Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2020

01-12-2020 | Care | Study protocol

A trauma medical home, evaluating collaborative care for the older injured patient: study protocol for a randomized controlled trial

Authors: Damaris Ortiz, Ashley D. Meagher, Heidi Lindroth, Emma Holler, Sujuan Gao, Babar Khan, Sue Lasiter, Malaz Boustani, Ben Zarzaur

Published in: Trials | Issue 1/2020

Login to get access

Abstract

Background

It is estimated that 55 million adults will be 65 years and older in the USA by 2020. These older adults are at increased risk for injury and their recovery is multi-faceted. A collaborative care model may improve psychological and functional outcomes of the non-neurologically impaired older trauma patient and reduce health care costs.

Methods

This is a randomized controlled trial of 430 patients aged 50 and older who have suffered a non-neurologic injury and are admitted to a level one trauma center in Indianapolis, IN, or Madison, WI. Participants will be assigned to either the Trauma Medical Home (TMH) intervention or usual care. The TMH intervention is a collaborative care model that includes validated protocols addressing the multi-faceted needs of this population, with the help of care coordination software and a mobile office concept. The primary outcome is self-reported physical recovery at 6- and 12-month follow-up. Secondary outcomes include self-reported psychological recovery, acute health care utilization, and cost-effectiveness of the intervention at 6 and 12 months. The TMH collaborative care model will be delivered by a registered nurse care coordinator. The assessments will be completed by trained blinded research assistants.

Discussion

The proposed study will evaluate a collaborative care model to help maximize psychological and functional recovery for non-neurologically injured older patients at four level one trauma centers in the Midwest.

