Shared Decision-Making and Dialysis Choice

NCT ID: NCT03868800

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2018-08-31

Brief Summary

The SDM-DC intervention is designed for patients with kidney failure who must make a decision regarding type of dialysis: haemodialysis or peritoneal dialysis. SDM-DC consists of patient and his or her relative(s) being given a patient decision aid called 'Dialysis choice' and booked for meetings with a dialysis coordinator.

Detailed Description

The dialysis coordinators were trained in the why, what and how in relation to SDM-DC and to deliver the intervention by tailoring to patients' needs and using three different communication skills: mirroring, active listening and value clarification. The patient decision aid was designed to be utilised during and between the SDM-DC meetings. The patient decision aid is in paper format and consists of a set of tools: a decision map, an overview of uremic symptoms, an overview of options, and the Ottawa Personal Decision Guide. More specifically, the patient decision aid makes explicit the dialysis decision, describes options, benefits and harms using the best available evidence, and intends to help patients clarify their values by indicating the importance of the benefits and harms out of scale from (0) to (5). Four videos with personal stories were available to be shown and discussed at the meetings if the patient preferred to see the reason why another patient has chosen a specific option. Each video showed one option with a patient telling why he/she chose that option, and how he/she weighed the advantages and disadvantages.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SDM-DC

All adult patients with kidney failure referred to a department of renal medicine at one of the four hospitals from the 1st of October 2016 to the 31st of May 2018 were offered the intervention and invited to participate in the study. The inclusion criterion was an estimated glomerular filtration rate below 20 ml/min and based on a clinical judgement made by the contact doctor and/or the contact nurse about the decline in the Estimated glomerular filtration rate to continue. Exclusion criteria were patients who had decided on conservative management, patients with a living donor and a set date for transplantation and patients not able to participate in the intervention due to cognitive impairment. The use of an interpreter was not an exclusion criterion.

Group Type: OTHER

SDM-DC

Intervention Type: OTHER

The SDM-DC intervention is designed for patients with kidney failure who must make a decision regarding type of dialysis: haemodialysis or peritoneal dialysis. SDM-DC consists of patient and his or her relative(s) being given a patient decision aid called 'Dialysis choice' and booked for meetings with a dialysis coordinator. There were optional videos describing other patients' experiences making this decision. The dialysis coordinators were trained in the why, what and how in relation to SDM-DC and to deliver the intervention by tailoring to patients' needs and using three different communication skills: mirroring, active listening and value clarification.

Interventions

SDM-DC

The SDM-DC intervention is designed for patients with kidney failure who must make a decision regarding type of dialysis: haemodialysis or peritoneal dialysis. SDM-DC consists of patient and his or her relative(s) being given a patient decision aid called 'Dialysis choice' and booked for meetings with a dialysis coordinator. There were optional videos describing other patients' experiences making this decision. The dialysis coordinators were trained in the why, what and how in relation to SDM-DC and to deliver the intervention by tailoring to patients' needs and using three different communication skills: mirroring, active listening and value clarification.

Intervention Type: OTHER

Other Intervention Names

Shared decision-making and dialysis choice

Eligibility Criteria

Inclusion Criteria

• Estimated glomerular filtration rate below 20 ml/min
• A clinical judgement made by the contact nurse and the contact physician

Exclusion Criteria

• Conservative care
• A set date for a transplantation with a living donor
• Not able to participate due to cognitive impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Hillerod Hospital, Denmark

OTHER

Sponsor Role: collaborator

Hospital of Southern Jutland

OTHER

Sponsor Role: collaborator

Regional Hospital Holstebro

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeanette Finderup, Master

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

References

Finderup J, Lomborg K, Jensen JD, Stacey D. Choice of dialysis modality: patients' experiences and quality of decision after shared decision-making. BMC Nephrol. 2020 Aug 5;21(1):330. doi: 10.1186/s12882-020-01956-w.

Reference Type: DERIVED

PMID: 32758177 (View on PubMed)

Other Identifiers

04032019

Identifier Type: -

Identifier Source: org_study_id