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| ID | Type | Description | Link |
|---|---|---|---|
| K23NS116453 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this study is to test the feasibility and acceptability of a tool to support decision making for parents of critically ill infants.
In this single-arm mixed methods prospective feasibility study, we will enroll infants, parents, and clinicians. The intervention is a paper-based decision guide that contains a values clarification exercise and question prompt list.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically Ill Infants | Other | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. |
|
| Parent(s) of Critically Ill Infant | Other | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. |
|
| Clinicians | Other | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Making Guide | Other | The tool includes a brief introduction to the tool and decision-making, a values clarification exercise, and a question prompt list. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate (Critically Ill Infants) | Intervention and study procedures considered feasible if infant enrollment rate is greater than or equal to 50%. | At enrollment (approximately 9 months) |
| Complete Data Collection (Critically Ill Infants) | Complete data collection defined as all eligible infant, parent, and clinician data points collected for a given case and was determined at the level of the critically ill infant. Data points for which the participant withdrew prior to relevant data collection were excluded. Intervention and study procedures considered feasible if complete data collection rate is greater than or equal to 80%. | approximately 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parent and Clinician Acceptability | Acceptability will be measured using an acceptability questionnaire, consisting of close-ended items with 5-point likert scale response options (strongly disagree, disagree, neither agree or disagree, agree, strongly agree). | Up to 4 weeks following use of the tool |
| Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) |
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Study participants will include English-speaking parents of critically ill infants and children admitted to Duke University Hospital.
Infant inclusion criteria will include
All parents of eligible infants will be considered for inclusion. Parent exclusion criteria will include 1) age < 18 years, 2) hearing or speech impairment, and 3) non-English speakers.
All clinicians of eligible infants will be considered for inclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Monica Lemmon, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28193115 | Background | Lemmon ME, Boss RD, Bonifacio SL, Foster-Barber A, Barkovich AJ, Glass HC. Characterization of Death in Neonatal Encephalopathy in the Hypothermia Era. J Child Neurol. 2017 Mar;32(4):360-365. doi: 10.1177/0883073816681904. Epub 2016 Dec 20. | |
| 1556799 | Background | Emanuel EJ, Emanuel LL. Four models of the physician-patient relationship. JAMA. 1992 Apr 22-29;267(16):2221-6. No abstract available. |
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There is no plan to share individual participant level data
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Participants were recruited based on assessment of infant eligibility and approval from primary physician. Parental consent was obtained based on eligible participants. The first participant was enrolled on May 2, 2023 and the last participant was enrolled January 29, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Critically Ill Infants | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. |
| FG001 | Parent(s) of Critically Ill Infant | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. |
| FG002 | Clinicians | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Measure Analysis Population Description: Demographic information includes 30 infants, 43 parents and 30 clinicians that completed demographic surveys. One parent was not included in this data due to withdrawal of participation before any data collection.
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| ID | Title | Description |
|---|---|---|
| BG000 | Critically Ill Infants | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. |
| BG001 | Parent(s) of Critically Ill Infant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | This row includes the infant population only. Infant age at enrollment is reported in days. Adults are not reported in this section. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Enrollment Rate (Critically Ill Infants) | Intervention and study procedures considered feasible if infant enrollment rate is greater than or equal to 50%. | Eligible critically ill infants. | Posted | Count of Participants | Participants | At enrollment (approximately 9 months) |
|
|
Up to 4 weeks following use of the tool
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Critically Ill Infants | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Monica Lemmon | Duke Univerisity Medical Center | 919-668-0477 | monica.lemmon@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2023 | Dec 19, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2023 | Jan 9, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2023 | Feb 1, 2024 | ICF_000.pdf |
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PROMIS measures assess the extent to which patients experience challenges with symptoms over the past 7 days. Scores are derived using a standardized T-score metric, with a mean of 50 and a standard deviation of 10. Higher scores reflect greater symptom severity. |
| Baseline, and up to 4 weeks following use of the tool |
| Parent Preparation for Decision Making, as Measured by the PrepDM | Items can be summed and scored. Score ranges from 0-100, where a higher score indicates higher perceived preparedness for decision making. | Up to 4 weeks following use of the tool |
| 15098087 | Background | Carlet J, Thijs LG, Antonelli M, Cassell J, Cox P, Hill N, Hinds C, Pimentel JM, Reinhart K, Thompson BT. Challenges in end-of-life care in the ICU. Statement of the 5th International Consensus Conference in Critical Care: Brussels, Belgium, April 2003. Intensive Care Med. 2004 May;30(5):770-84. doi: 10.1007/s00134-004-2241-5. Epub 2004 Apr 20. |
