Decision MakingNCT04985175
Impact of Decision Quality by Using Question Prompt List
A study testing Question prompt list in people with Decision Making, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Decision Making
- What is being tested?
- Question prompt list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Aug 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- vision or hearing function impairment;
- Severe illness;
- Urgent to dialysis for extend life;
- Dialysis modalities Already decided.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Decision Quality by Using Question Prompt List on the Shared Decision Making in End-stage Renal Disease Patients
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.
Read the 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
- Being tested
- Question prompt list
- Keywords
- Question prompt list, Shared decision making, End-stage renal disease, Health literacy
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Question prompt listBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: before the counseling (T0), immediately after counseling(T1)
Secondary outcomes (2)
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.
Measured: one month after treatment (T2)
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.
Measured: before the counseling (T0), immediately after counseling(T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start15 Aug 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects were randomized assigned to QPL group or usual care group.
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985175
- Sponsor's protocol ID
- 202104009RINA
- Status last verified
- May 2021
- First submitted
- 26 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Decision Quality by Using Question Prompt List on the Shared Decision Making in End-stage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT04985175
- Acronym / sponsor ID
- 202104009RINA
- Conditions
- Decision Making
- Keywords
- Question prompt list, Shared decision making, End-stage renal disease, Health literacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects were randomized assigned to QPL group or usual care group.
| Arm | Type | Receives |
|---|---|---|
| QPL group | Experimental | Behavioral: Question prompt listreceive 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) |
| 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) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- vision or hearing function impairment;
- Severe illness;
- Urgent to dialysis for extend life;
- Dialysis modalities Already decided.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Question prompt listThe 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. | Behavioural | QPL group |
Primary outcome
Decision conflict
Time frame: before 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-efficiency
Time frame: before 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.
2 secondary outcomes
Decision control preference
Time frame: one month after treatment (T2)
Decision control preference
Time frame: before the counseling (T0), immediately after counseling(T1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Question prompt list in people with Decision Making, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision conflict (time frame: before the counseling (T0), immediately after counseling(T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.