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Completed

NCT Number: NCT05095363

Palliative Care Planner (PCplanner)

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.

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Key information

Conditions

Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCplanner

Behavioral

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.

Primary outcomes

  1. Feasibility of intervention

    Time frame: Up to 16 weeks

    Number of participants who stated intervention was easy to use as measured by patient survey.

  2. 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.

  3. Completion of intervention

    Time frame: Up to 16 weeks

    Number of participants who completed all three surveys and intervention telephone visits.

  4. 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.

  5. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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)

  9. 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)

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Other outcomes

  1. Number of hospitalizations during study

    Time frame: Up to 16 weeks

    Admission to a hospital abstracted from electronic health record

  2. 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

  3. Referral to hospice during study

    Time frame: Up to 16 weeks

    Referral to inpatient or home hospice during study abstracted from electronic health record

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

The Palliative Care Planner (PCplanner) for Outpatients Pilot Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2021
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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