Condition category
Mental and Behavioural Disorders
Date applied
17/02/2016
Date assigned
19/02/2016
Last edited
16/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Delirium is a state of mental confusion. One third of hospitalized older adults who develop delirium are discharged from hospital while they still have symptoms, or develop symptoms shortly after discharge or an illness. Therefore, strategies for early detection and prevention of delirium at home must be created. The aim of this study is to develop and test the effectiveness, feasibility and acceptability of a nursing intervention to detect and prevent delirium among older adults who were recently hospitalized or had an acute illness.

Who can participate?
People aged 65 or over who have been recently discharged from hospital

What does the study involve?
Participants are randomly allocated into an experimental group or a control group. The control group receives standard home care. The experimental group receives both standard home care and nursing interventions tailored to detect/prevent delirium at five times following discharge (at 48 hours, 72 hours, 7 days, 14 days, and 21 days). Delirium symptoms are assessed at the start of the study and after one month.

What are the possible benefits and risks of participating?
Benefits for participants include five supplementary home visits from an experienced study nurse addressing health care problems , supervision of their medication adherence and monitoring of their health status during the first month of hospital discharge. There are no risks for participants.

Where is the study run from?
Centre Médico-Social de Sion (Switzerland)

When is the study starting and how long is it expected to run for?
February to November 2012

Who is funding the study?
Institut et Haute Ecole de la Santé La Source (Switzerland)

Who is the main contact?
Prof Henk Verloo
h.verloo@ecolelasource.ch

Trial website

Contact information

Type

Scientific

Primary contact

Prof Henk Verloo

ORCID ID

Contact details

Avenue Vinet 30
Lausanne
1004
Switzerland
+41 (0)21 641 38 67
h.verloo@ecolelasource.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect estimation of an innovative nursing intervention to improve delirium among home-dwelling older adults: a randomized controlled pilot trial

Acronym

Study hypothesis

The three hypotheses were, compared to older adults who receive usual care, those receiving the nursing preventive intervention over a month period have a significantly larger:
1. Decrease of delirium symptoms as measured by the Confusion Assessment Method (CAM)
2. Decrease of cognitive impairment as measured by the Mini Mental State Examination (MMSE)
3. Increase of functional independency as measured by the Katz and Lawton Index of activities of daily living/instrumental activities of daily living (ADL/IADL)

Ethics approval

Ethical Committee Valais, Switzerland, 15/11/2011, no CCVEM 030/11

Study design

Pragmatic randomized pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Delirium among home dwelling older adults

Intervention

Control group
Participants in the control group received only the usual home care but were assessed for delirium symptoms at study entry (M1) after one month (M2) and in patient records during the study period. The amount of usual care depended on the patient’s clinical status, the presence of informal caregivers, and the skill mix within the nursing workforce of the home health care center. The community health nurses conducted a total of 484 usual care visits during the study period, with an average of 2.28 (SD= 0.84) visits weekly pro participant.

Intervention group
In addition to the usual care and the delirium symptoms assessment mentioned before, each participant in the EG received five additional patient-centered nursing interventions. The community health nurses conducted a total of 452 usual care visits during the study period, with an average of 2.26 (SD= 1.34) visits weekly pro participant. The construction of the nursing intervention was based on the theoretical framework of prevention strategies from the Neuman System Model and from the Mapping Intervention Model of Bartholomew et al. It was completed with recommendations from different recent evidence-based guidelines as well as from geriatric friendly hospital recommendations.

All nursing interventions were dispensed by the research geriatric clinical nurse during home visits. This research nurse was trained by the PI over three days with the aim to assess delirium symptoms with the CAM and the health status of the participants, and to apply the five person-centered nursing interventions. These five interventions were structured according to six domains (assessment, detection, monitoring, support, dispensed care, health promotion, and education), 15 nursing intervention protocols (Appendices 1) and covered 70 nursing activities. The interventions had been previously judged and accepted by a panel of community nursing experts. Furthermore, the nursing interventions were adapted and standardized after being pre-tested with five discharged home-dwelling older patients. A user guide was developed with the aim to structure and standardize application by the research GCN. This procedure permitted the interventions to be patient-centered during the home visits by selecting the most appropriate domains, nursing activities, and nursing protocols in relation with the clinical status of the older adults and the presence or not of delirium symptoms or risk factors.

Each intervention started with an assessment of the physical and cognitive status including the CAM, pain and biologic parameters such as blood pressure, temperature, heart rate, glycaemia, oxygen saturation and pain evaluation. In addition, delirium risk factors were also assessed such as constipation/diarrhea, dehydration, infections and additional prescribed/over the counter medications. Subsequently, the nursing interventions provided took into consideration the assessed health status and delirium risk factors. Finally, each intervention was concluded with two or three oral health promotion recommendations to the participant and informal caregiver. The first intervention was made within two days after consent of the participants. Intervention two to five were conducted at 3, 7, 14, and 21 days after their consent. This interval was based on the average duration of a delirium episode, which usually varies between three to seven days. Two assessment visits were planned for all participants at an interval of 30 days (M1 and M2).

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Symptoms of delirium assessed with the Confusion Assessment Method (CAM) at M1 and M2

Secondary outcome measures

1. Cognitive impairment measured by the Mini Mental State Examination (MMSE) at M1 and M2
2. Functional status measured by the Katz and Lawton Index of activities of daily living/instrumental activities of daily living (ADL/IADL) at M1 and M2

Overall trial start date

01/01/2012

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 65 years or over
2. Recently discharged from hospital
3. Capable of understanding and answering questions in French

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Minimum 40

Participant exclusion criteria

1. Outpatient treatment still going on within the hospital premises
2. A medical prescription for a single intervention of home health care
3. If they were outside the study reach

Recruitment start date

15/02/2012

Recruitment end date

01/11/2012

Locations

Countries of recruitment

Switzerland

Trial participating centre

Centre Médico-Social de Sion
Avenue de la Gare 24
Sion
1951
Switzerland

Sponsor information

Organisation

Leenaards Foundation (Switzerland)

Sponsor details

Rue de la petite Chêne
18
Lausanne
1003
Switzerland
+41 (0)21 351 25 55
fondation@leenaards.ch

Sponsor type

Research organisation

Website

www.leenaards.ch

Funders

Funder type

University/education

Funder name

Institut et Haute Ecole de la Santé La Source (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The feasibility and acceptability publication has been accepted and is currently in press

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26034489
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26848261
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26977135

Publication citations

Additional files

Editorial Notes

15/03/2016: Publication reference added.