Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374277
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-15
Brief Title:
Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence
Sponsor:
University of Tennessee
Organization:
University of Tennessee
Study Overview
Official Title:
Pharmacy-led Transitions of Care Intervention to Address System-Level Barriers and Improve Medication Adherence in Socioeconomically Disadvantaged Populations
Status:
RECRUITING
Status Verified Date:
2024-04
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:
MedAAAction
Brief Summary:
Socioeconomically disadvantaged populations with multiple chronic conditions have high rates of nonadherence to essential chronic disease medications after hospital discharge Medication nonadherence after hospital discharge is significantly associated with increased mortality and higher rates of readmissions and costs among these patients Major patient-reported barriers to essential medication use after hospital discharge among low-income individuals are related to social determinants of health SDOH and include 1 financial barriers 2 transportation barriers and 3 system-level barriers Although medication therapy management services are important during care transitions these services have not proven effective in improving medication adherence after hospital discharge highlighting a critical need for innovative interventions The Medication Affordability Accessibility and Availability in Care Transitions Med AAAction Study will test the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital in-patients with MCC from three large healthcare systems in Tennessee The intervention will involve 1 medications with zero copay 2 bedside delivery then home delivery of medications and 3 care coordination provided by certified pharmacy technicianshealth coaches to assist with medication access medication reconciliation and rapid and ongoing primary care follow-up We will examine the impact of the intervention during 12 months on 1 medication adherence primary outcome and 2 rapid primary care follow-up 30-day readmissions hospitalizations and emergency department visits and costs We will conduct key informant interviews to understand patient experience with the acre received during and after care transitions By examining effectiveness of the intervention on outcomes including medication adherence health care utilization costs and patient experience this study will provide valuable results to health systems payers and policymakers to assist in future implementation and sustainability of the intervention for socioeconomically disadvantaged populations
Detailed Description:
Care transitions are a critical time for managing medications Socioeconomically disadvantaged populations with multiple chronic conditions MCC and polypharmacy have high rates of medication discrepancies and nonadherence to essential chronic disease medications following hospitalization Medication nonadherence after hospital discharge is significantly associated with increases in readmissions costs and mortality among patients with MCC Barriers to medication adherence for low-income patients are particularly acute during care transitions from the hospital to the community setting where patients experience difficulties accessing and affording essential medications Studies including our own have shown that major patient-reported barriers to essential medication use after hospital discharge among low-income primarily African American individuals are related to social determinants of health SDOH and include 1 financial barriers ie inability to afford medications 2 transportation barriers ie inability to access prescribed medications or needed follow-up care and 3 system-level barriers ie lack of availability of discharge medications and care coordination services to ensure rapid primary care follow-up
Although medication therapy management MTM and medication reconciliation services are important during care transitions these services have not proven effective in improving essential medication use and adherence after hospital discharge highlighting a critical need for innovative interventions that address the major barriers to adherence following hospitalization The PI Dr Surbhis pilot research has demonstrated the feasibility and potential to improve medication adherence among adult Medicaid and uninsured inpatients by directly addressing these barriers through full medication subsidy and bedside and subsequent home delivery of medications Additionally our previous research demonstrates that care coordination services provided by pharmacy technicians trained as coaches effectively increases rapid primary care follow-up after hospital discharge and has potential to help improve medication adherence However the effectiveness of interventions that directly address affordability accessibility and availability to improve post-discharge medication adherence in vulnerable populations is still unknown
The Medication Affordability Accessibility and Availability in Care Transitions Med AAAction Study will examine the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital inpatients with MCC from three large non-profit healthcare systems serving a disproportionate share of low-income patients in Tennessee The Med AAAction intervention will consist of the following components 1 medications with zero copay 2 bedside delivery and subsequent home delivery of medications and 3 care coordination provided by certified pharmacy technicianshealth coaches to assist with medication access medication reconciliation and rapid and ongoing primary care follow-up after hospital discharge Furthermore to understand patient experience with the care received during and after care transitions we will obtain qualitative data through interviews with patients enrolled in the study This study has a long-term goal to demonstrate the effectiveness of a care transitions adherence intervention model for vulnerable populations that can be readily adopted and sustained by health care delivery systems across the US The specific aims are as follows
