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| Name | Class |
|---|---|
| The Dunhill Medical Trust | OTHER |
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This study will test the feasibility of carrying out a randomised controlled trial, incorporating a mixed methods process evaluation, to evaluate advance care planning with older patients who have end-stage kidney disease.
Kidney failure becomes more common as people age. It increases the risks of other major illnesses, sudden worsening of symptoms, and death. Even so, many people with kidney failure do not talk about their preferences for end-of-life care.
Advance care planning (ACP) can help patients and families think through their preferences for future care and discuss these with the professionals looking after them. This may lead to care more in keeping with patients' wishes and so reduce distress for patients and families. ACP is recommended as good practice for people with kidney failure.
However, questions remain about the impact of ACP on patients and families; and also about the best ways to put ACP into practice. Doing research about ACP is challenging for everyone involved, so we need to thoroughly test our research methods in a pilot study before we attempt a larger study that would fully answer those questions.
To test our methods we will carry out a small-scale randomised controlled trial comparing those patients who use ACP with those who do not, in terms of: quality of life, anxiety, depression, physical functioning, well-being, satisfaction with decision-making and agreement between the patient and their nominated carer in terms of the patient's preferences for care at the end of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advance care plan | Experimental | Participants will be offered the opportunity to complete an advance care plan. |
|
| Usual care | No Intervention | Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advance care plan | Behavioral | Participants will be offered the opportunity to complete an ACP by a nurse trained as an ACP facilitator, who will discuss the process with them using standard materials. At least 48 hours later, they will complete an ACP document with the help of the ACP facilitator, working together with trained expert patients who will provide peer support at the time of ACP completion and subsequently by telephone, assisted where necessary by the ACP facilitator. |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney Disease Quality | Quality of life as measured by the Kidney Disease Quality of Life instrument - Short Form (KDQOL-36™). The KDQOL-36 has five scales, including two generic health related quality of life (HRQOL) scales from the Short-Form (SF)-12 version 1 (12 items total) and three kidney-specific scales (24 items total). Each scale has a minimum score of zero and a maximum of 100. Higher scores reflect better quality of life and a better outcome. Subscales are not combined. | 12 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Number of Participants with Agreement between the patient and their nominated carer in terms of the patient's preferences. We will measure this by asking the carer to make an independent assessment of the patient's preferences in relation to the key information covered by the ACP intervention, before taking part in the ACP. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter D O'Halloran, PhD | Queen's University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University Belfast | Belfast | Northern Ireland | BT7 1NN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33187506 | Derived | O'Halloran P, Noble H, Norwood K, Maxwell P, Murtagh F, Shields J, Mullan R, Matthews M, Cardwell C, Clarke M, Morton R, Shah K, Forbes T, Brazil K. Nurse-led advance care planning with older people who have end-stage kidney disease: feasibility of a deferred entry randomised controlled trial incorporating an economic evaluation and mixed methods process evaluation (ACReDiT). BMC Nephrol. 2020 Nov 13;21(1):478. doi: 10.1186/s12882-020-02129-5. |
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Deidentified data that underlie the results reported in this article are available to qualified researchers for approved scientific uses immediately following publication of the trial results* with no end date. Data access proposals should be directed to the corresponding author. The Trial Protocol is available on request.
Immediately following publication of the trial results* with no end date.
Available to qualified researchers for approved scientific uses.
