Hip FracturesNCT03224195
Patient Experience of Acute Rehabilitation After Hip Fracture
An observational study of Hip Fractures and Fracture of Hip, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to explore the patient experience of acute rehabilitation after hip fracture surgery. We also aim to identify patient perceived barriers to rehabilitation and recovery after hip fracture surgery. More specifically, the objectives of this study are to: 1. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Fracture of Hip, Fractured Hip
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Oct 2017to 1 Aug 2018
- 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
- Older adult
Study population: Patients aged 65 and over who have been admitted for surgical management of hip fracture who were mobile prior to fracture and do not have cognitive impairment
Who may be able to join
- • Adult who underwent surgery after admission to St. Thomas's Hospital with hip fracture.
- Admission during the 9 weeks beginning July 2, 2017.
- Mobile (with/without aid) before fracture.
- Informed consent.
- English speaking.
- Aged ≥ 60.
- Abbreviated Mental Test Score ≥ 8/10.
Who cannot join
- • Adults who do not undergo surgery after admission to St. Thomas's Hospital with hip fracture.
- Admissions outside the 9 weeks beginning July 2, 2017.
- Not mobile before fracture.
- Aged< 60.
- Not English speaking.
- AMTS < 8/10.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE17EH
About this study
The aim of this study is to explore the patient experience of acute rehabilitation after hip fracture surgery. We also aim to identify patient perceived barriers to rehabilitation and recovery after hip fracture surgery. More specifically, the objectives of this study are to:
- describe the rehabilitation experience of patients who underwent hip fracture surgery with respect to the frequency, intensity, type, and timing of rehabilitation and
- identify patient perceived barriers to rehabilitation and recovery related to the patient, their injury and their health care.
The results of this qualitative study will inform a future feasibility cluster randomised controlled trial aimed at optimising acute rehabilitation after hip fracture surgery. The findings will help to strengthen the patient and carergiver centred approach when developing the intervention to optimise rehabilitation and potentially improve outcomes after hip fracture surgery.
Read the detailed description
Each year, UK hospitals admit 75,000 older men and women with fracture of the hip. The injury has been dubbed the "hip attack", due to its clinical severity and adverse consequences. In fact, hip fracture is one of the most detrimental events in an older adult's life. Even with treatment, 30% of patients die within a year.Among survivors, 25% never walk again, and 22% transition from independent living to long-term care. Further, up to one third of patients develop new-onset depressive symptoms post fracture. Many fear admission to a nursing home, in fact a recent study noted that 80% would rather be dead.
Most hip fractures are treated surgically with the goals of reducing pain and re-establishing mobility. Allied health professionals develop rehabilitation interventions targeting the frequency, intensity, type and timing of rehabilitation to improve survival, recovery and quality of life after hip fracture surgery. Evaluation of these interventions rarely offer insight into the patient and caregiver experience. This insight is essential to determine feasibility, acceptability, and ultimately adherence to a new rehabilitation intervention.
As an example, clinicians and researchers suggest the timing of mobilisation will reduce complications and improve recovery after hip fracture surgery, particularly among older patients. The evidence to support these claims is inconsistent. Further, there is limited understanding of the patient experience of early mobilisation after hip fracture surgery. Indeed, for some patients the experience may be improved with a delay to first mobilisation.
To maximise adherence, it is important to also gauge patient's perceptions of perceived barriers to rehabilitation and recovery after hip fracture surgery. These barriers may present in the form of patient characteristics such as motivation. Alternatively, they may present in the form of injury characteristics such as perceived injury severity. Lastly, patient's may perceive healthcare barriers to rehabilitation such as perceived benefit.
DESIGN AND METHODS Design Qualitative study. Semi-structured interview The research assistant will first collect participant demographics - age, sex, previous functional status, previous place of residence - home or long-term care.
