跳至主要内容
临床试验/NCT04840420
NCT04840420Unknown不适用

An Effectiveness-implementation Hybrid Study of Social Prescribing in a Singapore Community Hospital Setting

Bright Vision Hospital0 个研究点目标入组 804 人开始时间: 2021年4月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
804
主要终点
BIT score

研究概览

简要总结

This research is an effectiveness-implementation hybrid study with two aims:

  1. to determine the utility of a WBC (Well Being Coordinator)-driven Social Prescribing model in the intermediate care setting;

and 2) to assess the patient health outcomes associated with the implementation pilot.

The implementation research questions include:

  1. Practical fit: Does the intervention fit with the daily life activities of study participants? What is the level of safety and burdensomeness of the frequency, intensity and duration of the intervention?
  2. Acceptability: What are the acceptance, retention and follow-up rates as the participants move through the intervention? What are the reasons for retention?
  3. Adoption: How well do the WBC carry out the assessment and intervention as planned?

The key hypotheses include:

  1. Participants in the intervention group will incur a higher improvement in perceived general wellbeing and social support than those participants in the control group.
  2. Participants in the intervention group will incur less healthcare utilisation than those in the control group.
  3. Improvement in the perceived general wellbeing and social support will be moderated by the level of social support of participants.

详细描述

The proposed study will adopt a sequential mixed-methods design combining:

  1. An open-label RCT to evaluate the effects of Social Prescribing on participants' general wellbeing, social support and healthcare utilisation. This open-label design approach is chosen in view of the challenge to blind the participants, investigators, and all peripheral staff to the treatment allocation in a practical clinical setting.

Potential patients will be recruited from 3 community hospitals (namely Bright Vision Hospital, Sengkang Community Hospital and Outram Community Hospital)

Randomisation Patients will be randomised to either the intervention or control group. An independent administrator in a central office will generate the entire randomisation sequence using GraphPad randomisation sequence software© 2017 before recruitment commenced. This data will be password protected and only accessible by the administrator. The individual allocation will be revealed to each patient, their ward doctor/clinician, the deprescribing and study teams just before the first deprescribing round, hereby ensuring allocation concealment.

Intervention

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the study team uses 7 categories of SDOH, namely Housing, Food, Economic Stability, Cognition and Learning, Social Environment, Access to Healthcare, and Digital Technologies. If there are care needs related to at least one category of SDOH, the patients will be deemed eligible for the Social Prescribing intervention. In addition, the patient must have the mental capacity to consent and participant in thesurvey.

排除标准

  • The following group of patients will be excluded from the study:
  • Patients who will be discharged to Nursing Homes;
  • Patients who are unable to complete the required survey used in this study due to physical/sensory/cognitive impairment; and/or
  • Patients who are diagnosed with a life-limiting condition with a prognosis of equal or less than 3 months.

结局指标

主要结局

BIT score

时间窗: 2 months post discharge

general wellbeing measured by the Brief Inventory of Thriving (BIT),

mMOS-SS score

时间窗: 2 months post discharge

social support will be measured by the modified Medical Outcomes Study - Social Support Survey (mMOS-SS)

次要结局

  • healthcare utilisation 12months post enrollment(12 months post enrollment)
  • qualitative study(1 day to 12 months post enrollment)
  • MBI(1 day to 6 months post enrollment)

研究者

发起方
Bright Vision Hospital
申办方类型
Other
责任方
Sponsor

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