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Recruitment began in December 2016 and lasted 189 days. Participants were recruited from two haemodialysis units in Northern Ireland, UK. Nephrologists approached patients and those interested were given patient information packs for themselves and a surrogate. The ACP nurse returned to the patient 2-7 days later to seek their consent. Surrogates could contact the research team directly using a dedicated phone number or email address, or a form and reply-paid envelope
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| ID | Title | Description |
|---|---|---|
| FG000 | Advance Care Plan | Participants will be offered the opportunity to complete an advance care plan. Advance care plan: Participants will be offered the opportunity to complete an ACP by a nurse trained as an ACP facilitator, who will discuss the process with them using standard materials. At least 48 hours later, they will complete an ACP document with the help of the ACP facilitator, working together with trained expert patients who will provide peer support at the time of ACP completion and subsequently by telephone, assisted where necessary by the ACP facilitator. |
| FG001 | Usual Care | Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Period |
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| Deferred Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Advance Care Plan | Participants will be offered the opportunity to complete an advance care plan. Advance care plan: Participants will be offered the opportunity to complete an ACP by a nurse trained as an ACP facilitator, who will discuss the process with them using standard materials. At least 48 hours later, they will complete an ACP document with the help of the ACP facilitator, working together with trained expert patients who will provide peer support at the time of ACP completion and subsequently by telephone, assisted where necessary by the ACP facilitator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Kidney Disease Quality | Quality of life as measured by the Kidney Disease Quality of Life instrument - Short Form (KDQOL-36™). The KDQOL-36 has five scales, including two generic health related quality of life (HRQOL) scales from the Short-Form (SF)-12 version 1 (12 items total) and three kidney-specific scales (24 items total). Each scale has a minimum score of zero and a maximum of 100. Higher scores reflect better quality of life and a better outcome. Subscales are not combined. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks post intervention |
|
15 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Advance Care Plan | Participants will be offered the opportunity to complete an advance care plan. Advance care plan: Participants will be offered the opportunity to complete an ACP by a nurse trained as an ACP facilitator, who will discuss the process with them using standard materials. At least 48 hours later, they will complete an ACP document with the help of the ACP facilitator, working together with trained expert patients who will provide peer support at the time of ACP completion and subsequently by telephone, assisted where necessary by the ACP facilitator. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Peter O'Halloran | Queen's University Belfast | 02890972490 | p.ohalloran@qub.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2017 | Nov 18, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2016 | Nov 18, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 12 weeks post intervention |
| Depression | Degree of anxiety, depression, well-being, functioning and risk as measured by the Clinical Outcomes in Routine Evaluation measure (CORE 34) a 34- item Likert-type scale scored on a 5-point scale ranging from 0 (not at all) to 4 (most or all the time). The minimum mean value is zero and the maximum is 4. Higher scores indicate greater distress and a worse outcome. Mean scores from reference groups are 1.86 (SD 0.75) for those referred to psychiatric services and 0.76 (SD 0.59) for the general population. | 12 weeks post intervention |
| The Degree to Which the Patient Felt That They Had Shared in Decision-making. | The degree to which the patient felt that they had shared in decision-making about their care as measured by the Patient Experience of Shared Decision Making (SHARED) instrument. This is a a ten-item Likert-type scale ranging from 'Disagree strongly' to 'Agree strongly', with one point for 'Agree', two for 'Agree strongly', and no points for disagreement. The minimum score is zero and the maximum is 20. Higher scores indicate more sharing and a better outcome. | 12 weeks post intervention |
| Withdrawal by Subject |
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| NOT COMPLETED |
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| BG001 | Usual Care | Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Usual Care | Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan). |
|
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| Secondary | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Number of Participants with Agreement between the patient and their nominated carer in terms of the patient's preferences. We will measure this by asking the carer to make an independent assessment of the patient's preferences in relation to the key information covered by the ACP intervention, before taking part in the ACP. | Posted | Count of Participants | Participants | 12 weeks post intervention |
|
|
|
| Secondary | Depression | Degree of anxiety, depression, well-being, functioning and risk as measured by the Clinical Outcomes in Routine Evaluation measure (CORE 34) a 34- item Likert-type scale scored on a 5-point scale ranging from 0 (not at all) to 4 (most or all the time). The minimum mean value is zero and the maximum is 4. Higher scores indicate greater distress and a worse outcome. Mean scores from reference groups are 1.86 (SD 0.75) for those referred to psychiatric services and 0.76 (SD 0.59) for the general population. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks post intervention |
|
|
|
| Secondary | The Degree to Which the Patient Felt That They Had Shared in Decision-making. | The degree to which the patient felt that they had shared in decision-making about their care as measured by the Patient Experience of Shared Decision Making (SHARED) instrument. This is a a ten-item Likert-type scale ranging from 'Disagree strongly' to 'Agree strongly', with one point for 'Agree', two for 'Agree strongly', and no points for disagreement. The minimum score is zero and the maximum is 20. Higher scores indicate more sharing and a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks post intervention |
|
|
|
| 1 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Usual Care | Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan). | 3 | 19 | 0 | 19 | 0 | 19 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Surrogate participated |
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| Surrogate did not participate |
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| Surrogate's understanding of ACP converged with patient's on at least one dimension of ACP |
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| Surrogate's understanding of ACP did not converged with patient's |
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