Impact of Decision Quality by Using Question Prompt List

NCT ID: NCT04985175

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-15
• Study Completion Date: 2022-08-31

Brief 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.

Detailed 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.

Conditions

Decision Making

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

QPL group

receive 2-pages ESRD QPL leaflets, circle the questions they want to ask before consultation. encourage asking questions with doctor during consultation. receive the nurse-led coaching of shared decision-making (SDM)

Group Type: EXPERIMENTAL

Question prompt list

Intervention Type: BEHAVIORAL

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.

Usual care group

without receiving provision of QPL encourage asking questions with doctor during consultation. receive the nurse-led coaching of shared decision-making (SDM)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, Xindian, Taiwan

Countries

Taiwan

Other Identifiers

202104009RINA

Identifier Type: -

Identifier Source: org_study_id