This randomized clinical trial assesses whether a community health worker–led advance care planning and symptom screening intervention reduced acute care use more than usual care in a community setting.
Key Points
Question
What is the effect of a community health worker–led advance care planning and symptom management intervention on acute care use among patients with advanced stages of hematologic and solid tumor cancers?
Findings
In this randomized clinical trial that included 128 adults with cancer, patients in the community health worker–led intervention had a 62% decreased risk of acute care use compared with patients who received usual cancer care alone.
Meaning
Community health worker–led approaches may be one approach to improve advance care planning and symptom management and reduce unnecessary acute care use among patients with cancer.
Abstract
Importance
Deficiencies in advance care planning and symptom management are associated with avoidable acute care use among patients with cancer. Community health worker (CHW)–led approaches may be an approach to reduce acute care use but remain untested in community settings.
Objective
To determine whether a CHW-led advance care planning and symptom screening intervention can reduce acute care use more than usual care in a community setting.
Design, Setting, and Participants
This randomized clinical trial was conducted among patients with newly diagnosed advanced-stage or recurrent solid and hematologic cancers from August 8, 2017, through November 30, 2021. Data analysis was performed November 30, 2021, through January 1, 2022, by intention to treat.
Interventions
Participants were randomized 1:1 to usual care (control group) or usual care with the 6-month CHW-led intervention (intervention group).
Main Outcomes and Measures
The primary outcome was acute care use. Secondary outcomes included advance care planning documentation, supportive care use, patient-reported outcomes, survival, and end-of-life care use.
Results
Among 128 participants, median (range) age was 67 (19-89) years; 61 (47.7%) were female; and 2 (1.6%) were American Indian or Alaska Native, 11 (8.6%) were Asian, 5 (3.9%) were Black, 23 (18.0%) were Hispanic or Latino, 2 (1.6%) were of mixed race, 2 (1.6%) were Native Hawaiian or other Pacific Islander, 86 (67.2%) were White, and 20 (15.6%) did not report race. Intervention participants had 62% lower risk of acute care use than the control (hazard ratio, 0.38; 95% CI, 0.19-0.76) within 6 months. At 12 months, intervention participants had 17% lower odds of acute care use (odds ratio [OR], 0.83; 95% CI, 0.69-0.98), 8 times the odds of advance care planning documentation (OR, 7.18; 95% CI, 2.85-18.13), 4 times the odds of palliative care (OR, 4.46; 95% CI, 1.88-10.55), nearly double the odds of hospice (OR, 1.83; 95% CI, 1.16-2.88), and nearly double the odds of improved mental and emotional health from enrollment to 6 and 12 months postenrollment (OR, 1.82; 95% CI, 1.03-3.28; and OR, 2.20; 95% CI, 1.04-4.65, respectively) than the control. There were no differences in the death (control, 26 [40.6%] vs intervention, 32 [50.0%]). Fewer intervention participants had acute care use (0 vs 6 [23.1%]) in the month before death than the control.
Conclusions and Relevance
In this randomized clinical trial, integration of a CHW-led intervention into cancer care reduced acute care use and is one approach to improve cancer care delivery for patients with advanced stages of disease in community settings.
Trial Registration
ClinicalTrials.gov Identifier: NCT03154190
Introduction
National guidelines recommend advance care planning (ACP) and symptom management for patients with advanced stages of cancer,1,2,3 yet a minority receive such care.4,5,6 This deficiency leads to lack of prognostic awareness7,8,9 and undertreated symptoms, which result in avoidable acute care use,10 care that differs from patients’ preferences,11,12,13,14 and psychological and physical distress.15,16 Although ACP and proactive symptom management can reduce acute care use and improve patient experiences,15,17,18,19 multilevel barriers inhibit delivery of such care. These include limited clinician time, lack of reimbursement, and cancer and palliative care workforce shortages.20,21,22,23,24
In response, we developed an approach that integrates lay or community health workers (CHWs), trained personnel who may not have a clinical background, to engage patients in ACP and proactively screen symptoms.25 Supportive cancer care interventions led by CHWs remain relatively uncommon in the US. While some interventions integrate CHWs into delivery of ACP for veterans, Medicare beneficiaries, and Latinx adults,18,26,27,28,29 less frequently are CHWs integrated into proactive cancer symptom screening,19,30 and none to our knowledge integrate CHWs into both ACP and proactive cancer symptom screening in community settings.
