Patient Discharge Clinical Trial
Official title:
Improving Hospital-to-Home Care Transitions for High-risk Younger Adult Patients at a Safety Net Hospital: Activating Partnerships Among Patients, Families and Medical Staff
Improving hospital-to-home care transitions can produce improvements in patient safety and
health care outcomes, while decreasing medical costs. Most transitions research has examined
strategies for older patients. This project, however, focuses on younger, high-risk patients
within a safety net system. The proposed intervention is based on research that patient
activation, as measured by the Patient Activation Measure (PAM), is correlated with risk for
hospital readmission. The intervention seeks to increase PAM scores by employing a
Transition Coach to coach patients, prior to and for 30-days after discharge, to (1) improve
self-management skills through goal setting and goal attainment; (2) to enhance patient
capacity to engage in trusting relationships with the Primary Care Provider (PCP), other
medical specialists, family members of friends, and the Transition Coach; and (3) to improve
ability to navigate the medical system.
The investigators will conduct a randomized trial to determine; (a) if PAM scores can be
increased in the 30-day after hospital discharge; (b) if increased PAM scores, in this
setting, are correlated with changes in healthcare utilization patterns; and (c) if the
intervention presents a viable strategy to change healthcare utilization patterns and reduce
rehospitalizations.
Patient Activation is defined as the "knowledge, skills, confidence, and inclination to
assume responsibility for managing one's health and healthcare needs." The 10-item version
of the Patient Activation Measure (PAM) has been demonstrated to be a valid tool for
measuring patient activation in a range of patient populations. Evidence demonstrates that
PAM scores are correlated with heath care outcomes and that targeted interventions can
modify PAM scores and improve outcomes.
Highly activated patients, based on their PAM scores, are less likely to experience 30-day
readmissions, while those with lower levels of activation have higher rates of
rehospitalization. The investigators propose an intervention to support younger adult
patients transitioning from hospital to home to assume increased self-care responsibility.
While hospitalization tends to promote the passive receipt of care, the intervention
supports patients to take on a more active role. A Transition Coach will assist patients to
prepare for discharge to enhance their ability to self-manage medications, follow-up
appointments, symptoms, community services, and personal goals. The investigators
hypothesize that intensified pre-discharge involvement in improving self-management skills
for younger high-risk patients can; (a) improve PAM scores, (b) improve post-discharge
engagement with medical, psychiatric and community-based care; and (c) present a strategy
for changing healthcare utilization patterns that maximize outpatient care and reducing
inpatient care, including hospital readmissions.
Patient Selection:
Cambridge Health Alliance (CHA) is a public safety-net system serving an ethnically diverse,
underserved patient population of whom 30% are non-English speaking and 87% are publically
insured. Our target group is high risk hospitalized medical patients age 60 and younger, who
are discharged to home and receive primary care within the CHA network. Patients are
considered high risk if they have had a previous inpatient admission or multiple Emergency
Department (ED) visits within the past year, which serves as a proxy for complicated medical
or psychosocial issues. Patients will be selected from the Medicine or Surgical Services at
Cambridge Hospital.
Study Protocol:
The study protocol is described below.
1. The investigators anticipate enrolling 100 intervention patients and 100 control
patients over 9 months.
2. A research assistant (RA) administers the Patient Activation Measure to intervention
patients and control patients, immediately after randomization.
2- The intervention occurs with selected patients. 3- RA administers a post-discharge PAM to
all patients 31 days after discharge.
Statistical Analysis:
Data will be extracted from the Electronic Medical Record (EMR) on all study patients.
Baseline data will include age, sex, insurance status, Charlson comorbidity score, mental
health and substance abuse disorders, marital status, homelessness, and address changes,
admissions and ED visits in the past year.
Modest sample sizes may limit our ability to observe statistically significant effects. The
PAM score is calculated with a scale of 0 to 100 (highest activation), with scores typically
converted to a four-category categorical scale. Based on previous work in safety net
settings,18 the investigators expect about 45% of control patients to have a PAM score of
Level 4 (highly activated). With 100 intervention and 100 control patients, assuming
two-sided alpha=0.05, the investigators would have 89% power to detect a 20% increase in the
percentage of highly activated patients in the intervention group, and 65% power to detect a
15% increase. A key outcome is having an outpatient visit within 7 days of discharge. Based
on our current work, only 15% of control patients in this group complete a 7-day visit. The
investigators would have 81% power to detect an increase of 15% in the visit rate in the
intervention group, and 50% power to detect a 10% increase.
Study Hypothesis:
The investigators expect to observe positive gains in PAM scores following the intervention,
increases in 7-day outpatient follow-up rates and reductions in 30-day readmissions.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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