Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310798
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-05
Brief Title:
Inter-organizational Health Planning for Older Adults Public Dental Care and Municipal Care
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Outcomes of Inter-organizational Health Planning Between Public Dental Care and Municipal Care Organizations for Older People A Study Protocol for a Randomized Controlled Study in Sweden
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAPA
Brief Summary:
Patient participation is key for healthy ageing and essential in health planning and decision-making Oral health is an important but sometimes neglected part of general health and there is little research on health planning in ordinary home settings where older adults dental and nursing staff participate It has been concluded that shared tools such as common documentation and working in teams enables person-centered care in ordinary home settings Therefore this protocol outlines the design of a randomized controlled trial RCT measuring and comparing effect of two models of team based oral health planning with a common tool digital platform in ordinary home care settings in Sweden The overall aim of this project is to evaluate a person-centered inter-professional and inter-organizational model for oral health planning supported by a digital platform to enable healthy ageing
Following ethics approval a study design was developed guided by the seven action-steps of the knowledge to action framework In the sixth action-step older adults within the existing dental care remuneration program in Sweden will serve as a base for the RCT From there older adultsdental hygienists DH and nursing assistants NA will be randomized into test and control groups The test group n 12 DH and 12 NA will participate in a two-day course where a three-step person-centered oral health model will be taught Control group will be 12 DH within dental care remuneration program conducting business as usual with unknown number of NA due to present guidelines In total 360 older adultspatients will be asked to participate Test group and control group will respectively have 180 patients each as such each team DH NA have 15 patients Primary outcomes include diverse oral health aspects - the Revised Oral Assessment Guide and the Geriatric Oral Health Assessment Index Secondary outcomes include a retrospective record review a health economic evaluation Person Centered care Assessment Tool and Oral Hygiene Ability Index Additionally qualitative studies from theoretical perspectives of change and learning based on interviews with key stakeholders will be conducted in both test and control group
Following ethics approval a study design was developed guided by the seven action-steps of the knowledge to action framework In the sixth action-step older adults within the existing dental care remuneration program in Sweden will serve as a base for the RCT From there older adultsdental hygienists DH and nursing assistants NA will be randomized into test and control groups The test group n 12 DH and 12 NA will participate in a two-day course where a three-step person-centered oral health model will be taught Control group will be 12 DH within dental care remuneration program conducting business as usual with unknown number of NA due to present guidelines In total 360 older adultspatients will be asked to participate Test group and control group will respectively have 180 patients each as such each team DH NA have 15 patients Primary outcomes include diverse oral health aspects - the Revised Oral Assessment Guide and the Geriatric Oral Health Assessment Index Secondary outcomes include a retrospective record review a health economic evaluation Person Centered care Assessment Tool and Oral Hygiene Ability Index Additionally qualitative studies from theoretical perspectives of change and learning based on interviews with key stakeholders will be conducted in both test and control group
Detailed Description:
The overall aim of this project is to evaluate a person-centered inter-professional and inter-organizational model for oral health planning supported by a digital platform to enable healthy ageing
The evaluation of the revised team-based model assisted by a digital platform is planned to be conducted as a randomized controlled trial RCT
All participation within the RCT both in terms of professionals and older adults will be voluntary and the project will be ethically reviewed In West Sweden the public dental care organization including 3200 dental care professionals is responsible for performing all oral assessments within the dental care remuneration programme This guarantees a large empirical base In pairs DHs within public dental care organizations in West Sweden will be randomized into test and control groups Due to geographical concerns NAs within the same municipality as the test control DHs will be asked to participate As such the test group will consist of 12 DHs and 12 NAs They will form teams in pairs and each team will collaborate with 15 older adults to conduct oral assessments and health planning in home settings The control group will consist of 12 DHs where each DH will perform oral assessments according to the dental care remuneration programme - that is they will conduct business as usual on 15 older adults each It is not mandatory but recommended for NAs to participate in the oral assessments therefore the number of participating NAs within the control group is unknown In total 360 oral assessments and health planning sessions will be performed within the RCT
The test group will participate in a two-day course where initially an informed consent will be signed by all participates thereafter they will practise
Oral assessments according to Revised oral assessment guide
Oral hygiene ability assessments according to Oral Hygiene Ability Index
Oral health-related quality of life assessment with the Geriatric Oral Health Assessment Index
Shared decision-making according to Ottawa Decision Support Framework
Using the digital platform The course will be both theoretical and practical with elements of reflection Also test group management within dental and municipal healthcare will participate in a common half-day course where they will learn about the intervention and the digital platform A dialogue regarding obstacles and opportunities will facilitate a common understanding and the continued implementation process They will also set common goals regarding how to support the intervention