Studies show that CHW-led ACP and CHW-led symptom screening are associated with reductions in acute care use among Medicare beneficiaries,19,26,30 yet few have evaluated the effectiveness of such approaches. In our randomized clinical trial among veterans with advanced stages of cancer, CHW-led ACP effectively improved ACP documentation and satisfaction and reduced acute care use and total costs more than usual care.18 Furthermore, the combined effectiveness of CHW-led ACP and proactive symptom screening remains unknown. Therefore, we conducted this randomized clinical trial among patients with advanced stages of solid and hematologic cancers in a community cancer clinic. The primary objective was to determine whether the intervention reduced acute care use more than usual care. Secondarily, we evaluated the effect on ACP documentation, palliative care, hospice use, patient satisfaction, overall mental and emotional health status, overall survival, and end-of-life care.
Methods
Study Design and Oversight
This 2-arm randomized clinical trial was conducted at the Virginia K. Crosson Cancer Center in Fullerton, California, from August 8, 2017, through November 30, 2021. Participants with newly diagnosed advanced stages or recurrent solid and hematologic cancers provided written informed consent. The protocol (Supplement 1) was approved by the Stanford University Institutional Review Board and Providence St. Jude Medical Center.31
Participant Selection
Eligible patients included those 18 years or older with newly diagnosed stage III and IV colon cancer; stage II, III, or IV rectal cancer; glioblastoma multiforme; stage IIIA, IIIB, or IV non–small cell lung cancer; small cell lung cancer; small cell castration-resistant prostate cancer; stage III or IV head and neck cancer; stage III or IV gastric cancer; stage III or IV esophageal cancer; stage II, III, or IV pancreatic cancer; stage IV renal cell carcinoma; stage IV breast cancer if triple negative (estrogen receptor, progesterone receptor, and ERBB2 [formerly HER2] negative) or receiving systemic chemotherapy; stage IV sarcoma; stage IV bladder carcinoma; stage III or IV melanoma; stage III or IV ovarian cancer; acute myeloid leukemia; or high-grade myelodysplastic syndrome. Any patient with recurrent or progressive cancer was also eligible. Exclusions included inability to consent, pregnant (as primary management is by obstetrics and gynecology teams), plan to move, or in hospice or home-based care at enrollment.
Procedures and Randomization
One week after the first oncology appointment or disease recurrence, consented participants completed baseline surveys to assess (1) symptom burden using the validated Edmonton Symptom Assessment System (ESAS)32; (2) experience with care, overall health status, and mental and emotional health status using the validated Consumer Assessment of Health Care Providers and Systems General Survey33; and (3) satisfaction with decision using the validated Satisfaction With Decision Scale.34 Participants were randomized 1:1 through a simple randomization strategy with computer-generated randomized numbers to either usual care alone (control group) or usual care with the 6-month CHW-led ACP and proactive symptom screening “Health Coach” intervention (intervention group).
Usual Care (Control Group)
All participants received usual care provided by the clinical team, which involved access to a social worker, navigator, palliative care team, mental health specialist, and ancillary services, such as yoga and classes, support groups, and nutrition counseling.
Health Coach (Intervention Group)
Two part-time (20 hours/week) CHWs were hired. Both were female. One self-identified as a middle-aged, White retired nurse and one self-identified as a 30-year-old Latinx woman who was bilingual in English and Spanish and had completed a bachelor of arts degree. The CHWs were hired based on their interpersonal skills through a rigorous selection process and trained prior to study start. Training included a condensed version of previously developed curricula by the principal investigator (M.I.P.), which included 40 hours of online skills-based training in motivational interviewing and end-of-life care, 2 weeks of observational training with the local palliative care team, and weekly hour-long case-review sessions and didactics with the supervising clinic nurse.31
Within 1 week of study enrollment, intervention participants were assigned to 1 of the CHWs who delivered a structured program, as described in our prior studies,19,30 twice monthly over 6 months. The program comprised 3 telephone segments that included (1) education about goals of care and advance directives; (2) tailored guidance on how to engage in ACP conversations with clinical teams and document advance directives; and (3) weekly proactive symptom screening using the ESAS.32 The CHWs also engaged participants 1:1 in open-ended discussions. The CHWs, as in our previous studies,19,30 reviewed symptom scores of 4 or greater or any scores that changed by 2 points from prior assessments with the supervising nurse, who conducted the appropriate clinical intervention. Intervention participants with limited English proficiency, as assessed as part of usual care by the clinic, were offered interpreter services in each CHW encounter.
Study Outcomes
The primary outcome was acute care use (emergency department [ED] and/or hospitalization) within 6 months postenrollment. Prespecified secondary outcomes were exploratory and included ACP documentation by the primary cancer clinician in the electronic health record (goals of care, advance directive, Physician Orders for Life Sustaining Treatment); health care use (ED visits, hospitalizations, palliative care, hospice) within 12 months; health care use in the 30 days prior to death; overall survival; and patient-reported outcomes (patient experience with care, overall health, and mental and emotional health status; satisfaction with decision-making).
