Symptom Management in Patients on Dialysis

End-stage Kidney Disease Clinical Trial

Official title:

Assessing the Feasibility of Self-reported MeasUrement of Physical and PsychosOcial Symptoms and Response Tool in Patients on Dialysis- Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05515991
• Other study ID #: 22-5199
• Secondary ID: UHNKHERGePROMSUP
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2023
• Est. completion date: May 2024

Study information

• Verified date: September 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a parallel arm, pilot study used to examine the feasibility of electronic patient reported outcome measures (ePROMs) for symptom assessment and monitoring as well as a linked self-management support and decision support information hub (https://symptomcare.org) to facilitate symptom management for patients on maintenance hemodialysis.

Two dialysis centers will be included in the study, with one center receiving SUPPORT-Dialysis (intervention arm) and the other receiving standard care (control arm).

Description:

In Canada, 20,000-25,000 patients with end-stage kidney disease (ESKD) experience a range of symptoms such as chronic pain, itchiness, fatigue, anxiety, depression and sleep disturbances [1-5]. These may impact quality of life, increase mortality, decrease treatment adherence, and increased hospitalizations [6-8]. These symptoms are under-managed and under-recognized among these patients, but screening and managing symptoms using patient reported outcomes measures (PROMs) may be a useful and inexpensive solution. PROMS have previously been used successfully in cancer care [8-9], and have potential for clinical care of patients with kidney failure as well.

Electronic collection of PROMs (ePROMs) facilitates PROMs use by allowing linkage to electronic patient records [10-11] and immediate scoring and presentation of results to patients and clinicians [12-14]. ePROMs allow the use of computer adaptive testing (CAT) to personalize questions, increase the precision of measurements and reduce survey burden [15-17]. The investigators also developed a self-management support and decision support resource hub(https://symptomcare.org) to help dialysis patients and their clinical team in identifying and managing relevant physical and psychological symptoms that require further assessment and potential intervention.

Patients will complete Patient Reported Outcome Measurement Information System (PROMIS) CAT surveys on an electronic data capture system (SUPPORT-Dialysis) every four weeks during their dialysis treatment for six months. In the intervention, patients with moderate/severe symptoms will be flagged for the clinical team. Moderate/severe symptoms will be determined based on whether the participants score above a pre-defined cut-off in the surveys. The participant, primary nurse, and nephrologist will also receive an output report and be given access to https://symptomcare.org for suggested symptom management actions.

To establish the feasibility and acceptability of the intervention, the investigators will assess

1. Recruitment Rate

2. Retention and Completion rate

3. Acceptability

4. Patient satisfaction

5. Staff satisfaction

Based on the objectives of this study, the investigators hypothesize the following:

1. Recruitment goals will be met; >50% of approached patients will consent; completion rate will be > 80% of participants at least 50% of the time, and dropout rate will be < 30%.

2. >80% of patients find the toolkit acceptable; <20% of staff find the process intrusive to workflow.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: May 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing maintenance hemodialysis for more than 3 months

Exclusion Criteria:

• Patients with severe acute illness or condition that hampers questionnaire completion assessed by clinical team.

• Dementia indicated in the medical record, indicated by the managing healthcare team.

• Unable to understand English - as assessed by clinical team.

• Life expectancy < 6 months as assessed by main responsible nephrologist.

• Unwilling or unable to provide informed consent.

Related Conditions & MeSH terms

• End-stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Other:
• SUPPORT-DIALYSIS with Access to Output Report and Information Hub
SUPPORT-Dialysis is a symptom assessment response toolkit, consisting of a screening and response component. Participants will be screened for symptoms and distress using an electronic assessment(ePROMs). Output reports based on ePROMs scores will be provided to patients as well as the clinical care team. Participants at Toronto General Hospital will complete the screening every 4 weeks for 6 months, and each time the output report will be provided to both patients and the clinical team.The second, response component of the intervention is the information support and self-management hub (https://symptomcare.org). All participants and the clinical team will be given access to this website, which provides information about self-management for patients as well as management advice for healthcare professionals.
• SUPPORT-DIALYSIS Only
SUPPORT-Dialysis screening will also be implemented at Humber River Hospital, but participants and clinical team will not be receiving the output screening report or be given access to the information hub with symptom management resources.

Locations

Country	Name	City	State
Canada	Etobicoke General Hospital	Brampton	Ontario
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Humber River Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (12)

Barbera L, Sutradhar R, Howell D, Sussman J, Seow H, Dudgeon D, Atzema C, Earle C, Husain A, Liu Y, Krzyzanowska MK. Does routine symptom screening with ESAS decrease ED visits in breast cancer patients undergoing adjuvant chemotherapy? Support Care Cancer. 2015 Oct;23(10):3025-32. doi: 10.1007/s00520-015-2671-3. Epub 2015 Feb 26. — View Citation

Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes. 2003 Jun 9;1:20. doi: 10.1186/1477-7525-1-20. — View Citation

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8. — View Citation

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. — View Citation

Dudgeon D, King S, Howell D, Green E, Gilbert J, Hughes E, Lalonde B, Angus H, Sawka C. Cancer Care Ontario's experience with implementation of routine physical and psychological symptom distress screening. Psychooncology. 2012 Apr;21(4):357-64. doi: 10.1002/pon.1918. Epub 2011 Feb 8. — View Citation

