Clinical trial NCT04288362: Patient Activation Through Community Empowerment/Engagement for Diabetes Management (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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
name: National University of Singapore
First posted: 2020-02-28
Enrollment: 1620
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomised controlled trial
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in HbA1c levels
timeFrame: From baseline to study endpoint, one year in general
Secondary outcomes:
measure: Change in mean Patient Activation Measures-13 (PAM-13) scores
timeFrame: From baseline to study endpoint, one year in general
measure: Change in proportion of patients in the various ranges of patient activation levels
timeFrame: From baseline to study endpoint, one year in general
measure: Change in healthcare utilisation in terms of number of polyclinic visits
timeFrame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
measure: Change in healthcare utilisation in terms of proportion (%) of patients with emergency department visits
timeFrame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
measure: Change in healthcare utilisation in terms of number of emergency department visits
timeFrame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
measure: Change in healthcare utilisation in terms of proportion (%) of patients with hospital inpatient admissions
timeFrame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
measure: Change in healthcare utilisation in terms of number of hospital inpatient admissions
timeFrame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
measure: Change in healthcare utilisation in terms of proportion (%) of patients with specialist outpatient clinic visits
timeFrame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
measure: Change in healthcare utilisation in terms of number of specialist outpatient clinic visits
timeFrame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
measure: Change in healthcare cost in terms of total healthcare cost of polyclinic, emergency department, hospital admissions and specialist outpatient clinic visits
timeFrame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
Other outcomes:
measure: Change in proportion of patients meeting their target blood pressure levels
timeFrame: From baseline to study endpoint, one year in general
measure: Change in proportion of patients meeting their target LDL-cholesteterol levels
timeFrame: From baseline to study endpoint, one year in general
measure: Change in body weight
timeFrame: From baseline to study endpoint, one year in general
measure: Change in exercise duration
timeFrame: From baseline to study endpoint, one year in general
measure: Change in smoking rates
timeFrame: From baseline to study endpoint, one year in general
measure: Change in the proportion (%) of patients who indicate community resource utilisation
timeFrame: From baseline to study endpoint, one year in general
measure: Change in Diabetes Foot Screening rates
timeFrame: From baseline to study endpoint, one year in general
measure: Change in Diabetes Retinal Photography rates
timeFrame: From baseline to study endpoint, one year in general
Locations:
city: Singapore
country: Singapore
facility: National University Polyclinics
Study officials:
affiliation: National University Health System, Singapore
name: Doris Young
role: STUDY_CHAIR
affiliation: National University Health System, Singapore
name: Victor Weng Keong Loh
role: STUDY_DIRECTOR
affiliation: National University Hospital, Singapore
name: Tong Wei Yew
role: STUDY_DIRECTOR
affiliation: National University of Singapore
name: Kavita Venkataraman
role: STUDY_DIRECTOR
affiliation: National University of Singapore
name: Brent Gibbons
role: STUDY_DIRECTOR
affiliation: National University of Singapore
name: Vikki Entwistle
role: STUDY_DIRECTOR
affiliation: National University of Singapore
name: Soon Guan Tan
role: STUDY_DIRECTOR
affiliation: National University Health System, Singapore
name: Meena Sundram
role: STUDY_DIRECTOR
affiliation: National University Health System, Singapore
name: Keith Tsou
role: STUDY_DIRECTOR
affiliation: National University Health System, Singapore
name: Yii Jen Lew
role: STUDY_DIRECTOR
affiliation: National University Health System, Singapore
name: Wee Hian Tan
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Milbank Q. 1996;74(4):511-44.
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.
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.
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.