To assess outcomes, at enrollment (baseline) and 6 and 12 months postenrollment, each participant completed telephone surveys with a research assistant (RA) (B.S. and E.S.), who also conducted electronic health record review of ACP documentation and health care use. All participants provided permission for the study team to obtain their outside facility medical records for acute care use external to the St. Jude comprehensive network. The study team and all cancer clinicians were blinded to the randomization assignment.
Baseline Characteristics
In phone interviews at baseline, participants completed surveys with an RA, which included questions regarding age, gender identity, ethnicity, race, education level, insurance status, and symptom burden using ESAS.32 The RA reviewed the electronic health record to obtain cancer diagnosis and date, stage, recurrent cancer status, and cancer-directed treatment (to demonstrate treatment receipt balance between study arms).
Statistical Analysis
We estimated that a sample size of 128 participants would have at least 90% power with a 2-sided type I error rate of .05 to detect at least a 55% difference in acute care use risk based on effect sizes from our prior studies that show 20% to 95% reduction in acute care use, albeit at the end of life.18,19 We analyzed all data on an intention-to-treat basis.
Primary Analyses
We compared risk of acute care use (defined as any ED visit and/or hospitalization) between groups within 6 months postenrollment using Cox proportional hazards models. We compared counts of ED visits and hospitalizations using generalized estimating equations (GEE)-log Poisson models with an offset term for length of follow-up.
Secondary Analyses
We used GEE-log binomial models to compare dichotomous outcomes (eg, ACP documentation, chemotherapy, radiation therapy, surgery, palliative care, and hospice use within 12 months) between groups. We compared overall survival using Kaplan-Meier methods and Cox proportional hazards models. Among participants who died within 12 months postenrollment, we described above and modeled (1) the proportion of participants with ED visits and/or hospitalizations in the 30 days prior to death and (2) the proportion who received palliative care and/or were enrolled in hospice in the 30 days prior to death.
We dichotomized patient-reported outcome variables and reported results as the proportion of participants who responded “always” and “strongly agree” for experience and satisfaction assessments, and “very good” or “excellent” for overall health and mental and emotional health status assessments. We used GEE-log binomial models clustered within participant with an exchangeable correlation structure to compare changes in patient-reported outcome responses between groups over time from baseline to 6 and 12 months postenrollment. Outcomes were modeled as a function of treatment group, categorical time (6 months, 12 months, or baseline) and an interaction term between treatment group and time. All significance testing was conducted at a 2-sided P value of .05 with Stata/SE, version 16.1 (StataCorp LLC).35 The study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines.
Results
Table 1 shows baseline demographic characteristics of the 128 study participants. The median (range) age was 67 (19-89) years; 64 (50.0%) were male. Participants self-reported race and ethnicity; 2 (1.6%) were American Indian or Alaska Native, 11 (8.6%) were Asian, 5 (3.9%) were Black, 23 (18.0%) were Hispanic or Latino, 2 (1.6%) were of mixed race, 2 (1.6%) were Native Hawaiian or other Pacific Islander, 86 (67.2%) were White, and 20 (15.6%) did not report race. A total of 81 (63.3%) had attained at least some college or 2-year degree, and 78 (60.9%) were privately insured. Most had gastrointestinal (49 [38.2%]) or thoracic (24 [18.8%]) cancers and were diagnosed with stage IV disease (97 [75.8%]). Fifty-two (40.6%) had recurrent cancer. Most received chemotherapy (120 [93.8%]). The Figure shows the flow of study participants; 64 (50.0%) were randomized to the intervention and 64 (50.0%) to the control. One died after randomization in the control group. None were lost to follow-up or withdrew. All 128 were included in the intention-to-treat analysis.
Table 1. Baseline Characteristics of Study Participantsa.
