Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Stewart Mercer
ORCID ID
Contact details
Department of General Practice & Primary Care
University of Glasgow
1 Horselethill Road
Glasgow
G12 9LX
United Kingdom
+44 (0) 141 330 8351
Stewart.Mercer@glasgow.ac.uk
Type
Public
Additional contact
Dr Bridie Fitzpatrick
ORCID ID
Contact details
Department of General Practice & Primary Care
University of Glasgow
1 Horselethill Road
Glasgow
G12 9LX
United Kingdom
+44 (0) 141 330 8357
Bridie.Fitzpatrick@glasgow.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
v1.1;08.01.2015
Study information
Scientific title
Glasgow ‘Deep End’ Links Worker Plan programme evaluation
Acronym
Study hypothesis
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
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)
Study design
A randomised controlled trial with quasi experimental evaluation and embedded theory-led process evaluation in three phases.
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
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
Phase
Drug names
Primary outcome measure
1. 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 measures
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)
Overall trial start date
01/08/2014
Overall trial end date
31/07/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient participants referred to the Links Worker by their GP
2. Volunteer staff from participating GP practices
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
150 GP practice staff and 862 GP practice patients
Total final enrolment
900
Participant 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
Recruitment start date
01/03/2015
Recruitment end date
28/02/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Glasgow
General Practice & Primary Care
1 Horselethill Road
Glasgow
G12 9LX
United Kingdom
Sponsor information
Organisation
University of Glasgow
Sponsor details
College of Medical
Veterinary and Life Sciences
Wolfson Medical School Building
University of Glasgow
University Avenue
Glasgow
G12 8QQ
United Kingdom
+44 (0) 141 330 2000
ihwadmin@glasgow.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NHS Health Scotland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
A 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 statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/02/2018
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2017 protocol in https://pubmed.ncbi.nlm.nih.gov/29090184/ (added 03/06/2020)
2019 results in https://doi.org/10.1370/afm.2429 (added 03/06/2020)