The 7-Visit Transition of Care Hospital to Home Intervention: A Pilot Study

NCT04955405 | Completed

• 1 other identifier: 3000006289
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

New approaches to care transitions must deploy a longer-term and more intensive program that provide an array of services that address underlying social determinants of health (e.g. lack of adequate social support, lack of self-efficacy in managing symptoms and medications, impoverished living conditions, inability to connect with primary care and access. In addition, programs must be adaptable to meet the specific needs of individual patients. Our collaboration of health services researchers, quantitative scientists, and physicians propose to develop and implement a 90-day intensive and comprehensive intervention to support newly discharged patients with COPD and/or CHF. The proposed intervention will utilize a three-person team (registered nurse, clinical social worker, and a pharmacist) to provide an array of medical and social services specifically targeted to meet the needs of individual patients and their families. Aim: To determine using a randomized control trial, whether participation in an intensive series of 7 home-visits that provide tailored medical and social services among newly discharged low-income Medicare patients with COPD and/or CHF results in a) better patient-reported outcomes and b) a reduced likelihood of repeat hospital care (ED use or hospitalization) relative to a group of patients who receive usual discharge instructions.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

• Hospital revisits (Emergency Department or Inpatient)

  A measure of whether a participant returned to the University of Alabama at Birmingham (UAB) Emergency Department or had an inpatient admission to UAB for any cause between 24 hours and 90 days following discharge from an index discharge. This measure will be calculated from UAB Health System Electronic Health record data. Bivariate and multivariate comparisons will be made between the intervention and control groups

  90 days

• Self-reported declarations on hospital revisits (Emergency Department or Inpatient)

  Participant self-report of any hospital visit or emergency department visit within 90 days following discharge from UAB Hospital Bivariate and multivariate comparisons between the intervention and control groups

  90 days

Secondary Outcomes (1)

• Self efficacy for managing medication and treatment

  baseline (day following discharge), 30 and 90 days (following discharge)

Other Outcomes (1)

• National Quality Forum's 3-item Care Transition Measure

  baseline (day following discharge); 30 days (following discharge)

Study Arms (2)

Seven telemedicine visits

EXPERIMENTAL

Will receive the seven visit telemedicine protocol

Other: The seven visit telemedicine protocol

Control - Usual Care

NO INTERVENTION

Will not receive the protocol

Interventions

The seven visit telemedicine protocol OTHER

The transition of care team (pharmacist, advanced practice provider, social worker) will conduct an initial visit as a team with the patient using the telemedicine platform. During the visit, the team will assess the clinical, social, and pharmaceutical needs of the patient. The transition of care team will then meet to discuss the specific needs of the patient and to develop a care plan for the next 6 telemedicine visits. Either the social worker or the advanced practice provider will conduct the next 6 visits. The pharmacist will provide medication counseling as needed and recommended by the entire care team. The next 3 visits will occur weekly, the following 2 visits will occur biweekly, and the remaining 1 visit will occur at some point during the third month.

Seven telemedicine visits

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English Speaking
• Chronic Heart Failure
• Chronic Obstructive Pulmonary Disease
• Age 60 years and older
• Able to provide consent

You may not qualify if:

• Does not provide consent
• Cognitive Impairment
• Less than 60 years
• Non-English Speaking

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham Health System

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 8, 2021
• Study Start: January 31, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)