Evaluating structured education in type 2 diabetes: lessons from the DESMOND RCT

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Evaluating structured education in type 2 diabetes: lessons from the

DESMOND RCT

• Dr. Sean Dineen

Department of Medicine, NUI, Galway

• Dr. Brian McGuire

Department of Psychology, NUI, Galway

Professor Andrew Murphy

Department of General Practice, NUI, Galway

1

A collaborative group in the UK (predominantly England) which aims to develop a new approach for systematic structured education for type 2 diabetes

Therapeutic Patient Education

“TPE should enable patients to acquire and maintain abilities that allow them to optimally manage their lives with their disease.

It is designed to help patients and their families understand the disease and the treatment, cooperate with health care providers, live healthily, and maintain or improve quality of life.”

WHO definition

3

Report on Structured Education

Key Criteria

• A Philosophy

• A Curriculum

• Trained Educators

• Quality Assurance

• Audit http://www.diabetes.nhs.uk/Work_areas/Patient_education.asp

4

The DESMOND Collaborative

DESMOND Network

Ongoing Module

Steering Group n = 40

Trainers

N = 5

Committee

Newly Diagnosed

Module

Educators

N = 85

5

The DESMOND Philosophy

• Each individual is responsible for the day to day management of their diabetes.

• People make the best possible decisions for themselves to achieve their best quality of life.

• All the barriers to self management lie in the individuals personal world.

• The consequences of self management decisions impact solely on them, their family and carers

• Acquiring new information is not easy.

• Many factors influence self management and we must create the environment to address these

6

So what does this mean in reality

• There are no ‘lectures’

• Everyone is encouraged to discuss their thoughts feelings and barriers

• Open questions are used to encourage learning

• Understanding is checked, personally relevant questions are addressed

• People completed their own ‘Health Profile’

• The trainers are warm , empathic , non judgemental and person centred

• Goals and action plans are developed by the individual

7

8

9

DESMOND – (6 hrs of contact time)

Broad Curriculum for the newly diagnosed

Housekeeping

The patient story

What diabetes is

Main ways to manage diabetes

5%

10%

5%

10%

Diabetes consequences/ personal risk 15%

Monitoring and taking action 10%

Food choices

Physical Activity

20%

5%

Stress and emotion

Screening/ annual clinics

5%

5%

Developing a personal plan 10%

10

11

Date …………………………………………

Name ……………………………………….

Which Risk Factor Do

I Want To Focus On?

High Blood Pressure

Low HDL

High Cholesterol

Smoking

Blood Glucose

Shape

Depression

Other Concerns?

What Am I Going To Do Now?

What Would Affect This?

 ………………………………

 ………………………………

 ………………………………

 ………………………………

 ………………………………

 ………………………………

Which Of These Am I Going To

Tackle?

You may choose one or more of the above to start with

 ……………………………...

 ……………………………..

 ……………………………..

How Am I Going To Do This?

 ……………………………………

 ……………………………………

 …………………………………….

What’s Going To Stop Me?

 ……………………………………

 ……………………………………

 ……………………………………

What Will I Do About That?

 …………………………….……..

 …………………………………...

 …………………………………...

23.4.2004 Goal Setting Sheet Version 1 Appendix Q

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DESMOND ‘Training the trainers’

• Educators delivering the DESMOND curriculum have been formally trained in this process by an experienced team

• Educators are part of a national collaborative and will be attending sessions on a regular basis

• Measures in place to quality assure the performance of the Curriculum and support Educators

13

DESMOND Training the Educators Programme

DAY ONE

1700 REGISTRATION MC

TEA & COFFEE WILL BE

SERVED

1730 Introductions HD

 Who

 Why

 What are you most concerned about?

1815 Background to DESMOND &

the care pathway SC

1845 The DESMOND philosophy

YD & CS

 Followed by a discussion and exploration of differences between DES-

MOND and current practice.

