Condition category
Not Applicable
Date applied
15/10/2018
Date assigned
02/11/2018
Last edited
30/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Community healthcare providers in the coastal areas of England, France, Belgium and the Netherlands face social, clinical and financial difficulties as people age and public funding decreases. Different home care systems exist in different countries and some are more effective than others. The aim of this study is to see whether different models of home care can be transferred across national boundaries and be effective under differing cultures and contexts.
In the Netherlands, a new method of community nursing whereby small, self-managing teams of health and care workers provide all aspects of care to patients in their homes has proved very successful and is being introduced in the other countries. As an addition to the implementation of the care model we are investigating how this is received by patients, carers and staff.

Who can participate?
Patients who require 6 weeks or more of community care under the new care model and their carers. Participants need to be over the age of 18 and able to understand spoken and written English. Patients who received 6 weeks or more of care under the existing model and their carers will also be able to participate. These patients will live in localities identified to match the demographics of the intervention area. Staff working under both models in the designated sites will also be approached to take part.

What does the study involve?
The new intervention will be compared with the existing model. Half of the participants will receive (or implement, if they are staff) the new model and the other half will receive/implement the existing model. TParticipants will be asked to feedback on their experiences under both models. Feedback will include questionnaires, interviews and focus groups.

What are the possible benefits and risks of participating?
The new way of nursing could improve patient care and outcomes. It could also lead on to improvements for their carers by reducing dependency. In addition, it could improve the health, wellbeing and job satisfaction for health care professionals. By investigating how the people concerned are experiencing care we can make sure that the model is effective and has the same benefits as have been shown in the Netherlands.
As the interventions mainly use questionnaires, the risks to individuals are low. Participants will be given time to participate and offered to stop if any difficulties do arise. Distress could be caused to carers if the research team contact them and the care receiver has died. To limit this risk, the research team will contact the patient's GP before contacting the patient or their carer.

Where is the study run from?
The study is taking place in two healthcare providers in Kent and Medway. The new care model is being introduced in Edenbridge, Kent and Hoo, Medway before being expanded outwards. It is possible sites in East Kent will also take part if the care model is introduced there. The sites chosen for comparison have not yet been chosen but will be from a GP practice that is unlikely to introduce the new care model within the next 18 months.

When is the study starting and how long is it expected to run for?
October 2018 to March 2021

Who is funding the study?
Interreg 2 Seas (France)

Who is the main contact?
Bethany Baldock
bethany.baldock@nhs.net

Trial website

https://www.kentcht.nhs.uk/2017/11/24/new-future-transforming-integrated

Contact information

Type

Public

Primary contact

Mrs Bethany Baldock

ORCID ID

Contact details

Trinity House
110-120 Upper Pemberton
Kennington
Ashford
TN25 4AZ
United Kingdom
01233667905
bethany.baldock@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

39700

Study information

Scientific title

TICC: Transforming Integrated Care in the Community

Acronym

TICC

Study hypothesis

TICC will create systemic change in health & social care, providing services better suited to our ageing population, addressing holistic needs. It will present a methodology to overcome blocking points in transferring socially innovative service models from one area to another. TICC will enable other health/social care organisations to implement new ideas, increase staff productivity, recruitment, retention, and patient satisfaction, and decrease costs, emergency admissions and staff absence. It will aim to postpone the moment when residential/end of life care is needed.

Ethics approval

London - Westminster, 30/08/2018, 18/LO/1458

Study design

Interventional non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Treatment

Patient information sheet

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

Condition

Community nursing care provided at the patient's home

Intervention

Three different groups of people will be recruited - patients, their carers, and healthcare staff providing the new model of community care. Patients requiring 6 weeks or more of the new model of community care will be invited to take part in the study and if they agree information about them will be collected, such as age, gender, educational level, current work status and living situation. They will be invited to complete a set of 3 questionnaires at the start, 6 weeks and then every 6 months until the end of the study. To be able to compare to normal care, patients from a similar area but receiving traditional community care will be invited to do the same. Other data that will be collected are length of time in the community care service, date care episode ended, number of times using the community nursing service, GP visits, hospital admissions, referrals and care home admissions.
Informal carers of the patients receiving the new model will be invited to take part in the study, and if they agree will be asked to give the following information: age, gender and length of care for relative/friend receiving care. They will be invited to complete a questionnaire on experienced burden at baseline, 6 weeks and then every 6 months until the end of the study.
All healthcare staff providing care as part of the new model of community care will be invited to take part in the study. Those that agree will be asked to provide the following information: age, gender, profession, years of experience and length of service in current organisation. They will be invited to complete three questionnaires on job satisfaction and empowerment as well as ask a question on intention to leave the role. A selection will then be asked to take part in an interview. One or two focus groups will then be held to further explore the impact of change to a new care model. To be able to compare to normal care, healthcare staff from a similar area but providing traditional community care will be invited to complete the questionnaires.
A patient or carer that takes part in the study could be involved for 2 years and during this they could have a maximum of 6 questionnaire time points to complete but participants who are recruited later will only participate for the remainder of the 2 years. Staff will complete questionnaires at baseline, 1 year and 2 year with focus groups at 6 months and 18 months and interviews at 1 year and 2 years. Once the study finishes at 2 years there will be no follow-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The barriers and facilitators to the implementation of a new care model in the UK will be assessed using questionnaires, GP dataon admissions and referrals, focus groups and interviews. Data collection is continuous but an initial assessment will be made at one year with an endpoint at the end of the two year period.

Secondary outcome measures

Suitability of the Buurtzorg model for implementation in the UK will be assessed using questionnaires, GP dataon admissions and referrals, focus groups and interviews. Data collection is continuous but an initial assessment will be made at one year with an endpoint at the end of the two year period.

Overall trial start date

31/10/2017

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Nurses and care workers:
1. Aged 18 years or older
2. Providing care as part of the new model of community nursing care

Patients:
1. Aged 18 years or older
2. Expected to receive the new model of community care for a minimum period of at least 6 weeks
3. Able to understand spoken and written English

Informal caregivers:
1. Aged 18 years or older
2. Providing some level of care or support for their friend or relative
3. Able to understand spoken and written English

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 800; UK Sample Size: 375

Participant exclusion criteria

1. Unsuitable to approach due to medical circumstances
2. Patients previously recruited to the study

Recruitment start date

02/10/2018

Recruitment end date

31/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Kent Community Health NHS Foundation Trust
Unit D The Oast Hermitage Court Barming
Maidstone
ME16 9NT
United Kingdom

Trial participating centre

Medway Community Healthcare
MCH House Bailey Drive
Gillingham
ME8 0PZ
United Kingdom

Sponsor information

Organisation

Kent Community Health NHS Foundation Trust

Sponsor details

Unit D
The Oast
Hermitage Court
Barming
Maidstone
ME16 9NT
United Kingdom
01233 667776
kentchft.ticc@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

European Commission

Alternative name(s)

EC

Funding Body Type

unknown

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer, reviewed journal, likely to be published in June 2022

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

30/06/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/04/2020: Due to current public health guidance, recruitment for this study has been paused. 25/03/2019: The condition has been changed from "Specialty: Health Services Research, Primary sub-specialty: Health Services Research; Health Category: Generic health relevance" to "Community nursing care provided at the patient's home" following a request from the NIHR. 23/11/2018: Internal review.