Advanced chronic kidney disease Urological and Genital Diseases Chronic kidney disease, stage 5
Conditions
Interventions
Current interventions as of 04/02/2015:
This is a multiple method study which includes quantitative and qualitative components. In the quantitative component longitudinal survey of qua
five in Northern Ireland and up to five in London. Each site offers the option of conservative management as a treatment option to patients who have reached end-stage renal disease. All patients who m
Sponsors
Queen's University of Belfast (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1. Stage 5 chronic kidney disease with estimated glomerular filtration rate = 20 mL/minute as measured by the Modification of Diet in Renal Disease (MDRD) formula (Levey et al 1999) 2. A confirmed decision for conservative management, i.e. management without dialysis or other renal replacement therapy. The decision for conservative kidney management will be confirmed with the nephrologist responsible for each patient. 3. Aged over 18 years Carers: 1. Primary carer for patient with stage 5 chronic kidney disease who has made a confirmed decision for conservative kidney management as agreed with clinicians 2. Aged over 18 years 3. Patient has agreed that the carer can be approached to participate 4. The carer has contacted staff and ‘opted in’ to the study (added 04/02/2015) Renal physicians/CNS: 1. Experience of managing clinical consultations of patients with stage 5 chronic kidney disease who opt for conservative kidney management 2. Employed in the renal specialty
Exclusion criteria
Exclusion criteria: Patients: 1. Patients lacking capacity to give consent to participate. Capacity for consent to participate will be assessed in collaboration with the clinicians. 2. Stage 1-4 chronic kidney disease 3. Hasn't made a confirmed decision for conservative management 4. Under the age of 18 5. Non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available Carers: 1. Carers who lack capacity to give consent to participate in the study 2. Under the age of 18 3. Patient has not agreed that the carer can be approached to participate 4. Non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available 5. Carer has not contacted staff and ‘opted in’ to the study (added 04/02/2015) Renal physicians/CNS: 1. No experience of managing clinical consultations of patients who opt for conservative kidney management 2. Not employed in the renal specialty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 04/02/2015: Quality of life (QOL) of patients at 3 months measured using the EQ-VAS. Previous primary outcome measures: Quality of life (QOL) of patients at 3 months measured using the EQ-5D-5L visual analogue scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/02/2015: Patients 1. Changes in QOL, symptoms, anxiety and depression in patients using the Kidney Disease QOL (KDQOL) tool, EQ-5D-5L (which includes the EQ-VAS) and Palliative Outcome Scale - Symptoms (POS-S) Renal 3-monthly up to 12 months 2. Changes in cognition and frailty status in patients using the 6-Item Cognitive Impairment Test (6CIT) and the 9-point Clinical Frailty Scale 3-monthly up to 12 months 3. Changes in Performance in patients using the Palliative Performance Scale (PPS) 3-monthly up to 12 months 4. Patient Satisfaction in Decision Making using the Decisional Conflict Scale (DCS) at baseline 5. Measurement of health and social care costs of patients receiving conservative kidney management using a Patient Service Use Log 3-monthly up to 12 months 6. Calculation of the number (%) of patient deaths 3-monthly and time to death Carers 1. Carer observation of patient's Satisfaction in Decision Making using the Decisional Conflict Scale (DCS) at baseline and 6-monthly where possible 2. Changes in QOL of carers using the EQ-5D-5L 3-monthly over 12 months 3. Carer's assessment of patient QOL using the EQ-5D-5L by proxy 3-monthly over 12 months 4. Subjective and objective burden of providing informal care in carers, loss of earnings and the opportunity costs of providing informal care using items from the iMTA Valuation of Informal Care Questionnaire (iVICQ; Hoefman et al 2011) 3 monthly over the 12 months. Renal Physicians/Clinical Nurse Specialists 1. Exploration of the decision-making process that precedes referral to conservative kidney management in relation to patient satisfaction with renal physicians/CNS via exploratory qualitative interviews. Previous secondary outc | — |
Countries
United Kingdom
Outcome results
None listed