Post-dischargeNCT01672385
Improving Transition Outcomes Through Accessible Health IT and Caregiver Support
A study testing Telemonitoring plus self-management support in people with Post-discharge, run by University of Michigan at 1 site in United States.
Trial summary
Background: Older hospitalized adults frequently experience preventable short-term readmissions due to inadequate transition support. Although proactive telephone follow-up improves transition outcomes, these services often are unsystematic and of low intensity. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Post-discharge
- What is being tested?
- Telemonitoring plus self-management support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Oct 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being discharged from study site with any diagnoses that indicate a chronic condition with a high risk of short-term readmission, for example: stroke, heart failure, coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease, peripheral vascular disease, deep venous thrombosis, pulmonary embolism, pneumonia, diabetes, urinary tract infection, cellulitis, gastroenteritis, fevers, and other infections
- At least 50 years of age
Who cannot join
- Serious mental illness, e.g., psychosis
- Are in hospice care
- Do not speak English
- Are unable to use a telephone
- Have a non-health system-affiliated primary care provider
- Are unable to nominate a potentially eligible CarePartner
- Are cognitively impaired as determined by a validate screener
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Background: Older hospitalized adults frequently experience preventable short-term readmissions due to inadequate transition support. Although proactive telephone follow-up improves transition outcomes, these services often are unsystematic and of low intensity. Informal caregivers are invaluable for ensuring successful transitions, but many patients live alone, have an in-home caregiver who is struggling with competing demands, or live at a distance from adult children or other potential sources of support. New models are needed for transition support that include low-cost technologies and more structured assistance for patients' informal caregiving network, while providing patients' clinical teams with the information they need to avert health crises.
Objectives: Consistent with NIA's goals to improve transition outcomes, we will evaluate a novel intervention designed to improve the effectiveness of transition support for older adults with common chronic conditions via three mechanisms of action: (a) direct tailored communication to patients via regular automated calls post discharge, (b) support for informal caregivers living outside of the patient's household via structured feedback about the patient's status and advice about how they can help, and (c) support for proactive care management including a web-based disease management tool, automated alerts about potential problems, and the capacity for asynchronous communication with patients and their caregivers. Specifically, the trial will determine: 1) whether the CarePartner intervention improves patients' readmission risk and functional status; 2) the impact of the intervention on patients' self-care behaviors and the quality of the transition process; and 3) whether the intervention improves caregiver burden and stress levels.
Read the detailed description
Methods: 846 older adults with complex chronic conditions will be identified upon admission to two community-based acute care medical services. Patients will be asked to identify a CarePartner (CP) living outside their household, i.e., an adult child or other social network member willing to play an active role in their transition support and organizing their broader network of informal caregivers. Patients will be randomized to the intervention or usual care. Intervention patients will receive automated assessment and behavior change calls, and their CPs will receive structured feedback and advice following each assessment. Patients' clinical team will have access to patients' assessment results via the web, will receive automated reports about urgent health problems, and will be able to communicate asynchronously with patients and CPs using a secure web page and a specially designed voicemail service. Patients will complete surveys at baseline, 30- and 90- days post discharge; utilization data will be obtained from hospital records. CPs, other caregivers, and clinicians will be interviewed to evaluate intervention effects on processes of self-care support, caregiver stress and communication, and the intervention's potential for broader implementation. The primary outcomes will be 30 day readmission rates; 2ndary outcomes measured at 30 and 90 days include functional status, self-care behaviors, and mortality risk.
- Conditions
- Post-discharge
- Being tested
- Telemonitoring plus self-management support
- Keywords
- CarePartner, informal caregiver, interactive voice response, transition, post-discharge, chronic illness, readmission, self-care
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring plus self-management supportOther
Patients in the intervention group receive automated telephone calls that ask about their health and self-care along with tailored health-related feedback. The patient's CarePartner receives health update reports about the patient and how they can help via e-mail. Urgent health problems are reported to the patient's health care team via fax or e-mail.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Telemonitoring plus self-management support Receives: Other: Telemonitoring plus self-management support |
| Usual Care Group | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Aim 1
To determine the extent to which the CarePartner model for supporting effective transitions from hospital to home improves outcomes of care, including lower readmission rates, emergency department visits, and improved patient functional status.
Measured: Outcomes will be measured at 30- and 90-days post discharge.
Specific Aim 2
To evaluate the impact of the intervention on process measures of transition quality (e.g., attendance at post-discharge appointments and patients' understanding of their personal health record), as well as on patients' medication-related self-management (e.g., adherence and medication beliefs).
Measured: Outcomes will be measured at 30- and 90-days post discharge.
Specific Aim 3
To determine the extent to which the intervention increases the quality and quantity of support for patients' self-care using a mixed methods approach to identify whether the service reduces caregivers' stress and increases their activation levels (e.g., by increasing their disease-specific communication with the patient and successful problem solving).
Measured: Outcomes will be measured at 30- and 90-days post discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-dischargeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Piette, University of Michigan
- Investigators
- John D. Piette, Ph.D., Principal investigator, VA Center for Clinical Management Research & the University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672385
- Sponsor's protocol ID
- R01AG039474-01
- Status last verified
- Nov 2016
- First submitted
- 21 Aug 2012
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Piette JD, Striplin D, Aikens JE, Lee A, Marinec N, Mansabdar M, Chen J, Gregory LA, Kim CS. Impacts of Post-Hospitalization Accessible Health Technology and Caregiver Support on 90-Day Acute Care Use and Self-Care Assistance: A Randomized Clinical Trial. Am J Med Qual. 2021 May-Jun 01;36(3):145-155. doi: 10.1177/1062860620943673.
