Impact of Decision Quality by Using Question Prompt List

Decision Making Clinical Trial

Official title:

Impact of Decision Quality by Using Question Prompt List on the Shared Decision Making in End-stage Renal Disease Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04985175
• Other study ID #: 202104009RINA
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: May 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the effects of a question prompt list (QPL) on a shared decision-making consultation among facing decision for dialysis in end-stage renal disease (ESRD) patients. A randomized controlled trial was conducted at the university medical center of North Taiwan. Subjects were randomized assigned to QPL group or usual care group. Decisional quality and decision control preferences were assessed with questionnaires. Measurements were performed at before the counseling (T0), immediately after counseling (T1), and evaluate decision regret at one month after treatment.

Description:

The aim of this study was to investigate the effectiveness of decisional quality and decisional control preferences by using a specific question prompt list (QPL) during a shared decision-making consultation among facing decision for dialysis in end-stage renal disease (ESRD) patients. A randomized controlled trial was conducted at the university medical center of North Taiwan. Recruit subjects are those who are about to receive the nurse-led coaching of shared decision-making (SDM) for patients with ESRD and attend the program. By using blocked Randomization design, the investigators assigned participants to QPL group or usual care. Prior to a clinic visit to discuss treatment, two-pages ESRD QPL leaflets are provided to QPL group, while usual care group without receiving provision of QPL. Measurements of outcome included decision quality (decision conflict, decisional self-efficiency) and decision control preference at before the counseling (T0), immediately after counseling (T1), and evaluate decision regret at one month after treatment (T2), at this time the patient has decided and started to accept the selected treatment (hemodialysis, peritoneal dialysis or conservative treatment). All statistical analyses were performed in SAS statistical software, version 9.4 (SAS, Cary, NC). The effects of the intervention were assessed by generalized estimating equation (GEE) analysis with the coefficient of interaction ( group × time) term. Statistical tests were two-sided with a significance level of 0.05. Hierarchical Linear Model was used to detect the impact of nested within physician.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 154
• Est. completion date: August 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with stage 5 chronic kidney disease who facing decision for dialysis;

• normal cognitive functions;

• be able to read, communicate in Mandarin or Taiwanese;

• ability to express willingness;

Exclusion Criteria:

• vision or hearing function impairment;

• Severe illness;

• Urgent to dialysis for extend life;

• Dialysis modalities Already decided.

Related Conditions & MeSH terms

• Decision Making
• Kidney Failure, Chronic

Intervention

Behavioral:
• Question prompt list
The specific QPS was a one page leaflet for chronic kidney disease which developed by applied literature and public QPL from the National Health Agency. It contains 3 domains 25 questions related to treatment, dialysis, and Kidney transplant. The QPL group participants were asked to read and mark those questions they concerned or write down additional problems.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City	Xindian

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision conflict	Decision conflict was measured by Decision conflict scale(DCS). The scale consists of 16 items into 5 subscales: Uncertainty(3 items), Informed(3 items), values clarity(3 items), support(3 items), and effective decision(4 items) that are rated on a 5-point likert-scale from "strongly agree" (0) to "strongly disagree" (4). The sum of scores are calculated from 0 to 100. The higher the score, the higher the level of decision conflict.	before the counseling (T0), immediately after counseling(T1)
Primary	Decisional self-efficiency	Decision self-efficiency was measured by Decisional Self-Efficiency Scale(DSES). The scale represents self-confidence or belief in decision making. The scale consists of 11 items that are rated on a 5-point likert-scale from "not at all confident" (0) to" very confident "(4) . The sum of scores are calculated from 0 to 100. The higher the score, the higher the level of self-confidence.	before the counseling (T0), immediately after counseling(T1)
Secondary	Decision control preference	Decision regret was measured by Decision regret Scale(DRS) .The scale consists of 5 items that are rated on a 5-point likert-scale from "strongly agree "(1) to" strongly disagree" (5) . The sum of scores are calculated from 0 to 100. The higher the score, the higher the level of regret.	one month after treatment (T2)
Secondary	Decision control preference	Decision control preference was measured by Decision control preference Scale(DCPS) .The scale asks two question:(1)control preference measured at before the counseling; (2) actual decision control level measured after counseling immediately.	before the counseling (T0), immediately after counseling(T1)