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CompletedNCT02532296Updated Aug 5, 2016

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

An interventional study of Transition Coach (TC) and Control in Patient Discharge, sponsored by Cambridge Health Alliance. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-05.

Sponsored by Cambridge Health Alliance · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

  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.

02

Conditions studied

  • Patient Discharge
03

In context

Lead sponsor

Cambridge Health Alliance is the lead sponsor of 52 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Age > 60;
  • Non-CHA PCP
  • Discharged to rehabilitation or transferred to an outside hospital or to Psychiatry service
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
201 participants (actual)

Study arms

  • Active comparator
    Control

    Receive usual hospital discharge, care transition and post-discharge care.

    Behavioral: Control

  • 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.

    Behavioral: Transition Coach (TC)

Interventions

  • BehavioralTransition 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.

  • BehavioralControl

    Receives usual hospital-based care, discharge preparation, transitional care and outpatient care.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7,14, 30, 60, 90 days post-discharge

Secondary outcomes

  1. Goal Setting and Achievement

    Number of goals defined and number of goals achieved

    Time frame: Hospital visit and 30 days post-discharge

  2. 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.

    Time frame: Hospital visit and 30 days post-discharge

  3. Relationship with PCP

    Number of PCP visits and was PCP acknowledged to be helpful in post-discharge period.

    Time frame: 30 days post-discharge

  4. Relationship with other medical providers

    Number of specialty (non-psych) visit. Number of Psychiatric visits.

    Time frame: 30 days post-discharge

  5. Relationship with Home Support

    Were friends or family acknowledged to be helpful in post-discharge period?

    Time frame: 30 days post-discharge

  6. Ability to navigate health care system

    Number of no-shows

    Time frame: 30, 60,180 days post-discharge

Other outcomes

  1. Pre-intervention utilization

    ED visits, hospital admissions, outpatient visits, outpatient no-shows

    Time frame: 1 year pre-hospitalization

07

Study locations

1 site
  • Cambridge Hospital
    Cambridge, Massachusetts 02139, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02532296
Lead sponsor
Cambridge Health Alliance
Responsible party
Sponsor
First posted
Aug 25, 2015
Start date
Jun 2015
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Aug 5, 2016

Study contacts

Richard B Balaban, MD
principal investigator · Cambridge Health Alliance

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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