Adherence with compression stockings in the management of venous leg ulcers

The intervention tests a new clinical decision-aid comprising a new questionnaire, to identify patient-specific barriers to compression adherence, followed by the systematic implementation of behavioural strategies via a clinical decision-making algorithm, attempting to improve patient adherence to wearing compression stockings. This clinical decision-aid is called the Personalised and Multidimensional Compression Assessment and Intervention (PAMCAI) tool. Participants in the intervention will receive the PAMCAI tool in addition to standard care. For the purpose of this trial, the PAMCAI too will be implemented via an electronic App, delivered via an iPad. Examples of barriers that may be identified and how they may be addressed: 1. Stockings are not comfortable: a) Change to a different style of stocking eg. from a circular-knit stocking to a flat-knit, or cut and sew fabric b) improved sizing eg larger foot or custom sizing c) change to a different fabric which causes less skin reaction 2. Unable to get stockings on and off: a) trial of different applicators that can assist the patient to manage on their own b) teaching a carer how to assist c) getting community assistance from an NGO to come into the home in the morning and/or at night 3. Poor patient understanding of their condition and/or why they need to wear stockings: a) individualized education provided based on their level of understanding b) including carers/family in receiving education 4. Poor motivation to wear stockings: a) additional face to face encounters to provide encouragement and positive reinforcement and answer any queries b) OT or OT assistant support phone calls between visits to motivate and remind patients to continue with their stockings. The PAMCAI tool will be incorporated into existing occupational therapy outpatient clinics dedicated to the treatment of vascular conditions, to be delivered by Occupational Therapists.. Participants in the intervention group will be assessed at their initial appointment using a new Barriers to Adherence Questionnaire. This comprises 24 questions to be answered Yes or No. The clinician completes the questionnaire with the patient. If a Yes response is recorded, the significance of an issue will be rated from 1 (mild) to 5 (severe). The electronic App will select the top three responses. A clinical decision-making algorithm will provide suggestions and resources to address the barriers identified. This algorithm has been developed specifically for this study based on clinical experience, expert opinion and consumer feedback. As adherence to compression stockings requires a change in individual behaviour, the intervention uses tools and frameworks guided by behaviour change theory supportive of individual barriers to adherence. This algorithm has been developed in accordance with Michie's Behaviour Change taxonomy in consultation with a selective sample of experts to inform our recommendations. The frequency of visits during the 6-month intervention period will be dependent on the recommendations from the algorithm. It is likely that each participant in the control group will be seen on two occasions (initial and final). Intervention participants may receive three of four appointments during this period. The minimum number of appointments will be 2. Both control and intervention participants will be recruited by the primary investigator (PI). After obtaining consent, participants will be randomised to either a control or intervention group. Both groups will be contacted by the PI who will obtain initial Demographic and economic details and conduct the CIVIQ-14 and EuroQuol EQ-5D-5L quality of life assessments. During the initial clinical appointment, the intervention group will be assessed by the treating OT with the VCSS, Adhesig Screening tool and their frequency of their stocking wear will be clarified. The PAMCAI tool will be implemented which includes the Compression Adherence Questionnaire which will list the patient specific barriers. At the final assessment, the VCSS, Adhesig, Frequency of Wear and 2 quality of life assessments will be repeated, and demographic and medical information will be reviewed. As adherence is the primary outcome measure for this study, this will be a focus of all interventions, based on patient report and clinician observation - using the Adhesig Screening tool and frequency of wear questionnaire to collect data about this. The 10th question of the VCSS considers Compression Wear. This is rated as 0 (not used) to 3 (full compliance). To ensure inter-rater reliability, we have defined the terms as percentages. 0 = not used: stockings are worn 1-10% of the time that is recommended. 1 = intermittent use: stockings are worn 11-50% of the time that is recommended 2 = most days: stockings are worn 51% to 90% of the time that is recommended. 3 = full compliance: stockings are worn greater than 90% of the time that is recommended. Adherence, for the purposes of this study will be considered to be: wearing compression stockings as recommended by the health practitioner. Please note that a timeframe is not included here as there are variations in health practitioner expectations. Almost always, the expectation is to wear the stocking all day every day, but not in every single case. For each participant, expectations for their garment wear will be documented, and their level of adherence will be determined as a percentage of that total time. In summary, our intervention will attempt to improve adherence in those with identified low adherence with the wearing of compression stockings by identifying personal barriers and then addressing each of them in a systematic way. Frequency of visits during the 6 month intervention period will be dependent on the recommendations from the algorithm. It is likely that each participant in the control group will be seen on two occasions. Intervention participants are likely to be seen three or four times in total during this time period. Minimum visits will be 2. Maximum visits will be 4, during each participant's 6 month intervention period. The questions posed within the questionnaire follow: Stocking Comfort: 1. Are stockings digging in at the ankle? 2. Do stockings feel too tight generally? 3. Do stockings slide down the leg? 4. Are stockings digging in at the top of the leg? 5. Are stockings too tight at the base of the toes? 6. Are stockings too tight over the toes themselves? 7. Is the fabric irritating the skin? 8. Is the foot section sliding up the foot (open toe stocking)? 9. Is there a large foot compared to a thin leg? 10. Do stockings feel too hot to wear sometimes? 11. Is there irritation from a silicone grip top/band? Patient understanding: 12. Is there a limited understanding of their medical condition? 13. Is there a limited understanding of why stockings are needed? 14. Was there a previous negative experience with stockings? 15. Was there previous conflicting medical advice? 16. Could the patient be experiencing low mood? 17. Does the patient have low belief in their own abilities Concern about Appearance: 18. Is the patient concerned that stockings will make them look old/frail? Applying and removing Stockings: 19. Is the patient unable to put stockings on? 20. Does the patient have wounds or dressings? 21. Is the patient unable to get stockings off? Caring for stockings: 22. Does the patient not know how to take care of their stockings (knowledge)? 23. Does that patient have difficulty taking care of their stockings (memory/planning)? 24. Does the patient not know who to contact if they have any problems/stockings need replacing? Each question has its own separate answer (suggestion) sheet in response. Some questions will prompt the clinician to consider booking the patient in for another visit or a phone call. Some questions will prompt the use of various patient handouts or videos.