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Clinical Trials/NCT03868800
NCT03868800
Completed
N/A

Shared Decision-Making and Dialysis Choice: A Complex Intervention

University of Aarhus0 sites402 target enrollmentOctober 1, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Kidney Diseases
Sponsor
University of Aarhus
Enrollment
402
Primary Endpoint
Knowledge, readiness for decision-making and decision quality
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
August 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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.

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