Palliative Care Planner (PCplanner)

May 11, 2023 updated by: Duke University

The Palliative Care Planner (PCplanner) for Outpatients Pilot Trial

The purpose of this research study is to determine the feasibility, acceptability, and evidence for clinical impact of a mobile app-based program called Palliative Care Planner (PCplanner) in addressing needs and promoting advance care planning discussions among patients with idiopathic pulmonary fibrosis and their clinicians.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Interstitial lung disease (ILD) affects roughly 6.3 to 76 per 100,000 people of predominantly older adult patients worldwide and is associated with high morbidity and mortality. Patients with such idiopathic pulmonary fibrosis suffer symptom burdens similar to patients with cancer and commonly experience long, costly hospitalizations that often include care in an intensive care unit (ICU). Despite the presence of numerous unmet needs, ILD patients uncommonly receive palliative care because of lack of symptom recognition, supports to provide advanced care planning (ACP) and symptom control, and processes to promote collaboration between primary teams and palliative care specialists to deliver the appropriate level of care. To address this important clinical gap, we propose adapting our existing needs-targeted PCplanner (Palliative Care planner) mobile app platform to the outpatient setting. PCplanner Outpatient will allow patients to report their needs, provide video content to stimulate knowledge of and discussion about more advanced care planning, and assist primary physicians in recognizing the optimal timing of specialist palliative care referral.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient has diagnosis of idiopathic pulmonary fibrosis
  • Patient has GAP (gender, age, physiology) index score ≥ 4
  • Patient is established in interstitial lung disease clinic (i.e., has had at least 1 previous clinic visit)

Exclusion Criteria:

  • Patient lacks fluency in English sufficient to complete study surveys
  • Patient is already seeing palliative care or enrolled in hospice
  • NEST score <10 at baseline T1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PCplanner mobile app platform
Participants who are randomized to the intervention arm will complete surveys at 3 timepoints and will be given resources on advance care planning via PCplanner, the mobile app platform. They will receive a telephone call by the study team about a week after enrollment to answer any questions about the resources provided. If needs and questions are not resolved quickly after the clinic visit, then another layer of patient support with a telephone call by a palliative care specialist will be provided to the participant to help develop potential management plans.
Behavioral: PCplanner
A mobile app platform that will display participant survey results to clinicians to facilitate communication on specific needs as well as provide resources on advance care planning to participants.
No Intervention: Usual Care
Participants who are randomized to the usual care arm will complete surveys at 3 timepoints and receive usual care by pulmonary clinician.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of intervention
Time Frame: Up to 16 weeks
Number of participants who stated intervention was easy to use as measured by patient survey.
Up to 16 weeks
Acceptability of intervention
Time Frame: Up to 16 weeks
Number of participants who stated they were satisfied with the intervention as measured by patient survey.
Up to 16 weeks
Completion of intervention
Time Frame: Up to 16 weeks
Number of participants who completed all three surveys and intervention telephone visits.
Up to 16 weeks
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
Time Frame: Baseline to week 8
Scale ranges from 0 to 130 with lower score indicates less unmet needs and higher score indicates more unmet needs on issues such as communication, symptoms, social support, and financial stress.
Baseline to week 8
Documentation of advance care planning in electronic health record
Time Frame: Up to 16 weeks
Includes all or any of the following: code status, healthcare power of attorney, advance directive
Up to 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
Time Frame: Baseline to week 16
Scale ranges from 0 to 130 with lower score indicates less unmet needs and higher score indicates more unmet needs on issues such as communication, symptoms, social support, and financial stress.
Baseline to week 16
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time Frame: Baseline to week 8
Score ranges from 0 to 27 with lower score indicates no or mild depression and higher score indicates more severe depression.
Baseline to week 8
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time Frame: Baseline to week 16
Score ranges from 0 to 27 with lower score indicates no or mild depression and higher score indicates more severe depression.
Baseline to week 16
Change in General Anxiety Disorder-7 (GAD-7) score
Time Frame: Baseline to week 8
Score ranges from 0 to 21 with lower score indicates no or mild anxiety and higher score indicates more severe generalized anxiety.
Baseline to week 8
Change in General Anxiety Disorder-7 (GAD-7) score
Time Frame: Baseline to week 16
Score ranges from 0 to 21 with lower score indicates no or mild anxiety and higher score indicates more severe generalized anxiety.
Baseline to week 16
Change in Patient Health Questionnaire-10 (PHQ-10) score
Time Frame: Baseline to week 8
Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Baseline to week 8
Change in Patient Health Questionnaire-10 (PHQ-10) score
Time Frame: Baseline to week 16
Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Baseline to week 16
Change in EuroQol - 5 Dimension (EQ-5D) score
Time Frame: Baseline to week 8
Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)
Baseline to week 8
Change in EuroQol - 5 Dimension (EQ-5D) score
Time Frame: Baseline to week 16
Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)
Baseline to week 16
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Time Frame: Baseline to week 8
Scores range from 0 to 100 with lower score indicates worse imaginable quality of life and higher score indicates better imaginable quality of life.
Baseline to week 8
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Time Frame: Baseline to week 16
Scores range from 0 to 100 with lower score indicates worse imaginable quality of life and higher score indicates better imaginable quality of life.
Baseline to week 16
Change in Therapeutic Alliance score
Time Frame: Baseline to week 8
Score ranges from 16 to 64 with lower score indicates lower perceived alliance between patient and their provider and higher score indicates better therapeutic alliance.
Baseline to week 8
Change in Therapeutic Alliance score
Time Frame: Baseline to week 16
Score ranges from 16 to 64 with lower score indicates lower perceived alliance between patient and their provider and higher score indicates better therapeutic alliance.
Baseline to week 16

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of hospitalizations during study
Time Frame: Up to 16 weeks
Admission to a hospital abstracted from electronic health record
Up to 16 weeks
Referral to palliative care specialist during study
Time Frame: Up to 16 weeks
Referral to palliative care specialist during study abstracted from electronic health record
Up to 16 weeks
Referral to hospice during study
Time Frame: Up to 16 weeks
Referral to inpatient or home hospice during study abstracted from electronic health record
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Cox, MD, Duke Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00108264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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