跳至主要内容
临床试验/NCT04288362
NCT04288362已完成不适用

The Patient Activation Through Community Empowerment/Engagement for Diabetes Management (PACE-D) Protocol: A Non-randomised Controlled Trial of Personalised Care and Support Planning for Persons Living With Diabetes

National University Health System, Singapore1 个研究点 分布在 1 个国家目标入组 1,620 人开始时间: 2019年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,620
试验地点
1
主要终点
Change in HbA1c levels

研究概览

简要总结

The study is a non-randomised controlled trial involving an intervention group and a control group. It aims to evaluate the effects of a patient engagement and empowerment model of collaborative care support planning on clinical outcomes of patients with diabetes mellitus as compared to usual care in the primary care setting. It also aims will be to examine the impact of the intervention on patient activation, patient and healthcare provider experience, and healthcare utilisation.

详细描述

The investigators will conduct a prospective study on existing patients with diabetes who are on follow-up with their teamlets at Pioneer (PIO), Jurong (JUR), Bukit Batok (BBK) and Choa Chu Kang (CCK) polyclinics for management of diabetes. Recruitment will occur for 18 months from the time of study implementation. One teamlet in JUR and one teamlet in PIO (total of two teamlets) will fall under intervention arm where the new care model based on the Year-of-Care (YOC) model will be delivered, whereas one teamlet in BBK and one teamlet in CCK (total of another two teamlets) will fall under the control arm where the current teamlet model will be continued.

In the intervention group, patients recruited will undergo the new care model which entails receiving the Care Planning Results Letter before the consultation at their annual review, involving them in the Care and Support Planning (CSP) consultation at the annual review, and referring them to suitable community resources to support self-management. The Care Planning Results Letter prompts patients to think the issues they would like to raise to their Doctor or Care Manager (who is a nurse trained in chronic disease management), checks on their mood, provides information on their most recent few laboratory test results, clinical parameters, smoking status, and attendances for foot and eye screenings. The letter also covers goal setting and action planning discussions. The patient is expected to bring it for the upcoming CSP consultation at the annual review. The CSP is a conversation which is conducted by the Doctor or Care Manager trained in the new care model. It focuses on a collaborative approach between the health care providers and the patient for joint goal setting and shared decision making to support self-management of their chronic condition(s).

In the control arm, the participants will receive the usual care with the teamlet model. There will not be any Care Planning Results Letter prepared for the patient. At the upcoming annual visit, the patient will continue to have the usual annual review for the laboratory test results and consultation. A flyer that lists the community programmes that support the patient for self-management will also be issued to the patient. If the patient is interested in any of these programmes, they may sign up with the respective community providers directly.

After the first CSP, selected patient participants may be invited for a one-to-one in-depth interviews (IDIs) to explore their perceptions about diabetes, diabetes management and the intervention programme in greater detail. The interviews will be conducted by researchers trained qualitative research methodology. They will be semi-structured with a topic guide to support exploration of the themes of interest, and will be informed by prior qualitative research with this and other similar interventions, as well as the results from the patient surveys. Health care providers who are involved in the delivery of CSPs in the intervention arm will also be invited for a one-to-one in-depth interviews (IDIs), to develop an understanding of how they find the training and new way of working with patients (particularly the care and support planning conversation).

研究设计

研究类型
Interventional
分配方式
Non 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
否

入选标准

  • •On follow up with an existing teamlet pre-assigned to participate in the study
  • •Adults with diabetes mellitus
  • •Age 21 years and above
  • •Ability to provide informed consent
  • •Ability to communicate in the language(s) which the physician is confident to carry out the care and support planning consult in English, Malay or Chinese
  • •Ability to read and comprehend the Diabetes Results Letter on their own OR has family members who are able to assist to that

排除标准

  • •Doctors, Care Managers and Care Coordinators involved in the care and support planning process
  • •Age 21 years and above
  • •Ability to provide informed consent

研究组 & 干预措施

Intervention Group

Experimental

干预措施: Intervention Group (Other)

Control Group

Active Comparator

干预措施: Control Group (Other)

结局指标

主要结局

Change in HbA1c levels

时间窗: From baseline to study endpoint, one year in general

Change in HbA1c levels in patients receiving the CSP intervention compared with patients receiving standard care.

次要结局

  • Change in mean Patient Activation Measures-13 (PAM-13) scores(From baseline to study endpoint, one year in general)
  • Change in healthcare cost in terms of total healthcare cost of polyclinic, emergency department, hospital admissions and specialist outpatient clinic visits(Two years in general from one year preceding recruitment to the period between first and second annual reviews)
  • Change in proportion of patients in the various ranges of patient activation levels(From baseline to study endpoint, one year in general)
  • Change in healthcare utilisation in terms of proportion (%) of patients with emergency department visits(Two years in general from one year preceding recruitment to the period between first and second annual reviews)
  • Change in healthcare utilisation in terms of proportion (%) of patients with hospital inpatient admissions(Two years in general from one year preceding recruitment to the period between first and second annual reviews)
  • Change in healthcare utilisation in terms of number of specialist outpatient clinic visits(Two years in general from one year preceding recruitment to the period between first and second annual reviews)
  • Change in healthcare utilisation in terms of number of polyclinic visits(Two years in general from one year preceding recruitment to the period between first and second annual reviews)
  • Change in healthcare utilisation in terms of number of hospital inpatient admissions(Two years in general from one year preceding recruitment to the period between first and second annual reviews)
  • Change in healthcare utilisation in terms of number of emergency department visits(Two years in general from one year preceding recruitment to the period between first and second annual reviews)
  • Change in healthcare utilisation in terms of proportion (%) of patients with specialist outpatient clinic visits(Two years in general from one year preceding recruitment to the period between first and second annual reviews)

研究者

发起方
National University Health System, Singapore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tan Wee Hian

PACE-D Programme Director, Consultant Family Physician

National University Health System, Singapore

研究点 (1)

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