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

Primary Purpose

Chronic Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SDM-DC
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    SDM-DC

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Patients experiences of a shared decision-making process
    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 7, 2019
    Last Updated
    March 12, 2019
    Sponsor
    University of Aarhus
    Collaborators
    Aarhus University Hospital, Hillerod Hospital, Denmark, Hospital of Southern Jutland, Regional Hospital Holstebro
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03868800
    Brief Title
    Shared Decision-Making and Dialysis Choice
    Acronym
    SDM-DC
    Official Title
    Shared Decision-Making and Dialysis Choice: A Complex Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    May 31, 2018 (Actual)
    Study Completion Date
    August 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus
    Collaborators
    Aarhus University Hospital, Hillerod Hospital, Denmark, Hospital of Southern Jutland, Regional Hospital Holstebro

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Diseases

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    402 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SDM-DC
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    SDM-DC
    Other Intervention Name(s)
    Shared decision-making and dialysis choice
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Patients experiences of a shared decision-making process
    Description
    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.
    Time Frame
    14 days after interventions
    Title
    Knowledge, readiness for decision-making and decision quality
    Description
    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.
    Time Frame
    14 days after interventions

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeanette Finderup, Master
    Organizational Affiliation
    Aarhus University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    32758177
    Citation
    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.
    Results Reference
    derived

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    Shared Decision-Making and Dialysis Choice

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