Ambulance 'Hypos Can Strike Twice' Study

NCT04243200 | Completed

• 1 other identifier: 191202
• Study Type: observational
• Target: 5,015
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Repeat ambulance calls and attendances for hypoglycaemia within 14 days.

  as stated above

  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.

  within 30 and 90 days from initial ambulance attendance

Study Arms (5)

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

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

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

Interventions

Hypos can strike twice OTHER

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.

Analyses of repeat ambulance calls and costs; Qualitative interviews of patients; Survey of patients receiving intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic patients needing an ambulance for hypoglycaemic events and ambulance staff attending these events.

You may qualify if:

• 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.

You may not qualify if:

• Patients: Children under the age of 18 years.
• Clinicians: Ambulance staff providing treatment and advice for incidents other than hypoglycaemia.

Sponsors & Collaborators

• University of Lincoln: lead

Study Sites (1)

Community and Health Research Unit, University of Lincoln

Lincoln, Lincolnshire, LN5 7AY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35135499 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Niro Siriwardena

  University of Lincoln, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 28, 2020
• Study Start: September 14, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)