Trial registration

Clinical Trials. NCT03108820. Registered on 11 April 2017.
Protocol Version 6: Study # 1612690852. April 12, 2019.
Sponsor: Indiana University. Human subjects and IRB contact information: irb@iu.​edu
Prospectively registered in the WHO ICTRP on 4 June 2017.
Appendix
Available only for authorised users
Literature
1.
2.
3.
Corso P, Finkelstein E, Miller T, Fiebelkorn I, Zaloshnja E. Incidence and lifetime costs of injuries in the United States. Inj Prev. 2006;12:212–8 PMCID: PMC2586784.PubMedPubMedCentralCrossRef
4.
Holbrook TL, Hoyt DB, Stein MB, et al. Perceived threat to life predicts posttraumatic stress disorder after major trauma: risk factors and functional outcome. J Trauma. 2001;51:287.PubMedCrossRef
5.
Zatzick D. Posttraumatic stress, functional impairment, and service utilization after injury: a public health approach. Semin Clin Neuropsychiatry. 2003;8:149.PubMedCrossRef
6.
Zatzick D, Jurkovich G, Russo J, et al. Posttraumatic distress, alcohol disorders, and recurrent trauma across level 1 trauma centers. J Trauma. 2004;57:360.PubMedCrossRef
7.
Zatzick D, Jurkovich GJ, Gentilello LM, et al. Posttraumatic stress, problem drinking, and functional outcomes after injury. Arch Surg. 2002;137:200.PubMedCrossRef
8.
Zatzick D, Kang SM, Muller HG, et al. Predicting posttraumatic distress in hospitalized trauma survivors with acute injuries. Am J Psychiatry. 2002;159:941.PubMedCrossRef
9.
Soderstrom CA, Smith GS, Dischinger PC, et al. Psychoactive substance use disorders among seriously injured trauma center patients. J Am Med Assoc. 1997;277:1769.CrossRef
10.
Michaels AJ, Michaels CE, Moon CH, et al. Posttraumatic stress disorder after injury: impact on general health outcome and early risk assessment. J Trauma. 1999;47:460.PubMedCrossRef
11.
Zarzaur BL, Bell TM. Trajectory subtypes after injury and patient-centered outcomes. J Surg Res. 2016;202(1):103–10.PubMedCrossRef
12.
Zatzick D, Jurkovich GJ, Rivara FP, et al. A national US study of posttraumatic stress disorder, depression, and work and functional outcomes after hospitalization for traumatic injury. Ann Surg. 2008;248(3):429–37.PubMed
13.
Sabin JA, Zatzick D, Jurkovich G, et al. Primary care utilization and detection of emotional distress after adolescent traumatic injury: identifying an unmet need. Pediatrics. 2006;117:130.PubMedCrossRef
14.
Glancy KE, Glancy CJ, Lucke JF, Mahurin K, Rhodes M, Tinkoff GH. A study of recovery in trauma patients. J Trauma. 1992;33:602–9.PubMedCrossRef
15.
Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press; 2001.
16.
Ghaffar O, McCullagh S, Ouchterlony D, Feinstein A. Randomized treatment trial in mild traumatic brain injury. J Psychosom Res. 2006;61(2):153–60.PubMedCrossRef
17.
Wade DT, Crawford S, Wenden FJ, King N, Moss NE. Does routine follow up after head injury help? A randomised controlled trial. J Neurol Neurosurg Psychiatry. 1997;62(5):478–84 PMCID: PMC486856.PubMedPubMedCentralCrossRef
18.
Wade DT, King NS, Wenden FJ, Crawford S, Caldwell FE. Routine follow up after head injury: a second randomised controlled trial. J Neurol Neurosurg Psychiatry. 1998;65(2):177–83 PMCID: PMC2170203.PubMedPubMedCentralCrossRef
19.
Whiteneck GG, Gassaway J, Dijkers MP, et al. Inpatient and postdischarge rehabilitation services provided in the first year after spinal cord injury: findings from the SCIRehab Study. Arch Phys Med Rehabil. 2011;92(3):361–8.PubMedCrossRef
20.
Counsell SR, Callahan CM, Buttar AB, et al. Geriatric Resources for Assessment and Care of Elders (GRACE): a new model of primary care for low-income seniors. J Am Geriatr Soc. 2006;54(7):1136–41.PubMedCrossRef
21.
Callahan CM, Kroenke K, Counsell SR, IMPACT Investigators, et al. Treatment of depression improves physical functioning in older adults. J Am Geriatr Soc. 2005;53(3):367–73.PubMedCrossRef
22.
Larsson P, Borge CR, Nygren-Bonnier M, et al. An evaluation of the short physical performance battery following pulmonary rehabilitation in patients with chronic obstructive pulmonary disease. BMC Res Notes. 2018;11:348.PubMedPubMedCentralCrossRef
23.
Guralnik JM, Ferrucci L, Pieper CF, et al. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000;55(4):M221–31.PubMedCrossRef
24.
Latham NK, Harris BA, Bean JF, et al. Effect of a home-based exercise program on functional recovery following rehabilitation after hip fracture: a randomized clinical trial. JAMA. 2014;311(7):700–8.PubMedPubMedCentralCrossRef
25.
Pan SL, Liang HW, Hou WH, Yeh TS. Responsiveness of SF-36 and Lower Extremity Functional Scale for assessing outcomes in traumatic injuries of lower extremities. Injury. 2014;45(11):1759–63.CrossRefPubMed
26.
27.
Halcomb E, Daly J, Davidson P, Elliott D, Griffiths R. Life beyond severe traumatic injury: an integrative review of the literature. Aust Crit Care. 2005;18(1):17–8 20-4.PubMedCrossRef
28.
Sluys K, Häggmark T, Iselius L. Outcome and quality of life 5 years after major trauma. J Trauma. 2005;59(1):223–32.PubMedCrossRef
29.
Volpato S, Cavalieri M, Guerra G, Sioulis F, Ranzini M, Maraldi C, Fellin R, Guralnik JM. Performance-based functional assessment in older hospitalized patients: feasibility and clinical correlates. J Gerontol A Biol Sci Med Sci. 2008;63(12):1393–8.PubMedCrossRef
30.
Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006;54(5):743–9.PubMedCrossRef
31.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83.PubMedCrossRef
32.
33.
Michaels AJ, Michaels CE, Smith JS, Moon CH, Peterson C, Long WB. Outcome from injury: general health, work status, and satisfaction 12 months after trauma. J Trauma. 2000;48:841–8.PubMedCrossRef
34.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–13 PMCID: PMC1495268.PubMedPubMedCentralCrossRef
35.
Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004;42(12):1194–201.PubMedCrossRef
36.
Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007;146(5):317–25.PubMedCrossRef
37.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–7.PubMedCrossRef
38.
Little RJA, Rubin DB. Statistical analysis with missing data. 2nd ed. New York: Wiley; 2002.CrossRef
39.
LaMantia MA, Alder CA, Callahan CM, Gao S, French DD, Austrom MG, Boustany K, Livin L, Bynagari B, Boustani MA. The aging brain care medical home: preliminary data. J Am Geriatr Soc. 2015;63(6):1209–13.PubMedCrossRef
40.
Metadata
Title
A trauma medical home, evaluating collaborative care for the older injured patient: study protocol for a randomized controlled trial
Authors
Damaris Ortiz
Ashley D. Meagher
Heidi Lindroth
Emma Holler
Sujuan Gao
Babar Khan
Sue Lasiter
Malaz Boustani
Ben Zarzaur
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04582-x

Other articles of this Issue 1/2020

Trials 1/2020 Go to the issue

Update

Update to the FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical analysis plan for the trials and for the individual patient data meta-analysis

Study protocol

Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial)

Methodology

Implementation of strength-based case management for opioid-dependent patients presenting in medical emergency departments: rationale and study design of a randomized trial

Study protocol

Can hypnosis and virtual reality reduce anxiety, pain and fatigue among patients who undergo cardiac surgery: a randomised controlled trial

Study protocol

Developing a core outcome set for the treatment of pregnant women with pregestational diabetes—a study protocol

Study protocol

Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event (RESTORE BRAIN study): a placebo controlled phase II study