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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA200867-05 | U.S. NIH Grant/Contract | View source | |
| OCR17893 | Other Identifier | UF OnCore | |
| PRO00002457 | Other Identifier | UFIRST Proposal |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Northwestern University | OTHER |
| Rush University | OTHER |
| Emory University |
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Our long-term goal is to improve spiritual care outcomes for elderly patients with cancer. The study team will use a spiritual intervention, Dignity Therapy (DT), to help these patients maintain pride, find spiritual comfort, enhance continuity of self, and ultimately make meaning of their life threatening illness.
The study team propose a 3 arm pre/posttest, RCT with a 4-step (approximately 12 months per step), stepped-wedge design to compare effects of usual outpatient palliative care (usual care) and usual care along with either nurse-led or chaplain-led DT on patient outcomes, cancer prognosis awareness. The study team will assign 6 outpatient palliative care sites to usual care during the first-step, and randomly assign two sites per step to begin and continue DT led by either a nurse or a chaplain during each of the next 3 steps. During the usual care steps, 280 patients will complete pretest measures and satisfaction with palliative spiritual care services, receive usual palliative care, and complete posttest measures. During the experimental steps as part of routine palliative care service delivery, 280 patients will complete pretest measures, receive nurse-led or chaplain-led DT, and complete posttest measures. Using mixed level analysis with site, provider (nurse, chaplain) and time (step) included in the model, the study team will compare the usual care and each of the DT groups for effects on dignity impact, existential tasks, and cancer prognosis awareness and explore the moderating effects of physical symptoms and spiritual distress. The study team will also determine the effect of usual care and DT on the patient's satisfaction with palliative spiritual care services and the report of the patient's unmet spiritual needs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual outpatient palliative care | Active Comparator | During the usual care steps, patients will receive usual outpatient palliative care |
|
| Dignity Therapy - Nurse Led | Experimental | During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT. |
|
| Dignity Therapy - Chaplain Led | Experimental | During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dignity Therapy - Nurse Led | Behavioral | The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience. |
| Measure | Description | Time Frame |
|---|---|---|
| Dignity Impact Scale | Our primary outcome measure is a 7-item Dignity Impact Scale. The items are scored on a 5-point scale from 'strongly disagree' (1) to 'strongly agree' (5). The scores can range from 7 to 35 with higher scores representing better outcome. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Preparation | Preparation for death subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 4 to 20 with higher scores representing better outcomes. | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana J Wilkie, PhD | University of Florida | Principal Investigator |
| Tammi Quest, MD | Emory University | Study Director |
| George Fitchett, PhD | Rush University | Principal Investigator |
| Michael Rabow, MD | University of California, San Francisco | Study Director |
| Linda Emanuel, MD/PhD | Northwestern University | Principal Investigator |
| Marvin Delgado, MD | MD Anderson | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30379798 | Background | Scarton LJ, Boyken L, Lucero RJ, Fitchett G, Handzo G, Emanuel L, Wilkie DJ. Effects of Dignity Therapy on Family Members: A Systematic Review. J Hosp Palliat Nurs. 2018 Dec;20(6):542-547. doi: 10.1097/NJH.0000000000000469. | |
| 29793345 | Background | Scarton L, Oh S, Sylvera A, Lamonge R, Yao Y, Chochinov H, Fitchett G, Handzo G, Emanuel L, Wilkie D. Dignity Impact as a Primary Outcome Measure for Dignity Therapy. Am J Hosp Palliat Care. 2018 Nov;35(11):1417-1420. doi: 10.1177/1049909118777987. Epub 2018 May 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chaplain Sequence 1 | 12 months of usual care followed by 36 months of chaplain led dignity therapy |
| FG001 | Nurse Sequence 1 | 12 months of usual care followed by 36 months of nurse-led dignity therapy |
| FG002 | Chaplain Sequence 2 | 24 months of usual care followed by 24 months of chaplain led dignity therapy |
| FG003 | Nurse Sequence 2 | 24 months of usual care followed by 24 months of nurse led dignity therapy |
| FG004 | Chaplain Sequence 3 | 36 months of usual care followed by 12 months of chaplain led dignity therapy |
| FG005 | Nurse Sequence 3 | 36 months of usual care followed by 12 months of nurse led dignity therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Step 1: Month 1-12 |
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| Step 2: Month 13-24 |
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| Step 3: Month 25-36 |
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| Step 4: Month 37-48 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Outpatient Palliative Care | During the usual care steps, patients will receive usual outpatient palliative care Usual care: Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Dignity Impact Scale | Our primary outcome measure is a 7-item Dignity Impact Scale. The items are scored on a 5-point scale from 'strongly disagree' (1) to 'strongly agree' (5). The scores can range from 7 to 35 with higher scores representing better outcome. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
|
From baseline to posttest (about 5 weeks).
