An interventional study of PCplanner in Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-12.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
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.
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 43 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants who are randomized to the usual care arm will complete surveys at 3 timepoints and receive usual care by pulmonary clinician.
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.
Feasibility of intervention
Number of participants who stated intervention was easy to use as measured by patient survey.
Time frame: Up to 16 weeks
Acceptability of intervention
Number of participants who stated they were satisfied with the intervention as measured by patient survey.
Time frame: Up to 16 weeks
Completion of intervention
Number of participants who completed all three surveys and intervention telephone visits.
Time frame: Up to 16 weeks
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
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.
Time frame: Baseline to week 8
Documentation of advance care planning in electronic health record
Includes all or any of the following: code status, healthcare power of attorney, advance directive
Time frame: Up to 16 weeks
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
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.
Time frame: Baseline to week 16
Change in Patient Health Questionnaire-9 (PHQ-9) score
Score ranges from 0 to 27 with lower score indicates no or mild depression and higher score indicates more severe depression.
Time frame: Baseline to week 8
Change in Patient Health Questionnaire-9 (PHQ-9) score
Score ranges from 0 to 27 with lower score indicates no or mild depression and higher score indicates more severe depression.
Time frame: Baseline to week 16
Change in General Anxiety Disorder-7 (GAD-7) score
Score ranges from 0 to 21 with lower score indicates no or mild anxiety and higher score indicates more severe generalized anxiety.
Time frame: Baseline to week 8
Change in General Anxiety Disorder-7 (GAD-7) score
Score ranges from 0 to 21 with lower score indicates no or mild anxiety and higher score indicates more severe generalized anxiety.
Time frame: Baseline to week 16
Change in Patient Health Questionnaire-10 (PHQ-10) score
Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Time frame: Baseline to week 8
Change in Patient Health Questionnaire-10 (PHQ-10) score
Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Time frame: Baseline to week 16
Change in EuroQol - 5 Dimension (EQ-5D) score
Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)
Time frame: Baseline to week 8
Change in EuroQol - 5 Dimension (EQ-5D) score
Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)
Time frame: Baseline to week 16
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Scores range from 0 to 100 with lower score indicates worse imaginable quality of life and higher score indicates better imaginable quality of life.
Time frame: Baseline to week 8
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Scores range from 0 to 100 with lower score indicates worse imaginable quality of life and higher score indicates better imaginable quality of life.
Time frame: Baseline to week 16
Change in Therapeutic Alliance score
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.
Time frame: Baseline to week 8
Change in Therapeutic Alliance score
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.
Time frame: Baseline to week 16
Number of hospitalizations during study
Admission to a hospital abstracted from electronic health record
Time frame: Up to 16 weeks
Referral to palliative care specialist during study
Referral to palliative care specialist during study abstracted from electronic health record
Time frame: Up to 16 weeks
Referral to hospice during study
Referral to inpatient or home hospice during study abstracted from electronic health record
Time frame: Up to 16 weeks
Plan to share: No
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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