Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Conditions
Keywords
palliative care, advance care planning
Brief summary
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.
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.
Interventions
BEHAVIORALPCplanner
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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The Palliative Care planner (PCplanner) is a mobile app platform that aims to facilitate communication on unmet needs and advance care planning between patients with idiopathic pulmonary fibrosis and their pulmonary clinicians. Participants will be randomized to intervention arm in a 2:1 intervention:control ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of intervention | Up to 16 weeks | Number of participants who completed all three surveys and intervention telephone visits. |
| Documentation of advance care planning in electronic health record | Up to 16 weeks | Includes all or any of the following: code status, healthcare power of attorney, advance directive |
| Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale | 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. |
| Feasibility of intervention | Up to 16 weeks | Number of participants who stated intervention was easy to use as measured by patient survey. |
| Acceptability of intervention | Up to 16 weeks | Number of participants who stated they were satisfied with the intervention as measured by patient survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Visual Analogue Scale (QOL VAS) | 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. |
| Change in Therapeutic Alliance score | 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. |
| Change in EuroQol - 5 Dimension (EQ-5D) score | Baseline to week 8 | Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible) |
| Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale | 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. |
| Change in Patient Health Questionnaire-9 (PHQ-9) score | 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. |
| Change in General Anxiety Disorder-7 (GAD-7) score | 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. |
| Change in Patient Health Questionnaire-10 (PHQ-10) score | Baseline to week 8 | Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of hospitalizations during study | Up to 16 weeks | Admission to a hospital abstracted from electronic health record |
| Referral to hospice during study | Up to 16 weeks | Referral to inpatient or home hospice during study abstracted from electronic health record |
| Referral to palliative care specialist during study | Up to 16 weeks | Referral to palliative care specialist during study abstracted from electronic health record |
Countries
United States
Outcome results
None listed