Evaluation of Methods for Implementation of a Comfort Care Order Set

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The overarching goal of this research program is to improve the quality of end-of-life care provided to Veterans dying in VA Medical Centers (VAMCs), by transferring the best practices of home hospice and palliative care for the last days and hours of life into the inpatient setting. This trial will examine two methods of delivering a Comfort Care Education Intervention utilizing the established infrastructure of VA Palliative Care Consult Teams (PCCT): a Basic Implementation Approach using a teleconference to review educational materials and activate PCCTs to educate other providers, and an Enhanced Implementation Approach utilizing in-person, train-the-"champion" workshops to prepare PCCT members to be leaders and trainers at their home sites. Findings will provide a robust evaluation of the implementation process, and will be used to refine the Comfort Care Education Intervention and implementation strategies in preparation for nationwide dissemination of best practices for end-of-life care within the VA Healthcare System.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Improve Care for Veterans During Serious Illness

NCT00106041

Palliative Care

COMPLETED NA

Enabling Advance Directive Completion

NCT01746368

Advance Directives

COMPLETED NA

The Effectiveness of the Care Programme for the Last Days of Life

NCT01890239

Older Patients Dying in Acute Geriatric Hospital Wards

COMPLETED NA

An Intervention to Improve End of Life Decision Making Among Homeless Persons

NCT00471016

End of Life Decision Making Advance Care Planning

COMPLETED NA

Palliative and End-of-life Care in Advanced Dementia: Evaluation of a Program of Organization of Care in Long-term Care

NCT01441726

Dementia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Anticipated Impacts on Veterans' Healthcare: The overarching goal of this research program is to improve the quality of end-of-life care provided to Veterans dying in VA Medical Centers (VAMCs), by transferring the best practices of home hospice and palliative care for the last days and hours of life into the inpatient setting.

Project Background: Often, patients who are near the end of life are not recognized as actively dying. As a result, their suffering may not be appreciated or managed properly, and may even be exacerbated by usual medical care when aggressive, futile, or iatrogenically harmful treatments are continued. During this time, supportive and comfort care treatment plans can be implemented to reduce suffering and improve the quality of care provided to these patients. The investigative team has developed and evaluated an education-based intervention to teach providers how to identify patients who are actively dying and to implement care plans appropriate for the last days or hours of life. To facilitate use of these interventions, an electronic Comfort Care Order Set (CCOS) was designed and integrated into the Computerized Patient Record System (CPRS) to support and guide the selection of comfort care treatments. The effectiveness of the Comfort Care Education Intervention has been demonstrated in 7 VAMCs and it is ready for implementation on a broader scale.

Project Objectives: This trial will extend this line of research by examining two methods of delivering this Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams (PCCT): a Basic Implementation Approach using a teleconference to review educational materials and activate PCCTs to educate other providers, and an Enhanced Implementation Approach utilizing in-person, train-the-"champion" workshops to prepare PCCT members to be leaders and trainers at their home sites. The aims of this study are 1) to compare the effectiveness of the two approaches for changing provider behavior, as reflected in documented processes of end-of-life care, 2) to formatively evaluate PCCT members' experiences with and perceptions of the two approaches, and 3) to quantitatively evaluate PCCT members' perceptions of the training received and its impact on attitudes, skills, and perceived efficacy to care for patients and teach other providers.

Project Methods: PCCTs at 47 VA Medical Centers will be recruited to participate in the trial and randomized to receive the Comfort Care Education Intervention using the Basic or the Enhanced Implementation Approach. Data on processes of end-of-life care will be abstracted from the CPRS medical records of Veterans who die before and after the interventions, including presence of an active opioid order at time of death (primary endpoint), other medication orders and administration, do-not-resuscitate orders, palliative care consult orders, location of death, presence of nasogastric tubes/intravenous lines, restraints, and pastoral care. Semi-structured telephone interviews will be conducted with all participating PCCT members to explore their perceptions of training, the process of teaching other providers at each site, barriers and facilitators they encountered, how prepared they felt to overcome these barriers, and specific needs and preferences regarding the implementation approach.

Findings will provide a robust evaluation of the implementation process, and will be used to refine the Comfort Care Education Intervention and implementation strategies in preparation for nationwide dissemination of best practices for end-of-life care within the VA Healthcare System.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Terminal Conditions, End of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Basic Implementation Approach

Basic approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams

Group Type ACTIVE_COMPARATOR

Basic Implementation Approach

Intervention Type OTHER

Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using a Basic Implementation Approach with a teleconference to review educational materials and activate PCCTs to educate other providers.

Enhanced Implementation Approach

Enhanced approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams

Group Type EXPERIMENTAL

Enhanced Implementation Approach

Intervention Type OTHER

Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using an Enhanced Implementation Approach with in-person, train-the-"champion" workshops to prepare PCCT members to be leaders and trainers at their home sites

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Basic Implementation Approach

Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using a Basic Implementation Approach with a teleconference to review educational materials and activate PCCTs to educate other providers.

Intervention Type OTHER

Enhanced Implementation Approach

Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using an Enhanced Implementation Approach with in-person, train-the-"champion" workshops to prepare PCCT members to be leaders and trainers at their home sites

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

To be eligible, each provider had to be a member of a VA palliative care consult team (PCCT)

Exclusion Criteria

VAMCs were excluded if the facility scored in the top 10th percentile or lowest 10th percentile on PROMISE after-death survey; if they had no prescribing provider on the PCCT team; or if there were fewer than 30 deaths in VAMC during the reporting period

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes