search
Back to results

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

Primary Purpose

Diabetes Mellitus, Chronic Disease, Patient Care Planning

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Intervention Group
Control Group
Sponsored by
National University Health System, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes, Long term conditions, Chronic disease management, Patient engagement, Patient empowerment, Self-management, Care Planning

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National University Polyclinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 23, 2020
Last Updated
April 25, 2022
Sponsor
National University Health System, Singapore
Collaborators
National University Hospital, Singapore, National University of Singapore
search

1. Study Identification

Unique Protocol Identification Number
NCT04288362
Brief Title
Patient Activation Through Community Empowerment/Engagement for Diabetes Management (PACE-D)
Acronym
PACE-D
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Health System, Singapore
Collaborators
National University Hospital, Singapore, National University of Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Chronic Disease, Patient Care Planning, Patient Participation, Self Care, Empowerment
Keywords
Diabetes, Long term conditions, Chronic disease management, Patient engagement, Patient empowerment, Self-management, Care Planning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-randomised controlled trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1620 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Intervention Group
Intervention Description
Participants in this arm will undergo the new care model for management of diabetes mellitus polyclinics.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Participants in this arm will continue to undergo the existing care model for management of diabetes mellitus in the polyclinics.
Primary Outcome Measure Information:
Title
Change in HbA1c levels
Description
Change in HbA1c levels in patients receiving the CSP intervention compared with patients receiving standard care.
Time Frame
From baseline to study endpoint, one year in general
Secondary Outcome Measure Information:
Title
Change in mean Patient Activation Measures-13 (PAM-13) scores
Description
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.
Time Frame
From baseline to study endpoint, one year in general
Title
Change in proportion of patients in the various ranges of patient activation levels
Description
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.
Time Frame
From baseline to study endpoint, one year in general
Title
Change in healthcare utilisation in terms of number of polyclinic visits
Description
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.
Time Frame
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Title
Change in healthcare utilisation in terms of proportion (%) of patients with emergency department visits
Description
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.
Time Frame
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Title
Change in healthcare utilisation in terms of number of emergency department visits
Description
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.
Time Frame
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Title
Change in healthcare utilisation in terms of proportion (%) of patients with hospital inpatient admissions
Description
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.
Time Frame
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Title
Change in healthcare utilisation in terms of number of hospital inpatient admissions
Description
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.
Time Frame
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Title
Change in healthcare utilisation in terms of proportion (%) of patients with specialist outpatient clinic visits
Description
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.
Time Frame
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Title
Change in healthcare utilisation in terms of number of specialist outpatient clinic visits
Description
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.
Time Frame
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Title
Change in healthcare cost in terms of total healthcare cost of polyclinic, emergency department, hospital admissions and specialist outpatient clinic visits
Description
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.
Time Frame
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Other Pre-specified Outcome Measures:
Title
Change in proportion of patients meeting their target blood pressure levels
Description
Change in proportion of patients meeting their target blood pressure levels for patients receiving the CSP intervention compared with patients receiving standard care.
Time Frame
From baseline to study endpoint, one year in general
Title
Change in proportion of patients meeting their target LDL-cholesteterol levels
Description
Change in proportion of patients meeting their target LDL-cholesteterol levels for patients receiving the CSP intervention compared with patients receiving standard care.
Time Frame
From baseline to study endpoint, one year in general
Title
Change in body weight
Description
Change in body weight (kg) in patients receiving the CSP intervention compared with patients receiving standard care.
Time Frame
From baseline to study endpoint, one year in general
Title
Change in exercise duration
Description
Change in exercise duration (minutes per week) in patients receiving the CSP intervention compared with patients receiving standard care.
Time Frame
From baseline to study endpoint, one year in general
Title
Change in smoking rates
Description
Change in smoking rates (cigarettes per day) in patients receiving the CSP intervention compared with patients receiving standard care.
Time Frame
From baseline to study endpoint, one year in general
Title
Change in the proportion (%) of patients who indicate community resource utilisation
Description
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.
Time Frame
From baseline to study endpoint, one year in general
Title
Change in Diabetes Foot Screening rates
Description
Change in Diabetes Foot Screening Rates in patients receiving the CSP intervention compared with patients receiving standard care.
Time Frame
From baseline to study endpoint, one year in general
Title
Change in Diabetes Retinal Photography rates
Description
Change in Diabetes Retinal Photography rates in patients receiving the CSP intervention compared with patients receiving standard care.
Time Frame
From baseline to study endpoint, one year in general

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris Young
Organizational Affiliation
National University Health System, Singapore
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Victor Weng Keong Loh
Organizational Affiliation
National University Health System, Singapore
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tong Wei Yew
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kavita Venkataraman
Organizational Affiliation
National University of Singapore
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Brent Gibbons
Organizational Affiliation
National University of Singapore
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vikki Entwistle
Organizational Affiliation
National University of Singapore
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Soon Guan Tan
Organizational Affiliation
National University of Singapore
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Meena Sundram
Organizational Affiliation
National University Health System, Singapore
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Keith Tsou
Organizational Affiliation
National University Health System, Singapore
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yii Jen Lew
Organizational Affiliation
National University Health System, Singapore
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wee Hian Tan
Organizational Affiliation
National University Health System, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Polyclinics
City
Singapore
ZIP/Postal Code
609606
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25733495
Citation
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.
Results Reference
background
PubMed Identifier
8941260
Citation
Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Milbank Q. 1996;74(4):511-44.
Results Reference
background
PubMed Identifier
12377092
Citation
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.
Results Reference
background
PubMed Identifier
15230939
Citation
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.
Results Reference
background
PubMed Identifier
32560689
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs