- Old Age, Long Term Care Facility, Fall Prevention
- Being tested
- Co-design workshop, Survey, Interview
- Keywords
- long term care, falls management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-design workshopOther
Co-design workshops to develop the implementation model
SurveyOther
Survey of care staff knowledge and confidence
InterviewOther
Interview to explore care staff experience of the falls management support
| Study group | Role | What they receive |
|---|---|---|
| Stakeholder | Stakeholder across the ICS: Key stakeholders within an ICS system including:
carers, registered health professionals, managers and owners/executives from care homes commissioners, health care professionals and regulators involved in care home and falls management pathways residents living in care homes relatives of residents living in care homes Receives: Other: Co-design workshop | |
| Care home staff | Any member of staff working in the case study care homes Receives: Other: Survey; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Key features of the falls management implementation model and outcomes framework using thematic analysis from the co-design workshops through study completion anticipated at 18 months
The data collected to address this primary includes:
- The number of workshops, location, duration and range of stakeholders attending
- Summary of key themes from each meeting drawn together from flipcharts, online flipchart programmes such as padlet and field notes
- Cross-comparison of themes between the stakeholder groups
- Record of between meeting activities to describe the types of information and activities undertaken
- List of problems and potential solutions
- Facilitator maintained notes on the decisions made in developing the model and the factors influencing the decisions
- Description of the key features of the model Description of outcomes framework
Measured: From enrolment to the end of the co-design workshops at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start2 Mar 2023
- Primary completion18 Mar 2025
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Katie Robinson, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947915
- Sponsor's protocol ID
- 22011
- Acronym
- CHAFFINCH
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small number of participants
Publications
Hallam-Bowles F, Kilby A, Gordon A, Timmons S, Logan P, Rees L, Lawry W; CHAFFINCH stakeholder group; Robinson K. A Qualitative Evaluation Exploring Co-Production of Falls Management in Care Homes. Health Expect. 2025 Dec;28(6):e70500. doi: 10.1111/hex.70500.
PubMed 41261769
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-producing a Novel Model an Outcome Framework for the Implementation of Falls Management in Care Home Settings.
- ClinicalTrials.gov ID
- NCT06947915
- Acronym / sponsor ID
- CHAFFINCH / 22011
- Conditions
- Old Age, Long Term Care Facility, Fall Prevention
- Keywords
- long term care, falls management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AIM: To co-produce a novel model for implementation of falls management for older people living in care homes
SECONDARY OBJECTIVES
Component One Objectives:
Primary :To co-produce a novel model for the implementation of falls management in care homes Secondary
- To facilitate a series of co-production workshops with representation of key stakeholders
- To co-produce a novel implementation model for falls management
- To co-produce an outcomes framework to evaluate the implementation model
- To explore the feasibility of delivering the model and using the outcomes framework across Nottingham and Nottinghamshire Integrated Care Systems (ICSs)
Component Two Objectives:
- To evaluate how and the extent to which co-production occurs during the process of developing a novel model and an outcomes framework for the implementation for falls management in care homes
- To reflect on challenges and facilitators of using co-production approaches in this context
- To evaluate how care home residents can be supported to voice their priorities within the process.
Detailed description
Component One: Co-production of the implementation model and outcomes framework A series of co-production workshops will be undertaken using a systemic action research methodology to develop and explore the feasibility of a novel implementation model and outcomes framework. This will involve three small workshop groups consisting of residents and relatives, care home staff only, and representatives from ICS partner organisations. All participants will be invited to attend a multi-stakeholder workshop in the later stages of the process to share ideas. Data collected for component one will be collected by the PI and PhD student. The novel model will be co-produced as part of this project but may include activities such as a care home audit programme, a reporting process, training and education and a community of practice. Following co-production of the model it will be delivered across Nottinghamshire ICB and refined in line with the systemic action research process.
Component Two: Evaluating the co-production process A process evaluation will be undertaken to explore how and the extent to which co-production occurs in component one, including reflection on challenges and facilitators, and how resident involvement is supported. Data collected for component two will be collected by the PhD student.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stakeholder | – | Other: Co-design workshopStakeholder across the ICS: Key stakeholders within an ICS system including: carers, registered health professionals, managers and owners/executives from care homes commissioners, health care professionals and regulators involved in care home and falls management pathways residents living in care homes relatives of residents living in care homes |
| Care home staff | – | Other: Survey, Other: InterviewAny member of staff working in the case study care homes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Care home staff, residents and ICS stakeholders
Key inclusion criteria (3 listed)
- Key stakeholders within an ICS system including: carers, registered health professionals, managers and owners/executives from care homes commissioners, health care professionals and regulators involved in care home and falls management pathways, residents living in care homes relatives of residents living in care homes
- 18 years and over (no upper age limit)
- Any member of staff working in the 10 case study care homes in Nottinghamshire
Key exclusion criteria (2 listed)
- Unable to read and understand written English
- Lack of capacity to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-design workshopCo-design workshops to develop the implementation model | Other | Stakeholder |
| SurveySurvey of care staff knowledge and confidence | Other | Care home staff |
| InterviewInterview to explore care staff experience of the falls management support | Other | Care home staff |
Primary outcome
Key features of the falls management implementation model and outcomes framework using thematic analysis from the co-design workshops through study completion anticipated at 18 months
Time frame: From enrolment to the end of the co-design workshops at 12 months
The data collected to address this primary includes: * The number of workshops, location, duration and range of stakeholders attending * Summary of key themes from each meeting drawn together from flipcharts, online flipchart programmes such as padlet and field notes * Cross-comparison of themes between the stakeholder groups * Record of between meeting activities to describe the types of information and activities undertaken * List of problems and potential solutions * Facilitator maintained notes on the decisions made in developing the model and the factors influencing the decisions * Description of the key features of the model Description of outcomes framework
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Results publication: PubMed 41261769Hallam-Bowles F, Kilby A, Gordon A, Timmons S, Logan P, Rees L, Lawry W; CHAFFINCH stakeholder group; Robinson K. A Qualitative Evaluation Exploring Co-Production of Falls Management in Care Homes. Health Expect. 2025 Dec;28(6):e70500. doi: 10.1111/hex.70500.
- Individual participant dataSharing planned: No. Due to the small number of participants
Related trials for Old Age
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
Not yet recruiting
A Clinician-Patient Dual Behavior Change Framework to Leverage Informed Digital Nudges to Reduce Hospital Readmissions and Improve Patient Outcomes: A Trial for Scalable Strategy to Reduce Readmissions (PREVENT-R)
Readmission, Readmission Rates
Not yet recruiting
Curriculum Design and Effectiveness in Death and Spiritual Care
Death, Spiritual Care
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Robinson principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Old Age and Long Term Care Facility, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Key features of the falls management implementation model and outcomes framework using thematic analysis from the co-design workshops through study completion anticipated at 18 months (time frame: From enrolment to the end of the co-design workshops at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06947915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.