A telephone-based case management intervention for patients at risk of high emergency department utilisation in the English NHS
| ISRCTN | ISRCTN12724749 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12724749 |
| EudraCT/CTIS number | 2015-000810-23 |
- Submission date
- 23/02/2015
- Registration date
- 05/03/2015
- Last edited
- 11/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
There is a relatively large group of patients with repeated emergency visits and admissions who
use a disproportionate amount of health care resources. Several studies have shown that programmes (interventions) that help people to develop the skills, knowledge and confidence to manage their own health (patient activation) can result in heath improvements, increased quality of life and fewer unplanned contacts with healthcare services without any increases in planned care. We want to test a proactive health coaching protocol designed for patients at high risk of being admitted to an emergency healthcare department. It involves regular and individualized contact with a trained nurse and includes care coordination efforts (where a number of healthcare professionals work together to deliver appropriate healthcare to a patient), advice and training. The overall goal of this study is to investigate whether this health coaching protocol can reduce avoidable use of the healthcare system by frequent visitors to emergency departments.
Who can participate?
Adults that are considered to be at high risk of hospital admissions in the next 6 months according to a risk prediction model.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are allocated a designated health coach. Following an initial assessment, the health coach regularly contacts the patient by telephone while also working with others, such as healthcare providers or social services, in order to improve and integrate care for that patient. Those in group 2 (control group) are not allocated a health coach. Participants in both the intervention and the control group are assessed in terms of how much they use healthcare services over a period of four years.
What are the possible benefits and risks of participating?
There are no benefits or risks to participating in this study.
Where is the study run from?
The study is conducted in participation with the NHS Vale of York and NHS Harrow Clinical Commissioning Groups and Hospitals.
When is the study starting and how long is it expected to run for?
February 2015 to April 2023 (updated 11/06/2019, previously: April 2021)
Who is funding the study?
Health Navigator AB (Sweden)
Who is the main contact?
1. Joachim Werr (joachim.werr@healthnavigator.se)
2. Eleitha Medina (eleitha.medina@health-navigator.co.uk)
Contact information
Scientific
Health Navigator AB
Sveavägen 63
Stockholm
SE-113 59
Sweden
| Phone | +46 70 626 65 71 |
|---|---|
| joachim.werr@healthnavigator.se |
Scientific
One King Street
London
W6 9HR
United Kingdom
| Phone | +44 79 9973 2622 |
|---|---|
| eleitha.medina@health-navigator.co.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Implementation of a telephone-based case management intervention for patients at risk of high emergency department utilisation in the English NHS |
| Study objectives | It is possible to reduce the rate of emergency admissions and emergency outpatient visits among patients with a predicted high healthcare utilisation |
| Ethics approval(s) | NRES Committee London – Bromley, 07/07/2015, ref: 15/LO/0992 |
| Health condition(s) or problem(s) studied | The study is based among patients deemed to have a high risk of emergency admission |
| Intervention | Each participant assigned to the intervention group will be allocated a designated health coach. Following an initial assessment, the health coach will be in regular contact with the patient by telephone while also engaging relevant other stakeholders (e.g. health care providers, or social services) with the objective of improving and integrating care for that patient. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Emergency hospitalizations, ascertained using hospital electronic medical records 2. Emergency hospital outpatient visits, ascertained using hospital electronic medical records These will be measured at the end of follow-up, i.e. after 2 years. |
| Secondary outcome measures | 1. Non-elective bed days, ascertained using hospital electronic medical records 2. Total hospital admissions, ascertained using hospital electronic medical records 3. Total bed days, ascertained using hospital electronic medical records 4. A&E attendances, ascertained using hospital electronic medical records 5. Total health-care costs, ascertained using hospital electronic medical records 6. Patient activation, ascertained using PAM-13 7. Quality of life, ascertained using SF-12 These will be measured at the end of follow-up, i.e. after 2 years. |
| Overall study start date | 01/02/2015 |
| Completion date | 01/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 7000 |
| Key inclusion criteria | 1. Patients residing in the studied region 2. Patients 18 years or older 3. Patients considered to be at high risk of non-elective admissions in the next 6 months according to a risk prediction model. The prediction model is based on patient administrative data, and makes an automated risk assessment based on the patient's sex, number of diagnoses (registered diagnoses in the past 2 years), planned and unplanned hospital contacts in the past 6 months and readmissions. The risk assessment is based on a logistic regression model which will be developed and validated specifically for the study. |
| Key exclusion criteria | 1. Patients who have had contact with healthcare services within the past six months, and have one or more of the following diagnoses (not necessarily the diagnosis relating to their contacts): 1.1. Dementia 1.2. Psychotic disorders 1.3. Mental disorders caused by misuse 1.4. Terminal cancer 2. Estimated remaining life expectancy of < 1 year 3. Has undergone major surgery in the last six months or planned to undergo major surgery in the foreseeable future 4. Severe hearing loss 5. Language difficulties that require an interpreter 6. Level of cognitive ability which is not sufficient for receiving and responding to telephone counselling 7. Does not have access to a telephone connection |
| Date of first enrolment | 04/05/2015 |
| Date of final enrolment | 05/05/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
YO30 4GQ
United Kingdom
HA1 3AW
United Kingdom
Sponsor information
Industry
Sveavägen 63
Stockholm
11359
Sweden
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
The following changes were made to the trial record:
1. The recruitment end date was changed from 06/05/2019 to 05/05/2021.
2. The overall end date was changed from 01/04/2021 to 01/04/2023.
3. The intention to publish date was added.
4. The plain English summary was updated to reflect these changes.
02/10/2018: The following changes have been made to the trial record:
1. The study contact has been updated from Gustaf Edgren to Eleitha Medina
2. The main study contact in the plain English summary has been changed from Magnus Liungman to Joachim Werr and Eleitha Medina
01/04/2016: The study contact has been updated from Magnus Liungman to Joachim Werr.
29/03/2016: Ethics approval information added.