| Variable | No. (%) | ||
|---|---|---|---|
| Total (n = 128) | Control group (n = 64) | Intervention group (n = 64) | |
| Age, median (range), y | 67 (19-89) | 67 (43-89) | 70 (19-89) |
| Gender identity | |||
| Female | 61 (47.7) | 31 (48.4) | 30 (46.9) |
| Male | 64 (50.0) | 32 (50.0) | 32 (50.0) |
| Nonbinary | 3 (2.3) | 1 (1.6) | 2 (3.1) |
| Race and ethnicity | |||
| American Indian or Alaska Native | 2 (1.6) | 1 (1.6) | 1 (1.6) |
| Asian | 11 (8.6) | 7 (10.9) | 4 (6.3) |
| Black | 5 (3.9) | 3 (4.7) | 2 (3.1) |
| Latino or Hispanic | 23 (18.0) | 11 (17.2) | 12 (18.8) |
| Mixed race | 2 (1.6) | 2 (3.1) | 0 |
| Native Hawaiian or other Pacific Islander | 2 (1.6) | 1 (1.6) | 1 (1.6) |
| White | 86 (67.2) | 40 (62.5) | 46 (71.8) |
| Prefer not to answer | 20 (15.6) | 10 (15.6) | 10 (15.6) |
| Education level | |||
| Less than 8th grade | 1 (0.8) | 1 (1.6) | 0 |
| Some high school | 2 (1.6) | 1 (1.6) | 1 (1.6) |
| High school graduate or GED | 13 (10.2) | 5 (7.8) | 8 (12.5) |
| Some college or 2-y degree | 42 (32.8) | 22 (34.4) | 20 (31.3) |
| 4-y College graduate | 19 (14.8) | 11 (17.2) | 8 (12.5) |
| More than 4-y college graduate | 20 (15.6) | 6 (9.4) | 14 (21.9) |
| Prefer not to answer | 31 (24.2) | 18 (28.1) | 13 (20.3) |
| Insurance status | |||
| Medicare | 41 (32.0) | 20 (31.2) | 21 (32.8) |
| Medicaid | 6 (4.7) | 3 (4.7) | 3 (4.7) |
| Private | 78 (60.9) | 40 (62.5) | 38 (59.4) |
| Uninsured | 3 (2.4) | 1 (1.6) | 2 (3.1) |
| Anatomic site of cancer diagnosis | |||
| Gynecology | 11 (8.6) | 4 (6.3) | 7 (10.9) |
| Genitourinary | 8 (6.3) | 3 (4.7) | 5 (7.8) |
| Gastrointestinal | 49 (38.2) | 29 (45.2) | 20 (31.3) |
| Breast | 9 (7.0) | 5 (7.8) | 4 (6.3) |
| Thoracic | 24 (18.8) | 10 (15.6) | 14 (21.9) |
| Malignant hematologic | 10 (7.8) | 5 (7.8) | 5 (7.8) |
| Head and neck | 6 (4.7) | 1 (1.6) | 5 (7.8) |
| Melanoma | 4 (3.1) | 2 (3.1) | 2 (3.1) |
| Glioblastoma | 6 (4.7) | 4 (6.3) | 2 (3.1) |
| Unknown primary | 1 (0.8) | 1 (1.6) | 0 |
| Cancer stage at diagnosis | |||
| III | 21 (16.4) | 9 (14.1) | 12 (18.8) |
| IV | 97 (75.8) | 49 (76.6) | 48 (75.0) |
| Not applicable (ie, leukemia, glioblastoma) | 10 (7.8) | 6 (9.3) | 4 (6.2) |
| Recurrent cancer | 52 (40.6) | 29 (45.3) | 23 (35.9) |
| Cancer-directed treatment | |||
| Chemotherapy | 120 (93.8) | 60/64 (93.8) | 60/64 (93.8) |
| Radiation therapy | 53 (41.4) | 28/64 (43.8) | 25/64 (40.3) |
| Surgery | 29 (22.7) | 10/64 (15.6) | 19/64 (29.7) |
| Symptom burden, mean (SD)b | 13.0 (11.3) | 12.8 (11.5) | 13.3 (10.5) |
Gender identity, ethnicity, race, age, education level, and symptom burden were self-reported by patients.
Symptom burden was assessed using the Edmonton Symptom Assessment Scale.
Figure. Flow of Participants Through the Study.
Primary Outcome
Table 2 shows acute care use within 6 months postenrollment. Fewer intervention participants had any acute care use (12 [18.8%] vs 26 [40.6%]) than the control. Intervention participants had 62% lower acute care use risk (hazard ratio [HR], 0.38; 95% CI, 0.19-0.76) than the control. Fewer intervention participants had ED use (10 [15.6%] vs 20 [31.3%]) than the control. Intervention group participants had 67% lower ED use risk (HR, 0.33; 95% CI 0.14-0.79) and 70% fewer mean ED visits per participant (risk ratio [RR], 0.30; 95% CI, 0.20-0.47) than the control. While there were no differences between groups in the proportion of participants with hospitalization (8 [12.5%] vs 19 [29.7%]) or hospitalization risk (HR, 0.33; 95% CI, 0.11-1.04), intervention participants had fewer mean hospitalizations per participant (RR, 0.48; 95% CI, 0.30-0.75).
Table 2. Acute Care Use Within 6 Months.
| Variable | No. (%) | HR or RR (95% CI)a | |
|---|---|---|---|
| Control group (n = 64) | Intervention group (n = 64) | ||
| Any acute care use | 26 (40.6) | 12 (18.8) | HR: 0.38 (0.19-0.76) |
| Emergency department | |||
| Any emergency department visit use | 20 (31.3) | 10 (15.6) | HR: 0.33 (0.14-0.79) |
| Emergency department visits, mean (SD) | 1.33 (2.53) | 0.41 (1.02) | RR: 0.30 (0.20-0.47) |
| Hospital visit | |||
| Any hospital visit | 19 (29.7) | 8 (12.5) | HR: 0.33 (0.11-1.04) |
| Hospital visits, mean (SD) | 0.91 (1.98) | 0.44 (1.28) | RR: 0.48 (0.30-0.75) |
Abbreviations: HR, hazard ratio; RR, risk ratio.
