Impact of Decision Quality by Using Question Prompt List

NCT04985175 | Unknown

• 1 other identifier: 202104009RINA
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Decision Making

Keywords

Question prompt list; Shared decision making; End-stage renal disease; Health literacy

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• Decision control preference

  one month after treatment (T2)

• Decision control preference

  before the counseling (T0), immediately after counseling(T1)

Study Arms (2)

QPL group

EXPERIMENTAL

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)

Behavioral: Question prompt list

Usual care group

NO INTERVENTION

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

Interventions

Question prompt list 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.

QPL group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• vision or hearing function impairment;
• Severe illness;
• Urgent to dialysis for extend life;
• Dialysis modalities Already decided.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Xindian, 231, Taiwan

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects were randomized assigned to QPL group or usual care group.

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 2, 2021
• Study Start: August 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: August 31, 2022
• Last Updated: August 9, 2021

Record last verified: 2021-05

Locations

TW (1)