Impact of Decision Quality by Using Question Prompt List
1. august 2021 oppdatert av: 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.
Studieoversikt
Status
Påmelding etter invitasjon
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
154
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Xindian
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Taipei City, Xindian, Taiwan, 231
- National Taiwan University Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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)
|
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 inngripen: 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)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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before the counseling (T0), immediately after counseling(T1)
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|
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.
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before the counseling (T0), immediately after counseling(T1)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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one month after treatment (T2)
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Decision control preference
Tidsramme: before the counseling (T0), immediately after counseling(T1)
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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.
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before the counseling (T0), immediately after counseling(T1)
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Samarbeidspartnere og etterforskere
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
15. august 2021
Primær fullføring (Forventet)
30. juni 2022
Studiet fullført (Forventet)
31. august 2022
Datoer for studieregistrering
Først innsendt
26. juli 2021
Først innsendt som oppfylte QC-kriteriene
26. juli 2021
Først lagt ut (Faktiske)
2. august 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. august 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. august 2021
Sist bekreftet
1. mai 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 202104009RINA
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