Advance Care PlanningNCT04445896
The Responses Study
An observational study of Advance Care Planning, run by King's College London at 1 site in United Kingdom.
Trial summary
The issue Patients who are living with a life-limiting and progressive illness are often encouraged by the healthcare professionals looking after them to undergo a process called Advance Care Planning (ACP). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- Qualitative Interview
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2022to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from Princess Alice Hospice. Princess Alice is a large Hospice in Surrey which provides inpatient, day services and community services to 9 boroughs in South London, Surrey and Middlesex, with a catchment population of approximately 1 million people. Community home visit and outpatient services are provided by a Consultant led, multi-disciplinary team, and provide care to approximately 850 patients at any one time. Princess Alice has a 20 bedded Palliative Medicine inpatient unit and accepts referrals for symptom control and terminal care admissions, with a typical length of stay of 7-10 days. Patients are referred to Princess Alice Hospice for Specialist Palliative Care if they have a diagnosis of a life-limiting or life-threatening disease. Princess Alice Hospice provides holistic palliative care that is aimed to provide physical, psychological, spiritual and social support.
Who may be able to join
- Aged 18 and over
- A palliative care diagnosis confirmed by a referring healthcare professional, i.e. a diagnosis of a life-threatening or life-limiting illness
- Have completed one or multiple ACP discussions as defined below, at any time prior to referral to study, with a healthcare professional
- Sufficient cognitive capacity to provide informed consent and complete an interview
- For the purposes of recruitment for this study, ACP is defined as:
- Any significant discussion with a healthcare professional where patients have discussed their values, goals or preferences for future care. These can include discussions about wishes for further disease-modifying treatment, wishes for intensity of general medical care, preferred places of care and death, discussions around resuscitation and transfer to hospital, and completion of advanced directives. Healthcare professionals can include any doctor, nurse or allied health professional.
Who cannot join
- Any patient the researcher has ever met or cared for in a clinical capacity, or knows in any other capacity
- Any patient who has only had ACP discussions with a volunteer (trained or untrained) or non-healthcare professional
- Inability to provide informed consent
- Any patient deemed by the referring healthcare professional to be potentially too unwell or frail to undertake an interview
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Patient Responses to Advance Care Planning: A Qualitative Study
The issue Patients who are living with a life-limiting and progressive illness are often encouraged by the healthcare professionals looking after them to undergo a process called Advance Care Planning (ACP). An advance care plan is a written guide of a patient's likes, dislikes, wishes, and the treatments they would want to refuse or the rituals they would want to follow - whether during illness or at the end of life. The planning process helps patients and their relatives think about different scenarios, and the plans that would be used by medical staff if that patient becomes too ill to communicate. ACP discussions can take many forms and are often described as a process.
It is accepted by healthcare professionals that ACP is useful to patients and their relatives. Research has also focussed on the positive nature of ACP, traditionally looking at issues such as how many patients have achieved their wishes and why, what makes ACP possible, and what prevents patients or healthcare professionals from starting these discussions. Some research has also looked at how patients experience the actual process of ACP itself.
Read more
However, there has been little research into the effect ACP discussions can have on a patient and their relatives, or how patients react to ACP discussions. As a result, researchers and healthcare professionals do not have a full understanding of the psychological impact on patients and their families, and any resulting changes in patients' outlook, emotional state, family and clinical relationships, and their behaviours.
Learning more about how patients respond to such important and challenging discussions about their care will be vital in improving healthcare professionals' understanding of how best to carry out ACP conversations, and how best to support patients and their relatives following ACP conversations. It is also important to explore not only the benefits of ACP but also the potential downsides or unexpected problems of having such a difficult conversation.
What the investigators will do The aim of this study is to explore how patients are affected by discussions about their future care, and if these discussions affect how patients think or feel in themselves and what they do. The investigators will conduct qualitative interviews with patients living with a life-limiting illness who have already had ACP discussions with a healthcare professional, to explore how and in what ways ACP discussions have affected patients and their families. Qualitative interviews are semi-structured interviews that are designed to explore issues and what these mean to people in-depth, in order to gather rich data that provides insight into a person's perspectives. They are well suited to exploring subjects about which little is yet known, and also subjects which can be sensitive or challenging.
