Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2022-03-16
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Usual Care
Participants who are randomized to the usual care arm will complete surveys at 3 timepoints and receive usual care by pulmonary clinician.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 is already seeing palliative care or enrolled in hospice
* NEST score \<10 at baseline T1
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Christopher Cox, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Health
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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Olson A, Hartmann N, Patnaik P, Wallace L, Schlenker-Herceg R, Nasser M, Richeldi L, Hoffmann-Vold AM, Cottin V. Estimation of the Prevalence of Progressive Fibrosing Interstitial Lung Diseases: Systematic Literature Review and Data from a Physician Survey. Adv Ther. 2021 Feb;38(2):854-867. doi: 10.1007/s12325-020-01578-6. Epub 2020 Dec 14.
Moens K, Higginson IJ, Harding R; EURO IMPACT. Are there differences in the prevalence of palliative care-related problems in people living with advanced cancer and eight non-cancer conditions? A systematic review. J Pain Symptom Manage. 2014 Oct;48(4):660-77. doi: 10.1016/j.jpainsymman.2013.11.009. Epub 2014 May 5.
Gore JM, Brophy CJ, Greenstone MA. How well do we care for patients with end stage chronic obstructive pulmonary disease (COPD)? A comparison of palliative care and quality of life in COPD and lung cancer. Thorax. 2000 Dec;55(12):1000-6. doi: 10.1136/thorax.55.12.1000.
Au DH, Udris EM, Fihn SD, McDonell MB, Curtis JR. Differences in health care utilization at the end of life among patients with chronic obstructive pulmonary disease and patients with lung cancer. Arch Intern Med. 2006 Feb 13;166(3):326-31. doi: 10.1001/archinte.166.3.326.
Bausewein C, Booth S, Gysels M, Kuhnbach R, Haberland B, Higginson IJ. Understanding breathlessness: cross-sectional comparison of symptom burden and palliative care needs in chronic obstructive pulmonary disease and cancer. J Palliat Med. 2010 Sep;13(9):1109-18. doi: 10.1089/jpm.2010.0068.
Bajwah S, Higginson IJ, Ross JR, Wells AU, Birring SS, Patel A, Riley J. Specialist palliative care is more than drugs: a retrospective study of ILD patients. Lung. 2012 Apr;190(2):215-20. doi: 10.1007/s00408-011-9355-7. Epub 2012 Jan 5.
Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med. 2004 Jan 12;164(1):83-91. doi: 10.1001/archinte.164.1.83.
Higginson IJ, Bausewein C, Reilly CC, Gao W, Gysels M, Dzingina M, McCrone P, Booth S, Jolley CJ, Moxham J. An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Lancet Respir Med. 2014 Dec;2(12):979-87. doi: 10.1016/S2213-2600(14)70226-7. Epub 2014 Oct 29.
Ley B, Ryerson CJ, Vittinghoff E, Ryu JH, Tomassetti S, Lee JS, Poletti V, Buccioli M, Elicker BM, Jones KD, King TE Jr, Collard HR. A multidimensional index and staging system for idiopathic pulmonary fibrosis. Ann Intern Med. 2012 May 15;156(10):684-91. doi: 10.7326/0003-4819-156-10-201205150-00004.
Ryerson CJ, Vittinghoff E, Ley B, Lee JS, Mooney JJ, Jones KD, Elicker BM, Wolters PJ, Koth LL, King TE Jr, Collard HR. Predicting survival across chronic interstitial lung disease: the ILD-GAP model. Chest. 2014 Apr;145(4):723-728. doi: 10.1378/chest.13-1474.
Gu J, Wang P, Chow SC, Dempsey K, Bermejo S, Swaminathan A, Soskis A, Fried J, Kloefkorn C, Jones C, Cox CE. An App Platform-Facilitated Collaborative Palliative Care Intervention for Outpatients With Interstitial Lung Disease: A Pilot Randomized Trial. Am J Hosp Palliat Care. 2025 Jul;42(7):653-660. doi: 10.1177/10499091241275966. Epub 2024 Aug 19.
Other Identifiers
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Pro00108264
Identifier Type: -
Identifier Source: org_study_id
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