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Ambulance 'Hypos Can Strike Twice' Study (Ambu-HS2)

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ClinicalTrials.gov Identifier: NCT04243200
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
University of Lincoln

Brief 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 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.


Condition or disease Intervention/treatment
Diabetes Other: Hypos can strike twice

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:

  1. Repeat ambulance calls and attendances for hypoglycaemia
  2. Recorded referrals to an appropriate healthcare professional (e.g. GP, nurse).
  3. 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.
  4. Costs of implementation 'Hypo's can strike twice' intervention vs costs of health service resource use.
  5. 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.

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Study Type : Observational
Estimated Enrollment : 12993 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Group/Cohort Intervention/treatment
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 .
Other: Hypos can strike twice
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.

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
Other: Hypos can strike twice
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.

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
Other: Hypos can strike twice
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.




Primary Outcome Measures :
  1. Repeat ambulance calls and attendances for hypoglycaemia within 14 days. [ Time Frame: 14 days from initial ambulance attendance ]
    as stated above


Secondary Outcome Measures :
  1. 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 ]
    as stated above



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetic patients needing an ambulance for hypoglycaemic events and ambulance staff attending these events.
Criteria

Inclusion criteria:

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.

Exclusion Criteria:

Patients: Children under the age of 18 years.

Clinicians: Ambulance staff providing treatment and advice for incidents other than hypoglycaemia.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243200


Contacts
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Contact: Niro Siriwardena +44 (0)1522 886939 nsiriwardena@lincoln.ac.uk
Contact: Despina Laparidou +44(0)1522 837407 dlaparidou@lincoln.ac.uk

Locations
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United Kingdom
Community and Health Research Unit, University of Lincoln
Lincoln, Lincolnshire, United Kingdom, LN5 7AY
Contact: Niro Siriwardena    +44(0)1522 886939    nsiriwardena@lincoln.ac.uk   
Sponsors and Collaborators
University of Lincoln
Investigators
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Principal Investigator: Niro Siriwardena University of Lincoln, UK
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Responsible Party: University of Lincoln
ClinicalTrials.gov Identifier: NCT04243200    
Other Study ID Numbers: 191202
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No