Cardiac ConditionNCT01431846
Transition From Hospital to Home Post Cardiac Condition
A study testing Intervention in people with Cardiac Condition, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The study had three parts: Part 1: Patients (or their home caretakers) who live outside of Denver and receive their primary care at a location other than the Denver VAMC were interviewed after their discharge. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Condition
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aims 1 and 3:
- Patients transferred from primary care VA facilities (i.e., Cheyenne, Grand Junction, Sheridan, Ft. Harrison) for cardiac care (e.g., heart failure, acute myocardial infarction) or procedures (coronary angiography, pacemaker implantation) to the Denver VAMC and discharged home to follow-up with their primary care provider, were eligible.
- Aim 2:
- Providers from VA primary care facilities, (i.e., Cheyenne, Grand Junction, Sheridan, and Ft. Harrison) who took care of patients discharged from the Denver VAMC for cardiology care, were eligible for the qualitative interviews.
Who cannot join
- Aims 1 and 3:
- Planned discharge to nursing home or skilled nursing facility;
- Irreversible, non-cardiac medical condition (e.g. metastatic cancer) likely to affect 6-month survival or ability to execute study protocol;
- Lack of telephone/ cell phone; and
- VA is not their primary source of care or their PCP is not in the VA system.
- Aim 2: There were exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220
About this study
Official title: Pilot Intervention to Improve the Transition From Hospital to Home
The study had three parts:
Part 1: Patients (or their home caretakers) who live outside of Denver and receive their primary care at a location other than the Denver VAMC were interviewed after their discharge. The interview covered the patient's perspective about the transition of their medical care from the Denver VA to their primary care facility.
Read more
Part 2: Primary care providers from the VA facilities that refer patients to the Denver VA were interviewed regarding their opinions of transition process from the Denver VA back to the primary care VA facilities.
Part 3: The data from the above interviews were used to develop an intervention to improve the transition process from the Denver VA back to the primary care VA facilities.
Read the detailed description
Aim 1 was to describe barriers and facilitators of the transition process from hospital to home through qualitative interviews among patients discharged from Denver VA Medical Center (tertiary facility) after being transferred from a primary care VA.
Aim 2 was to describe barriers and facilitators of the transition process through qualitative interviews among providers at primary care VA facilities who take care of patients discharged from the Denver VA Medical Center for a cardiac condition.
Aim 3 was to pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention. This pilot was informed by the interviews from Aims 1 and 2 and best practices from the literature. Finally, as part of Aim 3, the primary care providers who saw the patients who completed the pilot were contacted to ask for their input and feedback regarding the pilot project.
Description of Enrolled Population: Study Design and Research Methods This was a mixed methods study where both qualitative and quantitative methods were employed. Through a series of qualitative interviews (n=26), potential barriers and facilitators of the current discharge process were assessed in this hub and spoke model of cardiac care. Informed by these interviews, the transitions of care intervention refined elements from prior studies that have improved this transition process. Finally, a pilot test of this intervention was implemented to assess the effectiveness of the intervention to improve important processes of care during this transition period among patients (n=8) discharged from Denver VAMC after transfer from a primary care VA facility.
- Conditions
- Cardiac Condition
- Being tested
- Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
| Study group | Role | What they receive |
|---|---|---|
| Discharge Patient | No intervention | Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention. |
| Providers | No intervention | Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA. |
| Intervention | Experimental | Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
See Primary Outcome Description Below
Follow up appointment within 2 weeks of discharge back to their primary care providers at a primary care facility from a tertiary referral center.
Measured: Within 2 weeks of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ConditionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michael Ho, MD PhD, Principal investigator, VA Eastern Colorado Health Care System, Denver, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431846
- Sponsor's protocol ID
- RRP 11-242
- Status last verified
- Sep 2014
- First submitted
- 23 Jun 2011
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hira RS, Kennedy K, Nambi V, Jneid H, Alam M, Basra SS, Ho PM, Deswal A, Ballantyne CM, Petersen LA, Virani SS. Frequency and practice-level variation in inappropriate aspirin use for the primary prevention of cardiovascular disease: insights from the National Cardiovascular Disease Registry's Practice Innovation and Clinical Excellence registry. J Am Coll Cardiol. 2015 Jan 20;65(2):111-21. doi: 10.1016/j.jacc.2014.10.035.
