What are the best ways to improve shared decision-making for all patients booked for surgery?
| ISRCTN | ISRCTN17951423 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17951423 |
| IRAS number | 292800 |
| Secondary identifying numbers | CPMS 48738, IRAS 292800 |
- Submission date
- 15/06/2023
- Registration date
- 11/07/2023
- Last edited
- 06/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
Over 5 million people decide to have surgery each year. These decisions are important and life-changing. Shared decision-making (SDM) is the recommended way for patients and professionals to make joint decisions about care by talking about personal preferences and values. Unfortunately, SDM does not happen for everyone. Patients say they want to be more involved in decisions. Improving SDM is therefore a research priority. We don’t know how to improve SDM at a big (organisational) scale, or for under-served groups (e.g. deprived
(poor) or elderly people and ethnic-minority groups). We also need better ways to measure SDM. Our research will find these answers and create a new way to improve SDM.
The aim of this study is to create a new way (an ‘intervention’) for patients to measure their experience of SDM on a big scale, to feedback this experience to care teams, and change what patients and professionals do before surgery to improve care.
Who can participate?
1. Patients over the age of 18 years who have been booked for planned surgical procedures at participating hospitals
2. Healthcare professionals working in participating Trusts
3. Members of the wider community over the age of 18 years who are disproportionately affected by poor SDM and outcomes of surgery: those that are economically disadvantaged, from minority ethnic groups, and in older age. Ethnicity is expected to focus on British Asian/South Asian populations as the most common minority group in the UK, however, this will be informed in discussions with stakeholders and patient and public representatives.
What does the study involve?
The researchers will interview people in Bristol and Bradford to find out how to create an intervention that is inclusive of underserved groups. Next, they will have meetings for patients and professionals to agree on the best ways to measure SDM and its impact. The researchers plan to create and test their intervention in different settings and explain how it works to improve patient care. A scientific study will then test if the intervention makes any difference to patients and the health service compared to usual care.
What are the possible benefits and risks of participating?
The study will develop knowledge about how to improve SDM for under-served groups and will find ways to measure SDM and its impact. This will help the health service and other researchers to improve SDM for surgery.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
March 2022 to June 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Dr Christin Hoffmann, c.hoffmann@bristol.ac.uk
Contact information
Scientific
National Institute for Health and Care Research Bristol Biomedical Research Centre
Bristol Centre for Surgical Research
Bristol Medical School: Population Health Sciences
University of Bristol
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0002-6293-3813 |
|---|---|
| Phone | +44 (0)1174555993 |
| c.hoffmann@bristol.ac.uk |
Principal Investigator
National Institute for Health and Care Research Bristol Biomedical Research Centre
Bristol Centre for Surgical Research
Bristol Medical School: Population Health Sciences
University of Bristol
Bristol
BS8 2PS
United Kingdom
| ORCID ID |
0000-0002-2601-9258 |
|---|---|
| Phone | +44 (0)117 455 4930 |
| Angus.Mcnair@bristol.ac.uk |
Study information
| Study design | Multi-centre mixed-methods co-development study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community, Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Development, pilot, and evaluation of a decision support intervention that uses real-time feedback of patients’ experience of shared decision-making to change patient and professional decision-making processes before adult elective surgery and to improve patient and health service outcomes |
| Study acronym | ALPACA |
| Study hypothesis | It is possible to co-develop a decision support intervention that uses real-time monitoring and feedback of patients’ experience of shared decision-making to change patient and professional decision-making processes before adult elective surgery to improve patient and health service outcomes |
| Ethics approval(s) |
Approved 01/06/2023, North West - Liverpool Central Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom; +44 (0)2071048118, +44 (0)20 7104 8222, +44 (0)2071048016; liverpoolcentral.rec@hra.nhs.uk), ref: 21/NW/0091 |
| Ethics approval additional information | Approval to monitor patients’ experience of SDM in routine clinical practice was initially approved through a quality improvement proposal at North Bristol NHS Trust (reference: Q80008). This was then incorporated into a larger programme of work, where all processes were approved through the appropriate governance framework (Consent & SDM Programme Board, reporting to the Clinical Effectiveness & Audit Committee). Ethical approval required to conduct interviews with NHS patients and professionals was granted by the NHS HRA North West - Liverpool Central Research Ethics Committee (reference: 21/PR/0345). |
| Condition | Any patients requiring surgical treatment |
| Intervention | The overall aim of this project is to develop, pilot, and evaluate a decision-support intervention that uses real-time feedback of patients’ experience of SDM to change patient and professional decision-making processes before adult elective surgery and improve patient and health service outcomes. There are three phases with the following objectives: Phase 1: Assess the feasibility, usability and acceptability of implementing a system to monitor SDM for surgery automatically and in real time. Phase 2: Co-develop and refine the intervention with patients and professionals to understand how the intervention works, for whom, and in what context. Phase 3: Evaluate the effectiveness, cost-effectiveness, and implementation of the intervention to improve patient and health service outcomes in the English NHS. Intervention development and evaluation will be conducted according to Medical Research Council guidelines. Qualitative findings will be reported in accordance with COREQ (Consolidated criteria for reporting qualitative studies) guidelines. Phase 1 will use mixed methods to examine the feasibility and usability of a novel system to monitor SDM of surgical patients in real time. The study will conduct interviews and focus groups with diverse stakeholders (patients, professionals, members of the wider community) to explore views on real-time feedback of patients’ experience of SDM to improve outcomes for patients. Recruitment will focus on under-served groups (economically disadvantaged, minority ethnic, and older age) to inform the