DiabetesAmbu-HS2NCT04243200
Ambulance 'Hypos Can Strike Twice' Study
An observational study of Diabetes, run by University of Lincoln at 1 site in United Kingdom.
Trial summary
This study will assess the effectiveness the "Hypos can strike twice" intervention on people with diabetes experiencing hypoglycaemia (or "hypo", meaning low blood sugar). The intervention should help prevent recurrence of "hypos", improve patients' future health, reduce calls to ambulance services and thus reduce NHS… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Hypos can strike twice
- How many people
- 5,015 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2020to 30 Apr 2021
- 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: Diabetic patients needing an ambulance for hypoglycaemic events and ambulance staff attending these events.
Who may be able to join
- Patients: Adults aged 18 years+ with diabetes experiencing hypoglycaemia needing an ambulance service response. Hypoglycaemia for this study was identified as a 'clinical impression' of 'hypoglycaemia' or 'diabetic problem'. Hypoglycaemia may also be identified according to ambulance guidelines1 as any blood glucose less than 4mmol/L.
- Clinicians: Ambulance staff providing treatment and advice to people who have had a hypoglycaemic attack.
Who cannot join
- Patients: Children under the age of 18 years.
- Clinicians: Ambulance staff providing treatment and advice for incidents other than hypoglycaemia.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Community and Health Research Unit, University of Lincoln
Lincoln, Lincolnshire, LN5 7AY
About this study
Official title: Effect of Implementing an Ambulance Clinician Delivered Hypoglycaemia Intervention ('Hypos Can Strike Twice') on Repeat Ambulance Calls, Attendances and Transportation to Hospital: Non-randomised Stepped Wedge and Process Evaluation
This study will assess the effectiveness the "Hypos can strike twice" intervention on people with diabetes experiencing hypoglycaemia (or "hypo", meaning low blood sugar). The intervention should help prevent recurrence of "hypos", improve patients' future health, reduce calls to ambulance services and thus reduce NHS pressures and costs.
Hypoglycaemia affects increasing numbers of people with diabetes. It is a side effect of treatment with insulin or certain tablets, where blood glucose (sugar) falls causing the brain to malfunction. In mild cases this can lead to sweating, drowsiness and confusion; in more severe cases, coma can occur needing medical assistance for recovery, and if prolonged can be fatal. It results in 1% of calls to ambulance services.
Read more
The "Hypos can strike twice" intervention involves ambulance staff providing treatment to patients experiencing hypos and advising them to access follow-up care by their GP/specialist diabetes team. This is backed up by giving patients a "Hypos can strike twice" information booklet which they can read when they recover.
Universities of Lincoln and Leicester are working with East Midlands Ambulance Service NHS Trust and patient groups on this study. The "Hypos can strike twice" intervention has now been implemented by ambulance services in Leicester, Northamptonshire, Nottinghamshire, Derbyshire and Lincolnshire from October 2018-May 2019.
The investigators will analyse data from the ambulance services before, during and after the introduction of the 'Hypos can strike twice' intervention to evaluate the effect of the intervention on repeat ambulance calls and attendances for hypoglycaemia and the costs and consequences of implementing it. The investigators will also interview/survey ambulance staff who provided the intervention and patients who received it, to understand how and why it works (or does not) and how, if it works, it could be scaled up over a larger geographical area. The duration of this study is 1 year.
Read the detailed description
Research question
What is the effect on repeat ambulance calls and attendances for hypoglycaemia and what are the costs and consequences of implementing the 'Hypo's can strike twice' intervention to patients with diabetes and hypoglycaemia attended by East Midlands Ambulance Service NHS Trust in the East Midlands region of the UK?
Background
Severe hypoglycaemia (defined as cognitive impairment severe enough to require external assistance for recovery) frequently requires an ambulance resulting in Emergency Department attendance or hospital admission. Severe hypoglycaemia constitutes around 1% of 1.7 million emergency ambulance calls in England and Scotland resulting in 100 thousand paramedic attendances and estimated costs in England of £13.6 million annually. Hypoglycaemia is associated with adverse consequences including higher mortality, morbidity and health service costs due to hospital attendance/admission. It is also frightening for both patients and relatives and impairs quality of life and productivity, leading to poor long term control.
Aims and objectives
Aim: To evaluate the effect of implementing the 'Hypo's can strike twice' intervention to patients with diabetes and hypoglycaemia attended by East Midlands Ambulance Service NHS Trust in the East Midlands region. "Hypos can strike twice" is a complex intervention involving ambulance staff providing treatment and advice to people who have had a hypoglycaemic attack to access follow-up care by the GP or specialist diabetes team as detailed in national ambulance (JRCALC) clinical guidelines supported by the provision of a "Hypos can strike twice" booklet which the patient can read when they are fully recovered from the cognitive and other effects of the hypoglycaemic episode.
Objectives
To investigate the effect of implementing the 'Hypo's can strike twice' on:
- Repeat ambulance calls and attendances for hypoglycaemia
- Recorded referrals to an appropriate healthcare professional (e.g. GP, nurse).
- Completed care bundle for hypoglycaemia (proportion of patients with all of blood glucose recorded before treatment, blood glucose recorded after treatment and treatment given for hypoglycaemia.
- Costs of implementation 'Hypo's can strike twice' intervention vs costs of health service resource use.
- To conduct a process evaluation to explore how 'Hypo's can strike twice' exerts its effects and can be scaled up if effective by understanding implementation, mechanisms of impact, and contextual factors using interviews and surveys
Methods
Non-randomised stepped wedge design with mixed-methods process evaluation.
- Conditions
- Diabetes
- Being tested
- Hypos can strike twice
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypos can strike twiceOther
The "Hypos can strike twice" intervention involves ambulance staff providing treatment to patients experiencing hypos and advising them to access follow-up care by their GP/specialist diabetes team. This is backed up by giving patients a "Hypos can strike twice" information booklet which they can read when they recover.
| Study group | Role | What they receive |
|---|---|---|
| Analyses of repeat ambulance calls and costs | For our analyses of repeat ambulance calls and costs we will use routine anonymised data from routine call-and-dispatch and clinical records data from EMAS for 12 months before the intervention was first introduced (September 2017) to at least 6 months after the final step of the introduction in April 2019, i.e. October 2019. This is likely to involve the analysis of an estimated 11916 cases so that we can implement a stepped wedge (non-randomised control)design . Receives: Other: Hypos can strike twice | |
| Survey of patients receiving intervention | We will survey about 447 patients who received the intervention in order to obtain data from a sample of n=96 Receives: Other: Hypos can strike twice | |
| Survey of ambulance staff | We will send out surveys/questionnaires to all front-line ambulance staff (n=approximately 600) | |
| Qualitative interviews of staff | We will sample 10-15 staff for qualitative interviews. | |
| Qualitative interviews of patients | We will sample 10-15 patients for qualitative interviews Receives: Other: Hypos can strike twice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeat ambulance calls and attendances for hypoglycaemia within 14 days.
as stated above
Measured: 14 days from initial ambulance attendance
Secondary outcomes (1)
To assess whether the "Hypos can strike twice" intervention can reduce repeat ambulance calls and attendance for hypoglycaemia within 30 and 90 days.
as stated above
Measured: within 30 and 90 days from initial ambulance attendance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start14 Sep 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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 DiabetesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niro Siriwardena, Principal investigator, University of Lincoln, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243200
- Sponsor's protocol ID
- 191202
- Acronym
- Ambu-HS2
- Status last verified
- Apr 2021
- First submitted
- 23 Jan 2020
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laparidou D, Botan V, Law GR, Rowan E, Smith MD, Brewster A, Spaight R, Mountain P, Dunmore S, James J, Roberts L, Khunti K, Siriwardena AN. People with diabetes and ambulance staff perceptions of a booklet-based intervention for diabetic hypoglycaemia, "Hypos can strike twice": a mixed methods process evaluation. BMC Emerg Med. 2022 Feb 8;22(1):21. doi: 10.1186/s12873-022-00583-y.
