Patient Activation Through Community Empowerment/Engagement for Diabetes Management (PACE-D)

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Diabetes Mellitus, Chronic Disease, Patient Care Planning, Patient Participation, Self Care, Empowerment

Intervention / Treatment
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* Other: Intervention Group
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Doctors, Care Managers and Care Coordinators involved in the care and support planning process Age 21 years and above Ability to provide informed consent

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br> | Other: Intervention Group<br>* Participants in this arm will undergo the new care model for management of diabetes mellitus polyclinics.<br>|
| Active Comparator: Control Group<br> | Other: Control Group<br>* Participants in this arm will continue to undergo the existing care model for management of diabetes mellitus in the polyclinics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c levels | Change in HbA1c levels in patients receiving the CSP intervention compared with patients receiving standard care. | From baseline to study endpoint, one year in general | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean Patient Activation Measures-13 (PAM-13) scores | Change in mean Patient Activation Measures-13 (PAM-13) scores in patients receiving the CSP intervention compared with patients receiving standard care. PAM-13 is a validated tool with 13-item response rated on a 4-point Likert-type scale that will be converted to a linear score of 0 (lowest patient activation) to 100 (highest patient activation). Higher patient activation score from PAM-13 is associated better healthcare outcomes such as medication adherence. | From baseline to study endpoint, one year in general | 
| Change in proportion of patients in the various ranges of patient activation levels | Change in proportion of patients in the various ranges of patient activation levels for patients receiving the CSP intervention compared with patients receiving standard care. | From baseline to study endpoint, one year in general | 
| Change in healthcare utilisation in terms of number of polyclinic visits | Change in healthcare utilisation in terms of number of polyclinic visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | 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 emergency department visits | Change in healthcare utilisation in terms of proportion (%) of patients with emergency department visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | 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 | Change in healthcare utilisation in terms of number of emergency department visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | 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 | Change in healthcare utilisation in terms of proportion (%) of patients with hospital inpatient admissions for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | 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 | Change in healthcare utilisation in terms of number of hospital inpatient admissions for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | 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 | Change in healthcare utilisation in terms of proportion (%) of patients with specialist outpatient clinic visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | 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 | Change in healthcare utilisation in terms of number of specialist outpatient clinic visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | Two years in general from one year preceding recruitment to the period between first and second annual reviews | 
| Change in healthcare cost in terms of total healthcare cost of polyclinic, emergency department, hospital admissions and specialist outpatient clinic visits | Change in healthcare cost in terms of total healthcare cost of polyclinic, emergency department, hospital admissions and specialist outpatient clinic visits in patients receiving the CSP intervention compared with patients receiving standard care. | Two years in general from one year preceding recruitment to the period between first and second annual reviews | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Long term conditions, Chronic disease management, Patient engagement, Patient empowerment, Self-management, Care Planning