development of an inclusive intervention. This phase will also apply principles of behavioural/organisational change to inform the initial development of programme theory. Phase 2 of this programme will co-develop and refine the decision-support intervention with patients and professionals. It is anticipated that this intervention will include methods for 1) efficient, real-time evaluation of SDM by patients at scale, 2) timely feedback of experiences of SDM to care teams before surgery, and 3) activities to support meaningful change in decision-making processes before surgery to improve patient/health service outcomes. Co-development of the intervention will be achieved by understanding contexts in which the intervention will be delivered through consultation with patient and professional stakeholders and refining programme theory through focus groups with patient and/or professional stakeholders in local, specific contexts. Following this, the intervention will be piloted in new collaborating surgical specialties and hospitals not involved in the development process. The potential impact of the intervention will be explored using qualitative and quantitative methods, and the scope (population inclusion/exclusion) will be defined. Phase 3 will evaluate the effectiveness, cost-effectiveness, and implementation of the intervention. Evaluation will be undertaken from a pragmatic, real-world effectiveness perspective, designed in collaboration with the NIHR Bristol Trials Centre and stakeholders. A cluster design is planned because contamination needs to be avoided at an individual patient/clinician level. Mixed qualitative and quantitative process evaluation is planned throughout in accordance with MRC guidelines to understand the function of the intervention and mechanisms of action in context. A run-in period is planned where the intervention is delivered prior to randomisation without the active ingredients defined in the programme theory. It will likely involve real-time evaluation of patients’ experience of SDM without any form of feedback to clinical teams. Internal pilot to full trial progression criteria will be set out in advance using recommended guidelines. Implementation is planned by identifying and mapping key stakeholders relevant to implementation, and co-creating a strategy for implementation and long-term sustainability of the intervention involving official bodies and policymakers (e.g. GMC, NICE, medical royal colleges). |
| Intervention type | Mixed |
| Primary outcome measure | Patients’ experiences of shared decision making measured using the CollaboRATE and SHARED-Q10 at baseline (upon surgery booking) and follow-up (before surgery) |
| Secondary outcome measures | Will be established during the study |
| Overall study start date | 01/03/2022 |
| Overall study end date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient, Health professional, Population, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | max 130 |
| Total final enrolment | 117 |
| Participant inclusion criteria | All patients over the age of 18 years who have been booked for planned vascular, gastrointestinal, urological, neurosurgical, gynaecological, breast, cardiac and orthopaedic surgical procedures at participating hospitals will be eligible to participate. Healthcare professionals working in participating Trusts will be eligible for inclusion. Specifically, this includes professionals that 1. Booked eligible patients for surgery 2. Are involved in SDM discussions with eligible patients 3. Have overall responsibility for eligible patients’ care Professional participants may include surgeons, anaesthetists, nurses, perioperative care physicians and allied health professionals. Members of the wider community over the age of 18 years will be eligible to take part. Included will be people who are disproportionately affected by poor SDM and outcomes of surgery: those that are economically disadvantaged, from minority ethnic groups, and in older age. Ethnicity is expected to focus on British Asian/South Asian populations as the most common minority group in the UK, however, this will be informed in discussions with stakeholders and patient and public representatives. |
| Participant exclusion criteria | 1. Patients under the age of 18 years 2. Without capacity to consent for medical procedures 3. Undergoing unplanned (emergency) surgery or endoscopic procedures There are no specified exclusion criteria for healthcare professional participants or members of the wider community |
| Recruitment start date | 01/10/2023 |
| Recruitment end date | 19/07/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Sponsor information
University/education
Beacon House
Queens Road
Bristol
BS8 1QU
England
United Kingdom
| Phone | +44 (0)117 928 9000 |
|---|---|
| press-office@bristol.ac.uk | |
| Website | http://bristol.ac.uk/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Published as a supplement to the results publication, Other |
| Publication and dissemination plan | Results will be disseminated through conferences, peer-reviewed journals, social media and public engagement campaigns. Collaboration with organisations (NICE, NHS England, General Medical Council) will facilitate ongoing development, evaluation, and implementation of the intervention. Patients are central to the project and have been involved throughout. Patients helped define the research questions and draft this proposal. The intervention and agreed ways to measure SDM will be created in partnership with patients from different backgrounds. We will work with a patient co-applicant, patient advisory group, and patients on our steering group, ensuring the work focuses on patient needs throughout. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository. The researchers will make pseudo-anonymised datasets available via the University's Research Data Repository, data.bris to bona fide researchers, subject to a legally binding data access agreement. Any applications to access data will involve a case-by-case review by the University of Bristol Data Access Committee. Qualifying researchers will be required to sign a data access agreement and closely liaise with study team members to ensure that the data they plan to make public are sufficiently anonymised. Generally, data will be made available for non-commercial use, only for the purpose of health and care research and with appropriate approvals in place (e.g. research ethics or national equivalent). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 18/01/2024 | 19/01/2024 | Yes | No | |
| Results article | 10/04/2024 | 06/02/2025 | Yes | No |
Editorial Notes
06/02/2025: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The recruitment end date was changed from 01/06/2025 to 19/07/2024.
06/02/2025: Publication reference added.
19/01/2024: Publication reference added.
25/09/2023: The recruitment start date was changed from 01/09/2023 to 01/10/2023.
11/07/2023: Study's existence confirmed by the North West - Liverpool Central Research Ethics Committee.