At baseline two project coordinators DHs will collect informed consent from all participants before the intervention Thereafter empirical data will be collected All older adults that participate will be enrolled in the dental care remuneration programme and in home care Participants within the test and control groups will answer on the following parameters at baseline which will guide the evaluation
At baseline
Empirical data
Mini mental state examination MMSE-SR
Revised oral assessment guide
Geriatric Oral Health Assessment Index
Primary outcomes
Older adults oral health status according to Revised oral assessment guide
Older adults self-perception of their oral health-related quality of life according to Geriatric Oral Health Assessment Index
Secondary outcomes
Sure of myself Understand information Risk-benefit ratio Encouragement - test before and after health planning in oral assessments The Sure of myself Understanding information Risk-benefit ration Encouragement-test is based on four validated questions which describe the older adults uncertainty about which treatment to choose and aspects contributing to uncertainty about the benefits and risks of each option what matters most to the older adults support in making a choice and feeling sure about the best choice
Person-Centered care Assessment Tool to measure the professionals experience of the extent to which the care is experienced as being person-centred
All participants DHs NAs and older adults will be measured by health-related quality of life
Oral hygiene ability index for measuring ability to perform oral hygiene tasks The oral hygiene ability index should be used when indicated when Revised oral assessments guide shows 2 or 3 at the variables teeth gum saliva and oral mucosa or if the older adult expresses concerns about difficulties with maintaining oral hygiene
All scales will be measured in both the test and control groups relation 11 Thereafter test n12 and control n 12 groups will conduct 15 oral assessments each in ordinary home settings The DHs and NAs will individually rate their team performance level after each oral assessment from 1 to 10 1 very bad 10 excellent Within the test group options regarding dental care visits will be i regular dental care visits ii digital consultation iii mobile unit at ordinary home settings and iv doing nothing Within the control group the options regarding dental care visits will be business as usual namely i regular dental care visits ii digital consultation or iii doing nothing
Follow-up at 6 months
Retrospective records review Number of records including oral health aspects within municipal care Number of older adults having established contact with dental care Number of adults having been scheduled for dental treatment at mobile dental units and what treatment have been conducted
The oral health recommendations will be analysed compared to existing evidence-based guidelines and recommendations
Older adults oral health status according to Revised oral assessment guide
Older adults self-perception of oral health according to Geriatric oral health assessment index
All participants DHs NAs and older adults health-related quality of life
Follow-up at 12 months
Oral health status according to Revised oral assessment guide
Older adults self-perception of oral health according to Geriatric oral health assessment index
All participants DHs NAs and older adults health-related quality of life
Person-Centered care Assessment Tool Data analysis Baseline characteristics will be presented as numbers n Comparisons between group between baseline and follow-up on primary outcomes Revised oral assessment guide and Geriatric oral health assessment index will be presented as means and mean changes with 95 confidence intervals CI Continuous variables will be analysed by t-test unpaired for comparison between groups and paired for within group analyses Comparisons between groups will be analysed using chi-square tests The pre-chosen level of significance will be p 05 The oral health risk assessment instrument revised oral assessment guide was used in the power calculation Revised oral assessment index has a possible score of 2-27 Based on the assumption of a mean difference of 1 SD 3 between the test and control groups meaning that test group would improve and that the control group would worsen the power was calculated to 08 According to the power calculation the number of older adults needed was 143 in the test- and control- groups respectively Given that the participants are frail older adults an estimated dropout rate of approximately 25 needs to be taken into account which means that 180 older adults are needed in the test and control groups respectively The power-analysis has been conducted with assistance by a statistician AM
In parallel research will be conducted to describe the development of the inter-professional and inter-organizational digital platform Also individual interviews are planned with professionals DHs NAs and managers the dental team of the mobile unit dentist and dental nurse and older adults within the test and control groups Further on a health economic evaluation will be conducted
The evaluation of the revised team-based model assisted by a digital platform is planned to be conducted as a randomized controlled trial RCT
All participation within the RCT both in terms of professionals and older adults will be voluntary and the project will be ethically reviewed In West Sweden the public dental care organization including 3200 dental care professionals is responsible for performing all oral assessments within the dental care remuneration programme This guarantees a large empirical base In pairs DHs within public dental care organizations in West Sweden will be randomized into test and control groups Due to geographical concerns NAs within the same municipality as the test control DHs will be asked to participate As such the test group will consist of 12 DHs and 12 NAs They will form teams in pairs and each team will collaborate with 15 older adults to conduct oral assessments and health planning in home settings The control group will consist of 12 DHs where each DH will perform oral assessments according to the dental care remuneration programme - that is they will conduct business as usual on 15 older adults each It is not mandatory but recommended for NAs to participate in the oral assessments therefore the number of participating NAs within the control group is unknown In total 360 oral assessments and health planning sessions will be performed within the RCT
