Chronic Obstructive Pulmonary DiseaseNCT04955405
The 7-Visit Transition of Care Hospital to Home Intervention: A Pilot Study
A study testing The seven visit telemedicine protocol in people with Chronic Obstructive Pulmonary Disease and Chronic Heart Failure, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Heart Failure
- What is being tested?
- The seven visit telemedicine protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English Speaking
- Chronic Heart Failure
- Chronic Obstructive Pulmonary Disease
- Age 60 years and older
- Able to provide consent
Who cannot join
- Does not provide consent
- Cognitive Impairment
- Less than 60 years
- Non-English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham Health System
Birmingham, Alabama, 35294
About this study
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.
Read the detailed description
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.
- Being tested
- The seven visit telemedicine protocol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The seven visit telemedicine protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Seven telemedicine visits | Experimental | Will receive the seven visit telemedicine protocol Receives: Other: The seven visit telemedicine protocol |
| Control - Usual Care | No intervention | Will not receive the protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 90 days
Secondary outcomes (1)
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
Measured: baseline (day following discharge), 30 and 90 days (following discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start31 Jan 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allyson G. Hall, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955405
- Sponsor's protocol ID
- 3000006289
- Status last verified
- Feb 2024
- First submitted
- 16 Jun 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 7-Visit Transition of Care Hospital to Home Intervention: A Pilot Study
- ClinicalTrials.gov ID
- NCT04955405
- Acronym / sponsor ID
- 3000006289
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seven telemedicine visits | Experimental | Other: The seven visit telemedicine protocolWill receive the seven visit telemedicine protocol |
| Control - Usual Care | No intervention | –Will not receive the protocol |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English Speaking
- Chronic Heart Failure
- Chronic Obstructive Pulmonary Disease
- Age 60 years and older
- Able to provide consent
Key exclusion criteria (4 listed)
- Does not provide consent
- Cognitive Impairment
- Less than 60 years
- Non-English Speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The seven visit telemedicine protocolThe 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. | Other | Seven telemedicine visits |
Primary outcome
Hospital revisits (Emergency Department or Inpatient)
Time frame: 90 days
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
Self-reported declarations on hospital revisits (Emergency Department or Inpatient)
Time frame: 90 days
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
1 secondary outcome
Self efficacy for managing medication and treatment
Time frame: baseline (day following discharge), 30 and 90 days (following discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The seven visit telemedicine protocol in people with Chronic Obstructive Pulmonary Disease and Chronic Heart Failure, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital revisits (Emergency Department or Inpatient) (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.