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Involving Nursing Home Residents and Their Families in Acute Care Transfer Decisions

14 agosto 2020 aggiornato da: Ruth Tappen, Florida Atlantic University

Involving Nursing Home Residents and Their Families in Acute Transfer Decisions: Pilot Test of a New Decision Aid

This study addresses the Patient-Centered Outcomes Research Institute (PCORI) area of interest related to development of decision support tools that bring patients, families and clinicians together to decide, in this instance, whether or not transfer from the nursing home (NH) to acute care is necessary and appropriate. The purposes of this study were 1) to develop an evidence-based decision aid addressing potentially avoidable transfers of residents from nursing homes to hospitals (preceded this protocol), and 2) to evaluate this decision aid in terms of acceptability to residents and families and its effect on the quality of transfer decisions.

The primary hypotheses to be tested are:

Hypothesis 1: Resident and family members in the intervention group will report greater preparation for decision making and less decisional conflict than those in the no treatment control group.

Hypothesis 2: Residents and family members in the intervention group will demonstrate increased knowledge related to acute care transfer and less preference for acute care transfer than those in the no treatment control group.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Project Summary: The goal of this project is to develop (Phase I) and test (Phase II) a new Transfer Decision aid that will better prepare nursing home (NH) residents and their families to participate in decisions to transfer the resident to an acute care facility or remain in the NH for treatment.

Objectives: The specific aim of this study is to evaluate the decision aid, "Go to the Hospital or Stay Here?" in terms of acceptability to residents and families and its effect on decision making and transfer decisions by residents and families.

Study Design: A mixed methods design was used to address the study aims. In Phase I (not submitted to ClinicalTrials.gov), interviews of a diverse sample of NH residents, their family members, primary care providers, nurses and social workers in the NH were conducted and the results were used to create a Transfer Decision aid to be pilot tested in Phase II for its effect on decision making and transfer decisions.

Phase II involves a pretest, intervention for the half randomly selected to receive it, 14 day posttest and 90 day follow-up.

Study Population: Staff of 15 participating South Florida nursing homes (NHs) were asked to recommend residents and family members of residents who could participate in the study. Residents were tested for ability to provide consent using the Mini-Cog prior to enrollment.

General Analytic Strategy: Multiple linear regression (MLR) will be used to analyze the variance when predicting the primary and secondary outcome variables, preparation for decision making, decisional conflict, knowledge and number of transfers (McNeil, Newman & Kellee, 1996; Pedhazur & Schmelking, 1991). For qualitative data, Phase II interviews are transcribed and the transcriptions reviewed for accuracy. Responses were de-identified (names, gender and ethnic identity information removed). A framework for descriptive (labeling and categorizing), interpretive (based on underlying meaning) and pattern (thematic) codes was developed. Intercoder reliability was calculated.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

192

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Florida
      • Boca Raton, Florida, Stati Uniti, 33431
        • Florida Atlantic University, Christine E. Lynn College of Nursing

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Adult nursing home resident and/or family member or identified significant other of a nursing home resident. Cognitively unimpaired individuals. Long or short term residents of nursing home or rehabilitation center.

Exclusion Criteria:

  • Dementia as indicated by score on Mini-Cog. Inability to respond to questions due to physical disability or illness.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Decision aid
Provision of "Go to the Hospital or Stay Here?"
Comportamentale: Provision of "Go to the Hospital or Stay Here?"
Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days.
Altri nomi:
  • Transfer Decision Guide
Nessun intervento: No decision aid
Does not receive the decision aid.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Preparation for Decision Making
Lasso di tempo: Decision Aid group only: Post test (2-3 weeks after pretest) and at 3 month follow-up (after post test)

Range of possible raw scores: 10 - 50. Items can be summed and scored (sum the 10 items and divide by 10).

There are no subscales. A higher score is positive indicating perception of being better prepared to make the decision identified when test is administered.
Decision Aid group only: Post test (2-3 weeks after pretest) and at 3 month follow-up (after post test)
Decisional Conflict Scale
Lasso di tempo: Decision aid: Pretest (baseline) and Post test (2-3 weeks after pretest); No decision aid: Post test only

Scale Range of possible raw scores: 0 - 64.

A lower score indicates less decisional conflict related to making the identified decision. Decisional conflict is a state of uncertainty about a course of action. Decision supporting interventions are thought to be effective in
Decision aid: Pretest (baseline) and Post test (2-3 weeks after pretest); No decision aid: Post test only

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Knowledge Test
Lasso di tempo: Pretest (baseline) and Post test (2-3 weeks after pretest)

Decision Aid Quiz Investigator Developed: True/False Test of Knowledge based upon information in the Decision Aid.

Scale Range: 0 - 22. Total score is the number of questions answered correct.

A higher score indicates greater number of responses are correct. Items are scored as 0 = incorrect; 1 = correct.

Criteria used to assess this measure:

Items based upon concept mapping of the Decision Aid Reviewed by a panel of experts prior to administration
Pretest (baseline) and Post test (2-3 weeks after pretest)
Treatment Preference/Decisional Conflict Scale
Lasso di tempo: Post test (2-3 weeks after pretest)
Treatment Site Option Preference Administered prior to the Decisional Conflict Scale, this single item was used to ask participants if they preferred treatment in the hospital or nursing home or if the preference depended upon the seriousness of their condition (three choices). This is nominal level data. The administration of the item precedes administration of the Decisional Conflict Scale (DCS) described previously. Standard administration of the Decision Conflict Scale includes this item but it is not part of the DCS score.
Post test (2-3 weeks after pretest)
30 Day Hospital Readmission
Lasso di tempo: Length of stay ≤30 days at Post test
Report of all hospitalizations from facility staff or participants Hospital Transfers Occurring During Study Period, i.e., number of resident participants who were hospitalized from pretest to posttest and by end of 3 month follow-up period.
Length of stay ≤30 days at Post test

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Florida Atlantic University

Investigatori

  • Investigatore principale: Ruth M. Tappen, EdD, RN, FAAN, Christine E. Lynn College of Nursing, Florida Atlantic University

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2012

Completamento primario (Effettivo)

1 settembre 2015

Completamento dello studio (Effettivo)

1 settembre 2015

Date di iscrizione allo studio

Primo inviato

2 ottobre 2015

Primo inviato che soddisfa i criteri di controllo qualità

5 ottobre 2015

Primo Inserito (Stima)

6 ottobre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 agosto 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 agosto 2020

Ultimo verificato

1 agosto 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 343268
  • 1IP2PI000281-01 (Altro numero di sovvenzione/finanziamento: Patient-Centered Outcomes Research Institute)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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