Pragmatic Clinical Trial to Improve Patient Experience Among Adults During Transitions from Hospital to Home: the PArTNER study

Abstract

Introduction: Minority-serving hospitals (MSHs) need evidence-based strategies tailored to the populations they serve to improve patient-centered outcomes after hospitalization.

Methods: We conducted a pragmatic randomized clinical trial (RCT) from October 2014 to January 2017 at a MSH comparing the effectiveness of a stakeholder-supported Navigator intervention vs. Usual care on post-hospital patient experience, outcomes, and healthcare utilization. Community health workers and peer coaches delivered the intervention which included (1) in-hospital visits to assess barriers to health/healthcare and to develop a personalized Discharge Patient Education Tool (DPET); (2) a home visit to review the DPET; and (3) telephone-based peer coaching. The co-primary outcomes were between-group comparisons of 30-day changes in Patient-Reported Outcomes Measurement Information System (PROMIS) measures of anxiety and informational support (minimum important difference is 2 to 5 units change); a p-value <0.025 was considered significant using intention-to-treat analysis. Secondary outcomes included death, ED visits, or readmissions and measures of emotional, social, and physical health at 30 and 60 days.

Results: We enrolled 1029 adults hospitalized with heart failure (28%), pneumonia (22%), MI (10%), COPD (11%), or sickle cell disease (29%). Over 80% were non-Hispanic Black. Overall, there were no significant between-group differences in the 30-day change in anxiety (adjusted difference: -1.6, 97.5% CI -3.3 to 0.1, p=0.03), informational support (adjusted difference: -0.01, 97.5% CI -2.0 to 1.9, p=0.99), or any secondary outcomes. Exploratory analyses suggested the Navigator intervention improved anxiety among participants with COPD, a primary care provider, a hospitalization in the past 12 months, or higher baseline anxiety; among participants without health insurance, the intervention improved informational support (all p-values <0.05).

Conclusions: In this pragmatic RCT at a MSH, the Navigator intervention did not improve post-hospital anxiety, informational support, or other outcomes compared to Usual care. Benefits observed in participant subgroups should be confirmed in future studies.

Trial registration: Clinicaltrials.gov identifier: NCT02114515.

Figure 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 were randomly allocated to one of two groups: Navigator intervention or Usual care. The Navigator intervention was initiated during the index hospitalization and continued for 60 days post-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 introduced on hospital discharge who contacted 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.

Figure 2

CONSORT diagram for the PArTNER study, n=1029 randomized. Figure 2 outlines the Consolidated Standards for Reporting of Trials (CONSORT) Flow Diagram for the PArTNER study. Of the 2170 patients assessed for eligibility, 1031 were excluded for not meeting full eligibility criteria, declining to give consent, or inability to approach the participant. Participants who were not randomized, deemed ineligible after randomization, or declined to re-affirm consent (see Supplemental Appendix) were removed from the final study cohort. Electronic health records (EHR) were reviewed to assess follow-up outcomes in addition to participant self-report (reached for outcomes assessment [OA]). We could not assess EHRs in some participants in the Navigator intervention group due to withdrawal from the study. Participants were considered unable to reach if they were known to have died or withdrew consent before the end of their outcomes assessment window (on or before 44 days post-discharge for the 30-day OA; on or before 81 days post-discharge for the 60-day OA), were unable to be reached during an administrative hold period while awaiting Institutional Review Board approval, source document(s) for participant data were not available, or were unable to be reached for reasons that did not fall into these categories. Participants who provided enough data to compute either of our co-primary outcomes (either CPO at 30d) or sufficient data to compute any of our secondary outcomes at 30 days or 60 days (any SO @ 30d and any SO @ 60D, respectively) were included in the final intention-to-treat analysis. Abbreviations: ACF = acute care facility; AMA = against medical advice; EHR = electronic health record; OA = outcomes assessment; ITT = intention to treat; CPO = co-primary outcomes; SO = secondary outcome.