Hip FracturesNCT02842996
Patient Reported Experience Measures Following Hip Fracture Surgery in the Elderly
An observational study of Hip Fractures and Elderly, run by University of Birmingham.
Trial summary
With an ageing population, hip fractures are likely to become a significant public health burden. Hip fracture surgery is associated with significant morbidity and mortality. Patient outcomes and experience underpin the National Health Service (NHS) Constitution in driving quality improvement and performance. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Elderly, Emergency Surgery
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2016
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients aged over 65 years undergoing hip fracture surgery. Care-givers of patients having undergone hip fracture surgery.
Who may be able to join
- Age 65 or over.
- Due to have surgical fixation for proximal femoral fracture.
- Care-giver of a patient having undergone surgical fixation for proximal femoral fracture.
Who cannot join
- Patients admitted with multiple trauma.
- Patients who are unable to speak sufficient English to participate in the interview.
- Patients who are unable to consent due to lack of capacity.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Qualitative Study to Ascertain Patient Reported Experience Measures Following Hip Fracture Surgery in the Elderly
With an ageing population, hip fractures are likely to become a significant public health burden. Hip fracture surgery is associated with significant morbidity and mortality. Patient outcomes and experience underpin the National Health Service (NHS) Constitution in driving quality improvement and performance.
We aim to conduct a qualitative research study to ascertain the important patient and carer reported experience measures following hip fracture surgery in the elderly to improve quality of care and service provision.
To learn about patient and care-giver experience to ascertain which aspects are important to patients and what can be improved.
Read the detailed description
Rationale for research:
Recovery following hip fracture surgery has been associated with poor functional outcome; (Marcantonio et al. 2001; Luger et al. 2010) these patients may require longer hospital stays, are more often discharged to long-term care, and have a generally poor prognosis for returning home or regaining function in activities of daily living (ADL). (Dolan et al. 2000) Loss to living independently in the community has a significant detrimental effect on their quality of life and some patients have reported that they would rather be dead than experience the loss of independence that results from a hip fracture. (Salkeld et al. 2000) Patients report that going home following hip fracture surgery would be their main priority. (Robinson et al. 2015) Recovery for patients is multi-faceted and includes physical, social and emotional domains. (Miller \& Mythen 2014) Increasingly focus is being modified to include patient related experience of the healthcare pathway to inform policymakers, health regulation and service improvement. (Gibbons \& Fitzpatrick 2012) Patient public involvement (PPI) via the Clinical Research Ambassador Group (CRAG) at Heart of England NHS Foundation Trust has helped to identify the research question with particular focus on the improving the perioperative care pathway. Members of the CRAG group have reported the impact of hip fracture to include loss of functional ability leading to additional stress for family members. They have advocated a qualitative study to assess the impact on patients and their carers based on their personal experiences. We aim to conduct interviews to ascertain important and relevant patient reported experience measures in elderly patients undergoing hip fracture surgery.
Aims:
To review and evaluate the literature to ascertain the themes related to patient and carer experiences following hip fracture surgery which can improve quality of care.
To conduct interviews to ascertain what are the patient and carer experiences surrounding discharge from hospital following hip fracture surgery? To identify important themes to guide us in improving the care-pathway surrounding patient discharge following fractured neck of femur surgery in the elderly.
To pilot a resource/information pack designed specifically to improve patient and carer experience following hip fracture surgery?
Research questions:
In the published literature what are the themes related to patient and carer experiences following hip fracture surgery which can improve quality of care? What are the patient and carer experiences surrounding discharge from hospital following hip fracture surgery? From patient and carer experience following hip fracture surgery what are the important themes that can improve the discharge pathway for patients and their carers.
What information should be included in a resource pack designed to help patient and carer following hip fracture surgery? Will a resource/information pack designed specifically help to improve patient and carer experience following hip fracture surgery?
Qualitative Interviews:
To explore physical, mental and emotional impact on patient and care-givers following hip fracture surgery we will conduct semi-structured interviews of patients and their care-givers. Participants will include patients who have undergone hip fracture surgery and their named care-giver. Participants will be screened at a single study site using clinical databases as well as reviewing new patients that are admitted on the orthopaedic ward. Patients will be excluded if they are unable to consent or unable to partake in the interview due to speech and language impairment.
Conduct of Interviews:
Semi-structured interviews will be conducted with patients and their carers at their location of choice. This will be at their residence or at the study site; if they choose to travel to the study site their travel expenses will be re-imbursed. If patients and their carers are being interviewed at the same time, we will aim to interview them separately, unless they request to be interviewed together. The interviews will be carried out by one member of the research team this will aim to ensure consistency of interview questions and technique throughout the study. Prior to starting the interview with the participants we will reconfirm consent. The interviews will be audio-recorded and written notes will also be taken.
