Shared Decision-Making and Dialysis Choice (SDM-DC)

March 12, 2019 updated by: University of Aarhus

Shared Decision-Making and Dialysis Choice: A Complex Intervention

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
402

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: 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.
Other: 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.
Other Names:
  • Shared decision-making and dialysis choice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
14 days after interventions
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.
14 days after interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital
Hillerod Hospital, Denmark
Regional Hospital Holstebro
Hospital of Southern Jutland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeanette Finderup, Master, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04032019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. But restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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