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Impact of Decision Quality by Using Question Prompt List

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04985175
Enrollment
154
Registered
2021-08-02
Start date
2021-08-15
Completion date
2022-08-31
Last updated
2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Making

Keywords

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

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.

Interventions

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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Subjects were randomized assigned to QPL group or usual care group.

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Decision conflictbefore the counseling (T0), immediately after counseling(T1)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.
Decisional self-efficiencybefore the counseling (T0), immediately after counseling(T1)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.

Secondary

MeasureTime frameDescription
Decision control preferenceone month after treatment (T2)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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026