Nurse and Social Worker Palliative Telecare Team and Quality of Life in Patients With COPD, Heart Failure, or Interstitial Lung Disease: The ADAPT Randomized Clinical Trial

Abstract

Importance: Many patients with chronic obstructive pulmonary disease (COPD), heart failure (HF), and interstitial lung disease (ILD) endure poor quality of life despite conventional therapy. Palliative care approaches may benefit this population prior to end of life.

Objective: Determine the effect of a nurse and social worker palliative telecare team on quality of life in outpatients with COPD, HF, or ILD compared with usual care.

Design, setting, and participants: Single-blind, 2-group, multisite randomized clinical trial with accrual between October 27, 2016, and April 2, 2020, in 2 Veterans Administration health care systems (Colorado and Washington), and including community-based outpatient clinics. Outpatients with COPD, HF, or ILD at high risk of hospitalization or death who reported poor quality of life participated.

Intervention: The intervention involved 6 phone calls with a nurse to help with symptom management and 6 phone calls with a social worker to provide psychosocial care. The nurse and social worker met weekly with a study primary care and palliative care physician and as needed, a pulmonologist, and cardiologist. Usual care included an educational handout developed for the study that outlined self-care for COPD, ILD, or HF. Patients in both groups received care at the discretion of their clinicians, which could include care from nurses and social workers, and specialists in cardiology, pulmonology, palliative care, and mental health.

Main outcomes and measures: The primary outcome was difference in change in quality of life from baseline to 6 months between the intervention and usual care groups (FACT-G score range, 0-100, with higher scores indicating better quality of life, clinically meaningful change ≥4 points). Secondary quality-of-life outcomes at 6 months included disease-specific health status (Clinical COPD Questionnaire; Kansas City Cardiomyopathy Questionnaire-12), depression (Patient Health Questionnaire-8) and anxiety (Generalized Anxiety Disorder-7) symptoms.

Results: Among 306 randomized patients (mean [SD] age, 68.9 [7.7] years; 276 male [90.2%], 30 female [9.8%]; 245 White [80.1%]), 177 (57.8%) had COPD, 67 (21.9%) HF, 49 (16%) both COPD and HF, and 13 (4.2%) ILD. Baseline FACT-G scores were similar (intervention, 52.9; usual care, 52.7). FACT-G completion was 76% (intervention, 117 of 154; usual care, 116 of 152) at 6 months for both groups. Mean (SD) length of intervention was 115.1 (33.4) days and included a mean of 10.4 (3.3) intervention calls per patient. In the intervention group, 112 of 154 (73%) patients received the intervention as randomized. At 6 months, mean FACT-G score improved 6.0 points in the intervention group and 1.4 points in the usual care group (difference, 4.6 points [95% CI, 1.8-7.4]; P = .001; standardized mean difference, 0.41). The intervention also improved COPD health status (standardized mean difference, 0.44; P = .04), HF health status (standardized mean difference, 0.41; P = .01), depression (standardized mean difference, -0.50; P < .001), and anxiety (standardized mean difference, -0.51; P < .001) at 6 months.

Conclusions and relevance: For adults with COPD, HF, or ILD who were at high risk of death and had poor quality of life, a nurse and social worker palliative telecare team produced clinically meaningful improvements in quality of life at 6 months compared with usual care.

Trial registration: ClinicalTrials.gov Identifier: NCT02713347.

Figure 1.. Screening, Enrollment, Randomization, and Follow-Up in the ADAPT Trial

^aSee Population section for eligibility criteria. ^bMost did not meet criteria because they did not have a diagnosis of HF or COPD or their FACT-G score was >70 (see Outcomes section for explanation) or they were not bothered by any target symptoms. Specific numbers for reasons not meeting each eligibility criterion are not available because (1) patients were reconsidered during the accrual period to see if they developed eligibility, and the reasons for noneligibility changed with subsequent medical record reviews or screening calls; or (2) some disease-specific criteria changed during the accrual period, including dropping the requirement for spirometry. ^cIncluded concerns with the ability to get facility-based medical care recommended by the intervention. ^dPhone problems (16) were most common.

Figure 2.. Regression-Estimated Means and Change Scores for Quality-of-Life Outcomes

Values were obtained from linear mixed models (interaction between treatment status and dummy variables for time) and adjusted for disease status at randomization. All outcome measures are patient-reported. ^aSee Outcomes section for explanation of the FACT-G. ^bFor physical and for social/family well-being, the score range is 0 to 28; for emotional and for functional well-being, the score range is 0 to 24. Higher scores indicate better well-being; minimal clinically important difference [MCID], 2-3. ^cScore range, 0 to 24 (higher scores indicate more depressive symptoms; MCID, 3). Negative mean difference scores indicate improvement in symptoms.^dScore range, 0 to 21 (higher scores indicate more anxiety symptoms; MCID, 2-4). Negative mean difference scores indicate improvement in symptoms.

Figure 3.. Six-Month Change in FACT-G Score (Primary Outcome) by Participant and Randomization Group

The FACT-G is patient-reported (score range, 0-108, with higher scores indicating better quality of life; minimal clinically important difference, 4). For box plots, the ends of the boxes are located at the first and third quartiles. The horizontal black line in the middle illustrates the median, and the diamonds indicate the mean. Whiskers extend to the highest and lowest values within 1.5 times the IQR, and markers outside the boxes indicate outlying data. The parallel line plot contains 1 vertical line for each participant, which extends from their baseline value to their 6-month value. Descending lines indicate a reduction in outcome. Baseline values are placed in ascending order for the ADAPT intervention group and descending order for the usual care group.

Figure 4.. Regression-Estimated Mean Values and Change Scores for Disease-Specific Health Status Outcomes

^aCOPD-specific health status (CCQ) is patient-reported (score range, 0-6; higher scores indicate worse health status; minimal clinically important difference, 0.4).For the CCQ, negative mean difference scores indicate better status. ^bHeart failure–specific health status (KCCQ-12) is patient-reported (score range, 0-100; higher scores indicate better health status; minimal clinically important difference, 3.6-5). See the eFigure in Supplement 1.