Garin O, Ayuso-Mateos JL, Almansa J, Nieto M, Chatterji S, Vilagut G, Alonso J, Cieza A, Svetskova O, Burger H, Racca V, Francescutti C, Vieta E, Kostanjsek N, Raggi A, Leonardi M, Ferrer M; MHADIE consortium. Validation of the "World Health Organization Disability Assessment Schedule, WHODAS-2" in patients with chronic diseases. Health Qual Life Outcomes. 2010 May 19;8:51. doi: 10.1186/1477-7525-8-51. — View Citation

Howell D, Liu G. Can routine collection of patient reported outcome data actually improve person-centered health? Healthc Pap. 2011;11(4):42-7; discussion 55-8. doi: 10.12927/hcpap.2012.22703. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation

Spitzer RL, Williams JB, Kroenke K, Hornyak R, McMurray J. Validity and utility of the PRIME-MD patient health questionnaire in assessment of 3000 obstetric-gynecologic patients: the PRIME-MD Patient Health Questionnaire Obstetrics-Gynecology Study. Am J Obstet Gynecol. 2000 Sep;183(3):759-69. doi: 10.1067/mob.2000.106580. — View Citation

Tam E, Chen J, Zhang Q, et al. Routine physical function assessment through a Branching Logic Electronic Symptom Survey (BLESS) vs. the 32-combined item HAQ-DI + WHODAS (HW) survey: A quality improvement controlled trial. Journal of Clinical Oncology 2017;35:136.

Van Belle S, Paridaens R, Evers G, Kerger J, Bron D, Foubert J, Ponnet G, Vander Steichel D, Heremans C, Rosillon D. Comparison of proposed diagnostic criteria with FACT-F and VAS for cancer-related fatigue: proposal for use as a screening tool. Support Care Cancer. 2005 Apr;13(4):246-54. doi: 10.1007/s00520-004-0734-y. Epub 2004 Nov 12. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence Rate of Healthcare Use	Patients will complete the 'Healthcare Use Questionnaire' at each follow-up visit. Incidence rate of healthcare use will be determined via incidence of hospitalization and emergency visits every 4 weeks.	Baseline to Follow-up (6 months)
Other	Physical Health Component Score	Measured by the 36-Item Kidney Disease Quality of Life Instrument (KDQOL-36) and the 12-Item Short Form Health Survey (SF-12) embedded in ePROMs. SF-12 is a part of KDQOL-36, specifically items 1-12. Scoring wise, items 1, 8, & 12-36 have a minimum value of 1 and maximum value of 5. Items 2 & 3 have a minimum value of 1 and maximum value of 3. Items 4-7 have a minimum value of 1 and maximum value of 2. Items 9-11 have a minimum value of 1 and maximum value of 6. Whether higher or lower scores determine better outcomes depends on the item.	Baseline to Follow-up (6 months)
Other	Mental Health Component Score	Measured by the 36-Item Kidney Disease Quality of Life Instrument (KDQOL-36) and the 12-Item Short Form Health Survey (SF-12) embedded in ePROMs. SF-12 is a part of KDQOL-36, specifically items 1-12. Scoring wise, items 1, 8, & 12-36 have a minimum value of 1 and maximum value of 5. Items 2 & 3 have a minimum value of 1 and maximum value of 3. Items 4-7 have a minimum value of 1 and maximum value of 2. Items 9-11 have a minimum value of 1 and maximum value of 6. Whether higher or lower scores determine better outcomes depends on the item.	Baseline to Follow-up (6 months)
Other	Kidney Disease Quality of Life	Measured by the 36-Item Kidney Disease Quality of Life Instrument (KDQOL-36). Scoring wise, items 1, 8, & 12-36 have a minimum value of 1 and maximum value of 5. Items 2 & 3 have a minimum value of 1 and maximum value of 3. Items 4-7 have a minimum value of 1 and maximum value of 2. Items 9-11 have a minimum value of 1 and maximum value of 6. Whether higher or lower scores determine better outcomes depends on the item.	Baseline to Follow-up (6 months)
Primary	Recruitment Target	Feasibility of toolkit will be confirmed if recruitment target of 30 participants at each site are obtained in a 3-month period of the pilot.	Baseline
Primary	Proportion of Eligible Patients who decline consent	Feasibility of toolkit will be confirmed if decline rate is <50% for eligible patients.	Baseline
Primary	Proportion of Participants who miss or refuse ePROMs follow-ups	Feasibility of toolkit will be confirmed if <30% of participants complete <50% of all follow-up visits.	Baseline to follow-up (6 months)
Primary	Proportion of Enrolled Patients who Drop-Out From the Study	Feasibility of toolkit will be confirmed if the dropout rate is < 30%.	Baseline to follow-up (6 months)
Secondary	Patient Acceptability	Proportion of patients who find the tool 1) acceptable, 2) not burdensome and 3) important, based on responses to the "Patient Satisfaction Survey" they will complete.	Follow-up (every 4 weeks, up to 6 months)
Secondary	Clinical Team Acceptability	Proportion of staff who do not find the use of the tool intrusive to the workflow, based on responses to the "Staff Satisfaction Survey" they will complete.	Follow-up (every 4 weeks, up to 6 months)