Self-Management of Analgesia and Related Treatments at the End of life

ISRCTN	ISRCTN35327119
DOI	https://doi.org/10.1186/ISRCTN35327119
Secondary identifying numbers	HTA 12/188/05

Submission date: 21/07/2014
Registration date: 28/07/2014
Last edited: 04/04/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-develop-a-tool-to-help-people-better-manage-their-cancer-pain-smarte

Contact information

Prof Michael Bennett
Scientific

Academic Unit of Palliative Care
Leeds Institute of Health Sciences
101 Clarendon Road
Leeds
LS2 9LJ
United Kingdom

Email	m.i.bennett@leeds.ac.uk

Study information

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
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Self-Management of Analgesia and Related Treatments at the End of life: a pre-post observational study
Study acronym	SMARTE
Study objectives	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(s)	North West - Lancaster Research Ethics Committee, 27/10/2015, ref: 15/NW/0797
Health condition(s) or problem(s) studied	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 users 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 patients 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
Primary outcome measure	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 study start date	01/09/2014
Completion date	30/08/2016

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Both
Target number of participants	Phase 1: n=16. Phase 2: n=35. Phase 3: n=30. Total n=81
Key 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
Key exclusion criteria	Patients will be excluded if they lack capacity to consent to inclusion
Date of first enrolment	23/11/2015
Date of final enrolment	21/03/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Leeds Institute of Health Sciences

Leeds
LS2 9LJ
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

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

"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date	01/03/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2017		Yes	No
Plain English results			04/04/2022	No	Yes
HRA research summary			28/06/2023	No	No

Editorial Notes

04/04/2022: Plain English results added.
07/08/2018: Publication reference added.
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.