- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02532296
Improving Hospital-to-Home Care Transitions for High-risk Younger Adult Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
- The investigators anticipate enrolling 100 intervention patients and 100 control patients over 9 months.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Cambridge, Massachusetts, United States, 02139
- Cambridge Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control
Receive usual hospital discharge, care transition and post-discharge care.
|
Receives usual hospital-based care, discharge preparation, transitional care and outpatient care.
|
EXPERIMENTAL: Transition Coach Intervention
In addition to usual care, the intervention group receives care from a trained Transition Coach to support patients for 30 days after discharge.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline - Patient Activation Measure (PAM) and Utilization
Time Frame: 7,14, 30, 60, 90 days post-discharge
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal Setting and Achievement
Time Frame: Hospital visit and 30 days post-discharge
|
Number of goals defined and number of goals achieved
|
Hospital visit and 30 days post-discharge
|
Relationship with Transition Coach (TC)
Time Frame: Hospital visit and 30 days post-discharge
|
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
|
Relationship with PCP
Time Frame: 30 days post-discharge
|
Number of PCP visits and was PCP acknowledged to be helpful in post-discharge period.
|
30 days post-discharge
|
Relationship with other medical providers
Time Frame: 30 days post-discharge
|
Number of specialty (non-psych) visit.
Number of Psychiatric visits.
|
30 days post-discharge
|
Relationship with Home Support
Time Frame: 30 days post-discharge
|
Were friends or family acknowledged to be helpful in post-discharge period?
|
30 days post-discharge
|
Ability to navigate health care system
Time Frame: 30, 60,180 days post-discharge
|
Number of no-shows
|
30, 60,180 days post-discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-intervention utilization
Time Frame: 1 year pre-hospitalization
|
ED visits, hospital admissions, outpatient visits, outpatient no-shows
|
1 year pre-hospitalization
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard B Balaban, MD, Cambridge Health Alliance
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHA-3222
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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