Ethical considerations and consent:
Written consent will be obtained from participants during their in-patient hospital stay. An informal capacity/consent process will be used by a trained member of the research team. Written and verbal information will be provided about the study, using a suitable style and format for the participant. The researcher will ask the participant to recall study information to check understanding; this together with the clinical teams view will be used to assess capacity to consent. Consent will be sought for:
- Accessing medical records for the purpose of collecting relevant patient outcomes and patient health service use.
- Participating in a face to face interview following hospital discharge. If a patient is deemed to not have capacity they will not be included in the study.
Risks, burdens and benefits:
There is a small risk of distress for the patient and/or their carer during the interview when describing their memories and experiences. There may also be a time-burden to patients and their carers by taking part in the interview. To minimise these factors we will ensure that interviews are conducted on a day and time convenient to the patient and their carer. They will be able to stop the interview at any time and take a break if they require. If the patient/carer request or are identified as requiring support we will offer to contact their general practitioner (GP) on their behalf. The patient and their carer will be interviewed separately but if either requires support or feel vulnerable if left alone they will be interviewed together. If the patient requires the interview to be conducted in the community or at the patient's home there is a risk of the researcher, conducting the interview, to be put in a potential vulnerable situation. This will be minimised by ensuring the researcher follows Birmingham Heartlands Hospital lone worker policy.
Data analysis:
Interviews will be recorded and analysed anonymously with only the author knowing participant details. Data will be transcribed verbatim; transcripts will thereafter be reviewed to check for accuracy. Coding of the transcripts will occur, a second reviewer will check these. Results from the data analysis will guide development of a resource/information pack designed specifically help to improve patient and carer experience following hip fracture surgery.
Dissemination of results:
This study will not directly benefit the participants but it will improve services for patients in the future undergoing hip fracture surgery. It will identify areas of need/support to guide National Health Service (NHS) policymakers and healthcare provision and development of services to facilitate discharge to the community. By understanding the important patient reported experience measures we can go on to use these and compare quality of healthcare in this group of patients to improve care pathways.
- Conditions
- Hip Fractures, Elderly, Emergency Surgery
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient and carer study group | Patients having undergone hip fracture surgery and their care givers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient experiences following hip fracture surgery
Patients views and perceptions around their experience of hip fracture surgery with particular focus surrounding the discharge pathway.
Measured: 6 months
Carer experiences following hip fracture surgery
The views and perceptions of supporting a relative/friend having undergone hip fracture surgery, with particular focus on the discharge pathway.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842996
- Sponsor's protocol ID
- University of Birmingham
- Status last verified
- Jul 2016
- First submitted
- 7 Apr 2016
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study to Ascertain Patient Reported Experience Measures Following Hip Fracture Surgery in the Elderly
- ClinicalTrials.gov ID
- NCT02842996
- Acronym / sponsor ID
- University of Birmingham
- Conditions
- Hip Fractures, Elderly, Emergency Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Jul 2016 (estimated)
- 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.
With an ageing population, hip fractures are likely to become a significant public health burden. Hip fracture surgery is associated with significant morbidity and mortality. Patient outcomes and experience underpin the National Health Service (NHS) Constitution in driving quality improvement and performance.
We aim to conduct a qualitative research study to ascertain the important patient and carer reported experience measures following hip fracture surgery in the elderly to improve quality of care and service provision.
To learn about patient and care-giver experience to ascertain which aspects are important to patients and what can be improved.
Detailed description
Rationale for research:
Recovery following hip fracture surgery has been associated with poor functional outcome; (Marcantonio et al. 2001; Luger et al. 2010) these patients may require longer hospital stays, are more often discharged to long-term care, and have a generally poor prognosis for returning home or regaining function in activities of daily living (ADL). (Dolan et al. 2000) Loss to living independently in the community has a significant detrimental effect on their quality of life and some patients have reported that they would rather be dead than experience the loss of independence that results from a hip fracture. (Salkeld et al. 2000) Patients report that going home following hip fracture surgery would be their main priority. (Robinson et al. 2015) Recovery for patients is multi-faceted and includes physical, social and emotional domains. (Miller \& Mythen 2014) Increasingly focus is being modified to include patient related experience of the healthcare pathway to inform policymakers, health regulation and service improvement. (Gibbons \& Fitzpatrick 2012) Patient public involvement (PPI) via the Clinical Research Ambassador Group (CRAG) at Heart of England NHS Foundation Trust has helped to identify the research question with particular focus on the improving the perioperative care pathway. Members of the CRAG group have reported the impact of hip fracture to include loss of functional ability leading to additional stress for family members. They have advocated a qualitative study to assess the impact on patients and their carers based on their personal experiences. We aim to conduct interviews to ascertain important and relevant patient reported experience measures in elderly patients undergoing hip fracture surgery.
Aims:
To review and evaluate the literature to ascertain the themes related to patient and carer experiences following hip fracture surgery which can improve quality of care.