PubMed 35135499
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implementing an Ambulance Clinician Delivered Hypoglycaemia Intervention ('Hypos Can Strike Twice') on Repeat Ambulance Calls, Attendances and Transportation to Hospital: Non-randomised Stepped Wedge and Process Evaluation
- ClinicalTrials.gov ID
- NCT04243200
- Acronym / sponsor ID
- Ambu-HS2 / 191202
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,015 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 28 Jan 2020 (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.
This study will assess the effectiveness the "Hypos can strike twice" intervention on people with diabetes experiencing hypoglycaemia (or "hypo", meaning low blood sugar). The intervention should help prevent recurrence of "hypos", improve patients' future health, reduce calls to ambulance services and thus reduce NHS pressures and costs.
Hypoglycaemia affects increasing numbers of people with diabetes. It is a side effect of treatment with insulin or certain tablets, where blood glucose (sugar) falls causing the brain to malfunction. In mild cases this can lead to sweating, drowsiness and confusion; in more severe cases, coma can occur needing medical assistance for recovery, and if prolonged can be fatal. It results in 1% of calls to ambulance services.
The "Hypos can strike twice" intervention involves ambulance staff providing treatment to patients experiencing hypos and advising them to access follow-up care by their GP/specialist diabetes team. This is backed up by giving patients a "Hypos can strike twice" information booklet which they can read when they recover.
Universities of Lincoln and Leicester are working with East Midlands Ambulance Service NHS Trust and patient groups on this study. The "Hypos can strike twice" intervention has now been implemented by ambulance services in Leicester, Northamptonshire, Nottinghamshire, Derbyshire and Lincolnshire from October 2018-May 2019.
The investigators will analyse data from the ambulance services before, during and after the introduction of the 'Hypos can strike twice' intervention to evaluate the effect of the intervention on repeat ambulance calls and attendances for hypoglycaemia and the costs and consequences of implementing it. The investigators will also interview/survey ambulance staff who provided the intervention and patients who received it, to understand how and why it works (or does not) and how, if it works, it could be scaled up over a larger geographical area. The duration of this study is 1 year.
Detailed description
Research question
What is the effect on repeat ambulance calls and attendances for hypoglycaemia and what are the costs and consequences of implementing the 'Hypo's can strike twice' intervention to patients with diabetes and hypoglycaemia attended by East Midlands Ambulance Service NHS Trust in the East Midlands region of the UK?
Background
Severe hypoglycaemia (defined as cognitive impairment severe enough to require external assistance for recovery) frequently requires an ambulance resulting in Emergency Department attendance or hospital admission. Severe hypoglycaemia constitutes around 1% of 1.7 million emergency ambulance calls in England and Scotland resulting in 100 thousand paramedic attendances and estimated costs in England of £13.6 million annually. Hypoglycaemia is associated with adverse consequences including higher mortality, morbidity and health service costs due to hospital attendance/admission. It is also frightening for both patients and relatives and impairs quality of life and productivity, leading to poor long term control.
Aims and objectives
Aim: To evaluate the effect of implementing the 'Hypo's can strike twice' intervention to patients with diabetes and hypoglycaemia attended by East Midlands Ambulance Service NHS Trust in the East Midlands region. "Hypos can strike twice" is a complex intervention involving ambulance staff providing treatment and advice to people who have had a hypoglycaemic attack to access follow-up care by the GP or specialist diabetes team as detailed in national ambulance (JRCALC) clinical guidelines supported by the provision of a "Hypos can strike twice" booklet which the patient can read when they are fully recovered from the cognitive and other effects of the hypoglycaemic episode.
Objectives
To investigate the effect of implementing the 'Hypo's can strike twice' on:
- Repeat ambulance calls and attendances for hypoglycaemia
- Recorded referrals to an appropriate healthcare professional (e.g. GP, nurse).
- Completed care bundle for hypoglycaemia (proportion of patients with all of blood glucose recorded before treatment, blood glucose recorded after treatment and treatment given for hypoglycaemia.
- Costs of implementation 'Hypo's can strike twice' intervention vs costs of health service resource use.
- To conduct a process evaluation to explore how 'Hypo's can strike twice' exerts its effects and can be scaled up if effective by understanding implementation, mechanisms of impact, and contextual factors using interviews and surveys
Methods
Non-randomised stepped wedge design with mixed-methods process evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Analyses of repeat ambulance calls and costs | – | Other: Hypos can strike twiceFor our analyses of repeat ambulance calls and costs we will use routine anonymised data from routine call-and-dispatch and clinical records data from EMAS for 12 months before the intervention was first introduced (September 2017) to at least 6 months after the final step of the introduction in April 2019, i.e. October 2019. This is likely to involve the analysis of an estimated 11916 cases so that we can implement a stepped wedge (non-randomised control)design . |
| Survey of patients receiving intervention | – | Other: Hypos can strike twiceWe will survey about 447 patients who received the intervention in order to obtain data from a sample of n=96 |
| Survey of ambulance staff | – | –We will send out surveys/questionnaires to all front-line ambulance staff (n=approximately 600) |
| Qualitative interviews of staff | – | –We will sample 10-15 staff for qualitative interviews. |
| Qualitative interviews of patients | – | Other: Hypos can strike twiceWe will sample 10-15 patients for qualitative interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients needing an ambulance for hypoglycaemic events and ambulance staff attending these events.
Key inclusion criteria (2 listed)
- Patients: Adults aged 18 years+ with diabetes experiencing hypoglycaemia needing an ambulance service response. Hypoglycaemia for this study was identified as a 'clinical impression' of 'hypoglycaemia' or 'diabetic problem'. Hypoglycaemia may also be identified according to ambulance guidelines1 as any blood glucose less than 4mmol/L.
- Clinicians: Ambulance staff providing treatment and advice to people who have had a hypoglycaemic attack.
Key exclusion criteria (2 listed)
- Patients: Children under the age of 18 years.
- Clinicians: Ambulance staff providing treatment and advice for incidents other than hypoglycaemia.
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 |
|---|---|---|
| Hypos can strike twiceThe "Hypos can strike twice" intervention involves ambulance staff providing treatment to patients experiencing hypos and advising them to access follow-up care by their GP/specialist diabetes team. This is backed up by giving patients a "Hypos can strike twice" information booklet which they can read when they recover. | Other | Analyses of repeat ambulance calls and costs, Qualitative interviews of patients, Survey of patients receiving intervention |
Primary outcome
Repeat ambulance calls and attendances for hypoglycaemia within 14 days.
Time frame: 14 days from initial ambulance attendance
as stated above
1 secondary outcome
To assess whether the "Hypos can strike twice" intervention can reduce repeat ambulance calls and attendance for hypoglycaemia within 30 and 90 days.
Time frame: within 30 and 90 days from initial ambulance attendance
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 30 Sep 2021.
- Derived from this study: PubMed 35135499Laparidou D, Botan V, Law GR, Rowan E, Smith MD, Brewster A, Spaight R, Mountain P, Dunmore S, James J, Roberts L, Khunti K, Siriwardena AN. People with diabetes and ambulance staff perceptions of a booklet-based intervention for diabetic hypoglycaemia, "Hypos can strike twice": a mixed methods process evaluation. BMC Emerg Med. 2022 Feb 8;22(1):21. doi: 10.1186/s12873-022-00583-y.
- 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.
Niro Siriwardena principal investigator
University of Lincoln, UK
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 Diabetes, run by University of Lincoln 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 2 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 30 Sep 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?
Repeat ambulance calls and attendances for hypoglycaemia within 14 days. (time frame: 14 days from initial ambulance attendance). 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 NCT04243200, 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 30 Sep 2021.