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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 | Usual Outpatient Palliative Care | During the usual care steps, patients will receive usual outpatient palliative care Usual care: Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR. |
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Our loss to follow up was 22%, which was within our projected 20% to 30% attrition rate, but still may have unknown effects on validity of study findings. Our sample was intentionally focused on older adults with cancer. The recruited sample overrepresented the population with at least some college education and did not adequately represent the male or racial and ethnic minority populations. Future research is needed to determine the generalizability of DT.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Diana Wilkie | University of Florida | 352-273-6401 | diwilkie@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2020 | Aug 28, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2020 | Aug 29, 2023 | ICF_001.pdf |
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| OTHER |
| M.D. Anderson Cancer Center | OTHER |
| University of California, San Francisco | OTHER |
| Healthcare Chaplaincy | OTHER |
a 6-site, pre/posttest, randomized, controlled 4-step, stepped-wedge design to compare the effects of usual outpatient palliative care (arm 1) and usual outpatient palliative care along with nurse-led (arm 2) or chaplain-led (arm 3) DT on patient outcomes and palliative care processes. The study team will assign the 6 sites to usual care during the first-step period (approximately 12 months), and randomly assign 2 sites per step to begin and continue DT during each of the next 3 steps (12 months each).
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|
| Usual care | Behavioral | Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR. |
|
| Dignity Therapy - Chaplain Led | Behavioral | The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience. |
|
| Completion |
Life completion subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 7 to 35 with higher scores representing better outcomes. |
| 5 weeks |
| Peaceful Awareness | We measured peaceful awareness with the 2 items: terminal illness awareness and peaceful awareness questionnaire. The first focused on terminal illness acknowledgement (TIA) in which patients rated their current health status as 1) relatively healthy, 2) seriously but not terminally ill, or 3) seriously and terminally ill. The second item focused on the frequency of feeling deep inner peace or harmony, which was rated on a 6-point Likert scale ranging from 1) never or almost never to 6) many times a day. Scores of at least 3 on each of the two items defined positive peaceful awareness, a dichotomous measure. | 5 weeks |
| Treatment Preference | We measured treatment preferences with a single item from the standardized and validated Hypothetical Advanced Care Planning Scenario (H-CAP-S) that assesses treatment preferences. | 5 weeks |
| 30994466 | Background | Kittelson S, Scarton L, Barker P, Hauser J, O'Mahony S, Rabow M, Delgado Guay M, Quest TE, Emanuel L, Fitchett G, Handzo G, Yao Y, Chochinov HM, Wilkie D. Dignity Therapy Led by Nurses or Chaplains for Elderly Cancer Palliative Care Outpatients: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Apr 17;8(4):e12213. doi: 10.2196/12213. |
| 33760658 | Result | O'Mahony S, Kittelson S, Barker PC, Delgado Guay MO, Yao Y, Handzo GF, Chochinov HM, Fitchett G, Emanuel LL, Wilkie DJ. Association of Race with End-of-Life Treatment Preferences in Older Adults with Cancer Receiving Outpatient Palliative Care. J Palliat Med. 2021 Aug;24(8):1174-1182. doi: 10.1089/jpm.2020.0542. Epub 2021 Mar 23. |