The HRs were estimated using Cox regression models for acute care use, emergency department use, and hospitalization use within 6 months postenrollment. The RRs were estimated using generalized estimating equations log-Poisson models offset for follow-up time. All ratios are expressed as referent to the control group.
Secondary Outcomes
Acute Care Use
At 12-month follow-up (Table 3), intervention participants had 17% lower odds of any acute care use than the control (odds ratio [OR], 0.83; 95% CI, 0.69-0.98). There were no statistically significant differences in the odds of ED use (OR, 0.84; 95% CI, 0.70-1.00) or hospitalizations (OR, 0.85; 95% CI, 0.71-1.02); however, the intervention group had fewer mean ED visits per participant (RR, 0.45; 95% CI, 0.33-0.62) and fewer mean hospitalizations per participant (RR, 0.50; 95% CI, 0.36-0.70).
Table 3. Secondary Outcomes Within 12 Months Postenrollment and at the End of Life.
| Variable | No./total No. (%) | OR or RR (95% CI) | |
|---|---|---|---|
| Control group | Intervention group | ||
| Acute care usea | |||
| Any acute care use | 33/64 (51.6) | 21/64 (32.8) | OR: 0.83 (0.69-0.98) |
| ED visit | |||
| Any ED visit use | 29/64 (45.3) | 18/64 (28.1) | OR: 0.84 (0.70-1.00) |
| ED visits, mean (SD) | 2.02 (3.86) | 0.92 (1.67) | RR: 0.45 (0.33-0.62) |
| Hospital visit | |||
| Any hospital visit | 26/64 (40.6) | 16/64 (25.0) | OR: 0.85 (0.71-1.02) |
| Hospital visits, mean (SD) | 1.63 (3.03) | 0.82 (1.68) | RR: 0.50 (0.36-0.70) |
| Advance care planning | |||
| Goals of care discussion | 34/64 (53) | 58/64 (91) | OR: 8.53 (3.22-22.57) |
| Goals of care documentation | 34/64 (53) | 57/64 (89) | OR: 7.18 (2.85-18.13) |
| Advance directive | 12/64 (18.8) | 36/64 (56.3) | OR: 5.57 (2.51-12.38) |
| Physician Orders for Life Sustaining Treatment | 11/64 (17.2) | 24/64 (37.5) | OR: 2.89 (1.27-6.59) |
| Supportive care | |||
| Palliative care | 37/64 (57.8) | 55/64 (85.9) | OR: 4.46 (1.88-10.55) |
| Hospice | 10/64 (15.6) | 20/64 (31.3) | OR: 1.83 (1.16-2.88) |
| End-of-life health care useb | |||
| Any acute care usec | 6/26 (23.1) | 0/32 | NA |
| Any ED usec | 4/26 (15.4) | 0/32 | NA |
| Any hospital usec | 3/26 (11.5) | 0/32 | NA |
| Palliative care | 17/26 (65.4) | 26/32 (81.3) | OR: 2.29 (0.69-7.62) |
| Hospice | 9/26 (34.6) | 16/32 (50.0) | OR: 1.88 (0.57-4.85) |
Abbreviations: ED, emergency department; GEE, generalized estimating equations; OR, odds ratio; RR, risk ratio.
The ORs were estimated using GEE models for acute care use, ED use, or hospitalization use. The RRs were estimated using GEE log-Poisson models offset for follow-up time. All ratios are expressed as referent to the control group.
Results are presented as proportion of participants who died within 12 months postenrollment. A total of 26 (40.6%) participants died in the control group and 32 (50.0%) in the intervention group.
No events occurred in the intervention group, and therefore estimates could not be generated.
ACP Documentation
Intervention participants had greater documentation of ACP and supportive care use within 12 months postenrollment than the control (Table 2). Specifically, more intervention participants had documentation of their goals of care (57 [89.1%] vs 34 [53.1%]; OR, 7.18; 95% CI, 2.85-18.13), advance directives (36 [56.3%] vs 12 [18.8%]; OR, 5.57; 95% CI, 2.51-12.38), and Physician Orders for Life Sustaining Treatment (24 [37.5%] vs 11 [17.2%]; OR, 2.89; 95% CI, 1.27-6.59) than the control. More intervention participants had palliative care (55 [85.9%] vs 37 [57.8%]; OR, 4.46; 95% CI, 1.88-10.55) and hospice use (20 [31.3%] vs 10 [15.6%]; OR, 1.83; 95% CI, 1.16-2.88) than the control. There were no differences in length of hospice enrollment (median [range], 149 [34-326] vs 91 [25-330] days) (data not shown).
