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A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)

29 ottobre 2019 aggiornato da: University of Colorado, Denver
The purpose of this study is to test the acceptability and feasibility of a "toolkit" of patient decision aids (PtDAs) for heart failure patients who are considering an ICD implant.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Specific Aim 1: Examine acceptability and feasibility of a toolkit of patient decision aids (PtDAs) for patients with heart failure referred for primary prevention implantable cardioverter-defibrillators using a randomized control trial design across three diverse health care systems (Kaiser Colorado, The University of Colorado, and The Denver Veterans Hospital).

  1. Measure the acceptability of the decision aids
  2. Explore feasibility by measuring patient participation rates and adherence to the study protocol across all three sites.
  3. Conduct a preliminary assessment of outcomes by measuring changes in decision quality (knowledge and value concordance), quality of life, depressive symptoms, health status, and spiritual well-being.

Specific Aim 2: Determine the relative value of the various tools in the toolkit through in-depth interviews from study participants and providers at each intervention site

Tipo di studio

Interventistico

Iscrizione (Effettivo)

15

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
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • University of Colorado Hospital (UCH)
      • Denver, Colorado, Stati Uniti, 80220
        • Denver VA Medical Center
      • Denver, Colorado, Stati Uniti, 80218
        • Kaiser Permanente of Colorado

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • systolic heart failure (defined as an ejection fraction less than 35%)
  • have been referred for a primary prevention ICD
  • Note: Patients referred for an ICD with cardiac resynchronization therapy are NOT excluded.

Exclusion Criteria:

  • Already have an ICD
  • Non-English speaking (as the tools we have developed are only available in English currently)
  • Other ICD indications (e.g. secondary prevention, hypertrophic obstructive cardiomyopathy)
  • Cognitive Impairment defined only as people with an inability to consent

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: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Usual Care
Patients will receive no additional ICD specific information other than what is offered by the clinic consistent with usual care. The control group will be asked where they went for information in the follow-up interviews.
Sperimentale: ICD Decision Aid Toolkit
In the intervention arm, research assistants will provide the patients with the toolkit of decision aids. At that time, participants will have the option of using all of the decision aids or just some of the decision aids. Participants who do not have access to the internet, will be offered a DVD (digital video disc) version of the video and they will be asked if they would like to arrange a visit where they can review the website with the research assistant.
Comportamentale: ICD Decision Aid Toolkit
Research assistants will provide patients with a toolkit of decision aids. Participants will have the option of using all of the decision aids or just some of the decision aids.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Measure the acceptability and feasibility of the decision aids
Lasso di tempo: pre-ICD discussion - baseline

Acceptability-measure decision aid acceptability using modified version of decision aid acceptability developed by Barry et al.

Feasibility-explore participation rates and adherence to study protocol; weekly team meetings to discuss recruitment strategies Knowledge: 21 item knowledge measure developed in-house Decision Conflict: validated 15-item decision conflict measure developed by O'Connor et al.

Decision Regret: validated 5-item decision regret scale Decision choice: ultimate choice patient made about getting an ICD Decision participation: Prior to intervention, we measure patients' preferred role in decision making using the control preferences scale. After the decision, we measure the participants' actual role in decision making.

Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS). Chart Review Outcome: For those that had not yet had a procedure, we will review the charts at the end of study to determine if they received an ICD or not.
pre-ICD discussion - baseline

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Determine relative value of the four decision aids
Lasso di tempo: 3 months after baseline interview

Determine the relative value of the various tools in the toolkit through in-depth interviews from study participants and providers at each intervention site.

We will ask participants the following questions:

  • Have you made a decision about getting or not getting the ICD?
  • What information did you use to make your decision?
  • How are you feeling about your decision?
  • What else would have been helpful in making your decision?
  • (Intervention only) Did you use any of the decision aids you were given?
  • If yes, please tell us how you used them? Did the decision aids make you feel better or worse about your decision? Did you like one of them better than the others? Is there any aspect that wasn't helpful?
  • If no, please tell us why not? What would have been helpful?
  • Do you have any advice on the best way to deliver these decision aids to future patients?
3 months after baseline interview
Measure the acceptability and feasibility of the decision aids
Lasso di tempo: within 4 weeks of meeting with electrophysiologist

Acceptability-measure decision aid acceptability using modified version of decision aid acceptability developed by Barry et al.

Feasibility-explore participation rates and adherence to study protocol; weekly team meetings to discuss recruitment strategies Knowledge: 21 item knowledge measure developed in-house Decision Conflict: validated 15-item decision conflict measure developed by O'Connor et al.

Decision Regret: validated 5-item decision regret scale Decision choice: ultimate choice patient made about getting an ICD Decision participation: Prior to intervention, we measure patients' preferred role in decision making using the control preferences scale. After the decision, we measure the participants' actual role in decision making.

Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS). Chart Review Outcome: For those that had not yet had a procedure, we will review the charts at the end of study to determine if they received an ICD or not.
within 4 weeks of meeting with electrophysiologist
Measure the acceptability and feasibility of the decision aids
Lasso di tempo: 3 months after baseline interview

Acceptability-measure decision aid acceptability using modified version of decision aid acceptability developed by Barry et al.

Feasibility-explore participation rates and adherence to study protocol; weekly team meetings to discuss recruitment strategies Knowledge: 21 item knowledge measure developed in-house Decision Conflict: validated 15-item decision conflict measure developed by O'Connor et al.

Decision Regret: validated 5-item decision regret scale Decision choice: ultimate choice patient made about getting an ICD Decision participation: Prior to intervention, we measure patients' preferred role in decision making using the control preferences scale. After the decision, we measure the participants' actual role in decision making.

Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS). Chart Review Outcome: For those that had not yet had a procedure, we will review the charts at the end of study to determine if they received an ICD or not.
3 months after baseline interview

Collaboratori e investigatori

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

Sponsor

University of Colorado, Denver

Investigatori

  • Investigatore principale: Daniel D Matlock, MD, MPH, University of Colorado, Denver

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

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 settembre 2014

Completamento primario (Effettivo)

1 agosto 2016

Completamento dello studio (Effettivo)

1 novembre 2016

Date di iscrizione allo studio

Primo inviato

12 dicembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

30 dicembre 2013

Primo Inserito (Stima)

1 gennaio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 ottobre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 ottobre 2019

Ultimo verificato

1 ottobre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 13-3152
  • 121483 (Altro numero di sovvenzione/finanziamento: Patient Centered Outcomes Research Institute (PCORI))

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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