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Impact of Decision Quality by Using Question Prompt List

1. august 2021 opdateret af: National Taiwan University Hospital

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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

154

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Taiwan
    • Xindian
      • Taipei City, Xindian, Taiwan, 231
        • National Taiwan University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)
Adfærdsmæssigt: 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.
Ingen indgriben: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decision conflict
Tidsramme: 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.
before the counseling (T0), immediately after counseling(T1)
Decisional self-efficiency
Tidsramme: 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.
before the counseling (T0), immediately after counseling(T1)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decision control preference
Tidsramme: one 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.
one month after treatment (T2)
Decision control preference
Tidsramme: before the counseling (T0), immediately after counseling(T1)
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.
before the counseling (T0), immediately after counseling(T1)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Taiwan University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

15. august 2021

Primær færdiggørelse (Forventet)

30. juni 2022

Studieafslutning (Forventet)

31. august 2022

Datoer for studieregistrering

Først indsendt

26. juli 2021

Først indsendt, der opfyldte QC-kriterier

26. juli 2021

Først opslået (Faktiske)

2. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202104009RINA

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