End-of-Life Subgroup Analysis
A total of 32 (50.0%) participants died in the intervention group and 26 (40.6%) in the control group. There were no survival differences (eFigure in Supplement 2) (P = .56) or risk of death (data not shown) (HR, 1.16; 95% CI, 0.69-1.96). No intervention participants used acute care in the last month of life compared with 6 (23.1%) control participants (Table 3). Although more intervention participants had palliative care and hospice (16 [50.0%] vs 9 [34.6%]) prior to death than the control, differences were not statistically significant.
Patient-Reported Outcomes
There were no differences between groups in the proportion of participants who highly rated their satisfaction or their overall health status at any time point. However, more intervention participants highly rated their overall mental and emotional health status at 6 and 12 months than the control, and the difference over time between groups from baseline was significant (OR, 1.82; 95% CI, 1.03-3.28; OR, 2.20; 95% CI, 1.04-4.65, respectively) (Table 4).
Table 4. Patient-Reported Outcomes at 6 and 12 Months Postenrollment.
| Variable | No./total No. (%) | OR (95% CI)a | ||||||
|---|---|---|---|---|---|---|---|---|
| Control group | Intervention group | |||||||
| Baseline | 6 mo | 12 mo | Baseline | 6 mo | 12 mo | Baseline to 6 mo | Baseline to 12 mo | |
| Patient experience with care b | ||||||||
| In the last 3 mo, when you contacted this provider’s office during regular office hours, how often did you get an answer to your medical question that same day?c | 22/28 (78.6) | 21/27 (77.8) | 15/20 (75.0) | 22/32 (68.8) | 34/34 (100.0) | 17/21 (81.0) | NA | 1.83 (0.67-5.02) |
| In the last 3 mo, when you contacted this provider’s office after office hours, how often did you get an answer to your medical question that same day?c | 11/18 (61.1) | 9/13 (69.2) | 6/8 (75.0) | 9/12 (75.0) | 13/13 (100.0) | 10/11 (90.9) | NA | 1.71 (0.19-5.08) |
| In the last 3 mo, how often did your provider team explain things in a way that was easy to understand?c | 34/47 (72.3) | 35/41 (85.4) | 27/29 (93.1) | 38/51 (74.5) | 42/44 (95.5) | 24/28 (85.7) | 2.66 (0.13-1.15) | 1.42 (0.39-5.01) |
| In the last 3 mo, how often did this provider’s team listen carefully to you? | 40/47 (85.1) | 37/41 (90.2) | 28/30 (93.3) | 46/51 (90.2) | 42/44 (95.5) | 26/28 (93.0) | 0.44 (0.08-2.36) | 1.44 (0.22-9.33) |
| In the last 3 mo, how often did this provider’s team show respect for what you had to say? | 42/47 (89.4) | 38/41 (92.7) | 30/30 (100.0) | 47/51 (92.2) | 43/44 (97.7) | 28/28 (100.0) | 0.28 (0.03-2.53) | NA |
| In the last 3 mo, how often did this provider’s team spend enough time with you? | 40/46 (86.9) | 40/41 (97.6) | 30/30 (100.0) | 41/51 (80.4) | 44/44 (100.0) | 28/28 (100.0) | NA | NA |
| In the last 3 mo, when this provider’s team ordered a blood test, x-ray, or other test for you, how often did someone from this provider’s office follow up to give you those results?c | 37/43 (86.1) | 35/39 (89.7) | 28/30 (93.3) | 39/50 (78.0) | 38/44 (86.4) | 24/28 (85.7) | 0.57 (0.19-1.69) | 0.97 (0.58-1.64) |
| I am satisfied with the care I received at St. Joseph Heritage Healthcare.d | 47/47 (100.0) | 40/41 (97.6) | 27/30 (90.0) | 50/51 (98.0) | 44/44 (100.0) | 28/28 (100.0) | NA | NA |
| Using any number from 0 to 10, where 0 is the worst possible care and 10 is the best possible care, what number would you use to rate your care?e | 30/46 (65.2) | 27/41 (65.9) | 21/30 (70.0) | 37/52 (71.2) | 33/44 (75.0) | 22/28 (78.6) | 1.44 (0.77-3.00) | 2.04 (0.59-7.03) |
| Satisfaction with decision f | ||||||||
| I am satisfied that I am adequately informed about the treatment decisions available to me. | 47/47 (100.0) | 40/41 (97.6) | 29/30 (96.7) | 50/51 (98.0) | 44/44 (100.0) | 28/28 (100.0) | NA | NA |
| I made the best decisions possible about my treatment options. | 47/47 (100.0) | 40/41 (97.6) | 29/30 (96.7) | 50/51 (98.0) | 44/44 (100.0) | 28/28 (100.0) | NA | NA |
| I believe that my decisions were consistent with what’s important to me. | 47/47 (100.0) | 40/41 (97.6) | 29/30 (96.7) | 50/51 (98.0) | 44/44 (100.0) | 28/28 (100.0) | NA | NA |
| I expect to successfully carry out (or continue to carry out) the decision I made. | 47/47 (100.0) | 40/41 (97.6) | 29/30 (96.7) | 50/51 (98.0) | 44/44 (100.0) | 28/28 (100.0) | NA | NA |
| I was encouraged by the Cancer Center staff to speak up about my treatment preferences. | 47/47 (100.0) | 40/41 (97.6) | 29/30 (96.7) | 50/51 (98.0) | 44/44 (100.0) | 28/28 (100.0) | NA | NA |
| I am satisfied with the care I received at St. Joseph Heritage Healthcare. | 46/47 (97.9) | 39/41 (95.1) | 28/30 (93.3) | 49/51 (96.1) | 44/44 (100.0) | 28/28 (100.0) | NA | NA |
| Overall mental and emotional health status g | ||||||||
| In general, how would you rate your overall health? | 12/46 (26.1) | 10/41 (24.4) | 9/30 (30.0) | 12/52 (23.1) | 12/44 (27.3) | 9/28 (32.1) | 0.82 (0.33-2.05) | 1.65 (0.71-3.85) |
| In general, how would you rate your overall mental or emotional health? | 31/46 (67.4) | 13/41 (31.7) | 9/31 (29.0) | 34/52 (65.4) | 28/44 (63.6) | 18/29 (62.1) | 1.82 (1.03-3.28) | 2.20 (1.04-4.65) |
Odds ratios (ORs) estimated based on responses at 6 months and 12 months compared with baseline using generalized estimating equations (GEE) models clustered within person. Because of small cell sizes, some estimates could not be calculated.
Questions assessed with responses never, sometimes, usually, or always. Results expressed as proportion of participants who responded always at 6 and 12 months.
Results expressed as proportions of participants for whom the question pertained (ie, participants who had contacted the office either during or after hours; participants who had a test ordered).
Questions assessed with responses of strongly disagree, disagree, neither agree nor disagree, agree, or strongly agree. Results expressed as proportion of participants who responded strongly agree at 6 and 12 months.
Assessed using Consumer Assessment of Health Care Providers and Systems (CAHPS)–Clinician and Group Survey version 2.0 question No. 23, which measured rating of care; scores range from 0 to 10; higher scores indicate higher ratings. A total of 46 (71.9%) participants in the control group and 52 (81.3%) in the intervention group completed this question at baseline. A total of 41 participants (67.2%) in the control group and 44 (68.8%) in the intervention group completed this question at 6 months; 10 (15.6%) participants in the control group and 12 (18.8%) in the intervention group had died by the 6-month assessment. A total of 30 participants (78.9%) in the control group and 28 (87.5%) in the intervention group completed this question at 12 months; 26 (40.6%) in the control group and 32 (50.0%) in the intervention group had died by the 12-month assessment. Results expressed as proportion who ranked their care as 10. P value estimated using GEE comparing the change between groups over time from baseline to 6 and 12 months.
Assessed using the Satisfaction With Decision Scale. Questions were assessed with responses on a scale of strongly disagree, disagree, neither agree nor disagree, agree, or strongly agree. Results expressed as proportion who responded strongly agree at 6 months.
Assessed using the CAHPS–Clinician and Group Survey version 2.033 question No. 26, which measured rating of overall health with responses of excellent, very good, fair, or poor. A total of 46 (71.9%) participants in the control group and 52 (81.3%) in the intervention group completed this question at baseline. Results presented as proportion who rated excellent or very good. A total of 41 participants (67.2%) in the control group and 44 (68.8%) in the intervention group completed this question at 6 months; 10 (15.6%) participants in the control group and 12 (18.8%) in the intervention group had died by the 6-month assessment. A total of 30 participants (78.9%) in the control group and 28 (87.5%) in the intervention group completed this question at 12 months; 26 (40.6%) participants in the control group and 32 (50.0%) in the intervention group had died by the 12-month assessment. P value estimated using GEE comparing the change between groups over time from baseline to 6 and 12 months.
Discussion
This randomized clinical trial of a CHW-led ACP and proactive symptom screening intervention found effectively reduced acute care use among patients with cancer in a community clinic. The intervention also improved ACP documentation, palliative care, hospice, and mental and emotional health status over time.