| 33557587 | Result | Samuels V, Schoppee TM, Greenlee A, Gordon D, Jean S, Smith V, Reed T, Kittelson S, Quest T, O'Mahony S, Hauser J, Guay MOD, Rabow MW, Emanuel L, Fitchett G, Handzo G, Chochinov HM, Yao Y, Wilkie DJ. Interim Analysis of Attrition Rates in Palliative Care Study on Dignity Therapy. Am J Hosp Palliat Care. 2021 Dec;38(12):1503-1508. doi: 10.1177/1049909121994309. Epub 2021 Feb 9. |
| 33926243 | Result | Bluck S, Mroz EL, Wilkie DJ, Emanuel L, Handzo G, Fitchett G, Chochinov HM, Bylund CL. Quality of Life for Older Cancer Patients: Relation of Psychospiritual Distress to Meaning-Making During Dignity Therapy. Am J Hosp Palliat Care. 2022 Jan;39(1):54-61. doi: 10.1177/10499091211011712. Epub 2021 Apr 29. |
| 34036932 | Result | Schoppee TM, Scarton L, Bluck S, Yao Y, Keenan G, Handzo G, Chochinov HM, Fitchett G, Emanuel LL, Wilkie DJ. Description of a training protocol to improve research reproducibility for dignity therapy: an interview-based intervention. Palliat Support Care. 2022 Apr;20(2):178-188. doi: 10.1017/S1478951521000614. |
| 33984462 | Result | Damen A, Exline J, Pargament K, Yao Y, Chochinov H, Emanuel L, Handzo G, Wilkie DJ, Fitchett G. Prevalence, Predictors and Correlates of Religious and Spiritual Struggles in Palliative Cancer Patients. J Pain Symptom Manage. 2021 Sep;62(3):e139-e147. doi: 10.1016/j.jpainsymman.2021.04.024. Epub 2021 May 10. |
| 35713352 | Result | Bylund CL, Taylor G, Mroz E, Wilkie DJ, Yao Y, Emanuel L, Fitchett G, Handzo G, Chochinov HM, Bluck S. Empathic communication in dignity therapy: Feasibility of measurement and descriptive findings. Palliat Support Care. 2022 Jun;20(3):321-327. doi: 10.1017/S1478951521001188. |
| 34332045 | Result | Rantanen P, Chochinov HM, Emanuel LL, Handzo G, Wilkie DJ, Yao Y, Fitchett G. Existential Quality of Life and Associated Factors in Cancer Patients Receiving Palliative Care. J Pain Symptom Manage. 2022 Jan;63(1):61-70. doi: 10.1016/j.jpainsymman.2021.07.016. Epub 2021 Jul 29. |
| 35016670 | Result | Schoppee TM, Scarton L, Bluck S, Yao Y, Keenan G, Samuels V, Fitchett G, Handzo G, Chochinov HM, Emanuel LL, Wilkie DJ. Dignity therapy intervention fidelity: a cross-sectional descriptive study with older adult outpatients with cancer. BMC Palliat Care. 2022 Jan 11;21(1):8. doi: 10.1186/s12904-021-00888-y. |
| 36190483 | Result | Handzo GF, Chochinov HM, Emanuel L, Fitchett G, Hauser J, Kittelson S, Schoppee TM, Yao Y, Solomon S, Wilkie DJ. Letter to the Editor: Feasibility of Dignity Therapy to Reduce Death Anxiety. J Palliat Med. 2022 Oct;25(10):1458-1459. doi: 10.1089/jpm.2022.0263. No abstract available. |
| 36067074 | Result | Emanuel LL, Solomon S, Chochinov HM, Delgado Guay MO, Handzo G, Hauser J, Kittelson S, O'Mahony S, Quest TE, Rabow MW, Schoppee TM, Wilkie DJ, Yao Y, Fitchett G. Death Anxiety and Correlates in Cancer Patients Receiving Palliative Care. J Palliat Med. 2023 Feb;26(2):235-243. doi: 10.1089/jpm.2022.0052. Epub 2022 Sep 2. |
| 37565429 | Result | Al Yacoub R, Rangel AP, Shum-Jimenez A, Greenlee A, Yao Y, Schoppee TM, Fitchett G, Handzo G, Chochinov HM, Emanuel LL, Kittelson S, Wilkie DJ. Cost considerations for implementing dignity therapy in palliative care: Insights and implications. Palliat Support Care. 2023 Aug 11:1-5. doi: 10.1017/S1478951523001177. Online ahead of print. |
| 37676977 | Result | Wilkie DJ, Fitchett G, Yao Y, Schoppee T, Delgado Guay MO, Hauser J, Kittelson S, O'Mahony S, Rabow M, Quest T, Solomon S, Handzo G, Chochinov HM, Emanuel LL. Engaging Mortality: Effective Implementation of Dignity Therapy. J Palliat Med. 2024 Feb;27(2):176-184. doi: 10.1089/jpm.2023.0336. Epub 2023 Sep 7. |
