Ignite Creation Date:
2024-05-06 @ 7:27 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02532296
Status:
COMPLETED
Last Update Posted:
2016-08-05
First Post:
2015-07-17
Brief Title:
Improving Hospital-to-Home Care Transitions for High-risk Younger Adult Patients
Sponsor:
Cambridge Health Alliance
Organization:
Cambridge Health Alliance
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Patient Activation is defined as the knowledge skills confidence and inclination to assume responsibility for managing ones 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 settings18 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 alpha005 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
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 settings18 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 alpha005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None