Condition category
Nervous System Diseases
Date applied
03/02/2016
Date assigned
04/02/2016
Last edited
08/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A stroke is a serious condition where the blood supply to a part of the brain is cut off, usually by a blood clot blocking an artery (ischaemic stroke) or a bleed (haemorrhagic stroke). A large proportion of stroke victims suffer from long-term complications depending on the area of the brain that is affected, which can affect their ability to move, speak or even their cognitive function (memory loss, difficulty reasoning and confusion). Psychological problems, such as depression, are common after stroke and can have negative effects on stroke survivors and their carers. Although general psychological services exist (e.g. Improving Access to Psychological Therapies (IAPT) services), there is a lack of psychological support available for stroke survivors. This may be because of the range of difficulties that stroke survivors might have, such as communication problems, which make it more challenging for services to provide effective support. This study aims to find out whether existing IAPT services can be adapted so that they are useful for stroke survivors.

Who can participate?
Adults who have suffered from a stroke and their carers, as well as staff working in the hospital and community settings at each of the sites.

What does the study involve?
At the start of the study, interviews will be held with stroke survivors to find out about their experience and views of psychological services. Staff of stroke services and psychological services staff are also interviewed in order to assess the current psychological care offered. Following this, notes of patients who have previously been admitted to hospital are reviewed in order to find out whether the initial stages of the study (i.e. the process mapping and the development of the implementation package) even before the main part of the study has started, has an effect on the psychological support patients receive, for example by raising staff awareness of unmet needs. The main trial involves stroke services being randomly allocated to one of two dates to begin the implementation package, spaced three months apart. The implementation package is adopted into normal care and involves training the staff of stroke teams and IAPT teams in order to provide psychological help to stroke survivors when needed. After 6 weeks and 6 months, patients are asked to complete a number of questionnaires in order to find out if the package has had any effect on their mood and general wellbeing. At the end of the study, patients, carers and staff are interviewed in order to give their opinions about their experiences.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Four stroke services in NHS trusts based in the North-West of England

When is the study starting and how long is it expected to run for?
November 2015 to December 2016

Who is funding the study?
1. National Institute for Health Research (UK)
2. MQ: Transforming Mental health (UK)

Who is the main contact?
Dr Elizabeth Lightbody
CELightbody@uclan.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Elizabeth Lightbody

ORCID ID

Contact details

University of Central Lancashire
Clinical Practice Research Unit (CPRU)
Department of Nursing
Fylde Road
Preston
PR1 2HE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20096

Study information

Scientific title

Accelerating Delivery Of Psychological Therapies after Stroke (ADOPTS)

Acronym

ADOPTS

Study hypothesis

The aim of this study is to explore the feasibility and acceptability of providing psychological support to stroke survivors in the NHS through exploring the operationalisation of an Implementation Package using a stepped-wedge trial design.

Ethics approval

NRES Committee Yorkshire and The Humber - Leeds East, 20/08/2015, ref: 15/YH/0343

Study design

A feasibility stepped-wedge cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Topic: Stroke; Subtopic: Rehabilitation; Disease: Therapy type

Intervention

At the start of the study, stroke survivors are interviewed in order to find out about their experience and views of psychological services. In addition, staff at stroke services and psychological services staff are interviewed in order to inform the design of the implementation package (developed in earlier phases of the project).

The Implementation Package itself will establish a care pathway for patients with psychological needs after stroke, based on a stepped care model. The pathway will focus on the collaborative work between the stroke teams and IAPT teams, allowing psychological needs after stroke to be identified, treated and where necessary, for more complex cases, referred on to appropriate services. The Implementation Package will be individualised for each site, taking into consideration the staff and service user views, current practices and pathways, and available resources at each site.

While delivery will vary slightly across sites, the core aspects of the implementation strategies will be consistent across all sites and will include the care pathway, training, a manual and a model of supervision. The research team is experienced in developing intervention implementation packages and will use a co-design approach where stroke patients and carers are involved in its conception and design. The rationale for such a partnership is to maximise the “potential fit” of the intervention with the local context in which the intervention will be implemented thus maximising buy-in from clinical staff.

The trial will include exploring the usual practice before the study begins, delivery plan for the main intervention, and capturing the experiences of participants after the study has finished. The trial comprises of the following three elements: casenote review,main trial and process evaluation.

Casenote Review
Retrospective review of patient hospital casenotes to explore feasibility of stepped-wedge design. It is important to know whether the initial stages of the study (i.e. the process mapping and the development of the Implementation Package), even before the main intervention has started, has impacted on the psychological support patients receive, for example by raising staff awareness of unmet needs. This will inform the feasibility and suitability of the stepped wedge design for a future trial.