| 38602809 | Derived | Koch MK, Bluck S, Maggiore S, Chochinov HM, Cogdill-Richardson K, Bylund CL. Facing off-time mortality: Leaving a legacy. Psychol Aging. 2024 Jun;39(4):400-412. doi: 10.1037/pag0000815. Epub 2024 Apr 11. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| BG001 | Dignity Therapy - Nurse Led | During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT. Dignity Therapy - Nurse Led: The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience. |
| BG002 | Dignity Therapy - Chaplain Led | During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT. Dignity Therapy - Chaplain Led: The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Dignity Impact Scale | Mean | Standard Deviation | units on a scale (7-35) higher=better |
|
| Preparation | Mean | Standard Deviation | units on a scale (4-20) higher=better |
|
| Completion | Mean | Standard Deviation | units on a scale (7-35) higher=better |
|
| Peaceful Awareness | Count of Participants | Participants |
|
| Treatment Preference | Count of Participants | Participants |
|
| OG001 | Dignity Therapy - Nurse Led | During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT. Dignity Therapy - Nurse Led: The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience. |
| OG002 | Dignity Therapy - Chaplain Led | During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT. Dignity Therapy - Chaplain Led: The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience. |
|
|
|
| Secondary | Preparation | Preparation for death subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 4 to 20 with higher scores representing better outcomes. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
|
|
|
|
| Secondary | Completion | Life completion subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 7 to 35 with higher scores representing better outcomes. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
|
|
|
|
| Secondary | Peaceful Awareness | We measured peaceful awareness with the 2 items: terminal illness awareness and peaceful awareness questionnaire. The first focused on terminal illness acknowledgement (TIA) in which patients rated their current health status as 1) relatively healthy, 2) seriously but not terminally ill, or 3) seriously and terminally ill. The second item focused on the frequency of feeling deep inner peace or harmony, which was rated on a 6-point Likert scale ranging from 1) never or almost never to 6) many times a day. Scores of at least 3 on each of the two items defined positive peaceful awareness, a dichotomous measure. | Posted | Count of Participants | Participants | 5 weeks |
|
|
|
|
| Secondary | Treatment Preference | We measured treatment preferences with a single item from the standardized and validated Hypothetical Advanced Care Planning Scenario (H-CAP-S) that assesses treatment preferences. | Posted | Count of Participants | Participants | 5 weeks |
|
|
|
|
| 10 |
| 262 |
| 0 |
| 262 |
| 0 |
| 262 |
| EG001 | Dignity Therapy - Nurse Led | During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT. Dignity Therapy - Nurse Led: The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience. | 9 | 129 | 0 | 129 | 0 | 129 |
| EG002 | Dignity Therapy - Chaplain Led | During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT. Dignity Therapy - Chaplain Led: The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience. | 19 | 188 | 0 | 188 | 0 | 188 |
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| Median Difference (Net) |
| -0.79 |
| Standard Error of the Mean |
| 0.50 |
| 2-Sided |
| Superiority |
| Mean Difference (Net) |
| 0.91 |
| Standard Error of the Mean |
| 0.73 |
| 2-Sided |
| Superiority |
| Odds Ratio, log |
| 0.96 |
| Standard Error of the Mean |
| 0.64 |
| 2-Sided |
| Superiority |
| Limit to less invasive and less burdensome intervention |
|
| Provide comfort care only |
|
The outcome variable was scored as 1= "prolong life; treat everything" to 4 = "provide comfort care only". |
| 0.46 |
| Mean Difference (Net) |
| 0.13 |
| Standard Error of the Mean |
| 0.18 |
| 2-Sided |
| Superiority |