Heart Failure Clinical Trial
— ICSIOfficial title:
Health System Intervention to Improve Communication About End-of-Life Care for Vulnerable Patients
NCT number | NCT01933789 |
Other study ID # | 44023 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | December 2016 |
Verified date | March 2019 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to improve care delivered to patients with serious illness by enhancing communication among patients, families, and clinicians in the outpatient setting. We are testing a new way to help patients share their preferences for talking about end-of-life care with their clinicians and families. To do this we created a simple, short feedback form. The form is designed to help clinicians understand what patients would like to talk about. The goal of this research study is to show that using a feedback form is possible and can be helpful for patients and their families.
Status | Completed |
Enrollment | 817 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Eligible primary clinicians will include all clinicians who provide ongoing primary or specialty care to eligible patient populations. This will include primary care physicians (family medicine and internal medicine), oncologists, pulmonologists, cardiologists, gastroenterologists, nephrologists, neurologists, hepatologists, and geriatricians. Primary clinicians may also include nurse practitioners and physician assistants playing a "primary role" with eligible patients. A "primary role" denotes any clinician for whom having a discussion about end-of-life care with eligible patients would be indicated - Eligible interprofessional team members will include nurses, social workers and other clinicians who are part of an enrolled primary clinician's clinic team. - Eligible patients will be those under the care of a participating clinician who are 18 years of age or older, have had 2 or more visits with the primary clinician in the last 18 months, and meet diagnostic criteria. Diagnostic criteria include: 1) metastatic cancer or inoperable lung cancer; 2) chronic obstructive pulmonary disease with FEV1 values <35% predicted or oxygen dependence or restrictive lung disease with a TLC < 50% predicted; 3) New York Heart Association Class III or IV heart failure; 4) Child's Class C cirrhosis or MELD score of >17; 5) dialysis-dependent renal failure and either diabetes or a serum albumin of < 2.5; or, 6) older than 75 years with at least one life-limiting chronic illness or older than 90 years. Additional criteria include: PAH w. 6MWD <250m, restrictive lung disease (IPF, ILD) w/ TLC <50%, and cystic fibrosis with FEV1 < 30%. Eligible patients will also be English-speaking and have no significant dementia or cognitive impairment that would limit his/her ability to complete questionnaires. - Eligible family members will be identified by the patient, with the criterion that the patient would want the family member involved in medical decision-making for the patient if he/she was not able. For the purpose of this study, "family member" is not confined to legal next-of-kin or immediate family member. Any family member, friend, or caregiver is eligible who is English-speaking and has no dementia or delirium limiting his/her ability to complete questionnaires. Exclusion Criteria: - Reasons for exclusion for all subject groups include: legal or risk management concerns; and physical or mental limitations preventing ability to complete research activities. |
Country | Name | City | State |
---|---|---|---|
United States | Valley Medical Center | Renton | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Northwest Hospital and Medical Center | Seattle | Washington |
United States | Swedish Medical Center | Seattle | Washington |
United States | University of Washington Medical Center | Seattle | Washington |
United States | UW Neighborhood Clinics | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Patient-Centered Outcomes Research Institute |
United States,
Au DH, Udris EM, Engelberg RA, Diehr PH, Bryson CL, Reinke LF, Curtis JR. A randomized trial to improve communication about end-of-life care among patients with COPD. Chest. 2012 Mar;141(3):726-735. doi: 10.1378/chest.11-0362. Epub 2011 Sep 22. — View Citation
Curtis JR, Engelberg RA, Nielsen EL, Au DH, Patrick DL. Patient-physician communication about end-of-life care for patients with severe COPD. Eur Respir J. 2004 Aug;24(2):200-5. — View Citation
Curtis JR, Patrick DL. Barriers to communication about end-of-life care in AIDS patients. J Gen Intern Med. 1997 Dec;12(12):736-41. — View Citation
Curtis JR, Wenrich MD, Carline JD, Shannon SE, Ambrozy DM, Ramsey PG. Patients' perspectives on physician skill in end-of-life care: differences between patients with COPD, cancer, and AIDS. Chest. 2002 Jul;122(1):356-62. — View Citation
Engelberg R, Downey L, Curtis JR. Psychometric characteristics of a quality of communication questionnaire assessing communication about end-of-life care. J Palliat Med. 2006 Oct;9(5):1086-98. — View Citation
Knauft E, Nielsen EL, Engelberg RA, Patrick DL, Curtis JR. Barriers and facilitators to end-of-life care communication for patients with COPD. Chest. 2005 Jun;127(6):2188-96. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care) | Binary variable indicating whether patient's current preference was for life-extension or comfort care | 3 months after target visit | |
Other | Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care) | Binary variable indicating whether patient's treatment preference was stable between target visit (or baseline, if no 2-week questionnaire was returned) and 3 months. | 3 months after target visit | |
Primary | Occurrence of Discussion About Goals of Care at Target Visit | Patient's response to question, "Did you discuss with this doctor the kind of medical care you would want if you were too sick to speak for yourself?" | 2 weeks after target visit | |
Secondary | Occurrence of Discussion About Goals of Care at Target Visit | Electronic Health Record (EHR) documentation of discussion about advance care planning, prognosis, treatment preference, hospice, palliative care, or Physician Orders for Life-Sustaining Treatment (POLST) at target visit | Target visit | |
Secondary | Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | Patient's response to question, "Did you discuss with this doctor the kind of medical care you would want if you were too sick to speak for yourself?" | 2 weeks after target visit | |
Secondary | Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | Electronic Health Record (EHR) documentation of discussion about advance care planning, prognosis, treatment preference, hospice, palliative care, or Physician Orders for Life-Sustaining Treatment (POLST) at target visit | Target visit | |
Secondary | Goal-Concordant Care | Binary variable indicating whether patient's reported focus of current treatment was concordant with treatment preference | 3 months after target visit | |
Secondary | Goal-Concordant Care Among Patients With Stable Treatment Preference | Binary variable indicating whether patient's reported focus of current treatment was concordant with treatment preference | 3 months after target visit | |
