Follow-up Using Patient-Reported Outcome (PRO) Measures in Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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This randomized controlled trial (RCT) will evaluate if PRO-based follow-up is at least as effective as usual outpatient follow-up in managing decline in renal function and maintaining patients' quality of life. Furthermore, we intend to characterize the target patient group that is suitable for PRO-based follow up in a group of patients suffering from renal insufficiency.

Detailed Description
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This randomized controlled trial investigates the use of Patient-reported Outcome (PRO) follow-up among patients with chronic kidney disease. Usual outpatient follow-up visits will be replaced with diagnosis-specific electronic questionnaires filled in by the patient at home. Participants in the PRO-based follow up will complete a disease specific questionnaire every 3 months. Patients with an estimated Glomerular Filtration Rate (eGFR) < 40mL/min are randomized into three groups of follow-up PRO-based follow-up (The clinicians use the PRO data to decide whether a patient needs a visit or not) PRO-based telephone consultations (The clinician use the PRO-data to support the communication with the patient) Usual outpatient follow-up visits (Patients are seen in the outpatient clinic) The aim of this study is to compare the effect on the clinical outcomes, the utilisation of resources, and patient-reported outcome in three types of follow-up in a non-inferiority randomised controlled trial.

Official Title
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Tele Follow-up Using Patient-reported Outcomes (PRO) Measures in Patients With Chronic Kidney Disease - the PROKID Study

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Behavioral: PRO-based follow-up
* Behavioral: PRO-based telephone consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred to the renal care services at Aarhus University Hospital or Regional Hospital Central Jutland, Viborg Estimated Glomerular Filtration Rate (eGFR) between 10-39 mL/min 1.73m2. Aged ≥18 years old Ability to provide fully informed written consent for participation in the study Exclusion Criteria: Patients unwilling to participate in PRO-based follow-up Patients who, in the opinion of the consenting professional, cannot speak, read or write Danish sufficiently well to complete the PRO questionnaire unaided Patients with hearing disabilities Patients with an eGFR > 39mL/min 1.73m2 at their first visit at the hospital Patients who have received (or have a scheduled date to receive) a kidney transplant A terminal illness that, in the opinion of the consultant assessing eligibility, is likely to lead to the death of the patient within 6 months of starting participation in the study Patients receiving chemotherapy, with end stage Chronic Obstructive Lung disease, or with heart failure with Ejection Fraction (EF)< 15 %. A projected risk of progression to end-stage renal failure within 6 months, determined from albumin/creatinine ratio

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The randomization will be done by the AmbuFlex-system (a generic on-line system for self-recorded patient reported outcomes) as a part of the inclusion process. Patients in the intervention arms will receive diagnosis specific questionnaires through a safe internet connection every third month. The responses are seen by the clinicians in the Electronic Health Record. Patients will receive 2 reminders if they do not answer the questionnaires and clinicians will call the patient
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO-based follow-up<br>Patients will receive a questionnaire every 3 months. The PRO questionnaire is used as decision aid together with other available clinical data to decide whether the patient needs a visit or not. Hence, patients only visit the outpatient clinic if there is a clinical need or a patient's wish. The actual response for each questionnaire automatically results in a colour code (green, yellow or red). A red or yellow response indicates that the patient needs to be contacted. A green colour indicates no need for a visit. Based on an overview of the questionnaire and the patient's blood samples a physician decides whether this patient should have a telephone consultation or the patient needs to be seen in the clinic. | Behavioral: PRO-based follow-up<br>* Diagnose specific questionnaires are used to screen patients in need of contact to the outpatient clinic<br>* Other names: TelePRO;|
| Experimental: PRO-based telephone consultations<br>Patients receive an electronic questionnaire every 3 months prior to a scheduled telephone consultation.The PRO questionnaire is used as dialogue support during the telephone consultation. The actual response for each item automatically results in a colour code (green, yellow or red). A red response indicates that the patient has a problem; a yellow colour indicates a potential problem, while a green colour indicates no problems. | Behavioral: PRO-based telephone consultation<br>* diagnose-specific questionnaires are used to support communication between clinician and patient during a phone consultation<br>|
| No Intervention: Usual outpatient follow-up visits<br>Patients in the control group will continue to have usual scheduled outpatient follow-up visits at the hospital initiated by the physician every 3 months. These patients do not use the clinical PRO questionnaire, but complete the research questionnaires. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months | Measurement for renal function | Measured at baseline, 6, 12 and 18 months after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Overall mortality | 18 months after randomization | 
| End Stage Renal Disease (ESRD) | Has the patient initiated dialyses during follow-up, Hemodialysis, peritoneal dialysis | 18 months after randomization | 
| Kidney transplantation | Has the patient received a kidney transplant during follow-up | 18 months after randomization | 
| Hospital admission | Difference in number of admissions | From baseline at 18 months after randomization | 
| Number of contacts | Number of contacts includes all contacts with the outpatient clinic in the study follow-up period | 18 months after randomization | 
| General Health (SF36), | General health will be assessed by items from the SF-36 questionnaire | Baseline, 6,12 and 18 months after randomization | 
| Illness perception (BIPQ) | Illness perception will be assessed by the Brief Illness perception questionnaire | Baseline, 6,12 and 18 months after randomization | 
| Quality of Life (EQ-5D) | EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention | Baseline, 6,12 and 18 months after randomization | 
| Satisfaction with care | Satisfaction will be assessed by one item from the Danish Cancer Society Patient reported experience measures PREM (Barometer) Questionnaire | 6,12,18 months after randomization | 
| Confidence | Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire | 6,12,18 months after randomization | 
| Treatment safety | Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire | 6,12,18 months after randomization | 
| Patient involvement | Patient involvement will be assessed by 5 questions from DEFACTUM (Central Denmark Region) Questionnaire | Patient involvement will be measured at 6,12 and18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRO-based follow-up, TelePRO, Outpatients, Chronic Kidney Disease