Feasibility of Risk Sign Displays to Prevent Falls, Dehydration and Pulmonary Aspiration in Nursing Homes

NCT03123601 | Completed

• 1 other identifier: CNS2017-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: Prior research has shown a relationship between dehydration, falls and pulmonary aspiration among older adults in nursing and health care facilities, which contributes to its loss of independence and quality-of-life. Is believed that improving communication among health professional decreases the number of adverse events in institutionalized patients. This study will evaluate the feasibility of a set of sign displays designed to communicate fall, dehydration and pulmonary aspiration risks and will reflect on tailored interventions to manage these events in nursing homes. METHODS AND ANALYSIS: This will be a national, single-center, feasibility study. All patients, with chronic neurologic diseases selected from a nursing home, will be invited to participate. At baseline patients will undertake a screening risk assessment and it will be attributed a correspondent risk display. Study duration will be a minimum of 3 months per participant, including daily record of events and monthly interview assessments. Events data will be compared with historical data extracted retrospectively from medical and nursing charts.

Conditions

Nursing Home Residents

Keywords

Nursing home; Falls; Dysphasia; Choking; Dehydration

Outcome Measures

Primary Outcomes (1)

• Patients' adherence trough the number of times and reasons to taken off the risk display or refused to use during the period of the study and/or withdrawing from the study

  Minimum of 3 months

Secondary Outcomes (4)

• Patients' satisfaction with the sign displays measured with a 7-point likert scale and open-ended questions.

  Minimum of 3 months

• Health professionals' satisfaction measured with sign displays through 7-point likert scale and open-ended questions regarding the overall benefits of using the displays and overall perception of its impact on decreasing risk.

  Minimum of 3 months

• Comparison to historical medical and nursing charts data review of the relative frequency of number of events per number of days of hospitalization registered during the period of the study, with in an equal period of time, one year before.

  Minimum of 3 months

• Type and frequency of adverse events recorded during the period of the study

  Minimum of 3 months

Study Arms (1)

Risk sign displays

EXPERIMENTAL

At baseline patients will undertake a screening risk assessment and it will be attributed a correspondent risk display. Study duration will be a minimum of 3 months per participant, including daily record of events and monthly interview assessments. Events data will be compared with historical data extracted retrospectively from medical and nursing charts.

Device: Risk sign displays

Interventions

Risk sign displays DEVICE

Set of sign displays designed to communicate fall, dehydration and pulmonary aspiration risks and reflect on tailored interventions to manage these events in nursing homes. Risk sign displays are: * Small, lightweight rubber coloured bracelets with phrases related with the different risks: "prevent rather than fall", "contain to protect", "drink to hydrate" and "avoid choking". * Small and coloured signposts next to head of patients bed that are believed to offer some key advantages and increase technically the quality of immediate communication of information and data regarding procedures. It is expected to have greater subject compliance once they will have discrete messages with thoughtful design and colour.

Risk sign displays

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female staying at CNS nursing home for long term care;
• Risk of falling and/or dysphagia and/or dehydration defined by brief screening assessment;
• Being interested in participating in this study;
• Signing an informed consent form;
• Willing to comply with the monthly interviews required
• Eligibility validated by CNS health professionals in the multidisciplinary clinical meeting

You may not qualify if:

• Having significant active psychiatric problems (example: hallucinations, confusion, psychosis) that aggravates patient´s symptoms when dealing with the use of sign displays;
• Inability participate according to the CNS health professionals' judgement

Sponsors & Collaborators

• Campus Neurológico Sénior: lead
• University of Lisbon: collaborator

Study Sites (1)

Campus Neurológico Sénior

Torres Vedras, 2560-280 Torres Vedras, Portugal

Location

Related Publications (1)

• Duarte M, Bouca-Machado R, Domingos J, Godinho C, Ferreira JJ; CNS risk prompt display study group. Feasibility of using risk prompts to prevent falls, dehydration and pulmonary aspiration in nursing homes: a clinical study protocol. Pilot Feasibility Stud. 2018 Jan 25;4:39. doi: 10.1186/s40814-018-0236-1. eCollection 2018.

  PMID: 29416872 DERIVED

MeSH Terms

Conditions

Aphasia; Airway Obstruction; Dehydration

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes

Study Officials

• Joaquim J Ferreira, MD, PhD

  Campus Neurológico Sénior

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients, with chronic neurologic diseases selected from a nursing home, will be invited to participate. At baseline patients will undertake a screening risk assessment and it will be attributed a correspondent risk display. Study duration will be a minimum of 3 months per participant, including daily record of events and monthly interview assessments. Events data will be compared with historical data extracted retrospectively from medical and nursing charts.

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: April 21, 2017
• Study Start: November 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: May 30, 2017
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)