Main Trial
A stepped-wedge cluster randomised trial in 4 stroke services (clusters) which will be randomised to one of two dates to begin the roll-out period (3 months apart). Randomisation will be performed by an independent statistician in the Lancashire CTU using computer-generated pseudo-random numbers. All clusters start in a usual care phase (no intervention delivered at any site), then sequentially crossover to the roll-out phase, until all sites are receiving the intervention. The Implementation Package will be rolled out over a 3 month period to embed the pathway in the services prior to the start of formal data collection for the intervention phase.
The Implementation Package consists of providing a care pathway for psychological support after stroke. This pathway will be adopted as part of usual care, patients consent to data collection and follow up only. While delivery will vary slightly across sites, the core aspects of the implementation strategies will be consistent across all sites.
All recruited patients will receive a postal questionnaire at 6-weeks and 6-months post-stroke to collect outcome data

Process Evaluation
In order to understand the experiences of those involved in the study, process evaluation interviews will be held with both patients and staff. The interviews will establish what participants thought worked well, as well as areas they felt could be improved.
Through semi-structured interviews, patients and their carers will be asked to describe their experience of psychological support since their stroke, including whether they found their experience acceptable and suitable. Participants will be asked to comment on a proposed service model for future psychological support services for patients after stroke.
Following roll-out of the implementation package, staff will be interviewed about their experiences. The interview will aim to understand staff feelings towards implementing the intervention package, including the training and supervision they received, what they felt worked well, and what they felt could be improved. This will provide ideas for refinement of trial procedures and protocol should a large scale trial be conducted in future.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Patient Health Questionnaire 9 item (PHQ-9) at baseline, 6 weeks and 6 months.

Secondary outcome measures

1. Behavioual Outcomes of Anxiety Scale (BOA) at baseline, 6 weeks and 6 months
2. Generalised Anxiety Disorder 7 item (GAD-7) at baseline, 6 weeks and 6 months
3. Impact of Events Scale 6-items at 6 weeks and 6 months
4. Stroke Aphasia Depression Questionnaire 10 item (SADQ-10) at baseline, 6 weeks and 6 months
5. Work and Social Adjustment Scale 5-items at 6 weeks and 6 months

Overall trial start date

04/11/2015

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Case note review
All stroke patients on the acute stroke unit will be identified over one week during the usual care period (prior to process mapping and development of the implementation package), and one week during the period of rolling out the implementation package.

Main Trial
Consecutive stroke patients admitted to the acute stroke units will be identified who:
1. Survive to day 3 post-stroke or being discharged prior to day 3
2. Lives within catchment area of trust
3. Aged 18 or over

Process Evaluation
Stroke patients and carers
Stroke patients and carers will be purposely selected (12 per site) to recruit a balance in sex, age (younger and older), stroke severity (mild, moderate and severe), communication abilities and time since stroke.

Staff
Staff working within the stroke hospital settings within each of the sites. This may include nurses, doctors, OTs, physiotherapists, allied health professionals, reflecting the range of staff involved in the care pathway at each site.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Casenote review: Approximately 20 patients per site (total of 80 patients). Main Trial: Approximately 20-30 patients from each centre in each period (total of 320-480). Process Evaluation: Stroke patients and carers - Approximately 12 per site (total of 48)

Participant exclusion criteria

The participant exclusion criteria is the same for all three elements (casenote review, main trial and process evaluation) and are as follows:
1. Living outside area catchment area of trust
2. Aged under 18
3. Lacks capacity AND has no friend/relative/carer

Recruitment start date

04/11/2015

Recruitment end date

31/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Lancashire Teaching Hospitals NHS Foundation Trust
Sharoe Green Lane Fulwood
Preston
PR2 9HT
United Kingdom

Trial participating centre

Wirral University Teaching Hospital NHS Foundation Trust
Arrowe Park Road Upton, Wirral
Merseyside
CH49 5PE
United Kingdom

Trial participating centre

East Lancashire Hospitals NHS Trust
Royal Blackburn Hospital Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

Countess of Chester Hospital NHS Foundation Trust
The Countess of Chester Health Park Liverpool Road
Chester
CH2 1UL
United Kingdom

Sponsor information

Organisation

University of Central Lancashire

Sponsor details

Fylde Road
Preston
PR1 2HE
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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/02/2016: Verified study information with principal investigator.