A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
- Measure the acceptability of the decision aids
- Explore feasibility by measuring patient participation rates and adherence to the study protocol across all three sites.
- 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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Colorado
-
Aurora, Colorado, Förenta staterna, 80045
- University of Colorado Hospital (UCH)
-
Denver, Colorado, Förenta staterna, 80220
- Denver VA Medical Center
-
Denver, Colorado, Förenta staterna, 80218
- Kaiser Permanente of Colorado
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: 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.
|
|
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measure the acceptability and feasibility of the decision aids
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Determine relative value of the four decision aids
Tidsram: 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:
|
3 months after baseline interview
|
|
Measure the acceptability and feasibility of the decision aids
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Daniel D Matlock, MD, MPH, University of Colorado, Denver
Publikationer och användbara länkar
Allmänna publikationer
- Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
- Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399. Erratum In: N Engl J Med. 2005 May 19;352(20):2146.
- Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423.
- O'Connor AM, Wennberg JE, Legare F, Llewellyn-Thomas HA, Moulton BW, Sepucha KR, Sodano AG, King JS. Toward the 'tipping point': decision aids and informed patient choice. Health Aff (Millwood). 2007 May-Jun;26(3):716-25. doi: 10.1377/hlthaff.26.3.716.
- Kadish A, Dyer A, Daubert JP, Quigg R, Estes NA, Anderson KP, Calkins H, Hoch D, Goldberger J, Shalaby A, Sanders WE, Schaechter A, Levine JH; Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004 May 20;350(21):2151-8. doi: 10.1056/NEJMoa033088.
- O'Connor AM, Bennett CL, Stacey D, Barry M, Col NF, Eden KB, Entwistle VA, Fiset V, Holmes-Rovner M, Khangura S, Llewellyn-Thomas H, Rovner D. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD001431. doi: 10.1002/14651858.CD001431.pub2.
- Volandes AE, Paasche-Orlow MK, Barry MJ, Gillick MR, Minaker KL, Chang Y, Cook EF, Abbo ED, El-Jawahri A, Mitchell SL. Video decision support tool for advance care planning in dementia: randomised controlled trial. BMJ. 2009 May 28;338:b2159. doi: 10.1136/bmj.b2159.
- Col NF, Ngo L, Fortin JM, Goldberg RJ, O'Connor AM. Can computerized decision support help patients make complex treatment decisions? A randomized controlled trial of an individualized menopause decision aid. Med Decis Making. 2007 Sep-Oct;27(5):585-98. doi: 10.1177/0272989X07306781. Epub 2007 Sep 14.
- Jibaja-Weiss ML, Volk RJ, Granchi TS, Neff NE, Robinson EK, Spann SJ, Aoki N, Friedman LC, Beck JR. Entertainment education for breast cancer surgery decisions: a randomized trial among patients with low health literacy. Patient Educ Couns. 2011 Jul;84(1):41-8. doi: 10.1016/j.pec.2010.06.009. Epub 2010 Jul 7.
- Stevenson LW, Desai AS. Selecting patients for discussion of the ICD as primary prevention for sudden death in heart failure. J Card Fail. 2006 Aug;12(6):407-12. doi: 10.1016/j.cardfail.2006.06.001.
- Goldenberg I, Moss AJ, Hall WJ, McNitt S, Zareba W, Andrews ML, Cannom DS; Multicenter Automatic Defibrillator Implantation Trial (MADIT) II Investigators. Causes and consequences of heart failure after prophylactic implantation of a defibrillator in the multicenter automatic defibrillator implantation trial II. Circulation. 2006 Jun 20;113(24):2810-7. doi: 10.1161/CIRCULATIONAHA.105.577262. Epub 2006 Jun 12.
- Noyes K, Corona E, Zwanziger J, Hall WJ, Zhao H, Wang H, Moss AJ, Dick AW; Multicenter Automatic Defibrillator Implantation Trial II. Health-related quality of life consequences of implantable cardioverter defibrillators: results from MADIT II. Med Care. 2007 May;45(5):377-85. doi: 10.1097/01.mlr.0000257142.12600.c1.
- Mark DB, Anstrom KJ, Sun JL, Clapp-Channing NE, Tsiatis AA, Davidson-Ray L, Lee KL, Bardy GH; Sudden Cardiac Death in Heart Failure Trial Investigators. Quality of life with defibrillator therapy or amiodarone in heart failure. N Engl J Med. 2008 Sep 4;359(10):999-1008. doi: 10.1056/NEJMoa0706719.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 13-3152
- 121483 (Annat bidrag/finansieringsnummer: Patient Centered Outcomes Research Institute (PCORI))
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .