Links Worker Plan study

ISRCTN	ISRCTN80842457
DOI	https://doi.org/10.1186/ISRCTN80842457
Protocol serial number	v1.1;08.01.2015
Sponsor	University of Glasgow
Funder	NHS Health Scotland

Submission date: 31/03/2015
Registration date: 16/04/2015
Last edited: 17/05/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The Scottish Government funded Links Worker Programme aims to explore how GP practices and the primary care team can support people to live well in their community. The Links Worker Programme aims to support people by strengthening their connections to community resources in deprived areas in Scotland. This study is based in GP Practices that have applied to take part. A community Links Worker will be attached to a GP practice and they will help patients get in touch with existing community-based resources that may help them. Also, staff from the participating GP practices will be trained to help people in deprived areas make the most of their resources. The aim of the study is to see whether the Links Worker Programme improves patients’ quality of life. It will also see what parts of the Links Worker Programme are associated with positive changes in the GP practices that have a Links Worker.

Who can participate?
Patients (approved by their GP) and staff from participating GP practices

What does the study involve?
Patients are randomly put into one of two groups. In one group, patients go to their GP as usual but the GP practice has a Link Worker attached and the practice staff have Link Worker Programme training. In the other group, patients go to their GP as usual and receive standard care. All participants have interviews with researchers and complete questionnaires. There are further questionnaires about 9 months into the trial. The questionnaires ask about health, wellbeing and the patient's use of services (e.g. number of GP appointments).

What are the possible benefits and risks of participating?
By taking part in the trial participants will help inform researchers about how access to community resources helps people in deprived areas. There are no risks associated with this study.

Where is the study run from?
Trial study centre: participating GP practices (UK)
Trial run from: University of Glasgow (UK)

When is the study starting and how long is it expected to run for?
August 2014 to September 2016

Who is funding the study?
NHS Health Scotland (UK)

Who is the main contact?
1. Prof S Mercer (scientific)
Stewart.Mercer@glasgow.ac.uk
2. Dr B Fitzpatrick (public)
Bridie.Fitzpatrick@glasgow.ac.uk

Contact information

Dr Stewart Mercer
Scientific

Department of General Practice & Primary Care
University of Glasgow
1 Horselethill Road
Glasgow
G12 9LX
United Kingdom

Phone	+44 (0) 141 330 8351
Email	Stewart.Mercer@glasgow.ac.uk

Dr Bridie Fitzpatrick
Public

Department of General Practice & Primary Care
University of Glasgow
1 Horselethill Road
Glasgow
G12 9LX
United Kingdom

Phone	+44 (0) 141 330 8357
Email	Bridie.Fitzpatrick@glasgow.ac.uk

Study information

Primary study design	Interventional
Study design	A randomised controlled trial with quasi experimental evaluation and embedded theory-led process evaluation in three phases.
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Glasgow ‘Deep End’ Links Worker Plan programme evaluation
Study objectives	Implementation of the Links Worker Programme in GP practices serving socioeconomically deprived populations will: lead to improvements in the integration and use of community assets by practices; enhance practice staff’s knowledge and capacity and; improve patient-level outcomes of quality of life and well-being.
Ethics approval(s)	1. University of Glasgow, College of Social Sciences, 14/11/2014 (Phase 1) 2. University of Glasgow, College of Medical, Veterinary and Life Sciences, 02/03/2015 (Phase 2)
Health condition(s) or problem(s) studied	Social deprivation
Intervention	1. A community Links Worker will be attached to participating GP practices, and together they will implement a practice-wide links approach to existing community resources to benefit patients 2. Control group receives standard care provided by GP practices
Intervention type	Other
Primary outcome measure(s)	1. Patient participants' quality of life, measured at baseline and 9 month follow-up, measured by the Euro-Qol5D-5L and ICE-CAP questionnaires
Key secondary outcome measure(s)	1. At baseline and 9 month follow-up participants will complete questionnaires (Hospital Anxiety and Depression Scale, Rosenberg Self Esteem Scale, Work and Social Adjustment Scale and the Balanced Measure of Psychological need which assesses self-determination in term of competence, relatedness and autonomy) 2. We will assess burden of multi-morbidity and self-reported lifestyle activities (smoking, alcohol, exercise) and health care utilisation including medication, hospital admissions and GP consultations 3. We will assess knowledge of local community resources using questions devised and used in previous similar projects in Scotland 4. Demographic and socioeconomic variables will be collected 5. Staff outcome measures at baseline and 9 month follow-up will include questionnaires (Team Climate Inventory, job satisfaction, MAGPI (Morale Assessment in General Practice Index) and Maslach Burn-out Inventory)
Completion date	31/07/2017

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	All
Target sample size at registration	1000
Total final enrolment	900
Key inclusion criteria	1. Patient participants referred to the Links Worker by their GP 2. Volunteer staff from participating GP practices
Key exclusion criteria	1. Patients contraindicated by health or social reasons (such as terminal illness or a family or other social crisis) as assessed by their GP 2. No exclusion criteria for staff
Date of first enrolment	01/03/2015
Date of final enrolment	28/02/2016

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

University of Glasgow

General Practice & Primary Care
1 Horselethill Road
Glasgow
G12 9LX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2019	03/06/2020	Yes	No
Protocol article	protocol	25/01/2017	03/06/2020	Yes	No
Other publications	process evaluation	25/11/2021	17/05/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/05/2023: Publication reference added.
03/06/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
16/10/2017: Participant level dating sharing plans have been added.
13/10/2017: Overall trial end date has been updated from 30/09/2016 to 31/07/2017. Intention to publish date has been updated from 01/04/2017 to 01/02/2018.