Condition category
Not Applicable
Date applied
06/03/2017
Date assigned
08/03/2017
Last edited
08/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Nine million people live in rural (country) areas in England, of which one in five is over 65 years old. The population of over 85 year olds is the fastest growing age group in rural areas. Poverty is high in older rural people with a sixth of rural pensioners living in poverty. Access to primary care (first-line healthcare) for rural people is challenging with one in five living more than 4km from their general practice and one in three pensioner households not having access to a car. Therefore, in English rural areas, there are approximately 651,000 over 65 year olds that do not have access to a car and 316,000 people over 65 years old who live below the poverty threshold. Previous research has highlighted that socio-economically disadvantaged (poorer) older people in rural areas are at risk of poor access to healthcare. The study team has spent two years understanding why this group may find it difficult to access primary care by reviewing previous research, interviewing older people, conducting focus groups with health professionals and collecting population information. It is possible that improving the ease of the booking system and access to suitable transport options for those without access to a car could help rural older people to access healthcare. This study is looking at a support package to give to GP surgeries, designed to help improve access to primary care for this group. The aim of this study is to test the study procedures to find out if a full-scale trial would be possible.

Who can participate?
Older adults who have difficulty getting to their GP and are on two or more repeat prescriptions.

What does the study involve?
Four GP practices are randomly allocated to one of two groups. One of these practices is allocated to a group that continues to offer usual care to patients. The other three practices are allocated to a group that receive a Support Manual that informs four development meetings and £1500 to develop and/or deliver their own practice-level service changes to their patients. The service changes are aimed at improving the ease of the booking system and helping overcome transport barriers. During the first two months, two three-hour practice observations will take place. In the final two months there will be two group interviews with staff from each practice. In order to obtain information about the effectiveness of the program, data is collected from a random sample of ten patients from each practice. Each time the patient tries to book an appointment or attends the surgery they are asked to complete a questionnaire. Semi-structured interviews are also undertaken with two of the patients recruited from each practice.

What are the possible benefits and risks of participating?
Those taking part may benefit from their GP practice being supported to develop ways of improving the service. This study is very low risk and we don’t expect any significant risks for participating taking part.

Where is the study run from?
The study is run from Norwich Medical School and takes place in four GP practices (UK)

When is the study starting and how long is it expected to run for?
September 2016 to May 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr John Ford
john.ford@uea.ac.uk

Trial website

www.uea.ac.uk/GPstudy

Contact information

Type

Public

Primary contact

Dr John Ford

ORCID ID

http://orcid.org/0000-0001-8033-7081

Contact details

Norwich Medical School
University of East Anglia
Chancellors Drive
Norwich
NR4 7TJ
United Kingdom
+44 1603 591743
john.ford@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33077

Study information

Scientific title

Improving Primary care Access in Context and Theory (I-ACT trial): A theory informed trial using a realist perspective

Acronym

I-ACT

Study hypothesis

The aim of this feasibility study is to test the design and collect the necessary information needed to inform a definitive trial investigating the effectiveness of a GP practice a support package to improve access to primary care for socio-economically disadvantaged older people in rural areas.

Ethics approval

NRES North East - York Research Ethics Committee, 19/12/2016, ref: 16/NE/0424

Study design

Randomised; Interventional; Design type: Process of Care, Complex Intervention

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

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

Condition

Specialty: Primary Care, Primary sub-specialty: Public Health; UKCRC code/ Disease: Other/ Symptoms and signs involving the urinary system

Intervention

Practices will be randomised using simple block randomisation to ensure that one practice is allocated to the control arm and three to the intervention. Opaque sealed and numbered envelopes will be used. Practices will be randomised after all 10 participants have been recruited and the practice profiled.