PubMed 32723072
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Transition Outcomes Through Accessible Health IT and Caregiver Support
- ClinicalTrials.gov ID
- NCT01672385
- Acronym / sponsor ID
- R01AG039474-01
- Conditions
- Post-discharge
- Keywords
- CarePartner, informal caregiver, interactive voice response, transition, post-discharge, chronic illness, readmission, self-care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Aug 2012 (estimated)
- 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.
Background: Older hospitalized adults frequently experience preventable short-term readmissions due to inadequate transition support. Although proactive telephone follow-up improves transition outcomes, these services often are unsystematic and of low intensity. Informal caregivers are invaluable for ensuring successful transitions, but many patients live alone, have an in-home caregiver who is struggling with competing demands, or live at a distance from adult children or other potential sources of support. New models are needed for transition support that include low-cost technologies and more structured assistance for patients' informal caregiving network, while providing patients' clinical teams with the information they need to avert health crises.
Objectives: Consistent with NIA's goals to improve transition outcomes, we will evaluate a novel intervention designed to improve the effectiveness of transition support for older adults with common chronic conditions via three mechanisms of action: (a) direct tailored communication to patients via regular automated calls post discharge, (b) support for informal caregivers living outside of the patient's household via structured feedback about the patient's status and advice about how they can help, and (c) support for proactive care management including a web-based disease management tool, automated alerts about potential problems, and the capacity for asynchronous communication with patients and their caregivers. Specifically, the trial will determine: 1) whether the CarePartner intervention improves patients' readmission risk and functional status; 2) the impact of the intervention on patients' self-care behaviors and the quality of the transition process; and 3) whether the intervention improves caregiver burden and stress levels.
Detailed description
Methods: 846 older adults with complex chronic conditions will be identified upon admission to two community-based acute care medical services. Patients will be asked to identify a CarePartner (CP) living outside their household, i.e., an adult child or other social network member willing to play an active role in their transition support and organizing their broader network of informal caregivers. Patients will be randomized to the intervention or usual care. Intervention patients will receive automated assessment and behavior change calls, and their CPs will receive structured feedback and advice following each assessment. Patients' clinical team will have access to patients' assessment results via the web, will receive automated reports about urgent health problems, and will be able to communicate asynchronously with patients and CPs using a secure web page and a specially designed voicemail service. Patients will complete surveys at baseline, 30- and 90- days post discharge; utilization data will be obtained from hospital records. CPs, other caregivers, and clinicians will be interviewed to evaluate intervention effects on processes of self-care support, caregiver stress and communication, and the intervention's potential for broader implementation. The primary outcomes will be 30 day readmission rates; 2ndary outcomes measured at 30 and 90 days include functional status, self-care behaviors, and mortality risk.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Telemonitoring plus self-management supportTelemonitoring plus self-management support |
| Usual Care Group | No intervention | –Usual Care |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being discharged from study site with any diagnoses that indicate a chronic condition with a high risk of short-term readmission, for example: stroke, heart failure, coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease, peripheral vascular disease, deep venous thrombosis, pulmonary embolism, pneumonia, diabetes, urinary tract infection, cellulitis, gastroenteritis, fevers, and other infections
- At least 50 years of age
Key exclusion criteria (7 listed)
- Serious mental illness, e.g., psychosis
- Are in hospice care
- Do not speak English
- Are unable to use a telephone
- Have a non-health system-affiliated primary care provider
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 |
|---|---|---|
| Telemonitoring plus self-management supportPatients in the intervention group receive automated telephone calls that ask about their health and self-care along with tailored health-related feedback. The patient's CarePartner receives health update reports about the patient and how they can help via e-mail. Urgent health problems are reported to the patient's health care team via fax or e-mail. | Other | Intervention Group |
Primary outcome
Specific Aim 1
Time frame: Outcomes will be measured at 30- and 90-days post discharge.
To determine the extent to which the CarePartner model for supporting effective transitions from hospital to home improves outcomes of care, including lower readmission rates, emergency department visits, and improved patient functional status.
Specific Aim 2
Time frame: Outcomes will be measured at 30- and 90-days post discharge.
To evaluate the impact of the intervention on process measures of transition quality (e.g., attendance at post-discharge appointments and patients' understanding of their personal health record), as well as on patients' medication-related self-management (e.g., adherence and medication beliefs).
Specific Aim 3
Time frame: Outcomes will be measured at 30- and 90-days post discharge.
To determine the extent to which the intervention increases the quality and quantity of support for patients' self-care using a mixed methods approach to identify whether the service reduces caregivers' stress and increases their activation levels (e.g., by increasing their disease-specific communication with the patient and successful problem solving).
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 7 Nov 2016.
- Derived from this study: PubMed 32723072Piette JD, Striplin D, Aikens JE, Lee A, Marinec N, Mansabdar M, Chen J, Gregory LA, Kim CS. Impacts of Post-Hospitalization Accessible Health Technology and Caregiver Support on 90-Day Acute Care Use and Self-Care Assistance: A Randomized Clinical Trial. Am J Med Qual. 2021 May-Jun 01;36(3):145-155. doi: 10.1177/1062860620943673.
- 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.
John D. Piette, Ph.D. principal investigator
VA Center for Clinical Management Research & the University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring plus self-management support in people with Post-discharge, run by University of Michigan 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 2 inclusion and 7 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 7 Nov 2016. 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?
Specific Aim 1 (time frame: Outcomes will be measured at 30- and 90-days post discharge.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01672385, which also lists 1 linked publication.
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 7 Nov 2016.