跳至主要内容
临床试验/NCT06310798
NCT06310798Unknown不适用

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

Vastra Gotaland Region2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
360
试验地点
2
主要终点
Revised oral assessment guide

研究概览

简要总结

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 adults,dental 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 adults/patients 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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled within the Swedish dental remuneration program and enrolled within municipal care services.

排除标准

  • Younger than 65 years.

研究组 & 干预措施

Oral health planning control

No Intervention

Dental hygienists, nursing assistants and older adults participating in oral health planning in ordinary home settings (business as usual).

Inter-professional team test

Experimental

Dental hygienists, nursing assistants and older adults participating in new model for oral health planning in ordinary home settings.

干预措施: Inter-professional team test (Behavioral)

结局指标

主要结局

Revised oral assessment guide

时间窗: Measured at 12 months after baseline

Validated instrument for oral health assessments including nine items. Lowest rate: 2 - indicating healthy condition, maximum rate 27 indicating poor oral health.

Geriatric oral health assessment index

时间窗: Measured at 12 months after baseline

Validated instrument for oral health related quality of life including 12 items. Minimum rate 12, maximum rate 60. Higher scores indicate better oral health-related quality of life, while lower scores suggest poorer oral health-related quality of life.

次要结局

  • Sure of myself; understanding information; risk-benefit ration; encouragement-test(Measured at baseline)
  • Person centered care assessment tool(Measured at 12 months after baseline)

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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