EmergenciesNCT03514043
Patient and Staff Experience of Ambulatory Emergency Care on the Surgical Admissions Unit (SAU)
An observational study of Emergencies and Surgery, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Emergency ambulatory care ("day-case" care that does not involve staying in a hospital bed overnight) is now well-established for medical patients and is being used increasingly for surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies, Surgery
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2018to 31 Dec 2019
- 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: Adults presenting to the surgical assessment unit under the care of general surgeons who have their care managed in an ambulatory manner without inpatient admission. Staff who are involved in the care of these patients in the groups described in the group section.
Who may be able to join
- English-speaking adult patients of any gender over the age of 18 undergoing emergency ambulatory care via the surgical assessment unit for a general surgical condition will be included.
Who cannot join
- Children under the age of 18
- Adults without capacity to consent as participants for the study
- Patient participant exclusion criteria:
- Those who have primarily presented with a condition that is not within the remit of general surgeons
- Those who had their care continued as an inpatient immediately following their initial presentation.
- Unable to understand or speak English to the level required to understand the information sheet or conduct the interview
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Devon and Exeter Hospital NHS Foundation Trust
Exeter, Devon, EX2 5DW
About this study
Emergency ambulatory care ("day-case" care that does not involve staying in a hospital bed overnight) is now well-established for medical patients and is being used increasingly for surgical patients. However, it is not known how emergency surgical patients feel about being managed in this way compared to being admitted to a hospital ward. The investigating team believe that some people will find it easier and would prefer to be able to stay at home overnight but others may find this difficult or dislike this method of care.
The investigators want to explore staff and patients' experience of this type of care with semi-structured telephone interviews. The interviews will take around 20-30mins each. The anticipated number of patient participants needed is 20 and 12-15 staff members.
Read the detailed description
This is a qualitative study of patient and staff experience. Data will be collected by semi-structured telephone and face-to-face interviews.
Abdominal pain is a common reason for people to attend hospital as an emergency. It makes up a considerable proportion of the patients being admitted under the care of general surgeons. Other common reasons for people attending include infections such as abscesses and problems following previous surgery.
A Surgical Assessment Unit (SAU) is an ambulatory area with a waiting room and assessment cubicles. It is staffed by a triage nurse or healthcare assistant and doctors from the surgical team. Patients can be assessed and have investigations including blood tests and radiology procedures including x-rays, ultrasound and CT. After assessment they are either admitted to the ward, discharged home or have their care continued in an ambulatory manner returning in the next few days for further or repeat assessment.
Previously patients were either discharged or admitted for observation, investigation and treatment such as intravenous antibiotics. Many of these patients could be managed safely in a "day case" manner. This pathway allows for re-attendance should it be required.
Emergency ambulatory care is well-established in medicine for conditions such as suspected deep vein thrombosis (DVT) and transient ischaemic attack (TIA) but has not yet been widely adopted in surgery. There is uncertainty surrounding the best way of looking after these patients as the diagnosis is often uncertain and it can be difficult to judge which patients require admission.
Pilot studies have shown that up to 30% of emergency general surgical patients could be managed in this way. These studies also report a high patient satisfaction score but do not inform us what works, why and for whom. These would be important considerations for organisations looking to expand their emergency general surgical ambulatory service.
This study aims to expand upon previous work in this area by conducting semi-structured interviews with patients who have experienced emergency general surgical ambulatory care. The investigating team aim to achieve a representative sample of participants by age, attending condition and satisfaction score. They will identify themes that influence patient experience of emergency ambulatory care and whether this might vary depending on patient factors such as age, social support/responsibilities and attending condition.
Patient participants will be recruited to the study by the clinical team by means of short verbal explanation and the provision of an information sheet. Potential participants will give their contact details to be passed to the study team or will make contact themselves at a later stage. They will then by contacted by the study team and given further information over the telephone. Those wishing to proceed will have arrangements made for a telephone interview. A recording of consent will be made prior to the start of the interview and will be stored as a separate audio file.
The interview schedule has been drawn up based on areas that have emerged from work in the past using patient diaries. (Improving the Patient Experience of Ambulatory Care in the Surgical Assessment Unit, 2014) The PPI work done has included review of these questions for acceptability and ease of understanding and minor changes have been made to the wording of questions as a result. The prompts used are mainly to encourage explanations of why participants have answered the way they have.
