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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Chronic Disease; Patient Participation; Self Care; Empowerment; Patient Care Planning
• Intervention / Treatment: Other: Intervention Group; Other: Control Group

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 1620
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 609606
    • National University Polyclinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in proportion of patients meeting their target blood pressure levels	Change in proportion of patients meeting their target blood pressure levels for patients receiving the CSP intervention compared with patients receiving standard care.	From baseline to study endpoint, one year in general
Change in proportion of patients meeting their target LDL-cholesteterol levels	Change in proportion of patients meeting their target LDL-cholesteterol levels for patients receiving the CSP intervention compared with patients receiving standard care.	From baseline to study endpoint, one year in general
Change in body weight	Change in body weight (kg) in patients receiving the CSP intervention compared with patients receiving standard care.	From baseline to study endpoint, one year in general
Change in exercise duration	Change in exercise duration (minutes per week) in patients receiving the CSP intervention compared with patients receiving standard care.	From baseline to study endpoint, one year in general
Change in smoking rates	Change in smoking rates (cigarettes per day) in patients receiving the CSP intervention compared with patients receiving standard care.	From baseline to study endpoint, one year in general
Change in the proportion (%) of patients who indicate community resource utilisation	Change in the proportion (%) of patients who indicate community resource utilisation in the past 1 year between patients CSP intervention compared with patients receiving standard care. Community resource utilisation history is assessed through dichotomous questionnaire with yes/no response.	From baseline to study endpoint, one year in general
Change in Diabetes Foot Screening rates	Change in Diabetes Foot Screening Rates in patients receiving the CSP intervention compared with patients receiving standard care.	From baseline to study endpoint, one year in general
Change in Diabetes Retinal Photography rates	Change in Diabetes Retinal Photography rates in patients receiving the CSP intervention compared with patients receiving standard care.	From baseline to study endpoint, one year in general

Collaborators and Investigators

• Sponsor: National University Health System, Singapore
• Collaborators: National University Hospital, Singapore; National University of Singapore
• Investigators: Study Chair: Doris Young, National University Health System, Singapore; Study Director: Victor Weng Keong Loh, National University Health System, Singapore; Study Director: Tong Wei Yew, National University Hospital, Singapore; Study Director: Kavita Venkataraman, National University of Singapore; Study Director: Brent Gibbons, National University of Singapore; Study Director: Vikki Entwistle, National University of Singapore; Study Director: Soon Guan Tan, National University of Singapore; Study Director: Meena Sundram, National University Health System, Singapore; Study Director: Keith Tsou, National University Health System, Singapore; Study Director: Yii Jen Lew, National University Health System, Singapore; Principal Investigator: Wee Hian Tan, National University Health System, Singapore

Publications and helpful links

General Publications

• Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002 Oct 16;288(15):1909-14. doi: 10.1001/jama.288.15.1909.
• Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
• Coulter A, Entwistle VA, Eccles A, Ryan S, Shepperd S, Perera R. Personalised care planning for adults with chronic or long-term health conditions. Cochrane Database Syst Rev. 2015 Mar 3;2015(3):CD010523. doi: 10.1002/14651858.CD010523.pub2.
• Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Milbank Q. 1996;74(4):511-44.
• Tan WH, Loh VWK, Venkataraman K, Choong ST, Lew YJ, Sundram M, Tsou K, Tan SG, Gibbons B, Entwistle V, Young D, Tai ES, Yew TW. 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. BMC Fam Pract. 2020 Jun 19;21(1):114. doi: 10.1186/s12875-020-01173-2.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes; Patient empowerment; Self-management; Patient engagement; Chronic disease management; Long term conditions; Care Planning
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Chronic Disease
• Other Study ID Numbers: CS-SN-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No