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AzTrials

Cardiovascular DiseasesNCT05431894

Behavioral and Recovery Support for 30 Day Post-Discharge Care

A study testing Laguna Coach Intervention Group in people with Cardiovascular Diseases, run by Laguna Health, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will provide behavioral and mental health support to a select group of participants to supplement the hospital-provided discharge and recovery plans, based on clinical guidance and dedicated post-hospitalization behavioral protocols, with the goals of reducing readmission rates and costs. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Laguna Coach Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
1 siteUnited States
Study dates
18 Feb 2021to 13 Jun 2022
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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Admitted to the hospital with a diagnosis of a cardiovascular disease
  • Discharged to home
  • Converse in English or Spanish
  • Uses a telephone

Who cannot join

  • Participant unable to provide informed consent
  • Participant lacks cognitive ability to participate in the study interventions as judged by the primary attending physician

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

Other trials in United States

About this study

Official title: Behavioral and Recovery Support for 30 Day Post-Discharge Care in Participants With Cardiovascular Diseases

This study will provide behavioral and mental health support to a select group of participants to supplement the hospital-provided discharge and recovery plans, based on clinical guidance and dedicated post-hospitalization behavioral protocols, with the goals of reducing readmission rates and costs.

Read the detailed description

This study was designed to provide support to a select group of participants by supplementing the hospital-provided discharge instructions. Laguna integrated clinical guidance and dedicated post-hospitalization Laguna recovery protocols, with the aims of improving health outcomes, reducing health costs, and reducing readmission rates within 30 days post-discharge.

Participants in the intervention group received support from Laguna Health via phone, video, text, or web chat. Laguna provided contextual support to remove recovery barriers to these intervention participants.

Being tested
Laguna Coach Intervention Group
Keywords
Readmissions, Cardiovascular, Post-Discharge, Behavioral Health, Readmission Cost, 30 Day Readmission, Heart Failure, Care Management, Barriers to Care, Contextualizing Healthcare
Medical subject headings
Cardiovascular Diseases, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laguna Coach Intervention GroupBehavioural

    Behavioral and mental support was delivered through personal interactions with Laguna Coaches via phone, video, or web chat. Behavioral and mental support was individualized to best match each patient's needs and strengths. Support was provided to participants through human interactions over approximately 30 days.

Study groups in NCT05431894
Study groupRoleWhat they receive
Intervention ArmExperimentalGroup received support from Laguna Coaches
Receives: Behavioral: Laguna Coach Intervention Group
Control ArmNo interventionGroup received no support from Laguna Coaches

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Unplanned All Cause Readmission Rate

    Unplanned All-Cause 30 Day Readmission Rate

    Measured: 30 Days Post-Discharge

  2. Unplanned Readmission Total Cost

    Billed facility charges for readmissions hospitalization stays

    Measured: 30 Days Post-Discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study start18 Feb 2021
  3. Primary completion24 Feb 2022
  4. Study completion13 Jun 2022

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were assigned upon consent randomly to an intervention or control group. The intervention group received support from Laguna Coaches for 30 days, the control group did not receive any support from Laguna coaches.
Masking
None (open label)
Enrolment
408 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431894
Sponsor's protocol ID
EH21-092
Status last verified
Jun 2022
First submitted
20 Jun 2022
Last updated
24 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share individual participant data

Publications

  • Dieleman JL, Cao J, Chapin A, Chen C, Li Z, Liu A, Horst C, Kaldjian A, Matyasz T, Scott KW, Bui AL, Campbell M, Duber HC, Dunn AC, Flaxman AD, Fitzmaurice C, Naghavi M, Sadat N, Shieh P, Squires E, Yeung K, Murray CJL. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020 Mar 3;323(9):863-884. doi: 10.1001/jama.2020.0734.

    PubMed 32125402

  • Bailey MK, Weiss AJ, Barrett ML, Jiang HJ. Characteristics of 30-Day All-Cause Hospital Readmissions, 2010-2016. 2019 Feb 12. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #248. Available from http://www.ncbi.nlm.nih.gov/books/NBK538941/

    PubMed 30896914

  • Panagiotou OA, Kumar A, Gutman R, Keohane LM, Rivera-Hernandez M, Rahman M, Gozalo PL, Mor V, Trivedi AN. Hospital Readmission Rates in Medicare Advantage and Traditional Medicare: A Retrospective Population-Based Analysis. Ann Intern Med. 2019 Jul 16;171(2):99-106. doi: 10.7326/M18-1795. Epub 2019 Jun 25.