The interviews will last 20-40mins and will be recorded using digital recording software. They will be conducted by the principal investigator. No potentially identifiable information will be recorded and participants will be advised not to divulge identifiable information prior to the interview. If this occurs inadvertently it will be deleted prior to transcription. These audio recordings will be given an anonymous identification number and then be transcribed into text documents using a paid transcription service within the UK. Once the transcription has been completed the recording will be deleted.
The transcribed data will be stored on a NHS server. It will be available for access to the study team by password protection and on request in an anonymised form by the university sponsor. Once the study is complete it will be stored on a university repository for the period required for archive and deleted from the NHS server.
The transcribed data will be coded and then undergo thematic analysis using NVIVO software. Coding will be done by the principal investigator and a proportion of the data will be separately coded by the 2 senior members of the study team. Interim analysis will be conducted after each 5 patients and the interview schedule may undergo some change to explore in more detail areas of interest that emerge.
If groups are underrepresented in the interim analysis then there may be targeted recruitment to the underrepresented group. This may include the characteristics of patient age and overall satisfaction with care given.
- Conditions
- Emergencies, Surgery
- Keywords
- Ambulatory care, Emergency general surgery, Patient satisfaction
- Medical subject headings
- Emergencies, Patient Satisfaction
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 |
|---|---|---|
| Ambulatory care surgical patients | Patients who have attended the surgical assessment unit with an emergency general surgical condition and have their care completed without an inpatient stay. | |
| Surgical assessment unit staff | Staff who are involved in the care of patients on the surgical assessment unit. This includes senior and junior doctors, nurses, healthcare assistants and ward receptionists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors affecting patient satisfaction: semi-structured interviews
Factors that influence patients' experience of emergency general surgical care [semi-structured interviews with patients]
Measured: Will be measured within 3 weeks of attendance
Factors affecting implementation of ambulatory emergency care
Factors which affect how staff use ambulatory emergency care and what they perceive this issues to be with this method of care.
This will be measured using semi-structured interviews with staff.
Measured: Interviews will be conducted at a single timepoint from May 2019 to October 2019.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start5 Nov 2018
- Primary completion2 Oct 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies 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
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Devon and Exeter NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Lisa H Massey, MBBS (BSc), Principal investigator, Royal Devon and Exeter Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514043
- Sponsor's protocol ID
- 1718/01
- Status last verified
- Nov 2021
- First submitted
- 13 Apr 2018
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At the end of the study the research data will be uploaded to an open access repository held on a University of Exeter server. Depending on practicality this may include individual participant data at interview level or may include the data post-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Staff Experience of Ambulatory Emergency Care on the Surgical Admissions Unit (SAU)
- ClinicalTrials.gov ID
- NCT03514043
- Acronym / sponsor ID
- 1718/01
- Conditions
- Emergencies, Surgery
- Keywords
- Ambulatory care, Emergency general surgery, Patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Royal Devon and Exeter NHS Foundation Trust
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 May 2018 (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.
Emergency ambulatory care ("day-case" care that does not involve staying in a hospital bed overnight) is now well-established for medical patients and is being used increasingly for surgical patients. However, it is not known how emergency surgical patients feel about being managed in this way compared to being admitted to a hospital ward. The investigating team believe that some people will find it easier and would prefer to be able to stay at home overnight but others may find this difficult or dislike this method of care.
The investigators want to explore staff and patients' experience of this type of care with semi-structured telephone interviews. The interviews will take around 20-30mins each. The anticipated number of patient participants needed is 20 and 12-15 staff members.
Detailed description
This is a qualitative study of patient and staff experience. Data will be collected by semi-structured telephone and face-to-face interviews.
Abdominal pain is a common reason for people to attend hospital as an emergency. It makes up a considerable proportion of the patients being admitted under the care of general surgeons. Other common reasons for people attending include infections such as abscesses and problems following previous surgery.
A Surgical Assessment Unit (SAU) is an ambulatory area with a waiting room and assessment cubicles. It is staffed by a triage nurse or healthcare assistant and doctors from the surgical team. Patients can be assessed and have investigations including blood tests and radiology procedures including x-rays, ultrasound and CT. After assessment they are either admitted to the ward, discharged home or have their care continued in an ambulatory manner returning in the next few days for further or repeat assessment.
Previously patients were either discharged or admitted for observation, investigation and treatment such as intravenous antibiotics. Many of these patients could be managed safely in a "day case" manner. This pathway allows for re-attendance should it be required.
Emergency ambulatory care is well-established in medicine for conditions such as suspected deep vein thrombosis (DVT) and transient ischaemic attack (TIA) but has not yet been widely adopted in surgery. There is uncertainty surrounding the best way of looking after these patients as the diagnosis is often uncertain and it can be difficult to judge which patients require admission.
Pilot studies have shown that up to 30% of emergency general surgical patients could be managed in this way. These studies also report a high patient satisfaction score but do not inform us what works, why and for whom. These would be important considerations for organisations looking to expand their emergency general surgical ambulatory service.
This study aims to expand upon previous work in this area by conducting semi-structured interviews with patients who have experienced emergency general surgical ambulatory care. The investigating team aim to achieve a representative sample of participants by age, attending condition and satisfaction score. They will identify themes that influence patient experience of emergency ambulatory care and whether this might vary depending on patient factors such as age, social support/responsibilities and attending condition.
Patient participants will be recruited to the study by the clinical team by means of short verbal explanation and the provision of an information sheet. Potential participants will give their contact details to be passed to the study team or will make contact themselves at a later stage. They will then by contacted by the study team and given further information over the telephone. Those wishing to proceed will have arrangements made for a telephone interview. A recording of consent will be made prior to the start of the interview and will be stored as a separate audio file.
The interview schedule has been drawn up based on areas that have emerged from work in the past using patient diaries. (Improving the Patient Experience of Ambulatory Care in the Surgical Assessment Unit, 2014) The PPI work done has included review of these questions for acceptability and ease of understanding and minor changes have been made to the wording of questions as a result. The prompts used are mainly to encourage explanations of why participants have answered the way they have.
The interviews will last 20-40mins and will be recorded using digital recording software. They will be conducted by the principal investigator. No potentially identifiable information will be recorded and participants will be advised not to divulge identifiable information prior to the interview. If this occurs inadvertently it will be deleted prior to transcription. These audio recordings will be given an anonymous identification number and then be transcribed into text documents using a paid transcription service within the UK. Once the transcription has been completed the recording will be deleted.
The transcribed data will be stored on a NHS server. It will be available for access to the study team by password protection and on request in an anonymised form by the university sponsor. Once the study is complete it will be stored on a university repository for the period required for archive and deleted from the NHS server.
The transcribed data will be coded and then undergo thematic analysis using NVIVO software. Coding will be done by the principal investigator and a proportion of the data will be separately coded by the 2 senior members of the study team. Interim analysis will be conducted after each 5 patients and the interview schedule may undergo some change to explore in more detail areas of interest that emerge.
If groups are underrepresented in the interim analysis then there may be targeted recruitment to the underrepresented group. This may include the characteristics of patient age and overall satisfaction with care given.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulatory care surgical patients | – | –Patients who have attended the surgical assessment unit with an emergency general surgical condition and have their care completed without an inpatient stay. |
| Surgical assessment unit staff | – | –Staff who are involved in the care of patients on the surgical assessment unit. This includes senior and junior doctors, nurses, healthcare assistants and ward receptionists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults presenting to the surgical assessment unit under the care of general surgeons who have their care managed in an ambulatory manner without inpatient admission. Staff who are involved in the care of these patients in the groups described in the group section.
Key inclusion criteria (1 listed)
- English-speaking adult patients of any gender over the age of 18 undergoing emergency ambulatory care via the surgical assessment unit for a general surgical condition will be included.
Key exclusion criteria (6 listed)
- Children under the age of 18
- Adults without capacity to consent as participants for the study
- Those who have primarily presented with a condition that is not within the remit of general surgeons
- Those who had their care continued as an inpatient immediately following their initial presentation.
- Unable to understand or speak English to the level required to understand the information sheet or conduct the interview
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
Factors affecting patient satisfaction: semi-structured interviews
Time frame: Will be measured within 3 weeks of attendance
Factors that influence patients' experience of emergency general surgical care [semi-structured interviews with patients]
Factors affecting implementation of ambulatory emergency care
Time frame: Interviews will be conducted at a single timepoint from May 2019 to October 2019.
Factors which affect how staff use ambulatory emergency care and what they perceive this issues to be with this method of care. This will be measured using semi-structured interviews with staff.
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 10 Nov 2021.
- Individual participant dataSharing planned: Undecided. At the end of the study the research data will be uploaded to an open access repository held on a University of Exeter server. Depending on practicality this may include individual participant data at interview level or may include the data post-analysis.
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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.
Lisa H Massey, MBBS (BSc) principal investigator
Royal Devon and Exeter Hospital NHS Trust
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 Emergencies and Surgery, run by University of Exeter 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 1 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 10 Nov 2021. 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?
Factors affecting patient satisfaction: semi-structured interviews (time frame: Will be measured within 3 weeks of attendance). 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 10 Nov 2021.