Evaluation of Routinely Measured Patient-reported Outcomes in Hemodialysis Care

NCT03535922 | Completed

• 1 other identifier: RES0034066
• Study Type: interventional
• Target: 3,977
• Locations: 1 country
• Sites: 3

Brief Summary

Patient-reported outcome measures (PROMs) are reports coming directly from patients about how they function or feel in relation to a health condition and its therapy, without interpretation of the patient's responses by a clinician or anyone else. PROMs capture patients' experiences of symptoms and impact of disease on functioning and can support clinicians to monitor disease progression and facilitate patient-centered care. The EMPATHY trial will determine the effects of routinely measuring PROMs on the experiences of patients undergoing hemodialysis in Alberta and Ontario. In this study, two kinds of PROMs will be used: a disease-specific PROM and a generic PROM. The disease-specific PROM focuses on health symptoms related to kidney failure and the generic PROM focuses on general health. In the trial, patients will be invited to complete the PROMs, and results of the measures will be linked to treatment aids for clinicians, providing specific information on how symptoms can best be managed. These care pathways will also be available to patients not receiving PROMs. The main outcome of this study will be patient-clinician communication, which will be assessed using a questionnaire called the "Communication Assessment Tool". In addition to assessing the effect of using these questionnaires on patient-provider communication, this study will allow us to explore whether their use affects patient management and symptoms, use of healthcare services, and the overall cost of implementing these questionnaires in clinical practice. Each dialysis unit (including all patients) will be randomized to one of four study groups: 1) Patients will complete the disease-specific PROM; 2) Patients will complete the generic PROM; 3) Patients will complete both the disease-specific and generic PROM; 4) Patients will receive usual care. Clinicians (in dialysis units randomized to PROMs, groups 1-3) will receive the results of the questionnaires completed by the patients. This is intended to trigger the clinician to ask the patient about certain symptoms if any exist. All clinicians in all study groups will have access to the clinical "treatment aids", which are tools that help identify and manage certain symptoms that patients might have. For example, people with severe itching will be cared for based on a step-wise treatment algorithm. Patients will also receive a report of their questionnaire(s) results, with an explanation of what it means.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

Hemodialysis; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change in Communication Assessment Tool (CAT) scores over 12 months

  The CAT assesses patient perceptions of clinicians' interpersonal and communication skills. 'Communication' refers to the interactions between members of the healthcare team (i.e., nurses, nephrologists) and the patient.

  Measured at baseline, 6 months, and 12 months

Secondary Outcomes (8)

• Change in EQ-5D-5L scores over 12 months

  Measured at baseline, 6 months, and 12 months

• Change in Disease-specific PROM (ESAS or IPOS) scores over 12 months

  Measured at baseline, 6 months, and 12 months

• Symptom treatments initiated

  12 month study period

• Change in GAD-2 scores over 12 months

  Measured at baseline, 6 months, and 12 months

• Change in PHQ-2 scores over 12 months

  Measured at baseline, 6 months, and 12 months

Study Arms (4)

The disease-specific PROM group

EXPERIMENTAL

Hemodialysis (HD) units randomized to this PROMs assessment group will administer a disease-specific PROM every 2 months to all patients able to complete the instrument independently or with assistance for a period of 12 months. Patients will receive a copy of their PROM results in report form and patients will be prompted to follow-up with their care providers if they provide a positive response to any of the symptoms assessed by the PROM. The disease-specific PROM report will also be added to the patient's medical chart for review by clinicians. The report will display each patient's most recent results in comparison with their previous results, and in comparison with the general dialysis population. The PROM report will be accompanied by treatment aids for all symptoms. The proposed disease-specific PROM is the ESAS-r:Renal or the IPOS-Renal.

Other: PROMs Assessment

The generic PROM group

EXPERIMENTAL

HD units randomized to this PROMs assessment group will administer a generic PROM every 2 months to all patients able to complete the instrument independently or with assistance for a period of 12 months. Patients will receive a copy of their PROM results in report form and patients will be prompted to follow-up with their care providers if they provide a positive response to any of the symptoms assessed by the PROM. The generic PROM report will also be added to the patient's medical chart for review by clinicians. The report will display each patient's most recent results in comparison with their previous results, and in comparison with the general dialysis population. The PROM report will be accompanied by treatment aids for all symptoms. The proposed generic PROM is the EQ-5D-5L.

Other: PROMs Assessment

Disease-specific and generic PROMs group

EXPERIMENTAL

HD units randomized to this PROMs assessment group will administer a disease-specific and generic PROM every 2 months to all patients able to complete the instrument for a period of 12 months. Patients will receive a copy of both their PROMs results in report form and patients will be prompted to follow-up with their care providers if they provide a positive response to any of the symptoms assessed by the two PROMs. The disease-specific and generic PROMs reports will also be added to the patient's medical chart for review by clinicians. The report will display each patient's most recent results in comparison with their previous results, and in comparison with the general dialysis population. The PROMs reports will be accompanied by treatment aids for all symptoms.

