Condition category
Not Applicable
Date applied
31/03/2015
Date assigned
16/04/2015
Last edited
16/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Professor 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 measures

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

30/09/2016

Reason abandoned

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

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.

Intention to publish date

01/04/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes