Study Overview
Objective. To evaluate the efficacy of an intervention targeting both patients and clinicians intended to increase goals-of-care conversations.
Design. Multicenter cluster-randomized controlled trial.
Setting and participants. Clinicians (physicians or nurse practitioners) were recruited between February 2014 and November 2015 from 2 large health centers in the Pacific Northwest and were eligible if they provided primary or specialty care and had at least 5 eligible patients in their panels. Using the electronic health record (EHR) and clinic schedules, study staff identified and contacted (via mail or telephone) consecutive patients cared for by participating clinicians between March 2014 and May 2016 with the following eligibility criteria: age 18 years or older, 2 or more visits with the clinician in the last 18 months, and 1 or more qualifying conditions. Qualifying conditions included (1) metastatic cancer or inoperable lung cancer; (2) COPD with FEV1 values below 35% of that predicted or oxygen dependence, restrictive lung disease with a total lung capacity below 50% of that predicted, or cystic fibrosis with FEV1 below 30% of that predicted; (3) New York Heart Association class III or IV heart failure, pulmonary arterial hypertension, or left ventricular assist device or implantable cardioverter defibrillator implant; 4) cirrhosis or end-stage liver disease; (5) dialysis-dependent renal failure and diabetes; (6) age 75 or older with one or more life-limiting chronic illness; (7) age 90 or older; (8) hospitalization in the last 18 months with a life-limiting illness; (9) Charlson comorbidity index of 6 or higher. The qualifying criteria were selected to identify a median survival of approximately 2 years, suggesting relevance of goals-of-care discussions.
Intervention. The intervention was the patient-specific Jumpstart-Tips intervention, intended to prime clinicians and patients for a brief discussion of goals of care during a routine clinic visit. Patients in the intervention group received a survey to assess their preferences, barriers and facilitators for communication about end-of-life care. Survey responses were used to (1) generate an abstracted version of the patient’s preferences, (2) identify the most important communication barrier or facilitator, and (3) provide communication tips based on curricular materials from VitalTalk (http://vitaltalk.org) tailored to patient responses. The 1-page communication guide, called Jumpstart-Tips, was sent to clinicians 1 or 2 days prior to the target clinic visit date. Patients also received 1-page patient-specific Jumpstart-Tips forms, which summarized their survey responses and provided suggestions for having a goals-of-care conversation with the clinician. Patients in the control group completed the same surveys, but no information was provided to the patients or clinicians. Clinicians were randomly assigned in a 1:1 ratio to intervention or enhanced usual care.
Main outcome measures. The primary outcome was patient-reported occurrence of goals-of-care communication, which was evaluated using a validated dichotomous survey item. Other outcomes included clinician documentation of a goals-of-care conversation in the medical record, patient-reported quality of communication (measured using Quality of Communication questionnaire) at 2 weeks, patient reports of goal-concordant care at 3 months, and patient-reported symptoms of depression and anxiety at 3 and 6 months. All analyses included covariate adjustment for the baseline measure of the outcome and adjustment for other variables found to confound the association between randomization group and outcome.
Main results. Of 485 potentially eligible clinicians, 65 clinicians were randomized to the intervention group and 69 were randomized to the control group. Of these 132 clinicians, 124 had patients participating in the study: 537 out of 917 eligible patients enrolled, with 249 allocated to intervention and 288 to usual care.
Patients in the intervention group were more likely to report a goals-of-care conversation with their provider among all patients (74%, n = 137 vs 31%, n = 66; P n = 112 vs 28%, n = 44; P n = 140 vs 17%, n = 45; P n = 114 vs 17%, n = 34; P
Patients in the intervention group also reported higher quality ratings of goals-of-care conversations at the target visit (mean values, 4.6 v 2.1, P = 0.01, on the 4-indicator construct). Additionally, intervention members reported statistically significant higher ratings on 3 of the 7 individual quality-of-communication survey items.
Patient-assessed goal concordant care did not increase significantly overall (70% vs 57%; P = 0.08) but did increase for patients with stable goals between 3-month follow-up and last prior assessment (73% vs 57%; P = 0.03). Symptoms of depression or anxiety were not different between groups at 3 or 6 months.
Conclusion. The Jumpstart-Tips intervention was associated with an increase in patient reports and clinician documentation of goals-of-care communication. Increased patient-reported goal-concordant care among patients with stable goals was also associated with the intervention. Statistical significance was not detected for changes in depression or anxiety as a result of the intervention. The impact on goals-of-care discussion between patients and caregivers is suggestive of enhanced patient-centered care; however, further studies are needed to evaluate whether this communication is associated with changes in health care delivery.