Clinical trial NCT04985175: Impact of Decision Quality by Using Question Prompt List
Official title: Impact of Decision Quality by Using Question Prompt List on the Shared Decision Making in End-stage Renal Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decision Making
Keywords: Question prompt list
Shared decision making
End-stage renal disease
Health literacy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects were randomized assigned to QPL group or usual care group.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Decision conflict
timeFrame: before the counseling (T0), immediately after counseling(T1)
measure: Decisional self-efficiency
timeFrame: before the counseling (T0), immediately after counseling(T1)
Secondary outcomes:
measure: Decision control preference
timeFrame: one month after treatment (T2)
measure: Decision control preference
timeFrame: before the counseling (T0), immediately after counseling(T1)
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
state: Xindian
Study officials:
References: