A review of baseline characteristics from an innovative adherence support programme for ulcerative colitis

Dr Christina Jackson 1, Aileen Fraser 2, Gwen Wiseman 3

1Atlantis Healthcare, London, UK; 1Atlantis Healthcare, London, UK; 2Bristol Royal Infirmary, Bristol, UK;

3Warner Chilcott UK Ltd, (a subsidary of Actavis UK Ltd) Weybridge, UK

European Society for Patient Adherence, Compliance and Persistence Annual Meeting, 22 November 2014, Lausanne, Switzerland

Item code: UK/AS/0139/11-14 Date of Preparation: November 2014

Disclosure of interest

This analysis was sponsored by Warner Chilcott UK Ltd, a subsidary of Actavis Ltd

• Dr Christina Jackson, Health Psychology Specialist, Consultant and employee of Atlantis Healthcare

• Aileen Fraser, Inflammatory Bowel Disease (IBD) Clinical Nurse Specialist, Bristol Royal Infirmary, ConsultantSpecialist, Bristol Royal Infirmary, Consultant

• Gwen Wiseman, Medical Affairs Manager, Employee of Warner Chilcott UK Ltd

Ulcerative colitis

Ulcerative colitis is a chronic, relapsing and remitting lifelong condition of the large bowel associated with significant morbidity

It affects approx 146,000 people in the UK

The cause of ulcerative colitis is unknown

Symptoms include:• Inflammation of the large bowel

• Frequent diarrhoea

• Rectal bleeding

• Pain

• Urgency

• It can also affect a person’s social and psychological

wellbeing, particularly if poorly controlled

National Institute for Health and Care Excellence (2013) [Ulcerative colitis: Management in adults,

children and young people]. [CG166].

MesalazineCurrent medical approaches focus on treating active disease to address • symptoms• mucosal healing • quality of life• and thereafter to maintain remission

The chosen treatment for active disease depends on a variety of factors:• clinical severity• clinical severity• extent of disease• patient’s preference

Mesalazine is an anti-inflammatory treatment which is a key first-line therapy for the induction and maintenance of remission in mild to moderate ulcerative colitis (UC).

National Institute for Health and Care Excellence (2013) [Ulcerative colitis: Management in adults,

children and young people]. [CG166].

Clinical impact of non-adherence to mesalazine therapy

rem

ain

ing

in

re

mis

sio

n (

%)

Adherent75

100

Kane S, et al. Am J Med 2003; 114: 39–43.

*p <0.0001

Pa

tie

nts

rem

ain

ing

in

re

mis

sio

n (

%)

0 300

Non-adherent*

Time (months)

50

25

10 20

Adherence is a behaviour and is complex and multifactorial 1

• In ulcerative colitis, adherence is linked more to beliefs rather than to dosing and number of tablets1-2

• Adherence guidelines recommend addressing beliefs and practical barriers addressing beliefs and practical barriers to improve adherence3

• Effective adherence interventions are often complex and multiple behaviour change techniques and channels are likely to be required for the intervention to be efficacious4

1. World Health Organisation. Adherence to Long term therapies. 2003 2. Magowan SH et al. Am J Gastroenterol 2006; 101: A1144;

3. NICE. Medicines adherence. CG76 2009; 4. Haynes RB et al. Cochrane Database of Systematic Reviews 2008;2:CD000011

AssureAssure patient adherence programme for eligible patients prescribed Asacol®(mesalazine)

Developed with input from expert IBD nurses, gastroenterologists and health pyschologists

Uses the principles of cognitive behavioural Uses the principles of cognitive behavioural therapy to address patients negative and unhelpful beliefs about their treatment

Uses consumer-style communication to maximise patient engagement (copy and design)

Assesses each individual patient’s beliefs and tailors interventions accordingly

Measured by service evaluation on a continual basis

Research into UC shows your bowel may be inflamed even if you don’t have symptoms. Asacol aims to reduce bowel inflammation. Txt STOP to 441157070100 to opt out

Enrolment

At enrolment, patients complete a variety of on-line questionnaires based on validated measures to identify medication issues associated with non-adherence.

Beliefs about medicines Adherence (Visual Disease activity medicines

questionnaire (short form of BMQ-IBD Jackson et al., 2010b)

Low Mood (PHQ‐2, Kroenke et al., 2003)

Adherence (Visual Analogue Scale, Walsh

et al., 2002)

Disease activity (Manitoba IBD Index)

(Clara et al., 2009)

Patients separately provide consent to the use of their data for ongoing programme evaluation and administration.

Tailored to the patient

If you worry about side effects, remember: all medicines affect

Concerns SMS

medicines affect people in different

ways. You may not get any side effects. Txt STOP to 441157070100 to opt out

Tailored to the patient

Research into UC shows your bowel may be inflamed even if you don’t

Necessity SMS

even if you don’t have symptoms. Asacol aims to reduce bowel inflammation. Txt STOP to 441157070100 to opt out

Multi-channel support

TEXT DVDHELP

LINEEMAIL WEBSITE MAGAZINE

NURSE

ADVISOR

CALL

Aim

Conducting a series of ongoing service evaluations to understand the value of this programme

This is the first set of data presented from the Assure programme

The aim of this analysis was to examine the baseline characteristics of early enrollers and investigate associations with baseline adherence

MethodsBaseline data was collected from enrolling patients between January -November 2013

Descriptive statistics were calculated for all variables

Patients not answering any questions on the screening questionnaire were excluded

Data was analysed using SPSS statistical softwareData was analysed using SPSS statistical software

Mean scores for Necessity, Concerns, Efficacy, Trust in Medical Advice, Practical Barriers and Mood were cut at the midpoint

- scores below the midpoint labelled “helpful beliefs” - scores above the midpoint labelled “unhelpful beliefs”

Correlations between beliefs, mood and adherence were calculated using a non-parametric test (Spearman’s rho)

Results85 patients provided consent and completed the baseline questionnaires

Characteristics of Assure users (n=85)

Adherence (VAS)Although adherence was high in the sample, with a m edian score of 100% and IQR of 80 – 100% not all patients were adherent to medication.

Beliefs

Percentage of patients with scores above the midpoi nt (N = 84)

Mean scores for Necessity, Concerns, Efficacy, Trust in Medical Advice, Practical Barriers and Mood were cut at the midpoint

- scores below the midpoint labelled “helpful beliefs” - scores above the midpoint labelled “unhelpful beliefs”

Relationship between beliefs, mood and adherenceThere was a statistically significant, moderate, ne gative relationship between Necessity, Concerns, Practical Barriers and adherenc e.

Conclusion

In this analysis, despite more than half of the patients enrolled on this patient support programme taking mesalazine for > 12 months, many patients reported unhelpful beliefs and practical barriers at baseline

This analysis suggests that both newly diagnosed and established patients with ulcerative colitis need additional support to address unhelpful beliefs and barriers to medication.

Assure is ongoing and undergoing continual evaluation to demonstrate the value of this multi-channel patient support programme.

• Jackson C. et al., Patients’ views of an innovative adherence support programme in ulcerative colitis treatment: a qualitative analysis -Poster C-02

6 month persistence and adherence data will be presented next year

Acknowledgements

This analysis was conducted by Atlantis Healthcare, and sponsored by Warner Chilcott UK Ltd, a subsidary of Actavis UK Ltd.

Abstract editorial support was provided by Acumen Healthcare Communications Ltd, funded by Warner Chilcott UK Ltd.

Thank yougwen.wiseman@actavis.com