Trial Outcomes & Findings for Advance Care Planning With Older Patients Who Have End-stage Kidney Disease (NCT NCT02631200)

Last Updated: 2024-07-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

12 weeks post intervention

Results posted on

2024-07-29

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.	Usual Care Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan).
First Period STARTED	17	19
First Period COMPLETED	10	12
First Period NOT COMPLETED	7	7
Deferred Period STARTED	0	12
Deferred Period COMPLETED	0	7
Deferred Period NOT COMPLETED	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Usual Care Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan).
First Period Death	1	2
First Period Patient ill-health	2	4
First Period Withdrawal by Subject	4	1
Deferred Period Death	0	1
Deferred Period Received kidney transplant	0	1
Deferred Period Withdrawal by Subject	0	2
Deferred Period Lost to Follow-up	0	1

Baseline Characteristics

Advance Care Planning With Older Patients Who Have End-stage Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Advance Care Plan n=17 Participants 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.	Usual Care n=19 Participants Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan).	Total n=36 Participants Total of all reporting groups
Age, Continuous	75.6 years STANDARD_DEVIATION 6.81 • n=93 Participants	73.2 years STANDARD_DEVIATION 5.01 • n=4 Participants	74.9 years STANDARD_DEVIATION 6.89 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	16 Participants n=4 Participants	30 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	17 Participants n=93 Participants	19 Participants n=4 Participants	36 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United Kingdom	17 Participants n=93 Participants	19 Participants n=4 Participants	36 Participants n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks post intervention

Outcome measures

Outcome measures
Measure	Advance Care Plan n=10 Participants 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.	Usual Care n=12 Participants Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan).
Kidney Disease Quality KDQOL-36™ - Symptoms	75.4 score on a scale Standard Deviation 13.3	78.3 score on a scale Standard Deviation 19.2
Kidney Disease Quality KDQOL-36™ - Effects	78.4 score on a scale Standard Deviation 16.0	73.4 score on a scale Standard Deviation 21.6
Kidney Disease Quality KDQOL-36™ - Burden	46.9 score on a scale Standard Deviation 23.8	55.2 score on a scale Standard Deviation 25.7
Kidney Disease Quality SF12 physical	31.5 score on a scale Standard Deviation 9.5	34.9 score on a scale Standard Deviation 13.0
Kidney Disease Quality SF12 mental	53.3 score on a scale Standard Deviation 6.9	52.4 score on a scale Standard Deviation 6.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Advance Care Plan n=17 Participants 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.	Usual Care n=19 Participants Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an 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	7 Participants
Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences Surrogate not named	7 Participants	12 Participants
Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences Surrogate participated	7 Participants	3 Participants
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	4 Participants
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	0 Participants
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	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Advance Care Plan n=10 Participants 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.	Usual Care n=12 Participants Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan).
Depression	0.4 score on a scale Standard Deviation 0.3	0.4 score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Advance Care Plan n=2 Participants 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.	Usual Care n=6 Participants Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an 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	11.2 score on a scale Standard Deviation 6.0

Adverse Events

Advance Care Plan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Peter O'Halloran

Queen's University Belfast

Phone: 02890972490

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place