Improving Hospital-to-Home Care Transitions for High-risk Younger Adult Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532296
• Other study ID #: CHA-3222
• Status: Completed
• Phase: N/A
• First received: July 17, 2015
• Last updated: August 4, 2016
• Start date: June 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Cambridge Health Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 60 or less

• PCP within CHA network

• Have had at least one previous hospitalization or two or more Emergency Department visit within CHA in the past year

• Hospitalized at Cambridge Hospital on Medicine or Surgery Service

• Discharged from Medicine or Surgery service to home

Exclusion Criteria:

• Age > 60;

• Non-CHA PCP

• Discharged to rehabilitation or transferred to an outside hospital or to Psychiatry service

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Patient Discharge

Intervention

Behavioral:
• Transition Coach (TC)
TC reviews patient's medical record to understand current admission and the medical/psycho-social history. TC makes introductory hospital visit(s) with patient to establish rapport and to define post-discharge needs. Starting in-house and continuing after discharge, TC helps patient set transition goals to maximize healthcare outcomes. Post-discharge, TC offers a voluntary face-to-face visit with patient along with weekly outreach calls, which are designed to assist patient with goal setting and attainment, medical system navigation; medication management; medical follow-up; transportation; use of community resources; and self-care. Intervention lasts 30 days post-discharge; afterwards TC seeks to handoff to an outpatient care team member, to ensure continuity of care.
• Control
Receives usual hospital-based care, discharge preparation, transitional care and outpatient care.

Locations

Country	Name	City	State
United States	Cambridge Hospital	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge Health Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pre-intervention utilization	ED visits, hospital admissions, outpatient visits, outpatient no-shows	1 year pre-hospitalization	No
Primary	Change from Baseline - Patient Activation Measure (PAM) and Utilization	Comparison between pre-discharge PAM and 30-day post-discharge PAM. Hospital and ED visit and outpatient visits with PCP and Specialists at 7,14,30,60,90 days.	7,14, 30, 60, 90 days post-discharge	No
Secondary	Goal Setting and Achievement	Number of goals defined and number of goals achieved	Hospital visit and 30 days post-discharge	No
Secondary	Relationship with Transition Coach (TC)	Number of encounters with TC (Hospital visits, Face-to-face visits, telephone outreach) and was TC acknowledged to be helpful in post-discharge period.	Hospital visit and 30 days post-discharge	No
Secondary	Relationship with PCP	Number of PCP visits and was PCP acknowledged to be helpful in post-discharge period.	30 days post-discharge	No
Secondary	Relationship with other medical providers	Number of specialty (non-psych) visit. Number of Psychiatric visits.	30 days post-discharge	No
Secondary	Relationship with Home Support	Were friends or family acknowledged to be helpful in post-discharge period?	30 days post-discharge	No
Secondary	Ability to navigate health care system	Number of no-shows	30, 60,180 days post-discharge	No