Location of the study, and participation The study will be conducted from Princess Alice Hospice in Surrey, which provides both inpatient and community palliative care services to a large catchment population of approximately 1 million people, in South West London and Surrey.
The investigators aim to recruit 20 participants to represent a broad range of clinical and demographic characteristics, such as age, gender, ethnicity, diagnosis and borough in which they live, in order to explore the experiences of as diverse a group as possible. Participants will be interviewed in a place convenient for them, such as in their home or the Hospice.
Who the investigators are The study will be led by a clinician currently working in Palliative Care, as part of a Masters in Palliative Care, being undertaken at King's College London. The researcher will be supervised at all times by Dr. Katherine Bristowe and Dr. Lisa Brighton, of King's College London, who possess many years of experience in undertaking research among patients living with and dying from advanced disease, and their families.
- Conditions
- Advance Care Planning
- Being tested
- Qualitative Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative InterviewOther
Qualitative Interview to explore thoughts and feelings related to previous discussions around care at end of life
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Patients with a diagnosis of a life-limiting illness who have previosuly had a discussion with a healthcare professional about the care they would want at the end of life Receives: Other: Qualitative Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Themes emerging from Qualitative Interview
Key themes and concepts that emerge from multiple participants qualitative interviews that describe their experiences
Measured: Throughout study completion, estimated to be 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start2 Mar 2022
- Primary completion20 Oct 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Alice Hospice
- Responsible party
- Sponsor
- Investigators
- Katherine Bristowe, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445896
- Sponsor's protocol ID
- IRAS: 275766
- Status last verified
- Apr 2022
- First submitted
- 9 Mar 2020
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Patient Responses to Advance Care Planning: A Qualitative Study
- ClinicalTrials.gov ID
- NCT04445896
- Acronym / sponsor ID
- IRAS: 275766
- Conditions
- Advance Care Planning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Princess Alice Hospice
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The issue Patients who are living with a life-limiting and progressive illness are often encouraged by the healthcare professionals looking after them to undergo a process called Advance Care Planning (ACP). An advance care plan is a written guide of a patient's likes, dislikes, wishes, and the treatments they would want to refuse or the rituals they would want to follow - whether during illness or at the end of life. The planning process helps patients and their relatives think about different scenarios, and the plans that would be used by medical staff if that patient becomes too ill to communicate. ACP discussions can take many forms and are often described as a process.
It is accepted by healthcare professionals that ACP is useful to patients and their relatives. Research has also focussed on the positive nature of ACP, traditionally looking at issues such as how many patients have achieved their wishes and why, what makes ACP possible, and what prevents patients or healthcare professionals from starting these discussions. Some research has also looked at how patients experience the actual process of ACP itself.
However, there has been little research into the effect ACP discussions can have on a patient and their relatives, or how patients react to ACP discussions. As a result, researchers and healthcare professionals do not have a full understanding of the psychological impact on patients and their families, and any resulting changes in patients' outlook, emotional state, family and clinical relationships, and their behaviours.
Learning more about how patients respond to such important and challenging discussions about their care will be vital in improving healthcare professionals' understanding of how best to carry out ACP conversations, and how best to support patients and their relatives following ACP conversations. It is also important to explore not only the benefits of ACP but also the potential downsides or unexpected problems of having such a difficult conversation.
What the investigators will do The aim of this study is to explore how patients are affected by discussions about their future care, and if these discussions affect how patients think or feel in themselves and what they do. The investigators will conduct qualitative interviews with patients living with a life-limiting illness who have already had ACP discussions with a healthcare professional, to explore how and in what ways ACP discussions have affected patients and their families. Qualitative interviews are semi-structured interviews that are designed to explore issues and what these mean to people in-depth, in order to gather rich data that provides insight into a person's perspectives. They are well suited to exploring subjects about which little is yet known, and also subjects which can be sensitive or challenging.