Aim 1 To test the effectiveness of the intervention on essential chronic disease medication adherence primary outcome assessed by pill counts and a patient-reported adherence scale Hypothesis Intervention group participants will have higher mean adherence at 12 months compared with those randomized to the usual care
Aim 2 To test the effectiveness of the intervention on following secondary outcomes
Aim 2a Health care utilization outcomes including 1 primary care follow-up within 14 days of hospital discharge 2 30-day readmissions 3 overall and preventable hospitalizations at one year and 4 overall and preventable emergency department ED visits at one year using Tennessee Medicaid claims data and electronic medical records Hypothesis Intervention group participants will be more likely to have rapid primary care follow-up less likely to have 30-day readmissions and will have lower incidence of hospitalizations and ED visits over a one-year period compared with those randomized to usual care
Aim 2b Net cost savings associated with avoidable hospitalization and ED visits Hypothesis The intervention group will incur lower costs compared to usual care
Aim 3 To understand study participants experience with the intervention received during and after care transitions using qualitative key informant interviews
Impact By examining the effects of the intervention on medication adherence health care utilization costs and patient experience the study will provide valuable results to help health systems payers and policymakers achieve the Triple Aim - improving health outcomes and patient experience and reducing costs among socioeconomically disadvantaged populations
Although medication therapy management MTM and medication reconciliation services are important during care transitions these services have not proven effective in improving essential medication use and adherence after hospital discharge highlighting a critical need for innovative interventions that address the major barriers to adherence following hospitalization The PI Dr Surbhis pilot research has demonstrated the feasibility and potential to improve medication adherence among adult Medicaid and uninsured inpatients by directly addressing these barriers through full medication subsidy and bedside and subsequent home delivery of medications Additionally our previous research demonstrates that care coordination services provided by pharmacy technicians trained as coaches effectively increases rapid primary care follow-up after hospital discharge and has potential to help improve medication adherence However the effectiveness of interventions that directly address affordability accessibility and availability to improve post-discharge medication adherence in vulnerable populations is still unknown
The Medication Affordability Accessibility and Availability in Care Transitions Med AAAction Study will examine the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital inpatients with MCC from three large non-profit healthcare systems serving a disproportionate share of low-income patients in Tennessee The Med AAAction intervention will consist of the following components 1 medications with zero copay 2 bedside delivery and subsequent home delivery of medications and 3 care coordination provided by certified pharmacy technicianshealth coaches to assist with medication access medication reconciliation and rapid and ongoing primary care follow-up after hospital discharge Furthermore to understand patient experience with the care received during and after care transitions we will obtain qualitative data through interviews with patients enrolled in the study This study has a long-term goal to demonstrate the effectiveness of a care transitions adherence intervention model for vulnerable populations that can be readily adopted and sustained by health care delivery systems across the US The specific aims are as follows
Aim 1 To test the effectiveness of the intervention on essential chronic disease medication adherence primary outcome assessed by pill counts and a patient-reported adherence scale Hypothesis Intervention group participants will have higher mean adherence at 12 months compared with those randomized to the usual care
Aim 2 To test the effectiveness of the intervention on following secondary outcomes
Aim 2a Health care utilization outcomes including 1 primary care follow-up within 14 days of hospital discharge 2 30-day readmissions 3 overall and preventable hospitalizations at one year and 4 overall and preventable emergency department ED visits at one year using Tennessee Medicaid claims data and electronic medical records Hypothesis Intervention group participants will be more likely to have rapid primary care follow-up less likely to have 30-day readmissions and will have lower incidence of hospitalizations and ED visits over a one-year period compared with those randomized to usual care
Aim 2b Net cost savings associated with avoidable hospitalization and ED visits Hypothesis The intervention group will incur lower costs compared to usual care
Aim 3 To understand study participants experience with the intervention received during and after care transitions using qualitative key informant interviews
Impact By examining the effects of the intervention on medication adherence health care utilization costs and patient experience the study will provide valuable results to help health systems payers and policymakers achieve the Triple Aim - improving health outcomes and patient experience and reducing costs among socioeconomically disadvantaged populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None