Kidney Failure, Chronic
Conditions
Keywords
Advance Care Planning, Palliative care, Frail Elderly, Renal Dialysis
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAdvance 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.
Sponsors
The Dunhill Medical Trust
Queen's University, Belfast
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Attending the renal units taking part in the study * Receiving renal replacement therapy * Capacity to understand, retain, and weigh the necessary information and communicate their decisions * Identified by their consultant as having worsening symptoms, functional decline, and two or more co-morbidities.
Exclusion criteria
* Expected to die in the next three months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kidney Disease Quality | 12 weeks post intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | 12 weeks post intervention | 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. |
| Depression | 12 weeks post intervention | 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. |
| The Degree to Which the Patient Felt That They Had Shared in Decision-making. | 12 weeks post intervention | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| Usual Care Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan). | 19 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Deferred Period | Death | 0 | 1 |
| Deferred Period | Lost to Follow-up | 0 | 1 |
| Deferred Period | Received kidney transplant | 0 | 1 |
| Deferred Period | Withdrawal by Subject | 0 | 2 |
| First Period | Death | 1 | 2 |
| First Period | Patient ill-health | 2 | 4 |
| First Period | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Advance Care Plan | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 75.6 years STANDARD_DEVIATION 6.81 | 73.2 years STANDARD_DEVIATION 5.01 | 74.9 years STANDARD_DEVIATION 6.89 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 19 Participants | 36 Participants |
| Region of Enrollment United Kingdom | 17 Participants | 19 Participants | 36 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 17 | 3 / 19 |
| other Total, other adverse events | 0 / 17 | 0 / 19 |
| serious Total, serious adverse events | 0 / 17 | 0 / 19 |
Outcome results
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.
Time frame: 12 weeks post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advance Care Plan | Kidney Disease Quality | KDQOL-36™ - Effects | 78.4 score on a scale | Standard Deviation 16 |
| Advance Care Plan | Kidney Disease Quality | SF12 physical | 31.5 score on a scale | Standard Deviation 9.5 |
| Advance Care Plan | Kidney Disease Quality | KDQOL-36™ - Burden | 46.9 score on a scale | Standard Deviation 23.8 |
| Advance Care Plan | Kidney Disease Quality | SF12 mental | 53.3 score on a scale | Standard Deviation 6.9 |
| Advance Care Plan | Kidney Disease Quality | KDQOL-36™ - Symptoms | 75.4 score on a scale | Standard Deviation 13.3 |
| Usual Care | Kidney Disease Quality | SF12 mental | 52.4 score on a scale | Standard Deviation 6.9 |
| Usual Care | Kidney Disease Quality | KDQOL-36™ - Symptoms | 78.3 score on a scale | Standard Deviation 19.2 |
| Usual Care | Kidney Disease Quality | KDQOL-36™ - Effects | 73.4 score on a scale | Standard Deviation 21.6 |
| Usual Care | Kidney Disease Quality | KDQOL-36™ - Burden | 55.2 score on a scale | Standard Deviation 25.7 |
| Usual Care | Kidney Disease Quality | SF12 physical | 34.9 score on a scale | Standard Deviation 13 |
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.
Time frame: 12 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Advance Care Plan | Depression | 0.4 score on a scale | Standard Deviation 0.3 |
| Usual Care | Depression | 0.4 score on a scale | Standard Deviation 0.3 |
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.
Time frame: 12 weeks post intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Advance Care Plan | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Surrogate named | 10 Participants |
| Advance Care Plan | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Surrogate not named | 7 Participants |
| Advance Care Plan | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Surrogate participated | 7 Participants |
| Advance Care Plan | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Surrogate did not participate | 3 Participants |
| Advance Care Plan | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Surrogate's understanding of ACP converged with patient's on at least one dimension of ACP | 3 Participants |
| Advance Care Plan | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Surrogate's understanding of ACP did not converged with patient's | 4 Participants |
| Usual Care | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Surrogate's understanding of ACP converged with patient's on at least one dimension of ACP | 0 Participants |
| Usual Care | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Surrogate named | 7 Participants |
| Usual Care | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Surrogate did not participate | 4 Participants |
| Usual Care | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Surrogate not named | 12 Participants |
| Usual Care | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Surrogate's understanding of ACP did not converged with patient's | 3 Participants |
| Usual Care | Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences | Surrogate participated | 3 Participants |
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.
Time frame: 12 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Advance Care Plan | The Degree to Which the Patient Felt That They Had Shared in Decision-making. | 12 score on a scale | Standard Deviation 5.7 |
| Usual Care | The Degree to Which the Patient Felt That They Had Shared in Decision-making. | 11.2 score on a scale | Standard Deviation 6 |