Location of the study, and participation The study will be conducted from Princess Alice Hospice in Surrey, which provides both inpatient and community palliative care services to a large catchment population of approximately 1 million people, in South West London and Surrey.
The investigators aim to recruit 20 participants to represent a broad range of clinical and demographic characteristics, such as age, gender, ethnicity, diagnosis and borough in which they live, in order to explore the experiences of as diverse a group as possible. Participants will be interviewed in a place convenient for them, such as in their home or the Hospice.
Who the investigators are The study will be led by a clinician currently working in Palliative Care, as part of a Masters in Palliative Care, being undertaken at King's College London. The researcher will be supervised at all times by Dr. Katherine Bristowe and Dr. Lisa Brighton, of King's College London, who possess many years of experience in undertaking research among patients living with and dying from advanced disease, and their families.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | – | Other: Qualitative InterviewPatients with a diagnosis of a life-limiting illness who have previosuly had a discussion with a healthcare professional about the care they would want at the end of life |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from Princess Alice Hospice. Princess Alice is a large Hospice in Surrey which provides inpatient, day services and community services to 9 boroughs in South London, Surrey and Middlesex, with a catchment population of approximately 1 million people. Community home visit and outpatient services are provided by a Consultant led, multi-disciplinary team, and provide care to approximately 850 patients at any one time. Princess Alice has a 20 bedded Palliative Medicine inpatient unit and accepts referrals for symptom control and terminal care admissions, with a typical length of stay of 7-10 days. Patients are referred to Princess Alice Hospice for Specialist Palliative Care if they have a diagnosis of a life-limiting or life-threatening disease. Princess Alice Hospice provides holistic palliative care that is aimed to provide physical, psychological, spiritual and social support.
Key inclusion criteria (6 listed)
- Aged 18 and over
- A palliative care diagnosis confirmed by a referring healthcare professional, i.e. a diagnosis of a life-threatening or life-limiting illness
- Have completed one or multiple ACP discussions as defined below, at any time prior to referral to study, with a healthcare professional
- Sufficient cognitive capacity to provide informed consent and complete an interview
- Any significant discussion with a healthcare professional where patients have discussed their values, goals or preferences for future care. These can include discussions about wishes for further disease-modifying treatment, wishes for intensity of general medical care, preferred places of care and death, discussions around resuscitation and transfer to hospital, and completion of advanced directives. Healthcare professionals can include any doctor, nurse or allied health professional.
Key exclusion criteria (4 listed)
- Any patient the researcher has ever met or cared for in a clinical capacity, or knows in any other capacity
- Any patient who has only had ACP discussions with a volunteer (trained or untrained) or non-healthcare professional
- Inability to provide informed consent
- Any patient deemed by the referring healthcare professional to be potentially too unwell or frail to undertake an interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative InterviewQualitative Interview to explore thoughts and feelings related to previous discussions around care at end of life | Other | Study Participants |
Primary outcome
Themes emerging from Qualitative Interview
Time frame: Throughout study completion, estimated to be 1 year
Key themes and concepts that emerge from multiple participants qualitative interviews that describe their experiences
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Advance Care Planning
Active, not recruiting
ACP Video Intervention for Patients With Life-Limiting Illness
Health Care Utilization, End Stage Disease
Recruiting
Patient Navigation and the Planning Advance Care Together Website to Improve Goals of Care Conversations in Hematopoietic Cell Transplant Survivors, IMPACT-HCT Trial
Hematopoietic and Lymphatic System Neoplasm
Not yet recruiting
Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
Advance Care Planning, American Indian or Alaska Native
Not yet recruiting
Development and Evaluation of a Disease-oriented Scenario Game to Promote ACP Among Older Adults and Family Caregivers
Heart Failure, Older Adults (65 Years and Older)
Active, not recruiting
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Bristowe, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advance Care Planning, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Themes emerging from Qualitative Interview (time frame: Throughout study completion, estimated to be 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.