1945 The role of the Educator HD

 Now

 In the future

2030 DINNER

 Completion of the baseline assessment

DAY TWO

Morning

0900 Introduction to the day & housekeeping

SC

0910 The Patient Story SC

1000 Reflections YD

1010 The Professional Story—Diabetes CS

1050 Reflections YD

TEA & COFFEE WILL BE SERVED

1110 The Professional Story—Risk Factors CS

 Complete Health Profile

1150 Monitoring SC

1220 Reflections YD

1230 LUNCH

DAY TWO

Afternoon

1330 Food choices LO

1445 Reflections HD

1455 Exercise HD

 Medication

 Stress/Emotions

1530 TEA & COFFEE WILL BE

SERVED

1600 Self-management plan CS

1645 Reflections HD

1700 Finish

1930 DINNER

DESMOND

Sue Cradock = SC

Heather Daly = HD

Yvonne Doherty = YD

Lindsay Oliver = LO

Chas Skinner = CS

Marian Carey = MC

BREAKFAST WILL BE

SERVED BETWEEN 7:30am-

9:30am

Project Office

Diabetes Research Office

Level 1 Victoria Building

Leicester Royal Infirmary

Phone: 0116 258 7757

Fax: 0116 258 6992

Email: marian.carey@uhl-tr.nhs.uk

14

Complex Intervention MRC Guidance

Campbell, M. et al. BMJ 2000;321:694-696

• ‘Describing and evaluating educational interventions is a challenge and

many accounts are poorly described and evaluated’ – BMJ 1999

15

Pilot sites run

DESMOND course until end of April 2004

DESMOND Pilot Phase and Feedback Process

Ongoing feedback

Patients Health Care

Professionals

Structured

Feedback

Educators

Local Co-ordinators

Trainers

Review of curriculum

Delivery Resources Processes

RCT begins for

14 DESMOND

Centres

© The DESMOND Project

Refreshing

Curriculum & resources

Retraining

Educators & Local

Co-ordinators

16

Uncontrolled Pilot Study - Biomedical measures

Baseline 3/12 6/12 12/12 Measure

Date measure taken

HbA1c

Total Cholesterol (mmol/l)

HDL (mmol/l)

LDL (mmol/l)

Triglyceride

BP (mmHg) Systolic

BP (mmHG) Diastolic

Weight (kg)

Height (cm)

Waist (cm)

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Questionnaire Content

Quality of Life

(WHOQOL

– BREF)

Illness Perception

Questionnaire (IPQ-R)

Depression

(HADS)

Health Related QoL

(EuroQOL)

Physical Activity

(IPAQ)

Problem Areas in

Diabetes (PAID )

Health Service Use

(Health Economcs)

Baseline 3 /12 x x x x x x x x x x

6 /12 x x x x x x

12 / 12 x x x x x x x

18

Pilot Results: Baseline Health Beliefs

At baseline …

• Only 31% felt they understood their diabetes

• Only 44% agreed diabetes was a serious threat to their health

• Only 5.5% agreed that their life would be shorter because of their diabetes

19

Pilot Results Psychosocial

Important changes in illness beliefs

Changes in depressive symptomatology

Changes in physical quality of life improved

Changes in self reported physical activity

20

DESMOND - Time Frame for RCT

Beginning of

June 2004

Beginning of

July 2004 to end of Aug2004

Oct 2004

Participating PCTs confirmed

Practices

Recruited

Patients Recruited

End of Oct

2004 to end of

Sept 2005

July 2005 to

OCT 2006

Nov 2006

© The DESMOND Project

Randomised

Control Trial begins

Data analysis

Publication

Intervention Arm:

 Patient diagnosed with type 2 diabetes

 Given patient information leaflet, What is DESMOND leaflet, baseline Questionnaire

 Patient contacted by

DESMOND team

 Patient sent postal information

 Patient attends DESMOND, consent taken & baseline

Questionnaire collected – takes part in intervention

Control Arm:

 Patient diagnosed with type 2 diabetes

Given patient information leaflet, baseline questionnaire & Consent form

Patient given an appointment, gives

Consent and returns completed questionnaire – receives routine care

Follow

– up

Data Collection

 Biomedical data collected at baseline, 4, 8 and 12 months

Questionnaire data collected at baseline, 4, 8 and 12 months

21

DESMOND – what next?

