Clinical trial NCT05724043: SmartJournal for Improved Oral Care in Nursing Homes
Official title: Assessment of the SmartJournal Intervention for Improved Oral Care in Nursing Homes: an Evaluation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Health
Keywords: Oral health
Care-dependent elderly
Nursing home
Nursing staff
Intervention
Digital tool
Lead sponsor: Oral Health Center of Expertise Rogaland, Norway
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: University of Stavanger
name: University of Agder
name: Regional Research Funds Rogaland, Norway
First posted: 2023-02-13
Enrollment: 360
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic cluster randomized controlled trial (C-RCT) will be employed to assess effects of SmartJournal usage as specified in the study objectives. Nursing homes located in Rogaland, Norway, will be recruited and randomly assigned to an intervention group and a control group. Nursing homes in the intervention group will be provided with tablets containing SmartJournal and receive training and follow-up throughout the intervention period. Nursing homes in the control group will continue with existing oral care routines. The intervention will last for 12 weeks.
Primary purpose: PREVENTION

Brief summary: Poor oral health is common in care-dependent older adults, and healthcare professionals report numerous barriers when it comes to provision of oral care for elderly patients. Frequently reported barriers are lack of oral health knowledge/skills and care resistant behaviors (CRB) in patients suffering from dementia. Other barriers include lack of adequate oral care routines and satisfactory systems for documentation of issues related to oral health, a high workload and unclear responsibilities. To overcome these barriers, an easy-to-use digital tool named SmartJournal has been developed to assist health personnel in preserving the older patient's oral health. SmartJournal has three components: one for documentation of oral hygiene routines, one for monthly oral health assessment and one for e-learning (a digital knowledge base with information on geriatric oral health and handling of CRB). The objectives of the present study are to assess: 1) the effectiveness of SmartJournal in enhancing nursing home caregivers' capability, opportunity, motivation and routines related to oral care, 2) whether SmartJournal usage may result in improved oral health for nursing home residents and 3) whether SmartJournal usage may result in changes in documentation of oral health related issues in patient journals.

A cluster randomized controlled trial (C-RCT) will be employed to assess effects of SmartJournal usage as specified in the study objectives. Nursing homes located in Rogaland, Norway, will be recruited and randomly assigned to an intervention- and a control group. The intervention group will be provided with tablets containing SmartJournal, while the control group will continue with existing oral care routines. The intervention will last for 12 weeks. Measurements will be performed in both groups at baseline, immediately post-intervention (3 months) and at follow-up (9 months) and include: 1) a survey assessing caregivers' capability, opportunity, motivation and routines related to oral care, 2) oral examinations in residents using mucosal-plaque score (MPS) as a primary outcome variable for assessing oral health status, and 3) examination of patient journals to assess the frequency and quality of reported oral health related issues. We hypothesize that SmartJournal usage will have a positive effect as measured by favorable changes in study variable scores.

Detailed description: INTRODUCTION

Poor oral health is common in frail and care-dependent older adults and includes tooth loss, poor oral hygiene, high prevalence of dental caries and periodontal disease, defective dental prostheses, hyposalivation and various oral lesions caused by misfitting dentures and/or precancerous or cancerous states. Alarmingly, oral health is shown to be the most neglected area in Norwegian nursing homes and oral healthcare is the first task to be downgraded due to lack of resources. Neglect of oral health, resulting in poor oral hygiene, may cause infections and inflammation both locally and systemically. Oral infections have been associated with systemic conditions such as atherosclerosis, diabetes and aspiration pneumonia. Moreover, chewing difficulties as a result of poor dental status have been associated with altered dietary habits, malnutrition and cognitive decline. According to the World Health Organization, this is a worldwide problem as oral health is an often neglected area of healthy ageing. A few decades ago, most older adults were denture wearers. Today, an increasing number of elderly keep their natural teeth - often in combination with complex and expensive fixed and/or removable prosthesis. While dentures are easy to manage, the more complex prosthetic devices can represent a challenge with regard to handling and cleaning. Thus, care-dependent elderly have to rely on caregivers to maintain satisfactory oral health. Research from Sweden and Denmark has shown that about 80% of nursing home residents need assistance with daily oral hygiene practices. Thus, it is disturbing that healthcare professionals report numerous barriers when it comes to provision of adequate oral care. The most frequently reported barriers are lack of knowledge and skills and care resistant behaviors (CRB), in particular among patients suffering from dementia. Research has indicated that more than 50% of Norwegian nursing home residents with dementia refuse oral care assistance. In cases of frequent CRB, daily oral care may be postponed repeatedly, resulting in poor oral hygiene and increased risk of oral and systemic infections. Other reported barriers include lack of adequate oral care routines, lack of systems for documentation of issues related to oral health, a high workload and unclear responsibilities. To overcome the reported barriers for provision of adequate oral care in the elderly, an interactive and easy-to-use digital tool named SmartJournal has been developed to assist health personnel in preserving nursing home residents' oral health. SmartJournal, which is an application for tablet, is created by researchers at the Oral Health Centre of Expertise in Rogaland, Norway, in close collaboration with dental professionals, nursing home caregivers and innovative research- and development environments. The objectives of the current research are: to assess 1) the effectiveness of SmartJournal in enhancing nursing home caregivers' capability, opportunity, motivation and routines related to oral care, 2) whether SmartJournal usage may result in improved oral health for nursing home residents and 3) whether SmartJournal usage may result in changes in the documentation of oral health related issues in patient journals.

METHODS

Design and procedures

A pragmatic cluster randomized controlled trial (C-RCT) will be employed to assess effects of SmartJournal usage as specified in the study objectives. Nursing homes located in Rogaland, Norway, will be recruited and randomly assigned to an intervention group and a control group. Nursing homes in the intervention group will be provided with tablets containing SmartJournal, while nursing homes in the control group will continue with existing oral care routines. The intervention will last for 12 weeks. Following recruitment of participants and baseline measurements, nursing homes in the intervention group will be provided with SmartJournal toolboxes and packages with oral hygiene equipment, while nursing homes in the control group will receive oral hygiene equipment packages only. Training, follow-up and technical support for SmartJournal users will be provided by project staff employed at the Oral Health Centre of Expertise Rogaland.

Measurements

Effects of SmartJournal usage on caregivers' capability, opportunity, motivation and routines related to oral healthcare and handling of CRB will be measured by a survey questionnaire. Caregivers in both the intervention- and the control group will be asked to fill out the survey questionnaire three times: before the intervention (baseline), immediately after the intervention (at 3 months) and 6 months after the intervention (at 9 months). Effects of SmartJournal usage on nursing home residents' oral health will be assessed using the mucosal-plaque score (MPS) as a primary outcome measure. Residents in both the intervention- and the control group will have an assessment of MPS at three times: at baseline, 3 months and 9 months. MPS assessments will be performed by dental professionals employed at the Oral Health Center of Expertise Rogaland, Norway. Calibration will be undertaken to ensure reliability of the clinical measurements. Effects of SmartJournal usage on documentation of oral health related issues in patient journals will be measured both quantitatively (i.e., frequency of documentation) and qualitatively (i.e., qualitative assessment of documentation) at three times throughout the project period: at baseline, 3 months and 9 months. Additional journal data shown to be associated with oral health will also be retrieved and used to describe the study sample and to be included as covariates in statistical analyses. These data include socio-demographics, medical conditions and prescribed medication.

Power and sample size

Estimation of sample size is based on previous research using MPS as a primary outcome measure. We assume an alpha of 0.5, a power of 80% and a 33% drop-out rate due to the residents' frail condition and a median resident time of two years. A medical statistician has been consulted to further adapt the calculations to the present study setting (taking into account the number of eligible nursing homes and residents in Rogaland), recommending the inclusion of 12 nursing homes each with 30 residents opted for oral health assessments. Thus, a total of 360 residents will be included for oral health assessments, 180 in the intervention and control group, respectively. All eligible caregivers in the included nursing homes will be invited to take part in the survey.

Data analyses

The statistical software package SPSS (IBM) will be used for analyses of quantitative data such as survey data, MPS data and frequency data from patient journals. The analyses will include descriptive statistics and statistical techniques to look for changes and differences in the study variables within and between the intervention- and the control group throughout the project period (e.g., t-tests and analysis of variance tests). We hypothesize that SmartJournal usage will lead to favorable changes in variable scores. In caregivers: improved capability, opportunity, motivation and routines related to oral care (survey data). In residents: improved oral health as measured by MPS. In patient journals: enhanced reporting of oral health related issues. Additionally, regression analysis will be employed to investigate associations between study variables while adjusting for potential covariates. NVivo (Alfasoft) will be used to analyze qualitative data from patient journals.

Eligibility criteria: INCLUSION CRITERIA

Nursing homes:

* Located in Rogaland county, Norway
* Long-term facilities

Residents (patients):

* Long-term residents (i.e., residents with the nursing home as their permanent address)
* Residents with and without dementia, who can undergo oral examination

Nursing staff:

* All types of nursing staff (nurses, auxiliary nurses, students)
* Full- and parttime staff

EXCLUSION CRITERIA

Nursing homes:

* Specialized nursing homes (e.g., psychiatry, substance abuse)
* Short-term facilities (e.g., rehabilitation, respite care)
* Nursing homes already following a specific protocol for oral care and/or participate in other comprehensive interventions

Residents (patients):

* Short-term residents
* Critically ill and terminal patients receiving palliative care

Nursing staff:

• Staff with purely administrative tasks (e.g., heads of institutions)

Primary outcomes:
measure: Mucosal-plaque index (MPS)
timeFrame: Change in MPS from baseline at 3 months and 9 at months.
Secondary outcomes:
measure: Survey data
timeFrame: Change in variable scores for capability, opportunity, motivation and routines (measured in questionnaire) from baseline at 3 months and at 9 months.
Other outcomes:
measure: Patient journals
timeFrame: For oral health related documentation: change in frequency and content from baseline at 3 months and at 9 months. For sociodemographics, medical conditions and prescribed medication: measurement at baseline only.
Locations:
city: Stavanger
country: Norway
facility: Oral Health Centre of Expertise Rogaland, Norway
Study officials:
affiliation: Oral Health Centre of Expertise Rogaland, Norway
name: Elisabeth Lind Melbye, PhD
role: PRINCIPAL_INVESTIGATOR
References: