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Terminal Conditions, End of LifeBEACON IINCT02383173

Evaluation of Methods for Implementation of a Comfort Care Order Set

A study testing Basic Implementation Approach and Enhanced Implementation Approach in people with Terminal Conditions, End of Life, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Terminal Conditions, End of Life
What is being tested?
Basic Implementation Approach and Enhanced Implementation Approach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteUnited States
Study dates
1 Mar 2015to 31 Jan 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Birmingham VA Medical Center, Birmingham, AL

    Birmingham, Alabama, 35233-1927

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Basic Implementation Approach, Enhanced Implementation Approach
Keywords
end of life, palliative care, implementation
Medical subject headings
Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Basic Implementation ApproachOther

    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 ApproachOther

    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

Study groups in NCT02383173
Study groupRoleWhat they receive
Basic Implementation ApproachActive comparatorBasic approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams
Receives: Other: Basic Implementation Approach
Enhanced Implementation ApproachExperimentalEnhanced approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams
Receives: Other: Enhanced Implementation Approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of an Active Opioid Order at Time of Death

    presence of an active opioid order at time of death in Veteran's medical record

    Measured: at time of death for veterans who died in the 9 months following the intervention period

Secondary outcomes (8)
  1. Presence of an Order for Benzodiazepine Medication

    presence of an order for benzodiazepine medication in the last 7 days of life

    Measured: last 7 days of life for veterans who died in the 9 months following the intervention period

  2. Presence of a Do-not-resuscitate Order

    presence of a do-not-resuscitate order in the last 7 days of life

    Measured: last 7 days of life for veterans who died in the 9 months following the intervention period

  3. Presence of a Palliative Care Consult Order

    presence of a palliative care consult order in the last 7 days of life

    Measured: last 7 days of life for veterans who died in the 9 months following the intervention period

  4. Location of Death

    death in intensive care unit

    Measured: in the 9 months following the intervention period

  5. Presence of a Nasogastric Tube

    presence of a nasogastric tube at time of death

    Measured: in the 9 months following the intervention period

  6. Presence of an Intravenous Line

    presence of an intravenous line at time of death

    Measured: in the 9 months following the intervention period

  7. Presence of Restraints

    presence of restraints at time of death

    Measured: in the 9 months following the intervention period

  8. Presence of a Pastoral Care Visit

    presence of a pastoral care visit in the last 7 days of life

    Measured: last 7 days of life for veterans who died in the 9 months following the intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2015 (estimated)
  2. Study start1 Mar 2015
  3. Primary completion30 Apr 2019
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02383173
Sponsor's protocol ID
IIR 12-071
Acronym
BEACON II
Status last verified
Jul 2023
First submitted
23 Dec 2014
Last updated
27 Jul 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bailey FA, Williams BR, Goode PS, Kennedy RE, Redden DT, Kvale E, Bakitas M, Dionne-Odom JN, Burgio KL. Comparison of Two Methods for Implementing Comfort Care Order Sets in the Inpatient Setting: a Cluster Randomized Trial. J Gen Intern Med. 2021 Jul;36(7):1928-1936. doi: 10.1007/s11606-020-06482-x. Epub 2021 Feb 5.

    PubMed 33547573

Questions about this trial

What is this clinical trial studying?

A study testing Basic Implementation Approach and Enhanced Implementation Approach in people with Terminal Conditions, End of Life, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of an Active Opioid Order at Time of Death (time frame: at time of death for veterans who died in the 9 months following the intervention period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02383173, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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