Shared Decision-Making and Dialysis Cho… | Clinical Trial

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SDM-DC

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.

Other names: Shared decision-making and dialysis choice

Primary outcomes

Patients experiences of a shared decision-making process

Time frame: 14 days after interventions

Shared decision-making questionnaire was used to measure patients' perception of shared decision-making in the clinical encounter. It consists of nine statements to be rated on a six-point scale from 'completely disagree' (0) to 'completely agree' (5) The quality of the decision-making process was calculated as the mean score for each item in the SDM-Q9. To provide a total score of the SDM-Q9 a sum of all items was calculated and standardized on a scale on 0-100.
Knowledge, readiness for decision-making and decision quality

Time frame: 14 days after interventions

Decision Quality Measurement was used to measure the quality of the decision. The questionnaire consists of six knowledge statements and six readiness statements. All items on the questionnaire were rated as yes, no or unsure. It also consists of two open questions. A total knowledge and readiness score was calculated and standardized out of 100. Open questions were analysed using descriptive qualitative analysis and reported based on most common to least common comments. We decided that for a home-based treatment and choosing 'Treatment at home' in the preference question or deciding for a hospital-based treatment and not choosing 'Treatment at home' in the preference question were considered as concordant choices. Decision quality was defined as a knowledge score >66% on the knowledge score and combined with the concordance score.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

Aarhus University Hospital
Hillerod Hospital, Denmark
Hospital of Southern Jutland
Regional Hospital Holstebro

Registry information

Official study title

Shared Decision-Making and Dialysis Choice: A Complex Intervention

Acronym: SDM-DC

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Mar 11, 2019
Registry last updated: Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed