Hospital at Home for Elderly Acute Ill Patients

NCT05360914 | Recruiting

• 1 other identifier: Hospital at Home
• Study Type: interventional
• Target: 849
• Locations: 1 country
• Sites: 3

Brief Summary

Many elderly patients with uncomplicated treatment courses are admitted unnecessarily, which is a burden for the patient and society. Studies show that Hospital at Home (HaH) treatment is an alternative to hospitalization. The patient's risk of delirium, infection and loss of function is reduced when the patient avoids the hospital stay. HaH treatment is expected to be more cost-effective, improve patients' functional abilities and patients' satisfaction. Three municipalities, general practitioners, pre-hospital service and an emergency department (ED) in Central Denmark Region have organized the first HaH treatment model across disciplines and sectors. Specialists in the ED and the municipal acute teams provide HaH treatment for elderly acute ill patients. However, the model has not yet been evaluated. The aim of this study is to optimize the HaH treatment model for elderly acute ill patients. The objective is to increase patient satisfaction and optimize the use of resources in healthcare by avoiding unnecessary hospitalizations that impair and prolong treatment. This study is an open label randomized controlled trial (RCT) with a 1:2 allocation ratio of acute hospital admission versus HaH. During a pilot period, we tested and adapted the patient pathway of HaH to the practical reality, before we start the randomization for the RCT study. We will investigate the clinical effects and health economic consequences of HaH treatment compared with standard hospital treatment.

Conditions

Cystitis; Erysipelas; Pneumonia

Outcome Measures

Primary Outcomes (2)

• Rate of 30-days re-admission

  Rate of 30-days re-admission after discharge

  30 days period after discharge

• Health Related Quality of Life

  Estimating quality of life by using EuroQoL-5 Dimensions. We will use EuroQoL-5 Dimensions to measure Health Related Quality of Life. The five dimensions include mobility, self-care, usual activity, pain/discomfort and anexiety/depression.This tool will provide us with health states (11111 being the best health state and 55555 the worse health state). We will use the Danish weight to give weights to different health states obtained from EuroQoL-5 Dimensions.

  From inclusion to 3 months follow-up

Secondary Outcomes (3)

• Functional mobility test

  From inclusion to 3 months follow-up

• Mortality rate

  From inclusion to 3 months follow-up

• Number of contacts to primary and secondary health care system

  From inclusion to 3 months follow-up

Study Arms (2)

Hospital at Home (HaH) treatment

EXPERIMENTAL

The patients in this arm will receive the intervention.

Other: Hospital at Home (HaH) treatment

Standard hospital admission

ACTIVE COMPARATOR

The patients in this arm are the control group and will receive the standard hospital treatment.

Other: Standard hospital admission

Interventions

Hospital at Home (HaH) treatment OTHER

The intervention is a new pathway of providing acut treatment for elderly acute ill patients in their own home. If the patient is randomized to the intervention group, the municipalities acute teams start the treatment. The acute team can take venous blood tests, ECG and bladder scan at home. The acute team handles the treatment at home and follows the patient closely. During the treatment course, the acute team and the ED specialist discuss the treatment process either over the phone or virtually on an iPad, where the patient is also involved. If the specialist would like to see the patient for assessment or send the patient for an X-ray, the specialist informs the acute team that the patient must go to a short check-up in the ED. Here, the specialist examines the patient himself and assesses whether the patient can continue to be treated at home, or whether the patient must be admitted to the hospital due to deterioration of the condition.

Hospital at Home (HaH) treatment

Standard hospital admission OTHER

The active comparator is the standard hospital admission for elderly acute ill patients.

Standard hospital admission

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• The patient should be aged 65 and over
• Diagnosed with a stable acute medical conditions e.g. cystitis, erysipelas, pneumonia
• The patient should be living in their own home or a nursing home before entering the study
• The patient should be residing in one of the three municipalities (Viborg, Skive and Silkeborg)
• The patient must have been seen by the GP or the pre-hospital service in the case of disease in question
• The patient should speak and understand Danish.
• The patient should give informed consent to participate in the study.

You may not qualify if:

• The patient is unable to give written consent
• The capacity of the municipal acut team care was fully utilised.

Sponsors & Collaborators

• Defactum, Central Denmark Region: lead
• Interdisciplinary Centre for Organizational Architecture (ICOA), Aarhus University, Denmark: collaborator
• Research Center for Emergency Medicine, Aarhus University, Denmark: collaborator
• Viborg Regional Hospital: collaborator

Study Sites (3)

Silkeborg municipality

Silkeborg, 8600, Denmark

RECRUITING

Skive municipality

Skive, Denmark

RECRUITING

Viborg municipality

Viborg, Denmark

RECRUITING

Related Publications (10)

• Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993 Feb 1;118(3):219-23. doi: 10.7326/0003-4819-118-3-199302010-00011.

  PMID: 8417639 BACKGROUND

• Leff B, Burton L, Mader SL, Naughton B, Burl J, Greenough WB 3rd, Guido S, Steinwachs D. Comparison of functional outcomes associated with hospital at home care and traditional acute hospital care. J Am Geriatr Soc. 2009 Feb;57(2):273-8. doi: 10.1111/j.1532-5415.2008.02103.x. Epub 2008 Dec 11.

  PMID: 19170781 BACKGROUND

• Isaia G, Astengo MA, Tibaldi V, Zanocchi M, Bardelli B, Obialero R, Tizzani A, Bo M, Moiraghi C, Molaschi M, Ricauda NA. Delirium in elderly home-treated patients: a prospective study with 6-month follow-up. Age (Dordr). 2009 Jun;31(2):109-17. doi: 10.1007/s11357-009-9086-3. Epub 2009 Jan 30.

  PMID: 19507055 BACKGROUND

• Wilson A, Wynn A, Parker H. Patient and carer satisfaction with 'hospital at home': quantitative and qualitative results from a randomised controlled trial. Br J Gen Pract. 2002 Jan;52(474):9-13.

  PMID: 11791829 BACKGROUND

• Aimonino Ricauda N, Tibaldi V, Leff B, Scarafiotti C, Marinello R, Zanocchi M, Molaschi M. Substitutive "hospital at home" versus inpatient care for elderly patients with exacerbations of chronic obstructive pulmonary disease: a prospective randomized, controlled trial. J Am Geriatr Soc. 2008 Mar;56(3):493-500. doi: 10.1111/j.1532-5415.2007.01562.x. Epub 2008 Jan 4.

  PMID: 18179503 BACKGROUND

• Shepperd S, Iliffe S. Hospital at home versus in-patient hospital care. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD000356. doi: 10.1002/14651858.CD000356.pub2.

  PMID: 16034853 BACKGROUND

• Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.

  PMID: 23295957 BACKGROUND

• Levine DM, Ouchi K, Blanchfield B, Saenz A, Burke K, Paz M, Diamond K, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial. Ann Intern Med. 2020 Jan 21;172(2):77-85. doi: 10.7326/M19-0600. Epub 2019 Dec 17.

  PMID: 31842232 BACKGROUND

• Shepperd S, Doll H, Angus RM, Clarke MJ, Iliffe S, Kalra L, Ricauda NA, Wilson AD. Admission avoidance hospital at home. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD007491. doi: 10.1002/14651858.CD007491.

  PMID: 18843751 BACKGROUND

• Thomsen AML, Tayyari N, Duvald I, Kirkegaard H, Obel B, Nielsen CP. Hospital at home for elderly acute patients: a study protocol for a randomised controlled trial. BMJ Open. 2024 May 2;14(5):e083372. doi: 10.1136/bmjopen-2023-083372.

  PMID: 38697766 DERIVED

Related Links

• The Danish National program for elderly care
• Effective municipality program with focus on prevention of admission and re-admission

MeSH Terms

Conditions

Cystitis; Erysipelas; Pneumonia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Camilla Palmhøj Nielsen, Ph.D

  Defactum, Central Denmark Region

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Palmhøj Nielsen, Ph.D

CONTACT

+4521621238; camilla.palmhoj@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research director

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 4, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)