An interventional study of The seven visit telemedicine protocol in Chronic Obstructive Pulmonary Disease and Chronic Heart Failure, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
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.
The long-term objective of this study is to inform and enhance the ability of UAB Hospitalist Medicine (UABHM) and UAB Health System (UABHS) reduce the likelihood of unplanned readmissions among discharged patients with a diagnosis of chronic obstructive pulmonary disease (COPD) and/or chronic heart failure (CHF). The project involves the implementation of a series of 7 telemedicine visits over 3 months to 35 patients recently discharged from UAB Hospital Medicine.
The Intervention Prior to discharge from the hospital 70 eligible patients will be recruited by physicians who are a part of the hospital medicine service. Thirty-five patients will be assigned to a treatment group and 35 patients to a control group. Consent will be obtained prior to discharge
Intervention Group: Either prior to discharge or during an initial phone call once they are home, patients will be introduced to the telemedicine technology platform. They will also be asked to complete a baseline survey that asks questions about the care transition process from the hospital to home, informational support, physical function, self-efficacy, and emotional distress. An appointment will be set for the patient's first visit with the care transition intervention team.
During the initial first visit, the advanced practice provider will conduct a medical assessment, the social worker will assess living and psychosocial conditions. The pharmacist
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 pharmacist will conduct medication reconciliation with a review of the patient's medication profile in totality and cross comparing the medications with all comorbid disease states to assure that no additional medications are warranted at that time. The pharmacist will then run the medications through a number of trusted databases such as Lexicomp or Clinical Pharmacology to confirm that there are no harmful drug-drug interactions that require modification prior to discharge.
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. Notes from each telemedicine encounter will be developed and stored in RedCap for team review.
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.
Participants will be asked to complete a baseline survey, and follow-up surveys at the end of the 4th week and again at the end of week 12.
Control Group: The control group will complete a baseline survey, and follow-up surveys at the end of the 4th week and at week 12.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 30 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Exclusion Criteria:
Will receive the seven visit telemedicine protocol
Other: The seven visit telemedicine protocol
Will not receive the protocol
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.
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
Time frame: 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
Time frame: 90 days
Self efficacy for managing medication and treatment
Patient-reported measure comes from the PROMIS item bank (Self-Efficacy for Managing Medication and Treatment, v1.0 short form available from: https://www.healthmeasures.net/search-view-measures?task=Search.search) Calculation of score: Each of 4 items has five response options (1=not at all confident, 2=a little confident; 3=somewhat confident; 4=quite confident; 5=very confident) . Response to each question will be summed into a raw score. Raw scores will range from 20 to 4 The raw score will then located on an applicable conversion table maintained by the PROMIS, to translate the raw score into a T-score for each participant. The T-score rescales the raw score into a standardized score. Higher scores are a better outcome. Analysis: Compare self-efficacy between intervention and control groups at 30 and 90 days; Compare the change in self-efficacy between 30 and 90 days between intervention and control groups
Time frame: baseline (day following discharge), 30 and 90 days (following discharge)
National Quality Forum's 3-item Care Transition Measure
The 3-item care transition measure rates patient perceptions of information provided at hospital discharge. This will be measured at baseline (within one day of discharge and within 30 days of the discharge from the hospital. Response categories for each item range: Strongly Disagree=1; disagree=2; Agree=3; Strong Agree=4. Scores will be summed and divided by total possible score. Will use linear transformation to convert to a 0 to 100 scale. Higher scores represent a better outcome (See National Quality Forum, Specifications for the Three-Item Transition Measure available at: https://mhdo.maine.gov/_pdf/NQF_CTM_3_%20Specs_FINAL.pdf), Analysis: Compare intervention and control groups at baseline and at 30 days. Compare the change in score between baseline and 30 days between intervention and control groups
Time frame: baseline (day following discharge); 30 days (following discharge)
Plan to share: No
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University of Alabama at Birmingham