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Kidney DiseasesHIGHwayNCT05324878

Honoring Individual Goals and Hopes: Implementing Advance Care Planning for Persons With Kidney Disease on Dialysis

An observational study of Kidney Diseases and Kidney Failure, run by George Washington University at 3 sites 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 PCORI HIGHway project name embodies its goal: the way to "Honor Individuals Goals and Hopes". HIGHway trains and supports dialysis center social workers and nurses to communicate with their patients about their hopes and goals for their future care plans. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Kidney Diseases, Kidney Failure
What is being tested?
Training
How many people
55 participants
Where
3 sitesUnited States
Study dates
1 Sep 2021to 31 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: There are three separate study populations for this study, with procedures and instruments specific to the population Population 1: Social workers/nurses and dialysis centers will be selected based on demographic data of the center (urbanicity, population served, size of center, patients treated, etc) to provide for diversity of centers participating. Population 2: Patients receiving care at the dialysis center where participating social worker/nurses works. 2a. When an advance care planning conversation takes place, social worker/nurse will provide patient with an informational flyer about the HIGHway project and a postcard. 2b. Social worker/nurse will identify one patient willing to have a recording made of advance care planning conversation between social worker/nurse and patient.

Who may be able to join

  • Social worker or nurse must work at a participating dialysis center.
  • Social worker, nurse and patients must speak, read and write English.
  • All participants must be 18 y old.
  • Social workers and nurses Commitment to attend initial 6-h training and booster sessions.

Who cannot join

  • Under 18 years old
  • Unable to speak, read and write English

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • American Renal Associates LLC Corporate Office

    Beverly, Massachusetts, 01915

  • DaVita World Headquarters

    Denver, Colorado, 80202

  • Fresenius Medical Care Corporate Headquarters

    Waltham, Massachusetts, 02451

Other trials in United States

About this study

Official title: HIGHway Project: Honoring Individual Goals and Hopes: Implementing Advance Care Planning for Persons With Kidney Disease on Dialysis

The PCORI HIGHway project name embodies its goal: the way to "Honor Individuals Goals and Hopes". HIGHway trains and supports dialysis center social workers and nurses to communicate with their patients about their hopes and goals for their future care plans. This process, known as advance care planning (ACP), helps relieve patient concerns about the future, lays the foundation for better goal-concordant care at the end of life, and fosters deeper connection between patient and the dialysis care team. The HIGHway project will provide training and ongoing coaching to social workers and other change team members at 50-60 dialysis centers throughout the US. The goal is to integrate advance care planning conversations between dialysis patients and their health care team into the ongoing workflow of dialysis centers. The project is funded by the Patient Centered Outcomes Research Institute (PCORI), a non-profit organization chartered by Congress to fund projects to promote patient-centered care.

Read the detailed description

OBJECTIVES Primary Objective: The HIGHWay project trains dialysis center teams to conduct ACP conversations with patients with kidney failure. Emphasis is on training and supporting the dialysis center social worker to be the team leader for ACP, in collaboration with the nephrologist and other clinicians.

Aims:

  1. Implement the HIGHway intervention with a project team consisting of a social worker, nephrologist and nurse at 50 clinics, and train them to conduct ACP using best practices.
  2. Assist social workers/nurses to implement ACP into their regular workflow with personal coaching, webinars and multimedia teaching materials.
  3. Use a dedicated web-based application software to guide social workers/nurses on the ACP process of patients in dialysis centers and provide resources for holding ACP conversations.
  4. Provide ongoing coaching through monthly teleconferences to bolster social worker/nurse skills through case discussion and mentoring.
  5. Develop a long-term implementation and scale-up plan for training social workers/nurses in ACP in different dialysis centers in conjunction with the Coalition for Supportive Care of Kidney Patients, Forum of ESRD Networks, the National Council of Nephrology Social Workers, the National Renal Administrators Association, and dialysis organizations.

RELEVANT BACKGROUND Patient-centered care problem addressed: Patients on dialysis want to discuss their preferences for treatment at the end of life, but few do so, and most nephrologists are reluctant or feel unprepared to lead such discussions. Effective tools are critically needed to elicit such preferences since over 50,000 Americans die of kidney disease annually, more than from breast or prostate cancer. For dialysis patients with significant co-morbidities, risk of death within a year of starting dialysis is stark. Of those who had 4 or more comorbidities, 26% died within 30 days of dialysis initiation, and 60% died within a year. These patients have higher - and often unwanted - intensity of care at end of life; in a four-year study of the United States Renal Data System, 49% of elderly long-term hemodialysis (HD) patients spent time in an intensive care unit in their final month of life, compared with 24% of cancer patients. Meaningful end-of-life conversations can change these outcomes and are associated with increased hospice referral, less aggressive and expensive medical treatment, and higher levels of family satisfaction. Yet less than 10% of end-stage renal disease (ESRD) patients report having a conversation about any end-of-life issues with their nephrologist in the previous year, although 90% said such conversations were important. Few patients with ESRD engage in ACP, and the vast majority lack a written advance directive or surrogate decision maker, leaving them unprepared to provide guidance in medical decisions in a crisis.