Participants will then complete a semi-structured face-to-face interview delivered by a research assistant. The interview will be on an interview topic guide comprised of 3 core topics related to our aims. The questions are flexible, open-ended and broad, while focused on the topic to elicit rich responses from participants. The interviews will explore the experiences of patients who underwent rehabilitation after hip fracture surgery. Each semi-structured interview will last 30-45 minutes and will be recorded with an audio recorder. The research assistant will take reflective field notes to assist interpretation of the interview data.
Data preparation Participant demographics (age, sex, previous functional status, previous place of residence - home or long-term-care) and field notes will be entered into a Microsoft Excel Spreadsheet on a secure controlled access server at Kings College London on the same day as the interview by the research assistant. This server is accessible only to staff at Kings College London. The data will be password-protected and accessible only to the research team.
Recording of semi-structured interviews will be downloaded onto the secure server on the same day as the interview by the research assistant. Recordings will then be permanently deleted from the voice recorder. Interviews will be transcribed verbatim into Microsoft Word documents on the server by the research assistant. Transcripts will then be checked by a Kings College London supervisor, de-identified (by removal of names/locations) and uploaded into the NVivo software. On completion of the transcription the audio recordings will be deleted permanently from the server.
The spreadsheet and transcriptions will be archived on the secure controlled access server for 3 years to allow for analysis, journal submission, response to reviewer's comments, and publication.
Analysis The resulting data will be open coded and thematically analysed using a constant comparative approach with the software package NVivo. Analysis will take place iteratively throughout the project with ongoing coding completed to identify themes and subthemes as they emerge. This will entail the identification of common themes in the data through the reading and re-reading of transcripts first for a descriptive and then an analytic account. Matrices will be used to compare the occurrence of themes across participants.
Upon writing materials for publication, anonymized quotations from the data set will be used to support and illustrate the emergent themes.
Setting George Perkins Ward (trauma orthopaedics), St Thomas's Hospital. The interview will take place in a confidential, private room on the Ward.
Sample size We will recruit 20 participants. We based the sample size on qualitative analysis sample size recommendations. Further, a recent Canadian qualitative study on patient perspective to guide recovery reached data saturation with no new themes emerging after 19 interviews.
Sample technique We will use purposeful-criterion sampling to recruit participants. The first 20 patients/caregivers admitted to George Perkins Ward, St Thomas's Hospital who meet inclusion and exclusion criteria and give informed consent to participate will be included. We chose criterion sampling as we have a predetermined criterion of importance (i.e. adults (and their caregivers) who sustained hip fractures).
Identification of potential participants A member of the clinical team will identify potential participants at the daily multidisciplinary team handover on George Perkins ward, Guy's and St. Thomas' NHS Foundation Trust. During handover, each patient case is discussed including admitting diagnosis, surgery, Abbreviated Mental Test Score (AMTS), functional status, caregiver involvement, and any communication difficulties.
A member of the research team not involved in direct clinical care will be notified by the clinical team of potential participants on attendance at George Perkins Ward. The member of the research team not involved in direct clinical care will then complete the recruitment and consent process.
Recruitment and Consent We will adopt a previous published recruitment strategy developed by the Warwick Hip Trauma Evaluation. As part of usual care patients are assessed for capacity to consent using the 10-item AMTS preoperatively. A score below 8 suggests cognitive impairment.
Those with a score of 8 or more will be approached in hospital after their hip fracture surgery. They (and their caregiver) will be provided with an information sheet and given the opportunity to ask questions. At least 24 hours later they will be given the opportunity to ask any additional questions, and if they wish to take part, to provide written consent. Caregivers who participate will also sign a consent form.
On approach, potential participants and their caregiver will be invited to take part in the study. They will be provided with an information sheet and given the opportunity to ask questions. At least 24 hours later they will be given the opportunity to ask any additional questions, and if they wish to take part, will sign an agreement form and we will aim to interview a caregiver as well as the patient (patient/carer dyad). Caregivers who participate will also sign a consent form.
If the participant declines to participate, we will record the reason offered.
- Conditions
- Hip Fractures, Fracture of Hip, Fractured Hip
- Keywords
- rehabilitation, patient perspective, semi-structured interview
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
patient perspective of acute rehabilitation following hip fracture
nil outcome measure- semi-structured interview
Measured: interviews over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start6 Oct 2017
- Primary completion5 Apr 2018
- Study completion1 Aug 2018
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.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224195
- Sponsor's protocol ID
- 213682
- Status last verified
- Aug 2018
- First submitted
- 19 Jul 2017
- Last updated
- 2 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Experience of Acute Rehabilitation After Hip Fracture
- ClinicalTrials.gov ID
- NCT03224195
- Acronym / sponsor ID
- 213682
- Conditions
- Hip Fractures, Fracture of Hip, Fractured Hip
- Keywords
- rehabilitation, patient perspective, semi-structured interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 21 Jul 2017 (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.
The aim of this study is to explore the patient experience of acute rehabilitation after hip fracture surgery. We also aim to identify patient perceived barriers to rehabilitation and recovery after hip fracture surgery. More specifically, the objectives of this study are to:
- describe the rehabilitation experience of patients who underwent hip fracture surgery with respect to the frequency, intensity, type, and timing of rehabilitation and
- identify patient perceived barriers to rehabilitation and recovery related to the patient, their injury and their health care.
The results of this qualitative study will inform a future feasibility cluster randomised controlled trial aimed at optimising acute rehabilitation after hip fracture surgery. The findings will help to strengthen the patient and carergiver centred approach when developing the intervention to optimise rehabilitation and potentially improve outcomes after hip fracture surgery.
Detailed description
Each year, UK hospitals admit 75,000 older men and women with fracture of the hip. The injury has been dubbed the "hip attack", due to its clinical severity and adverse consequences. In fact, hip fracture is one of the most detrimental events in an older adult's life. Even with treatment, 30% of patients die within a year.Among survivors, 25% never walk again, and 22% transition from independent living to long-term care. Further, up to one third of patients develop new-onset depressive symptoms post fracture. Many fear admission to a nursing home, in fact a recent study noted that 80% would rather be dead.
Most hip fractures are treated surgically with the goals of reducing pain and re-establishing mobility. Allied health professionals develop rehabilitation interventions targeting the frequency, intensity, type and timing of rehabilitation to improve survival, recovery and quality of life after hip fracture surgery. Evaluation of these interventions rarely offer insight into the patient and caregiver experience. This insight is essential to determine feasibility, acceptability, and ultimately adherence to a new rehabilitation intervention.
As an example, clinicians and researchers suggest the timing of mobilisation will reduce complications and improve recovery after hip fracture surgery, particularly among older patients. The evidence to support these claims is inconsistent. Further, there is limited understanding of the patient experience of early mobilisation after hip fracture surgery. Indeed, for some patients the experience may be improved with a delay to first mobilisation.
To maximise adherence, it is important to also gauge patient's perceptions of perceived barriers to rehabilitation and recovery after hip fracture surgery. These barriers may present in the form of patient characteristics such as motivation. Alternatively, they may present in the form of injury characteristics such as perceived injury severity. Lastly, patient's may perceive healthcare barriers to rehabilitation such as perceived benefit.
DESIGN AND METHODS Design Qualitative study. Semi-structured interview The research assistant will first collect participant demographics - age, sex, previous functional status, previous place of residence - home or long-term care.
Participants will then complete a semi-structured face-to-face interview delivered by a research assistant. The interview will be on an interview topic guide comprised of 3 core topics related to our aims. The questions are flexible, open-ended and broad, while focused on the topic to elicit rich responses from participants. The interviews will explore the experiences of patients who underwent rehabilitation after hip fracture surgery. Each semi-structured interview will last 30-45 minutes and will be recorded with an audio recorder. The research assistant will take reflective field notes to assist interpretation of the interview data.
Data preparation Participant demographics (age, sex, previous functional status, previous place of residence - home or long-term-care) and field notes will be entered into a Microsoft Excel Spreadsheet on a secure controlled access server at Kings College London on the same day as the interview by the research assistant. This server is accessible only to staff at Kings College London. The data will be password-protected and accessible only to the research team.
