Cancer Clinical Trial - Goals of Care Conversations Study

Status Enrolling by invitation

Clinical Trial Summary

The long term goal is to improve quality of care in Veterans with serious illnesses by aligning medical care with Veterans' goals and values. The objective of this study is to use a sequentially randomized trial to determine what implementation strategies are effective to increase early, outpatient goals of care conversations. The study will use interviews with and surveys of medical providers, patients, and caregivers, along with medical record data. This work is significant because it tests ways Veterans can express their goals and preferences for life sustaining treatments and have them honored.

Clinical Trial Description

The aims of this study are as follows: Aim 1. Use a clinician-level SMART in three VA health systems to determine the effectiveness of clinician and patient implementation strategies to improve the occurrence of documented goals of care conversations in Veterans with serious medical illness. Hypothesis 1 (first stage of the SMART): Compared to a low intensity clinician strategy alone, a low intensity clinician and patient strategy will lead to increased documentation of goals of care conversations. Hypothesis 2. Among those who do not respond to low intensity strategies, compared to a high intensity clinician strategy paired with a low intensity patient strategy, a high intensity clinician and patient strategy will lead to increased documentation of goals of care conversations. Aim 2a. Identify the sequence of implementation strategies that leads to the overall greatest increase in documentation of goals of care conversations. Aim 2b (exploratory). Identify patient and clinician characteristics that modify the effect of sequences of implementation strategies on documentation of goals of care conversations. Aim 3. Understand clinician and patient implementation strategy success or failure using a mixed method evaluation involving clinicians, leaders, patients, and caregivers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05001009
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	September 13, 2022
Completion date	September 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05346796` - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial	N/A
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Completed	`NCT04867850` - Effect of Behavioral Nudges on Serious Illness Conversation Documentation	N/A
Enrolling by invitation	`NCT04086251` - Remote Electronic Patient Monitoring in Oncology Patients	N/A
Completed	`NCT01285037` - A Study of LY2801653 in Advanced Cancer	Phase 1
Completed	`NCT00680992` - Study of Denosumab in Subjects With Giant Cell Tumor of Bone	Phase 2
Completed	`NCT00062842` - Study of Irinotecan on a Weekly Schedule in Children	Phase 1
Active, not recruiting	`NCT04548063` - Consent Forms in Cancer Research: Examining the Effect of Length on Readability	N/A
Completed	`NCT04337203` - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship	N/A
Recruiting	`NCT04349293` - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways	N/A
Terminated	`NCT02866851` - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy	N/A
Active, not recruiting	`NCT05304988` - Development and Validation of the EFT for Adolescents With Cancer
Completed	`NCT00340522` - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting	`NCT04843891` - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.	Phase 1
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Completed	`NCT03167372` - Pilot Comparison of N-of-1 Trials of Light Therapy	N/A
Completed	`NCT03109041` - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source	Phase 1
Terminated	`NCT01441115` - ECI301 and Radiation for Advanced or Metastatic Cancer	Phase 1
Recruiting	`NCT06206785` - Resting Energy Expenditure in Palliative Cancer Patients
Recruiting	`NCT05318196` - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Goals of Care Conversations Study — LSTDI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms