Design of the patient navigator to Reduce Readmissions (PArTNER) study: A pragmatic clinical effectiveness trial

Abstract

Previous work indicates the potential for community health workers and peer coaches serving as patient navigators to improve processes of care and health outcomes during care transitions, but have not been sufficiently tested to determine if such programs improve measures of patient experience in minority serving institutions. The objectives of the Patient Navigator to Reduce Readmissions (PArTNER) study was to: 1) conduct a pragmatic clinical effectiveness trial comparing a multi-faceted, stakeholder-supported Navigator intervention (in-person CHW visits in the hospital and after hospital discharge, plus telephone-based peer coaching) versus usual care on the experience of hospital-to-home care transitions in patients hospitalized with heart failure, pneumonia, chronic obstructive pulmonary disease, myocardial infarction, or sickle cell disease; 2) examine the effectiveness of the Navigator intervention in patient subgroups; and 3) understand the barriers and facilitators of successfully implementing the Navigator intervention across patient populations. The co-primary outcomes are the 30-day changes in: 1) Patient Reported Outcomes Measurement Information System (PROMIS) emotional distress-anxiety, and 2) PROMIS informational support. Secondary outcomes at 30 and 60 days include other PROMIS health measures and hospital readmissions. Innovative features of the PArTNER study include early and continuous engagement of patients, their caregivers, clinicians, health system administrators, and other stakeholders to inform the design and implementation of the Navigator intervention. In this report, we describe the design of the PArTNER study.

Keywords: Community health worker; Hospital readmissions; Hospital-to-home transition; Peer coaching; Pragmatic clinical trial.

Fig. 1

PArTNER study design. In the PArTNER study, participants hospitalized with a physician diagnosis of heart failure, pneumonia, chronic obstructive pulmonary disease (COPD), myocardial infarction, or sickle cell disease are randomly allocated to one of two groups: Navigator intervention or Usual care. The Navigator intervention spanned over a 2-month period after hospital discharge and included: 1) community health workers (CHWs) who conducted in-person study visits in the hospital and a single home visit 1–3 days post-discharge to assess barriers to patient-centered transitions from hospital to home, and 2) peer coaches are introduced on hospital discharge and contact participants via telephone at approximately 1, 2, 3, 5, and 7 weeks post-discharge to continue supports initiated by CHWs. Following in-person baseline data collection prior to randomization, follow-up outcomes were assessed via telephone at 30 days and 60 days post-discharge.

Fig. 2

Pragmatic design features of the PArTNER study according to the PRECIS-2 instrument. The study design features were based on input from patients, caregivers, clinicians, and hospital administrators during the planning stages of the PArTNER trial; goal was to develop a study consistent with a pragmatic (effectiveness) trial [26]. The “follow-up” category was graded as a 4 out of 5 as participants were contacted by phone to outcome data, rather than relying on passive approaches to data collection. Passive appraoches to data collection for assessing patient-reported measures of physical, emotional, and social health are not currently available.