The test group will participate in a two-day course where initially an informed consent will be signed by all participates thereafter they will practise
Oral assessments according to Revised oral assessment guide
Oral hygiene ability assessments according to Oral Hygiene Ability Index
Oral health-related quality of life assessment with the Geriatric Oral Health Assessment Index
Shared decision-making according to Ottawa Decision Support Framework
Using the digital platform The course will be both theoretical and practical with elements of reflection Also test group management within dental and municipal healthcare will participate in a common half-day course where they will learn about the intervention and the digital platform A dialogue regarding obstacles and opportunities will facilitate a common understanding and the continued implementation process They will also set common goals regarding how to support the intervention
At baseline two project coordinators DHs will collect informed consent from all participants before the intervention Thereafter empirical data will be collected All older adults that participate will be enrolled in the dental care remuneration programme and in home care Participants within the test and control groups will answer on the following parameters at baseline which will guide the evaluation
At baseline
Empirical data
Mini mental state examination MMSE-SR
Revised oral assessment guide
Geriatric Oral Health Assessment Index
Primary outcomes
Older adults oral health status according to Revised oral assessment guide
Older adults self-perception of their oral health-related quality of life according to Geriatric Oral Health Assessment Index
Secondary outcomes
Sure of myself Understand information Risk-benefit ratio Encouragement - test before and after health planning in oral assessments The Sure of myself Understanding information Risk-benefit ration Encouragement-test is based on four validated questions which describe the older adults uncertainty about which treatment to choose and aspects contributing to uncertainty about the benefits and risks of each option what matters most to the older adults support in making a choice and feeling sure about the best choice
Person-Centered care Assessment Tool to measure the professionals experience of the extent to which the care is experienced as being person-centred
All participants DHs NAs and older adults will be measured by health-related quality of life
Oral hygiene ability index for measuring ability to perform oral hygiene tasks The oral hygiene ability index should be used when indicated when Revised oral assessments guide shows 2 or 3 at the variables teeth gum saliva and oral mucosa or if the older adult expresses concerns about difficulties with maintaining oral hygiene
All scales will be measured in both the test and control groups relation 11 Thereafter test n12 and control n 12 groups will conduct 15 oral assessments each in ordinary home settings The DHs and NAs will individually rate their team performance level after each oral assessment from 1 to 10 1 very bad 10 excellent Within the test group options regarding dental care visits will be i regular dental care visits ii digital consultation iii mobile unit at ordinary home settings and iv doing nothing Within the control group the options regarding dental care visits will be business as usual namely i regular dental care visits ii digital consultation or iii doing nothing
Follow-up at 6 months
Retrospective records review Number of records including oral health aspects within municipal care Number of older adults having established contact with dental care Number of adults having been scheduled for dental treatment at mobile dental units and what treatment have been conducted
The oral health recommendations will be analysed compared to existing evidence-based guidelines and recommendations
Older adults oral health status according to Revised oral assessment guide
Older adults self-perception of oral health according to Geriatric oral health assessment index
All participants DHs NAs and older adults health-related quality of life
Follow-up at 12 months
Oral health status according to Revised oral assessment guide
Older adults self-perception of oral health according to Geriatric oral health assessment index
All participants DHs NAs and older adults health-related quality of life
Person-Centered care Assessment Tool Data analysis Baseline characteristics will be presented as numbers n Comparisons between group between baseline and follow-up on primary outcomes Revised oral assessment guide and Geriatric oral health assessment index will be presented as means and mean changes with 95 confidence intervals CI Continuous variables will be analysed by t-test unpaired for comparison between groups and paired for within group analyses Comparisons between groups will be analysed using chi-square tests The pre-chosen level of significance will be p 05 The oral health risk assessment instrument revised oral assessment guide was used in the power calculation Revised oral assessment index has a possible score of 2-27 Based on the assumption of a mean difference of 1 SD 3 between the test and control groups meaning that test group would improve and that the control group would worsen the power was calculated to 08 According to the power calculation the number of older adults needed was 143 in the test- and control- groups respectively Given that the participants are frail older adults an estimated dropout rate of approximately 25 needs to be taken into account which means that 180 older adults are needed in the test and control groups respectively The power-analysis has been conducted with assistance by a statistician AM
In parallel research will be conducted to describe the development of the inter-professional and inter-organizational digital platform Also individual interviews are planned with professionals DHs NAs and managers the dental team of the mobile unit dentist and dental nurse and older adults within the test and control groups Further on a health economic evaluation will be conducted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None