Behavioral and Recovery Support for 30 Day Post-Discharge Care

NCT05431894 | Completed DMC

• 1 other identifier: EH21-092
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Keywords

Readmissions; Cardiovascular; Post-Discharge; Behavioral Health; Readmission Cost; 30 Day Readmission; Heart Failure; Care Management; Barriers to Care; Contextualizing Healthcare

Outcome Measures

Primary Outcomes (2)

• Unplanned All Cause Readmission Rate

  Unplanned All-Cause 30 Day Readmission Rate

  30 Days Post-Discharge

• Unplanned Readmission Total Cost

  Billed facility charges for readmissions hospitalization stays

  30 Days Post-Discharge

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Group received support from Laguna Coaches

Behavioral: Laguna Coach Intervention Group

Control Arm

NO INTERVENTION

Group received no support from Laguna Coaches

Interventions

Laguna Coach Intervention Group 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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Laguna Health, Inc: lead
• Endeavor Health: collaborator

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related Publications (13)

• 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.

  PMID: 32125402 BACKGROUND

• 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/

  PMID: 30896914 BACKGROUND

• 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.

  PMID: 31234205 BACKGROUND

• 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.

  PMID: 24091935 BACKGROUND

• 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.

  PMID: 26743119 BACKGROUND

• 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.

  PMID: 25339632 BACKGROUND

• 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.

  PMID: 24239154 BACKGROUND

• 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.

  PMID: 23072736 BACKGROUND

• 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.

  PMID: 19949133 BACKGROUND

• 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.

  PMID: 34800472 BACKGROUND

• 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.

  PMID: 33486973 BACKGROUND

• 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.

  PMID: 32686892 BACKGROUND

• 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.

  PMID: 22010201 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Alfonso Tafur, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: February 18, 2021
• Primary Completion: February 24, 2022
• Study Completion: June 13, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)