ISRCTN ISRCTN80842457
DOI https://doi.org/10.1186/ISRCTN80842457
Secondary identifying numbers v1.1;08.01.2015
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

Study designA randomised controlled trial with quasi experimental evaluation and embedded theory-led process evaluation in three phases.
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)GP practice
Study typeQuality of life
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleGlasgow ‘Deep End’ Links Worker Plan programme evaluation
Study objectivesImplementation 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) studiedSocial deprivation
Intervention1. 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 typeOther
Primary outcome measure1. Patient participants' quality of life, measured at baseline and 9 month follow-up, measured by the Euro-Qol5D-5L and ICE-CAP questionnaires
Secondary outcome measures1. 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)
Overall study start date01/08/2014
Completion date31/07/2017

Eligibility

Participant type(s)Mixed
Age groupAdult
SexBoth
Target number of participants150 GP practice staff and 862 GP practice patients
Total final enrolment900
Key inclusion criteria1. Patient participants referred to the Links Worker by their GP
2. Volunteer staff from participating GP practices
Key exclusion criteria1. 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 enrolment01/03/2015
Date of final enrolment28/02/2016

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

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

Sponsor information

University of Glasgow
University/education

College of Medical, Veterinary and Life Sciences
Wolfson Medical School Building
University of Glasgow
University Avenue
Glasgow
G12 8QQ
Scotland
United Kingdom

Phone +44 (0) 141 330 2000
Email ihwadmin@glasgow.ac.uk
ROR logo "ROR" https://ror.org/00vtgdb53

Funders

Funder type

Government

NHS Health Scotland

No information available

Results and Publications

Intention to publish date01/02/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planA lay-friendly summary of the study findings will be mailed to all participants at the end of the study. We aim to publish in high impact peer reviewed journals, including open access journals and the HTA journal series, and presentations will be given at international scientific conferences. Furthermore, the results will be highlighted to the relevant individual in public bodies to ensure that these are translated into practice as soon as possible. The final report will be published on the Health Scotland website after the key publication from the study has been accepted for publication by a scientific journal, which we would expect to be no more than 6 months after the end of the project.
IPD sharing planThe 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?
Protocol article protocol 25/01/2017 03/06/2020 Yes No
Results article results 01/11/2019 03/06/2020 Yes No
Other publications process evaluation 25/11/2021 17/05/2023 Yes No

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.