Condition category
Not Applicable
Date applied
23/02/2015
Date assigned
05/03/2015
Last edited
01/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 2021

Who is funding the study?
Health Navigator AB (Sweden)

Who is the main contact?
Mr Magnus Liungman
magnus.liungman@healthnavigator.se

Trial website

Contact information

Type

Scientific

Primary contact

Mr Joachim Werr

ORCID ID

Contact details

Health Navigator AB
Sveavägen 63
Stockholm
SE-113 59
Sweden
+46 70 626 65 71
joachim.werr@healthnavigator.se

Type

Scientific

Additional contact

Dr Gustaf Edgren

ORCID ID

Contact details

Health Navigator
Sveavägen 63
Stockholm
11359
Sweden

Additional identifiers

EudraCT number

2015-000810-23

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Implementation of a telephone-based case management intervention for patients at risk of high emergency department utilisation in the English NHS

Acronym

Study hypothesis

It is possible to reduce the rate of emergency admissions and emergency outpatient visits among patients with a predicted high healthcare utilisation

Ethics approval

NRES Committee London – Bromley, 07/07/2015, ref: 15/LO/0992

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/02/2015

Overall trial end date

01/04/2021

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

7000

Participant 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

Recruitment start date

04/05/2015

Recruitment end date

06/05/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Vale of York
York
YO30 4GQ
United Kingdom

Trial participating centre

NHS Harrow
London
HA1 3AW
United Kingdom

Sponsor information

Organisation

Health Navigator AB

Sponsor details

Sveavägen 63
Stockholm
11359
Sweden

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Health Navigator AB (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/04/2016: The study contact has been updated from Magnus Liungman to Joachim Werr. 29/03/2016: Ethics approval information added.