Advancing Symptom Alleviation With Palliative Treatment

NCT02713347 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2024-08-09

Study results available
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Summary

Chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), and interstitial lung disease (i.e., pulmonary fibrosis) are common serious illnesses. Despite disease-specific medical care, people with these illnesses often left with poor quality of life (i.e., burdensome symptoms, impaired function). Furthermore, while these illnesses are leading causes of hospitalization and mortality, few people with these illnesses engage in advance care planning, the process of considering and communicating healthcare values and goals. The investigators are conducting a randomized clinical trial to study a symptom management, psychosocial care and advance care planning intervention to improve quality of life. The study is important because it aims to improve quality of life and provision of care according to peoples' goals and preferences in common, burdensome illnesses. Furthermore, this study will generate information that supports the broader dissemination and implementation of the intervention and informs the development of future palliative care and team-based interventions in the VA.

Conditions

  • Heart Failure
  • Pulmonary Disease, Chronic Obstructive
  • Emphysema
  • Pulmonary Fibrosis, Interstitial Lung Disease

Interventions

BEHAVIORAL

ADAPT Intervention

The intervention includes 3 components: 1. nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, and pain. 2. social worker provides structured counseling targeting adjustment to illness and depression and advance care planning. 3. collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker. The team has as-needed consultation with a cardiologist or pulmonologist. The nurse and social worker visits are in-person or by phone.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • David Bekelman, MD MPH · Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02713347 on ClinicalTrials.gov