    PubMed 31234205

  • Mitchell SE, Gardiner PM, Sadikova E, Martin JM, Jack BW, Hibbard JH, Paasche-Orlow MK. Patient activation and 30-day post-discharge hospital utilization. J Gen Intern Med. 2014 Feb;29(2):349-55. doi: 10.1007/s11606-013-2647-2. Epub 2013 Oct 4.

    PubMed 24091935

  • Riegel B, Masterson Creber R, Hill J, Chittams J, Hoke L. Effectiveness of Motivational Interviewing in Decreasing Hospital Readmission in Adults With Heart Failure and Multimorbidity. Clin Nurs Res. 2016 Aug;25(4):362-77. doi: 10.1177/1054773815623252. Epub 2016 Jan 6.

    PubMed 26743119

  • Villani A, Malfatto G, Compare A, Della Rosa F, Bellardita L, Branzi G, Molinari E, Parati G. Clinical and psychological telemonitoring and telecare of high risk heart failure patients. J Telemed Telecare. 2014 Dec;20(8):468-75. doi: 10.1177/1357633X14555644. Epub 2014 Oct 22.

    PubMed 25339632

  • Roncella A, Pristipino C, Cianfrocca C, Scorza S, Pasceri V, Pelliccia F, Denollet J, Pedersen SS, Speciale G. One-year results of the randomized, controlled, short-term psychotherapy in acute myocardial infarction (STEP-IN-AMI) trial. Int J Cardiol. 2013 Dec 10;170(2):132-9. doi: 10.1016/j.ijcard.2013.08.094. Epub 2013 Sep 8.

    PubMed 24239154

  • Allen LA, Smoyer Tomic KE, Smith DM, Wilson KL, Agodoa I. Rates and predictors of 30-day readmission among commercially insured and Medicaid-enrolled patients hospitalized with systolic heart failure. Circ Heart Fail. 2012 Nov;5(6):672-9. doi: 10.1161/CIRCHEARTFAILURE.112.967356. Epub 2012 Oct 16.

    PubMed 23072736

  • Bhalla R, Kalkut G. Could Medicare readmission policy exacerbate health care system inequity? Ann Intern Med. 2010 Jan 19;152(2):114-7. doi: 10.7326/0003-4819-152-2-201001190-00185. Epub 2009 Nov 30.

    PubMed 19949133

  • Ogunmoroti O, Osibogun O, Spatz ES, Okunrintemi V, Mathews L, Ndumele CE, Michos ED. A systematic review of the bidirectional relationship between depressive symptoms and cardiovascular health. Prev Med. 2022 Jan;154:106891. doi: 10.1016/j.ypmed.2021.106891. Epub 2021 Nov 17.

    PubMed 34800472

  • Levine GN, Cohen BE, Commodore-Mensah Y, Fleury J, Huffman JC, Khalid U, Labarthe DR, Lavretsky H, Michos ED, Spatz ES, Kubzansky LD. Psychological Health, Well-Being, and the Mind-Heart-Body Connection: A Scientific Statement From the American Heart Association. Circulation. 2021 Mar 9;143(10):e763-e783. doi: 10.1161/CIR.0000000000000947. Epub 2021 Jan 25.

    PubMed 33486973

  • Sreenivasan J, Abu-Haniyeh A, Hooda U, Khan MS, Aronow WS, Michos ED, Cooper HA, Panza JA. Rate, causes, and predictors of 90-day readmissions and the association with index hospitalization coronary revascularization following non-ST elevation myocardial infarction in the United States. Catheter Cardiovasc Interv. 2021 Jul 1;98(1):12-21. doi: 10.1002/ccd.29119. Epub 2020 Jul 20.

    PubMed 32686892

  • Reese RL, Freedland KE, Steinmeyer BC, Rich MW, Rackley JW, Carney RM. Depression and rehospitalization following acute myocardial infarction. Circ Cardiovasc Qual Outcomes. 2011 Nov 1;4(6):626-33. doi: 10.1161/CIRCOUTCOMES.111.961896. Epub 2011 Oct 18.

    PubMed 22010201

Questions about this trial

What is this clinical trial studying?

A study testing Laguna Coach Intervention Group in people with Cardiovascular Diseases, run by Laguna Health, Inc 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 2 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 24 Jun 2022. 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?

Unplanned All Cause Readmission Rate (time frame: 30 Days Post-Discharge). 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?

On the ClinicalTrials.gov record for NCT05431894, which also lists 13 linked publications.

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 24 Jun 2022.

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