DESMOND BME and lay educators

Blood glucose v. urine monitoring

DESMOND national roll-out

DESMOND

Ongoing Model development

22

Evaluation of the

DESMOND Programme in

Ireland

Proposal to Evaluate

DESMOND in Ireland

1. HRB Health Partnership application March

2007 (substantial support from Galway

PCCCC)

2. Recruitment of four DESMOND trainers late 2007

3. Commence DESMOND intervention late

2007

4. (Hopefully) HRB funding for evaluation

March 2008 for 2 years

Overview: Study Methodology

• GP practices that have referred to

Diabetes Centre

• Recruit newly diagnosed T2DM

• Deliver DESMOND training (3 groups per month for 8 months, n=240)

• Compare treatment group with medical treatment as usual using historical controls n=240

• 1-year follow-up

• Precursor to RCT

Research Questions

1. Is DESMOND feasible and effective in the

Irish health context? (Campbell 2007, what

“works” is context dependent).

Outcomes:

(1) Biomedical: HbA1c, fasting blood glucose, body weight & BMI, blood pressure, need for diabetes medication, use of specialist diabetes services.

(2) Psychosocial: diabetes knowledge, emotional status, diabetes self-efficacy, illnessrelated cognitions, quality of life.

Research Questions

2. Is DESMOND cost effective in the

Irish health context?

Identify, measure, value and compare costs e.g. time input of health professionals, overhead costs, contacts with health services – GP, hospital contact, admissions, prescriptions.

Patient and family costs, time input.

Research Questions

3. Are patients and GPs satisfied with the programme?

Is the programme “palatable” to patients and

GPs?

Is the format appropriate for the Irish context?

Are expectations met?

Sensitivity of Outcome

Measures

• Feedback from UK experience is that patient psychosocial outcomes are positive but not necessarily reflected in some biomedical outcomes, especially the “gold standard” HbA1c.

• So, what does this mean and how do we marry the “soft” outcomes

(psychological wellbeing) and the

“hard” outcomes?

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Other Questions…

• Information, attitudes and behaviour have a complex relationship - does information provision lead to behaviour change?

• Is 6 hours really enough?

• Will any changes be maintained?

• Is there a role for qualitative ( group shudder ) analysis and how is this translated for funders?

Session aims

• To discuss/ inform/ educate/ make you bloody well remember how to:

1. Decide whether to accept external commission or not

2. Design a study that is doable locally and publishable in the Lancet

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• Andrew:

Session overview

Context

• Sean:

Description of DESMOND and it’s evaluation in UK

• Brian:

Suggested design of

DESMOND evaluation in

HSE, West

32

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Key question

Can you evaluate X project in Y weeks for zero euros …. and be publishable (or not) ?

– Mc Loughlin, M., P. Armstrong, et al. (2005). "A comparative study on attitudes, mental health and job stress amongst GPs participating, or not, in a rural outof-hours co-operative." Family Practice 22(3) : 275-9.

– Ononeze, V. and S. Woods (2003). The management of

1, 164 patients presenting with chest pain to Portiuncla

Hospital Ballinasloe, Western Health Board : 1-34.

– Daly, M., A. W. Murphy, et al. (2003). "Primary care anticoagulant management using near patient testing."

Irish Journal of Medical Science 172 (1): 30-2.

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People, funding and papers

• People

– In a hurry

– Strategic D of CCHSR D

• Funding

– Piggy backing onto initiatives

– Cheap labour: HRB summer students/ Interns/

Masters/

• Papers

– Role of R and D reports

– Non peer reviewed journals 36

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