Recording of semi-structured interviews will be downloaded onto the secure server on the same day as the interview by the research assistant. Recordings will then be permanently deleted from the voice recorder. Interviews will be transcribed verbatim into Microsoft Word documents on the server by the research assistant. Transcripts will then be checked by a Kings College London supervisor, de-identified (by removal of names/locations) and uploaded into the NVivo software. On completion of the transcription the audio recordings will be deleted permanently from the server.
The spreadsheet and transcriptions will be archived on the secure controlled access server for 3 years to allow for analysis, journal submission, response to reviewer's comments, and publication.
Analysis The resulting data will be open coded and thematically analysed using a constant comparative approach with the software package NVivo. Analysis will take place iteratively throughout the project with ongoing coding completed to identify themes and subthemes as they emerge. This will entail the identification of common themes in the data through the reading and re-reading of transcripts first for a descriptive and then an analytic account. Matrices will be used to compare the occurrence of themes across participants.
Upon writing materials for publication, anonymized quotations from the data set will be used to support and illustrate the emergent themes.
Setting George Perkins Ward (trauma orthopaedics), St Thomas's Hospital. The interview will take place in a confidential, private room on the Ward.
Sample size We will recruit 20 participants. We based the sample size on qualitative analysis sample size recommendations. Further, a recent Canadian qualitative study on patient perspective to guide recovery reached data saturation with no new themes emerging after 19 interviews.
Sample technique We will use purposeful-criterion sampling to recruit participants. The first 20 patients/caregivers admitted to George Perkins Ward, St Thomas's Hospital who meet inclusion and exclusion criteria and give informed consent to participate will be included. We chose criterion sampling as we have a predetermined criterion of importance (i.e. adults (and their caregivers) who sustained hip fractures).
Identification of potential participants A member of the clinical team will identify potential participants at the daily multidisciplinary team handover on George Perkins ward, Guy's and St. Thomas' NHS Foundation Trust. During handover, each patient case is discussed including admitting diagnosis, surgery, Abbreviated Mental Test Score (AMTS), functional status, caregiver involvement, and any communication difficulties.
A member of the research team not involved in direct clinical care will be notified by the clinical team of potential participants on attendance at George Perkins Ward. The member of the research team not involved in direct clinical care will then complete the recruitment and consent process.
Recruitment and Consent We will adopt a previous published recruitment strategy developed by the Warwick Hip Trauma Evaluation. As part of usual care patients are assessed for capacity to consent using the 10-item AMTS preoperatively. A score below 8 suggests cognitive impairment.
Those with a score of 8 or more will be approached in hospital after their hip fracture surgery. They (and their caregiver) will be provided with an information sheet and given the opportunity to ask questions. At least 24 hours later they will be given the opportunity to ask any additional questions, and if they wish to take part, to provide written consent. Caregivers who participate will also sign a consent form.
On approach, potential participants and their caregiver will be invited to take part in the study. They will be provided with an information sheet and given the opportunity to ask questions. At least 24 hours later they will be given the opportunity to ask any additional questions, and if they wish to take part, will sign an agreement form and we will aim to interview a caregiver as well as the patient (patient/carer dyad). Caregivers who participate will also sign a consent form.
If the participant declines to participate, we will record the reason offered.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients aged 65 and over who have been admitted for surgical management of hip fracture who were mobile prior to fracture and do not have cognitive impairment
Key inclusion criteria (7 listed)
- • Adult who underwent surgery after admission to St. Thomas's Hospital with hip fracture.
Key exclusion criteria (6 listed)
- • Adults who do not undergo surgery after admission to St. Thomas's Hospital with hip fracture.
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 perspective of acute rehabilitation following hip fracture
Time frame: interviews over 8 weeks
nil outcome measure- semi-structured interview
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 2 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hip Fractures and Fracture of Hip, run by Guy's and St Thomas' NHS Foundation Trust 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 7 inclusion and 6 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 2 Aug 2018. 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?
patient perspective of acute rehabilitation following hip fracture (time frame: interviews over 8 weeks). 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 2 Aug 2018.