PubMed 25593051
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Intervention to Improve the Transition From Hospital to Home
- ClinicalTrials.gov ID
- NCT01431846
- Acronym / sponsor ID
- RRP 11-242
- Conditions
- Cardiac Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Sep 2011 (estimated)
- Results
- Posted 10 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study had three parts:
Part 1: Patients (or their home caretakers) who live outside of Denver and receive their primary care at a location other than the Denver VAMC were interviewed after their discharge. The interview covered the patient's perspective about the transition of their medical care from the Denver VA to their primary care facility.
Part 2: Primary care providers from the VA facilities that refer patients to the Denver VA were interviewed regarding their opinions of transition process from the Denver VA back to the primary care VA facilities.
Part 3: The data from the above interviews were used to develop an intervention to improve the transition process from the Denver VA back to the primary care VA facilities.
Detailed description
Aim 1 was to describe barriers and facilitators of the transition process from hospital to home through qualitative interviews among patients discharged from Denver VA Medical Center (tertiary facility) after being transferred from a primary care VA.
Aim 2 was to describe barriers and facilitators of the transition process through qualitative interviews among providers at primary care VA facilities who take care of patients discharged from the Denver VA Medical Center for a cardiac condition.
Aim 3 was to pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention. This pilot was informed by the interviews from Aims 1 and 2 and best practices from the literature. Finally, as part of Aim 3, the primary care providers who saw the patients who completed the pilot were contacted to ask for their input and feedback regarding the pilot project.
Description of Enrolled Population: Study Design and Research Methods This was a mixed methods study where both qualitative and quantitative methods were employed. Through a series of qualitative interviews (n=26), potential barriers and facilitators of the current discharge process were assessed in this hub and spoke model of cardiac care. Informed by these interviews, the transitions of care intervention refined elements from prior studies that have improved this transition process. Finally, a pilot test of this intervention was implemented to assess the effectiveness of the intervention to improve important processes of care during this transition period among patients (n=8) discharged from Denver VAMC after transfer from a primary care VA facility.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Discharge Patient | No intervention | –Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention. |
| Providers | No intervention | –Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA. |
| Intervention | Experimental | Behavioral: InterventionInformed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients transferred from primary care VA facilities (i.e., Cheyenne, Grand Junction, Sheridan, Ft. Harrison) for cardiac care (e.g., heart failure, acute myocardial infarction) or procedures (coronary angiography, pacemaker implantation) to the Denver VAMC and discharged home to follow-up with their primary care provider, were eligible.
- Providers from VA primary care facilities, (i.e., Cheyenne, Grand Junction, Sheridan, and Ft. Harrison) who took care of patients discharged from the Denver VAMC for cardiology care, were eligible for the qualitative interviews.
Key exclusion criteria (6 listed)
- Aim 2: There were exclusion criteria.
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 |
|---|---|---|
| InterventionInformed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention | Behavioural | Intervention |
Primary outcome
See Primary Outcome Description Below
Time frame: Within 2 weeks of discharge
Follow up appointment within 2 weeks of discharge back to their primary care providers at a primary care facility from a tertiary referral center.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25593051Hira RS, Kennedy K, Nambi V, Jneid H, Alam M, Basra SS, Ho PM, Deswal A, Ballantyne CM, Petersen LA, Virani SS. Frequency and practice-level variation in inappropriate aspirin use for the primary prevention of cardiovascular disease: insights from the National Cardiovascular Disease Registry's Practice Innovation and Clinical Excellence registry. J Am Coll Cardiol. 2015 Jan 20;65(2):111-21. doi: 10.1016/j.jacc.2014.10.035.
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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.
Michael Ho, MD PhD principal investigator
VA Eastern Colorado Health Care System, Denver, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Cardiac Condition, run by US Department of Veterans Affairs 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 4 inclusion and 6 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 Apr 2015. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
See Primary Outcome Description Below (time frame: Within 2 weeks of discharge). 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 NCT01431846, 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 28 Apr 2015.