Secondary | Quality of Communication (QOC): Four-Indicator Latent Construct | Quality of Communication: patient ratings of clinician on seven aspects of end-of-life communication, each aspect having a pseudo-continuous response range of 0 ('clinician didn't do this') to 11 ('the very best I could imagine'). Measured with QOC items 1, 2, 5, & 6 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable; Higher value indicates better outcome (i.e., higher quality communication) Unit of measurement: scores on a scale |
2 weeks from target visit | |
Secondary | Quality of Communication (QOC): Individual QOC Items | Quality of Communication: patient ratings of clinician on seven aspects of end-of-life communication, each aspect having a pseudo-continuous response range of 0 ('clinician didn't do this') to 11 ('the very best I could imagine'). Individual QOC Items. Theoretical range: 0-11 Actual range: 0-11 Higher value indicates better outcome (i.e., higher quality communication) Unit of measurement: units on a scale |
2 weeks from target visit | |
Secondary | Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct | Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with PHQ items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale |
3 months after target visit | |
Secondary | Patient Health Questionnaire (PHQ-8): Eight-Item Scale | Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Eight-Item Scale: Sum of responses for the eight symptoms (weighted by 8/7 if only 7 items answered). Theoretical range: 0-24 Actual range: 0-24 Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale |
3 months after target visit | |
Secondary | Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct | Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with PHQ items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale |
6 months after target visit | |
Secondary | Patient Health Questionnaire (PHQ-8): Eight-Item Scale | Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Eight-Item Scale: Sum of responses for the eight symptoms (weighted by 8/7 if only 7 items answered). Theoretical range: 0-24 Actual range: 0-24 Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale |
6 months after target visit | |
Secondary | Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct | Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with GAD items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale |
3 months after target visit | |
Secondary | Generalized Anxiety Disorder (GAD-7): Seven-Item Scale | Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Seven-Item Scale: Sum of responses for the seven symptoms (weighted by 7/6 if only 6 items answered). (Strong floor effect.) Theoretical range: 0-21 Actual range: 0-21 Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale |
3 months after target visit | |
Secondary | Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct | Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with GAD items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale |
6 months after target visit | |
Secondary | Generalized Anxiety Disorder (GAD-7): Seven-Item Scale | Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Seven-Item Scale: Sum of responses for the seven symptoms (weighted by 7/6 if only 6 items answered). (Strong floor effect.) Theoretical range: 0-21 Actual range: 0-21 Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale |
6 months after target visit | |
Secondary | Avoidance of Life-Sustaining Therapies, All Patients | Review of EHR documentation to assess use of three indicators of life-sustaining therapies (LST): admission to an ICU, receipt of CPR, and receipt of mechanical ventilation | 6-month period following the target visit | |
Secondary | Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference | Review of EHR documentation to assess use of three indicators of life-sustaining therapies (LST): admission to an ICU, receipt of CPR, and receipt of mechanical ventilation for patients preferring "comfort" (quality of life over extending life) at the end-of-life | 6-month period following the target visit | |
Secondary | Palliative Care Consultation, Inpatient Stay - All Patients | EHR documentation of palliative care consultation during an inpatient stay for all patients with target visit and chart abstraction. | 3-month period following the target visit | |
Secondary | Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit | EHR documentation of palliative care consultation during an inpatient stay for patients who reported preference for "comfort care" (quality of life over extending life) and wanted a discussion. | 3-month period following the target visit | |
Secondary | Palliative Care Consultation, Inpatient Stay - All Patients | EHR documentation of palliative care consultation during an inpatient stay for all patients with target visit and chart abstraction. | 6-month period following the target visit | |
Secondary | Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit | EHR documentation of palliative care consultation during an inpatient stay for patients who reported preference for "comfort care" (quality of life over extending life) and wanted a discussion. | 6-month period following the target visit | |
Secondary | Palliative Care Referral, Outpatient Visit - All Patients | EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit. | 3-month period following the target visit | |
Secondary | Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit | EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit for patients who reported preference for "comfort care" (quality of life over extending life) and wanted a discussion. | 3-month period following the target visit | |
Secondary | Palliative Care Referral, Outpatient Visit - All Patients | EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit. | 6-month period following the target visit | |
Secondary | Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit | EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit for patients who reported preference for "comfort care" (quality of life over extending life) and wanted a discussion. | 6-month period following the target visit | |
Secondary | Palliative Care Consultation and/or Referral - All Patients | EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay. | 3-month period following the target visit | |
Secondary | Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit | EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay for patients who reported preference for "comfort care" (quality of life over extending life) and wanted a discussion. | 3-month period following the target visit | |
Secondary | Palliative Care Consultation and/or Referral - All Patients | EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay. | 6-month period following the target visit | |
Secondary | Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit | EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay for patients who reported preference for "comfort care" (quality of life over extending life) and wanted a discussion. | 6-month period following the target visit |
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