Other: PROMs Assessment

The control or 'usual care' group

NO INTERVENTION

HD units randomized to this group will follow usual care and patients will not have any PROMs assessment; however, all the treatment aids will be made available for clinicians in this study group during the 12 months trial period.

Interventions

PROMs Assessment OTHER

Routine measurement and reporting of disease-specific PROMs, generic PROMs, or combination of both

Disease-specific and generic PROMs group; The disease-specific PROM group; The generic PROM group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing hemodialysis within an eligible in-centre dialysis unit in Alberta or Ontario
• years or older at the start of the study
• Willing and able to complete the PROMs as part of the trial

You may not qualify if:

• Cognitive impairment present
• Undergoing acute dialysis or transiently dialyzing in the unit

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (3)

Alberta Kidney Care - South

Calgary, Alberta, T2N 2T9, Canada

Location

Alberta Kidney Care - North

Edmonton, Alberta, T6G 2E1, Canada

Location

Ontario Renal Network

Toronto, Ontario, M5G 2L3, Canada

Location

Related Publications (11)

• Boyce MB, Browne JP. Does providing feedback on patient-reported outcomes to healthcare professionals result in better outcomes for patients? A systematic review. Qual Life Res. 2013 Nov;22(9):2265-78. doi: 10.1007/s11136-013-0390-0. Epub 2013 Mar 17.

  PMID: 23504544 BACKGROUND

• Marshall S, Haywood K, Fitzpatrick R. Impact of patient-reported outcome measures on routine practice: a structured review. J Eval Clin Pract. 2006 Oct;12(5):559-68. doi: 10.1111/j.1365-2753.2006.00650.x.

  PMID: 16987118 BACKGROUND

• Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008 Mar;17(2):179-93. doi: 10.1007/s11136-007-9295-0. Epub 2008 Jan 4.

  PMID: 18175207 BACKGROUND

• Boyce MB, Browne JP, Greenhalgh J. The experiences of professionals with using information from patient-reported outcome measures to improve the quality of healthcare: a systematic review of qualitative research. BMJ Qual Saf. 2014 Jun;23(6):508-18. doi: 10.1136/bmjqs-2013-002524. Epub 2014 Feb 6.

  PMID: 24505110 BACKGROUND

• Antunes B, Harding R, Higginson IJ; EUROIMPACT. Implementing patient-reported outcome measures in palliative care clinical practice: a systematic review of facilitators and barriers. Palliat Med. 2014 Feb;28(2):158-75. doi: 10.1177/0269216313491619. Epub 2013 Jun 25.

  PMID: 23801463 BACKGROUND

• Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care. 1989 Mar;27(3 Suppl):S217-32. doi: 10.1097/00005650-198903001-00018.

  PMID: 2646490 BACKGROUND

• Laupacis A, Wong C, Churchill D. The use of generic and specific quality-of-life measures in hemodialysis patients treated with erythropoietin. The Canadian Erythropoietin Study Group. Control Clin Trials. 1991 Aug;12(4 Suppl):168S-179S. doi: 10.1016/s0197-2456(05)80021-2.

  PMID: 1663853 BACKGROUND

• Perrone RD, Coons SJ, Cavanaugh K, Finkelstein F, Meyer KB. Patient-reported outcomes in clinical trials of CKD-related therapies: report of a symposium sponsored by the national kidney foundation and the U.S. Food and Drug Administration. Am J Kidney Dis. 2013 Dec;62(6):1046-57. doi: 10.1053/j.ajkd.2013.07.004. Epub 2013 Aug 26.

  PMID: 23988757 BACKGROUND

• Davison SN, Jhangri GS, Johnson JA. Longitudinal validation of a modified Edmonton symptom assessment system (ESAS) in haemodialysis patients. Nephrol Dial Transplant. 2006 Nov;21(11):3189-95. doi: 10.1093/ndt/gfl380. Epub 2006 Sep 6.

  PMID: 16957010 BACKGROUND

• Fayers PM. Evaluating the effectiveness of using PROs in clinical practice: a role for cluster-randomised trials. Qual Life Res. 2008 Dec;17(10):1315-21. doi: 10.1007/s11136-008-9391-9. Epub 2008 Sep 27.

  PMID: 18821031 BACKGROUND

• Johnson JA, Al Sayah F, Buzinski R, Corradetti B, Davison SN, Elliott MJ, Klarenbach S, Manns B, Schick-Makaroff K, Short H, Thomas C, Walsh M. A cluster randomized controlled trial for the Evaluation of routinely Measured PATient reported outcomes in HemodialYsis care (EMPATHY): a study protocol. BMC Health Serv Res. 2020 Aug 10;20(1):731. doi: 10.1186/s12913-020-05557-z.

  PMID: 32778102 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Johnson, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 24, 2018
• Study Start: September 17, 2018
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)