Condition category
Signs and Symptoms
Date applied
21/07/2014
Date assigned
28/07/2014
Last edited
24/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Michael Bennett

ORCID ID

Contact details

Academic Unit of Palliative Care
Leeds Institute of Health Sciences
101 Clarendon Road
Leeds
LS2 9LJ
United Kingdom
-
m.i.bennett@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 12/188/05

Study information

Scientific title

Self-Management of Analgesia and Related Treatments at the End of life: a pre-post observational study

Acronym

SMARTE

Study hypothesis

We aim to develop a support tool to improve the management of medications for pain relief, nausea, constipation and drowsiness in patients with significant pain approaching the end of life. Ultimately we aim to establish the acceptability and up-take of our prototype SMST and determine the feasibility of evaluating this intervention within a larger trial.

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1218805
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/130671/PRO-12-188-05.pdf

Ethics approval

North West - Lancaster Research Ethics Committee, 27/10/2015, ref: 15/NW/0797

Study design

Phase I - development; design: evidence synthesis
Phase II - modelling; design: focus groups
Phase III - assessing feasibility; design: pre-post observational study

Primary study design

Interventional

Secondary study design

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

Significant pain experienced by patients approaching the end of life living within the community

Intervention

We aim to develop a support tool to improve the management of medications for pain relief, nausea, constipation and drowsiness in patients with significant pain approaching the end of life.

A patient decision aid or SMST should help patients make informed choices about managing their healthcare by taking into account their values and preferences and those of their informal carer(s). We have defined an SMST as a set of materials and coaching procedures which delivers knowledge, facilitates the generation of specific action plans and enhances the user’s capacity to monitor and reflect on their actions. Ideally patients and their carers using our SMST should feel empowered with increased knowledge and skills to recognise worsening symptoms, be able to self-initiate therapeutic adjustments and know how and when to access help from their local healthcare system. We envisage that our SMST will include the following four components.

Initial assessment
At the initial meeting the Clinical Nurse Specialist (CNS) will discuss with the patient and their informal carer what strategies they already use to manage their medications for pain relief, nausea, constipation and drowsiness. The CNS will discuss what roles and tasks are required by each person to engage patients and their informal carer in self-management and encourage behaviour change. This initial assessment may also include a discussion about: 1. Concerns and fears about using opioids
2. Barriers and fears about self-management
3. Prioritising symptoms to self-manage
4. Providing the necessary information to support self-management
5. Trade-offs between symptom management and side-effects and how they will deal with the outcomes.

Information provision
The CNS will provide relevant information about managing medications for pain relief, nausea, constipation and/or drowsiness. This information will present benefits and burdens of medications in verbal, written, or audio-visual formats and will encourage a conversation about the trade-offs between symptom management and side-effects and how the consequences of these compromises might be dealt with.

Competencies based action plan (assessing capabilities)
Following provision of information, the CNS will undertake a competency-based assessment of the patient’s ability to self-manage, with support from a carer where appropriate. The purpose of this assessment is to identify the issues and situations that patients and carers feel they would like to self-manage. The CNS work with the patient and their carer to identify and record the self-management tasks that are required. This will form the basis of the self-management action plan. The CNS will help patients to develop their self-management action plan by balancing their values and preferences with the tasks and requirement of medication management alongside the possible side-effects.

Coaching, monitoring and modification
Strategies to encourage self-management require patients and their informal carers to change their behaviour and adopt new roles. Patients and carers must shift from a position of passively receiving medical information to actively engaging with supported decision making about their healthcare. For patients to successfully fulfil this new role they must feel that they can legitimately occupy it, understand what is required of them to fulfil this role and receive role support from a professional. This process of legitimisation begins with the initial assessment and provision of information and it continues through the collaborative development of the self-management action plan. Finally, to maintain and encourage this behaviour change a timetable of regular monitoring of self-management progress must be established between the CNS, patient and carer.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Average pain intensity measured using the Brief Pain Inventory (BPI)

Secondary outcome measures

1. Neuropathic pain: Self-administered Leeds Assessment of Neuropathic pain Symptoms and Signs (S-LANSS)
2. Self-efficacy: Patient Activation Measure (PAM)
3. Cognitive representation of medications: Beliefs about Medicines Questionnaire (BMQ)
4. Intensity of common symptoms: Edmonton Symptom Assessment System (EASA)
5. Carer experience: Family Pain Questionnaire (FPQ)
6. Health-related quality of life: European Quality of life - 5 Dimensions (EQ-5D) questionnaire
7. Satisfaction with information: Satisfaction with Information about Medicines Scale (SIMS)
8. Patient records: We will ask patients to give their consent for us to check their patient and pharmacy records. From these records we will collect data on healthcare resource use, date and place of death

Overall trial start date

01/09/2014

Overall trial end date

30/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Patients will be included if they are:
1. Approaching the end of life - defined as patients with an incurable advanced disease, considered to be within the last year of life
2. Experiencing significant pain: assessed using Brief Pain Inventory (BPI) and defined as a score of =>4/10 pain severity sub-scale and =>4/10 pain impact sub-scale
3. Treated with, or starting, opioid analgesia
4. Experiencing, or anticipating, adverse effects of nausea, constipation and drowsiness
5. Living at home and being cared for by specialist palliative care services in West Yorkshire and Hampshire.

Staff will be included if they are:
1. Clinical Nurse Specialists (CNSs) part of a community palliative care team
2. Service providers or managers of specialist palliative care services
3. Local commissioners of palliative care services
4. Working within palliative care services in West Yorkshire and Hampshire

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Phase 1: n=16. Phase 2: n=35. Phase 3: n=30. Total n=81

Participant exclusion criteria

Patients will be excluded if they lack capacity to consent to inclusion

Recruitment start date

23/11/2015

Recruitment end date

21/03/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds Institute of Health Sciences
Leeds
LS2 9LJ
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

c/o Medicine and Health Research Governance
Medicine and Health Faculty Office
Worsley Building
Leeds
LS2 9NL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Health Technology Assessment (HTA) programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/03/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added. In addition, the recruitment dates have been updated from 01/12/2014 - 28/02/2016 to 23/11/2015 - 21/03/2016.