Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to compare the decision making of subjects with advanced CHF having a verbal discussion about goals of care compared to subjects using a video.


Clinical Trial Description

Aim #1: To compare the impact of the intervention on the distribution of end-of-life knowledge, decisional conflict, and preferences among 248 subjects with advanced heart failure randomly assigned to one of two ACP modalities: 1. a video visually depicting the goals of care along with a patient checklist (intervention, 124 subjects), or 2. usual care, i.e., verbal narrative (control, 124 subjects). Hypothesis #1: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to: 1a. Have more knowledge about their choices 1b. Have less decisional conflict about their decisions 1c. Opt for comfort care and less likely to choose life-prolonging measures Aim #2: To compare stability of preferences over time (1, 3, and 6 months), concordance rate of preferences (preferences expressed vs. preferences documented in the medical record - both inpatient and outpatient records), and advance care planning discussions (as reported by the patient), among 248 subjects randomized to the video (N=124) vs. verbal narrative (N=124). Hypothesis #2: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to: 1a. Have more stable preferences over time 1b. Higher concordance rates 1c. Have had an advance care planning discussion Aim #3: To compare quality of life, anxiety and depression, referral to hospice, place of death, after death bereavement (caregiver), and resource utilization after 6 months and 1 year (or death) among 248 subjects randomized to the video (N=124) vs. verbal narrative (N=124). Hypothesis #3: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to: 1a. Have a better quality of life (FACIT-Pal, FACIT-Sp-12) 1b. Have earlier referral to hospice in subjects who die 1d. Die at home or hospice (or inpatient hospice setting) in subjects who die 1e. Have better caregiver bereavement score (for caregiver subjects who die). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01589120
Study type Interventional
Source Massachusetts General Hospital
Contact Angelo Volandes, MD
Phone 617 643 4266
Email avolandes@partners.org
Status Recruiting
Phase N/A
Start date April 2012

See also
  Status Clinical Trial Phase
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT03463148 - Validation of a Sensor for Non-Invasive Measurements
Completed NCT03339310 - Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System N/A
Completed NCT00288587 - Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF) Phase 4
Recruiting NCT05423652 - Aiding COPD and CHF Ultrasound-guided Management Through ENhanced Point Of Care UltraSound N/A
Recruiting NCT05865197 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF
Recruiting NCT02020811 - Safety and Efficacy of Immages System in Patients Recieving IV Therapy N/A
Withdrawn NCT01809730 - Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients N/A
Completed NCT01316432 - PK/PD Study of Subcutaneous Cenderitide Infusion in CHF Patients Phase 1
Completed NCT02632552 - A Technology Assisted Care Transition Intervention for Veterans With CHF or COPD N/A
Completed NCT03207802 - Remotely Monitoring Patients With Chronic Conditions in Their Home
Terminated NCT04154579 - Arts & Health Education to Improve Health, Resilience, and Well-Being N/A
Terminated NCT03102437 - Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System N/A
Completed NCT03808948 - FAST PV and mGFR™ Technology in Congestive Heart Failure N/A
Recruiting NCT04591964 - Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application Early Phase 1
Completed NCT05843201 - AquaPass Device in Treatment of CHF Patients N/A
Active, not recruiting NCT04090671 - Evaluation of the Multidimensional Dyspnea Profile (MDP) N/A
Completed NCT03905252 - Biomarkers for Human Heart Failure
Completed NCT04261452 - Heart Failure Worsens Muscle Strength in COPD N/A