| 17353493 | Background | White DB, Braddock CH 3rd, Bereknyei S, Curtis JR. Toward shared decision making at the end of life in intensive care units: opportunities for improvement. Arch Intern Med. 2007 Mar 12;167(5):461-7. doi: 10.1001/archinte.167.5.461. |
| 10966293 | Background | Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000 Aug;28(8):3044-9. doi: 10.1097/00003246-200008000-00061. |
| 15640361 | Background | Curtis JR, Engelberg RA, Wenrich MD, Shannon SE, Treece PD, Rubenfeld GD. Missed opportunities during family conferences about end-of-life care in the intensive care unit. Am J Respir Crit Care Med. 2005 Apr 15;171(8):844-9. doi: 10.1164/rccm.200409-1267OC. Epub 2005 Jan 7. |
| 22635048 | Background | Cox CE, Lewis CL, Hanson LC, Hough CL, Kahn JM, White DB, Song MK, Tulsky JA, Carson SS. Development and pilot testing of a decision aid for surrogates of patients with prolonged mechanical ventilation. Crit Care Med. 2012 Aug;40(8):2327-34. doi: 10.1097/CCM.0b013e3182536a63. |
| 28402085 | Background | Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5. |
| 30690645 | Background | Cox CE, White DB, Hough CL, Jones DM, Kahn JM, Olsen MK, Lewis CL, Hanson LC, Carson SS. Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial. Ann Intern Med. 2019 Mar 5;170(5):285-297. doi: 10.7326/M18-2335. Epub 2019 Jan 29. |
| 18762529 | Background | Boss RD, Hutton N, Sulpar LJ, West AM, Donohue PK. Values parents apply to decision-making regarding delivery room resuscitation for high-risk newborns. Pediatrics. 2008 Sep;122(3):583-9. doi: 10.1542/peds.2007-1972. |
| 12193517 | Background | Zupancic JA, Kirpalani H, Barrett J, Stewart S, Gafni A, Streiner D, Beecroft ML, Smith P. Characterising doctor-parent communication in counselling for impending preterm delivery. Arch Dis Child Fetal Neonatal Ed. 2002 Sep;87(2):F113-7. doi: 10.1136/fn.87.2.f113. |
| 40319938 | Derived | Lemmon ME, Bansal S, Nanduri N, Davalos A, Glass HC, Lord B, Moline K, Pilon B, Sharpe R, Brandon D, Hong H, Samsa G, Cox CE, Pollak KI. Feasibility of an Intervention to Support Shared Decision-Making for Critically Ill Infants. J Pediatr. 2025 Aug;283:114632. doi: 10.1016/j.jpeds.2025.114632. Epub 2025 May 2. |
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
| BG002 | Clinicians | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. |
| BG003 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| days |
|
| Age, Continuous | This row includes the adult population only (parents and clinicians). Infants are not reported in this section. | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Complete Data Collection (Critically Ill Infants) | Complete data collection defined as all eligible infant, parent, and clinician data points collected for a given case and was determined at the level of the critically ill infant. Data points for which the participant withdrew prior to relevant data collection were excluded. Intervention and study procedures considered feasible if complete data collection rate is greater than or equal to 80%. | Critically ill infants who completed the study. | Posted | Count of Participants | Participants | approximately 9 months |
|
|
|
| Secondary | Parent and Clinician Acceptability | Acceptability will be measured using an acceptability questionnaire, consisting of close-ended items with 5-point likert scale response options (strongly disagree, disagree, neither agree or disagree, agree, strongly agree). | Not applicable to the infant group. | Posted | Count of Participants | Participants | Up to 4 weeks following use of the tool |
|
|
|
| Secondary | Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) | PROMIS measures assess the extent to which patients experience challenges with symptoms over the past 7 days. Scores are derived using a standardized T-score metric, with a mean of 50 and a standard deviation of 10. Higher scores reflect greater symptom severity. | Only applicable to the parent group. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, and up to 4 weeks following use of the tool |
|
|
|
| Secondary | Parent Preparation for Decision Making, as Measured by the PrepDM | Items can be summed and scored. Score ranges from 0-100, where a higher score indicates higher perceived preparedness for decision making. | Only applicable to the parent group. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 4 weeks following use of the tool |
|
|
|
| 4 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Parent(s) of Critically Ill Infant | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. | 0 | 44 | 0 | 44 | 0 | 44 |
| EG002 | Clinicians | Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Would recommend to other parents (agreed/ Strongly agreed) |
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| Would recommend to other parents (all other response items) |
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| Would use in the future (agreed/strongly agreed) |
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| Would use in the future (all other response items) |
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| Baseline PROMIS: Emotional Distress-Anxiety |
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| Post Intervention PROMIS: Emotional Distress-Anxiety |
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| Baseline PROMIS: Emotional Distress - Depression |
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| Post Intervention PROMIS: Emotional Distress - Depression |
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| Baseline PROMIS: Fatigue |
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| Post Intervention: Fatigue |
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| Baseline PROMIS: Pain Interference |
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| Post Intervention PROMIS: Pain Interference |
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| Baseline PROMIS: Physical Function |
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| Post Intervention PROMIS: Physical Function |
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| Baseline PROMIS: Sleep Disturbance |
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| Post-Intervention PROMIS: Sleep Disturbance |
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