Ambulance 'Hypos Can Strike Twice' Study

NCT ID: NCT04243200

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5015 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2021-04-30

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.

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.

Conditions

Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Survey of ambulance staff

We will send out surveys/questionnaires to all front-line ambulance staff (n=approximately 600)

No interventions assigned to this group

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 .

Hypos can strike twice

Intervention Type: 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.

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

Hypos can strike twice

Intervention Type: 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.

Qualitative interviews of staff

We will sample 10-15 staff for qualitative interviews.

No interventions assigned to this group

Qualitative interviews of patients

We will sample 10-15 patients for qualitative interviews

Hypos can strike twice

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lincoln

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niro Siriwardena

Role: PRINCIPAL_INVESTIGATOR

University of Lincoln, UK

Locations

Community and Health Research Unit, University of Lincoln

Lincoln, Lincolnshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35135499 (View on PubMed)

Other Identifiers

191202

Identifier Type: -

Identifier Source: org_study_id