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N/A N=817 Randomized Supportive Care

Improving Communication About Serious Illness

Critical Illness · Chronic Disease · Terminal Care · Palliative Care · Communication

Enrolled (actual)
817
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Occurrence of Discussion About Goals of Care at Target Visit — 137; 66; 47; 145 Participants — p=<0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Communication Feedback Form for Patients with Serious Illness (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Washington
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Occurrence of Discussion About Goals of Care at Target Visit
140; 45; 87; 220 <0.001 sig
SECONDARY
Occurrence of Discussion About Goals of Care at Target Visit
140; 45; 87; 220 <0.001 sig
SECONDARY
Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline
114; 34; 66; 165
SECONDARY
Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline
114; 34; 66; 165
SECONDARY
Goal-Concordant Care
74; 116; 93; 84; 9; 11 0.073
SECONDARY
Goal-Concordant Care Among Patients With Stable Treatment Preference
27; 43; 74; 57; 3; 3 0.017 sig
SECONDARY
Quality of Communication (QOC): Four-Indicator Latent Construct
4.585; 2.128 0.010 sig
SECONDARY
Quality of Communication (QOC): Individual QOC Items
10; 8; 9; 8; 0; 0 0.001 sig
SECONDARY
Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct
0.399; 0.244 0.106
SECONDARY
Patient Health Questionnaire (PHQ-8): Eight-Item Scale
5.853; 4.850 0.343
SECONDARY
Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct
0.399; 0.244 0.106
SECONDARY
Patient Health Questionnaire (PHQ-8): Eight-Item Scale
5.853; 4.850 0.343
SECONDARY
Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct
0.297; 0.209 0.689
SECONDARY
Generalized Anxiety Disorder (GAD-7): Seven-Item Scale
1; 1 0.852
SECONDARY
Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct
0.297; 0.209 0.689
SECONDARY
Generalized Anxiety Disorder (GAD-7): Seven-Item Scale
1; 1 0.852
SECONDARY
Avoidance of Life-Sustaining Therapies, All Patients
18; 14; 209; 251 0.418
SECONDARY
Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference
7; 10; 102; 102 0.568
SECONDARY
Palliative Care Consultation, Inpatient Stay - All Patients
218; 257; 9; 8 0.644
SECONDARY
Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit
91; 114; 2; 5 0.908
SECONDARY
Palliative Care Consultation, Inpatient Stay - All Patients
218; 257; 9; 8 0.644
SECONDARY
Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit
91; 114; 2; 5 0.908
SECONDARY
Palliative Care Referral, Outpatient Visit - All Patients
213; 244; 14; 21 0.501
SECONDARY
Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit
89; 108; 4; 11 0.192
SECONDARY
Palliative Care Referral, Outpatient Visit - All Patients
213; 244; 14; 21 0.501
SECONDARY
Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit
89; 108; 4; 11 0.192
SECONDARY
Palliative Care Consultation and/or Referral - All Patients
206; 240; 21; 25 0.955
SECONDARY
Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit
87; 106; 6; 13 0.303
SECONDARY
Palliative Care Consultation and/or Referral - All Patients
206; 240; 21; 25 0.955
SECONDARY
Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit
87; 106; 6; 13 0.303

Summary

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.

Eligibility Criteria

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 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01933789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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