A prior study funded by PCORI developed and tested an intervention to enable more advance care planning to take place in dialysis centers. The Shared Decision Making - Renal Supportive Care (SDM-RSC) study tested a multi-modal patient-centered intervention to improve advance care planning for dialysis patients. Through qualitative interviews with advisory boards comprised of patients and stakeholders, SDM-RSC investigators designed an intervention that focused on goals of care conversations between patients and family members with the nephrologist and social worker. The SDM-RSC intervention targeted deficiencies in communication, estimating prognosis, and transition planning for seriously ill dialysis patients. The intervention showed capacity to increase substantially completion of advance directives and medical orders (Medical Orders for Life-Sustaining Treatment [MOLST]/Physician Orders for Life-Sustaining Treatment [POLST]) associated with improved patient-level end-of-life (EOL) outcomes. Among study participants, the advance directive completion rate and understanding of advance directives were substantially higher than in usual care; 75% of participants named and documented a healthcare proxy and 63% had medical orders (MOLST or POLST) (in comparison to 49% with advance directives and 3% with medical orders in usual care). The average duration time for an ACP conversation was about 45 minutes. Overall clinic-level hospice usage using retrospective data did not vary significantly between the pre- and post-intervention 6-month periods with an observed average rate of 25% which is close to the 2015 national average of 26% among all ESRD Medicare decedents. However, among deceased study participants who engaged in a Shared Decision Making and Renal Supportive Care (SDMRSC) meeting, 48% voluntarily withdrew from dialysis prior to death and 39% received hospice services (compared to the overall rate in these dialysis centers of 24.8%).

There were high levels of family satisfaction (FAMCARE results) and no adverse intervention effects on patients or surrogates on measures of depression and health-related quality of life. The stakeholder advisory council and the respondents on post-intervention interviews recommended the following: a) streamlining and focusing the social worker training; b) offering the advance care planning conversation to all dialysis patients, not just those who were seriously ill, c) broadening the population to include home dialysis patients; and d) offering a telehealth option for conducting the discussions.

The current study builds on the SDM-RSC results to implement the revised intervention in a broader population with a larger number of participating dialysis centers.

Being tested
Training
Keywords
advance care planning, social workers, implementation research, patient-centered care, shared decision-making, nurses
Medical subject headings
Kidney Diseases, Renal Insufficiency

What participants receive

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

  • TrainingOther

    Social workers/nurses participants are agreeing to participating in the training program (3 sessions of 2 hours over a period of six weeks - one session every 2 weeks), follow up training sessions (occurring monthly), mentorship calls with social worker faculty on the project team, recording one conversation between social worker and a patient for quality improvement purposes, and completing evaluation of the project interventions (5-minute questionnaire after each education session, 15-minute questionnaire at end of participation in project).

Study groups in NCT05324878
Study groupRoleWhat they receive
Population 1: Social workers/NursesSocial workers and nurses working at participating dialysis centers. Dialysis centers will be selected based on demographic data of the center (urbanicity, population served, size of center, patients treated, etc) to provide for diversity of centers participating.
Receives: Other: Training
Population 2a: Patients receiving care at the dialysis center2a. When an advance care planning conversation takes place, social worker/nurse will provide patient with an informational flyer about the HIGHway project and a postcard.
Population 2b: Patients receiving care at the dialysis center2b. Social worker/nurse will identify one patient willing to have a recording made of advance care planning conversation between social worker/nurse and patient.

What is being measured

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

  1. Advance care conversations attempted, held, documented

    Patient/Provider Outcome: Self-report of number of conversations social worker has with dialysis patients Self -report of number of conversations social worker has with dialysis patients.

    Measured: During the implementation of the project, one report, year 1

  2. Fidelity of ACP conversations per the HIGHway process taught in trainings

    Each social worker will record one ACP conversation with a patient and be assessed on their fidelity to the ACP conversation checklist

    Measured: Through implementation completion, one in year 1

  3. Relevance and Significance of ACP intervention for patients

    Survey given to patients after an ACP conversation to assess relevance and significance of the conversation to their care

    Measured: Through implementation completion, one in year 1

Secondary outcomes (4)
  1. Implementation Outcome: Appropriateness

    The perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer; to address an issue

    Measured: After finish implementation, one time, year 1

  2. Implementation Outcome: Acceptability

    Perception that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory.

    Measured: Immediately after finish implementation, one in year 1

  3. Characteristics of HIGHway Approach

    Perceived usefulness of each element of HIGHway

    Measured: Immediately after finish implementation, one in year 1

  4. Feasibility of HIGHway

    The extent to which HIGHway was successfully used or carried out

    Measured: Immediately after finish implementation, one in year 1

Timeline

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

  1. First posted12 Apr 2022
  2. Study start1 Sep 2021
  3. Primary completion31 May 2024
  4. Study completion31 Jul 2024

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05324878
Sponsor's protocol ID
NCR213481
Other IDs
DI-2020C2-20362
Acronym
HIGHway
Status last verified
Nov 2024
First submitted
11 Mar 2022
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rodriguez de Sosa GM, Thamer M, Anderson E, Unruh ML, Lupu DE. Patient-Centered Advance Care Planning in Dialysis: The HIGHWay (Honor Individual Goals and Hopes Way) Initiative. Kidney360. 2025 Apr 25;6(6):957-967. doi: 10.34067/KID.0000000767.

    PubMed 40279178
  • Rodriguez de Sosa G, Nicklas A, Thamer M, Anderson E, Reddy N, Stevelos J, Germain MJ, Unruh ML, Lupu DE. Implementing Advance Care Planning for dialysis patients: HIGHway project. BMC Palliat Care. 2022 Jul 16;21(1):129. doi: 10.1186/s12904-022-01011-5.

    PubMed 35841019

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Diseases and Kidney Failure, run by George Washington University at 3 sites 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 4 inclusion and 2 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Advance care conversations attempted, held, documented (time frame: During the implementation of the project, one report, year 1). The study lists 3 primary outcomes in all. 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 NCT05324878, which also lists 2 linked publications.

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 20 Nov 2024.

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