Although acute care use is part of the cancer care trajectory,36,37 half of all cancer-related hospitalizations in the US are avoidable.38,39 Most interventions that aim to reduce acute care use are led by clinical professionals and have mixed results on acute care use. The Centers for Medicare & Medicaid Services Oncology Care Model, for example, did not reduce hospitalizations,40 while others, such as hospital-at-home, reduced hospitalization rates similar to our findings.41 In this study, led by CHWs, reductions in acute care use risk at 6 months were driven by lower proportions of participants who used the ED, fewer mean ED visits per participant, and fewer mean hospitalizations per participant. While there were no significant differences between groups in the proportions of participants with a hospitalization, the mean number of hospitalizations per participant in the intervention was half that of the control. As in our prior work,18 acute care use reductions were sustained after the intervention, suggesting a potential enduring effect. As expected, at 12-month follow-up, more participants had either an ED visit or a hospitalization, and the between-group differences were smaller. Yet the intervention sustained reductions in the numbers of visits to these services, with 55% reductions in ED visits and 50% reductions in hospitalizations 6 months after the intervention ended.
Routine delivery of ACP and cancer symptom management remains challenging nationally. In current practice, ACP is infrequently discussed with patients or, if discussed at all, is discussed too late in patients’ care; centers on hypothetical scenarios; and lacks the fluidity to accommodate changes in patients’ preferences.22,42,43 Furthermore, unlike in this study, ACP is usually led by cancer clinicians, who may not have the time, training, or experience to successfully engage patients and their caregivers in frequent discussions over time.20,44,45 To date, most ACP interventions do not reduce acute care use among patients with cancer.46,47,48 In our prior work, however, a CHW-led ACP intervention among veterans significantly reduced acute care use, albeit at the end of life.18 In contrast, while most symptom screening interventions reduce acute care,17,49,50 they are not widely used in practice. Multilevel barriers to the integration of proactive cancer symptom screening approaches include inadequate clinical staffing and workflows to conduct screening and ensure appropriate interventions,51,52 limited patient and clinician access to electronic patient-reported outcome technology, and lack of financial reimbursement.20,53
In this study, we developed and implemented a high-touch, low-cost, technology-independent intervention that integrates CHWs into cancer care soon after an initial or recurrent cancer diagnosis. The intervention was informed by patient, clinician, and payer stakeholders as a potentially more acceptable and effective approach to overcome our previously identified structural barriers in the delivery of these important services.20,21,22,25 Key intervention features may have led to its success, such as more time for and encouragement of intervention participants to discuss ACP, their symptom burden, and questions. It is plausible that participants were more informed after their CHW-led interactions to engage in subsequent ACP and symptom burden discussions with their clinicians. Although we did not measure this directly, interviews with veteran and caregiver participants in our prior study support this supposition.54 The low implementation cost of the intervention is also a key feature. It is possible that total cost reductions from averted acute care use exceeded the low intervention implementation costs (approximately $87 000 annually to support salary and benefits for 2 part-time CHWs and 5% full-time equivalent supervising nurse). However, the scalability of this approach and a future cost analysis is warranted.
Finally, mental and emotional health needs of patients with cancer are prevalent but frequently unaddressed during and after cancer treatment.55,56 In this study, as in prior work,30 the CHW-led proactive symptom screening component likely led to earlier identification of unmet needs. However, other aspects of the intervention may have contributed to these results. For example, the relationship between the participant and the CHW may have provided unmeasured aspects of social support. Future research is needed to better understand these important secondary findings.
Limitations
Our study had limitations. First, this study was conducted in 1 community clinic and had a low number of Black participants. This may limit generalizability. Second, we did not obtain claims data. Although 95% of participants exclusively used acute care services within the St. Jude comprehensive health network, we combined measures to overcome this limitation, including personal histories, electronic health record review, and outside facility health records review among participants receiving external care. Third, accrual took longer than anticipated owing to small numbers of eligible participants. In addition, stage-based inclusion criteria posed challenges owing to incomplete staging of cancer at many participants’ first oncology visit. Fourth, a small sample had died by the 12-month follow-up; therefore, a longer follow-up may be necessary to see differences, if any, that emerge as more participants reach the end of life. Finally, we did not adjust P values for secondary analyses because we viewed them as exploratory.
Conclusions
In this randomized clinical trial, integration of a CHW-led ACP and proactive symptom screening intervention into cancer care reduced acute care use. This intervention may be one approach to sustainably reduce acute care use and improve ACP documentation, palliative care and hospice use, and overall mental and emotional health.
Trial Protocol
eFigure. Survival by Treatment Group
Data Sharing Statement
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Trial Protocol
eFigure. Survival by Treatment Group
Data Sharing Statement