To conduct interviews to ascertain what are the patient and carer experiences surrounding discharge from hospital following hip fracture surgery? To identify important themes to guide us in improving the care-pathway surrounding patient discharge following fractured neck of femur surgery in the elderly.
To pilot a resource/information pack designed specifically to improve patient and carer experience following hip fracture surgery?
Research questions:
In the published literature what are the themes related to patient and carer experiences following hip fracture surgery which can improve quality of care? What are the patient and carer experiences surrounding discharge from hospital following hip fracture surgery? From patient and carer experience following hip fracture surgery what are the important themes that can improve the discharge pathway for patients and their carers.
What information should be included in a resource pack designed to help patient and carer following hip fracture surgery? Will a resource/information pack designed specifically help to improve patient and carer experience following hip fracture surgery?
Qualitative Interviews:
To explore physical, mental and emotional impact on patient and care-givers following hip fracture surgery we will conduct semi-structured interviews of patients and their care-givers. Participants will include patients who have undergone hip fracture surgery and their named care-giver. Participants will be screened at a single study site using clinical databases as well as reviewing new patients that are admitted on the orthopaedic ward. Patients will be excluded if they are unable to consent or unable to partake in the interview due to speech and language impairment.
Conduct of Interviews:
Semi-structured interviews will be conducted with patients and their carers at their location of choice. This will be at their residence or at the study site; if they choose to travel to the study site their travel expenses will be re-imbursed. If patients and their carers are being interviewed at the same time, we will aim to interview them separately, unless they request to be interviewed together. The interviews will be carried out by one member of the research team this will aim to ensure consistency of interview questions and technique throughout the study. Prior to starting the interview with the participants we will reconfirm consent. The interviews will be audio-recorded and written notes will also be taken.
Ethical considerations and consent:
Written consent will be obtained from participants during their in-patient hospital stay. An informal capacity/consent process will be used by a trained member of the research team. Written and verbal information will be provided about the study, using a suitable style and format for the participant. The researcher will ask the participant to recall study information to check understanding; this together with the clinical teams view will be used to assess capacity to consent. Consent will be sought for:
- Accessing medical records for the purpose of collecting relevant patient outcomes and patient health service use.
- Participating in a face to face interview following hospital discharge. If a patient is deemed to not have capacity they will not be included in the study.
Risks, burdens and benefits:
There is a small risk of distress for the patient and/or their carer during the interview when describing their memories and experiences. There may also be a time-burden to patients and their carers by taking part in the interview. To minimise these factors we will ensure that interviews are conducted on a day and time convenient to the patient and their carer. They will be able to stop the interview at any time and take a break if they require. If the patient/carer request or are identified as requiring support we will offer to contact their general practitioner (GP) on their behalf. The patient and their carer will be interviewed separately but if either requires support or feel vulnerable if left alone they will be interviewed together. If the patient requires the interview to be conducted in the community or at the patient's home there is a risk of the researcher, conducting the interview, to be put in a potential vulnerable situation. This will be minimised by ensuring the researcher follows Birmingham Heartlands Hospital lone worker policy.
Data analysis:
Interviews will be recorded and analysed anonymously with only the author knowing participant details. Data will be transcribed verbatim; transcripts will thereafter be reviewed to check for accuracy. Coding of the transcripts will occur, a second reviewer will check these. Results from the data analysis will guide development of a resource/information pack designed specifically help to improve patient and carer experience following hip fracture surgery.
Dissemination of results:
This study will not directly benefit the participants but it will improve services for patients in the future undergoing hip fracture surgery. It will identify areas of need/support to guide National Health Service (NHS) policymakers and healthcare provision and development of services to facilitate discharge to the community. By understanding the important patient reported experience measures we can go on to use these and compare quality of healthcare in this group of patients to improve care pathways.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient and carer study group | – | –Patients having undergone hip fracture surgery and their care givers. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients aged over 65 years undergoing hip fracture surgery. Care-givers of patients having undergone hip fracture surgery.
Key inclusion criteria (3 listed)
- Age 65 or over.
- Due to have surgical fixation for proximal femoral fracture.
- Care-giver of a patient having undergone surgical fixation for proximal femoral fracture.
Key exclusion criteria (3 listed)
- Patients admitted with multiple trauma.
- Patients who are unable to speak sufficient English to participate in the interview.
- Patients who are unable to consent due to lack of capacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient experiences following hip fracture surgery
Time frame: 6 months
Patients views and perceptions around their experience of hip fracture surgery with particular focus surrounding the discharge pathway.
Carer experiences following hip fracture surgery
Time frame: 6 months
The views and perceptions of supporting a relative/friend having undergone hip fracture surgery, with particular focus on the discharge pathway.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Elderly, run by University of Birmingham.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanisha Patel, MBChB, FRCA (0121 424 4696, vanisha.patel@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient experiences following hip fracture surgery (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2016.