Behavioral and Recovery Support for 30 Day Post-Discharge Care

NCT ID: NCT05431894

Last Updated: 2022-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-18

Study Completion Date

2022-06-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Arm

Group received support from Laguna Coaches

Group Type EXPERIMENTAL

Laguna Coach Intervention Group

Intervention Type BEHAVIORAL

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.

Control Arm

Group received no support from Laguna Coaches

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Laguna Coach Intervention Group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endeavor Health

OTHER

Sponsor Role collaborator

Laguna Health, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alfonso Tafur, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

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NorthShore University HealthSystem

Evanston, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32125402 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 30896914 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31234205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24091935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26743119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25339632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24239154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23072736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19949133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34800472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33486973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32686892 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22010201 (View on PubMed)

Other Identifiers

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EH21-092

Identifier Type: -

Identifier Source: org_study_id

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