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| Name | Class |
|---|---|
| Health Education England, Wessex | OTHER |
| University of Nottingham | OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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Patient experiences of the NHS ACL treatment pathway are unknown.
This study aims to explore patient experiences of anterior cruciate ligament ruptures at three different time points on the patient pathway: (1) 12 participants up to 2 weeks before surgery, (2) 12 participants 3 months after surgery, (3) 12 participants 12 months after surgery.
The anterior cruciate ligament is one of four key ligaments in the knee. It is the most commonly injured knee ligament with an estimated 200,000 injuries occurring each year in the US (UK data unavailable). Surgery is currently standard treatment for this injury and helps patients return to work and their preinjury activity levels (such as running, playing football or netball). Patients expect surgery to be successful. However, the number of patients who are able to return to their normal activities is low, with only 24% returning at 1 year after surgery. Research has shown that after surgery, patients lack confidence, feel fearful about reinjuring their knee and need to continue to seek advice from healthcare professionals.
Receiving physiotherapy before surgery (called 'prehabilitation') is recommended by researchers and physiotherapists to help patients prepare for surgery and postoperative rehabilitation. Although physiotherapy is recommended, some patients don't receive any treatment before their operation, but it is not known why this might be. There are also no guidelines for the treatment patients receive and current treatment varies.
If an intervention to be delivered to patients prior to anterior cruciate ligament surgery (prehabilitation treatment package) is developed, patient care may be improved. Patient outcomes could also be improved resulting in more patients returning to physical activity after surgery.
This study will firstly, interview participants at three different time points along the patient pathway (1) 12 participants up to 2 weeks before surgery, (2) 12 participants 3 months after surgery, (3) 12 participants 12 months after surgery.
The interviews will allow participants to tell the story of their experiences from the point of receiving their injury diagnosis to returning to physical activity and what they expect from their surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 - Preoperative | Interviews to be completed with approximately 12 participants at three time points:
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| Phase 2 - Nominal Group Technique panel | Consensus meeting with up to 12 participants (clinicians, patients and stakeholders) to develop the prehabilitation intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase 1 - semi-structured interviews | Other | Semi-structured face-to-face or virtual interviews. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed Semi-structured Interviews | Understanding of patients' lived experiences of the treatment pathway following a diagnosis of an ACL rupture and agreed surgical management. Qualitative data collected from individual semi-structured interviews. | Interviews completed within approximately 60 minutes |
| Number of Participants in the Nominal Group Technique Panel | Intervention developed with clinicians, patients and stakeholders for use with patients awaiting anterior cruciate ligament reconstruction in the National Health Service (NHS). Consensus was determined through voting set at an 70% threshold. | Two online meetings completed, up to 2 hours on 2 days approximately 1-month apart. |
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Inclusion Criteria:
Phase 1:
Phase 2
≥ 18-years-old
Participants will be in one of the following categories:
Exclusion Criteria:
Phase 1:
Phase 2:
(1) Anyone with a recognised conflict of interest
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Phase 1: Patients who have had or who are awaiting an anterior cruciate ligament reconstruction in the NHS
Phase 2: Healthcare professional with a special interest/expertise in treating ACL injuries, therapy manager of an NHS musculoskeletal outpatient therapy department or patient who is awaiting or has had an anterior cruciate ligament reconstruction in the NHS
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| Name | Affiliation | Role |
|---|---|---|
| Hayley Carter | University Hospitals of Derby and Burton NHS Foundation Trust / University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research and Development Department, Medical School, Royal Derby Hospital | Derby | DE22 3DT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39289010 | Derived | Carter HM, Beard DJ, Leighton P, Moffatt F, Smith BE, Webster KE, Logan P. 'Going through the motions'; a rich account of the complexity of the anterior cruciate ligament reconstruction pathway, a UK qualitative study. BMJ Open. 2024 Sep 17;14(9):e079468. doi: 10.1136/bmjopen-2023-079468. | |
| 39025812 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 - Preoperative | Interviews were completed with 18 participants who were at one of three time points on the patient pathway:
Phase 1 - semi-structured interviews: Semi-structured face-to-face or virtual interviews. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2022 |
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| Phase 2 - consensus meeting | Other | Face-to-face or virtual meeting(s) |
|
| Carter H, Beard D, Leighton P, Moffatt F, Smith BE, Webster KE, Logan P. Development of an intervention for patients following an anterior cruciate ligament rupture: an online nominal group technique consensus study. BMJ Open. 2024 Jul 18;14(7):e082387. doi: 10.1136/bmjopen-2023-082387. |
| FG001 |
| Phase 2 - Nominal Group Technique Panel |
Consensus meetings were completed with 8 participants (clinicians, patients and stakeholders) to develop the intervention. Phase 2 - 2 online consensus meeting |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 - Preoperative | Interviews were completed with 18 participants who were at one of three time points on the patient pathway:
Phase 1 - semi-structured interviews: Semi-structured face-to-face or virtual interviews. |
| BG001 | Phase 2 - Nominal Group Technique Panel | Consensus meetings were completed with 8 participants (clinicians, patients and stakeholders) to develop the intervention. Phase 2 - 2 online consensus meeting |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Time-point on the pathway | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Completed Semi-structured Interviews | Understanding of patients' lived experiences of the treatment pathway following a diagnosis of an ACL rupture and agreed surgical management. Qualitative data collected from individual semi-structured interviews. | All participants remained in the study. | Posted | Count of Participants | Participants | Interviews completed within approximately 60 minutes |
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| Primary | Number of Participants in the Nominal Group Technique Panel | Intervention developed with clinicians, patients and stakeholders for use with patients awaiting anterior cruciate ligament reconstruction in the National Health Service (NHS). Consensus was determined through voting set at an 70% threshold. | All participant data analysed. | Posted | Count of Participants | Participants | Two online meetings completed, up to 2 hours on 2 days approximately 1-month apart. |
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The CI monitored risks for participants for the duration of the study (phase 1, 4 months). All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed for Phase 2.
Phase 1 - The CI will be responsible for assessing and managing risk, reporting this to the TMG and TSC as appropriate. This will be assessed and collected during the interviews with no further follow-up.
There are no known risks to participation in phase 2 and averse events were not recorded over a period of time.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1 - Preoperative | Interviews were completed with 18 participants who were at one of three time points on the patient pathway:
Phase 1 - semi-structured interviews: Semi-structured face-to-face or virtual interviews. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG001 | Phase 2 - Nominal Group Technique Panel | Consensus meetings were completed with 8 participants (clinicians, patients and stakeholders) to develop the intervention. Phase 2 - 2 online consensus meeting | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hayley Carter | University Hospitals of Derby and Burton NHS Foundation Trust | 01332254631 | hayley.carter1@nhs.net |
| Dec 18, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Male |
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| Indian |
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| British Asian |
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| Pakistani |
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| 3-months post-operative |
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| 12-months postoperative |
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| Explore views and involvement in prehabilitation |
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| Explore sources and consistency of healthcare advice |
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