Intervention: Practices allocated to the intervention arm will be supported to improve the following two areas for socio-economically disadvantaged older people:
1. Ease of the booking system and
2. Transport barriers
Each practice in the intervention arm will be asked to nominate a GP and practice manager as development leads. A Support Manual will be provided to help intervention practices meet the above objectives for all patients in the population of interest, not just those who are providing data. The Support Manual will include:
1. An overview of the trial.
2. Service specifications outlining the essential characteristics of the planned changes to ensure that it will meet the research requirements.
3. An evidence briefing providing an up-to-date review of the published and grey literature looking at barriers to improve access to primary care and possible interventions.
4. An outline of the four development meetings.
5. A logic model to support development
6. Feedback to practices from the practice profiling.
7. Time specific milestones to guide development and implementation.
The support manual will be presented to all intervention practices at an initial induction meeting of practice managers.
The Support Manual will be complimented by four weekly development meetings for one hour at the practice in which the practice manager and GP will meet with members of the research team to develop their service and £1500 to contribute to the service development and/or delivery. The four weekly meetings will consist of:
1. Problem solving, brain storming and initial actions
2. Options appraisal, decision making and next steps
3. Reviewing decision and completion of logic model
4. Agreeing service changes and process measures
The development meetings will be audio-recorded to help understand the decision making process. Consent will be obtained from GPs, practice managers and any other staff who attend before audio-recording the meetings. The final service changes will require agreement between the research team and practice before implementation. The research team will also agree specific activity and process measures to assess implementation. The logic model produced by the practice and research team will provide a clear description of the service changes and hypothesised causal pathways.

Control: Participants in practices not randomised to the intervention arm will receive usual care and access the GP surgery in the standard manner.

During the first two months, two three-hour practice observations will take place. In the final two months there will be two group interviews with staff from each practice.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Pre-appointment transport options, ease of appointment and perceived convenience measured by a self-completed questionnaire designed for the purpose of this study at baseline, 6 months and each time appointment is booked
2. Post-appointment suitability of received appointment and transport to get to the appointment measured by a self-completed questionnaire designed for the purpose of this study at baseline, 6 months and each time appointment is booked

Secondary outcome measures

1. Confidence and trust in GP practice measured by a self-completed questionnaire designed for the purpose of this study at baseline, 6 months and each time appointment is booked
2. Patient Activation Measure (PAM) measured by a self-completed questionnaire designed for the purpose of this study at baseline and 6 months
3. Quality of life (EQ5D and ICECAP-O) measured by a self-completed questionnaire designed for the purpose of this study at baseline and 6 months
4. Number and type of health professional contact measured by routine practice data for trial period from 6 months at baseline and follow-up
5. Hospital admissions measured by routine practice data for trial period from 6 months at baseline and follow-up
6. Intervention activity and process measures agreed by research team and practices measured by routine practice data for trial period from 6 months at follow-up
7. Number of referrals measured by routine practice data for trial period from 6 months at baseline and follow-up
8. Number of repeat medications measured by routine practice data for trial period from 6 months at baseline and follow-up

Overall trial start date

01/09/2016

Overall trial end date

30/05/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 65 years and over
2. With difficulty accessing the general practice
3. Two or more repeat prescriptions
4. Twelve or fewer nurse or GP consultations in the past 12 months (face-to-face, telephone or home visit)
5. No access to a car within their household
6. Living in a postcode in the highest Index of Multiple Deprivation quartile in the practice

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 56; UK Sample Size: 56

Participant exclusion criteria

1. Significant cognitive impairment that would prevent them providing informed consent, such as dementia
2. Not able to speak English
3. Generally do not book their own appointments

Recruitment start date

01/04/2017

Recruitment end date

31/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Norfolk CCG
Lakeside 400, Old Chapel Way, Broadland Business Park, Thorpe St Andrew
Norwich
NR7 0WG
United Kingdom

Sponsor information

Organisation

University of East Anglia

Sponsor details

Norwich Medical School
University of East Anglia
Chancellors Drive
Norwich
NR4 7TJ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

An open evening dissemination event will be held at the University of East Anglia. Participating practices and patients will be invited as well as local GPs, practice managers, commissioners and researchers.
Findings will be presented at the annual Society of Academic Primary Care conference or similar. There will be a main feasibility study journal article published and, if time allows, an accompanying methodological paper.

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

Intention to publish date

30/05/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes