Implementation Challenges of Wound Interdisciplinary Teams (WIT): A Community‐Based Pragmatic Randomised Controlled Trial

Background of WIT study 2008 OHTAC systematic review MDWCTs might improve healing of chronic wounds, but results not definitive In 2010, OHTAC commissioned THETA to conduct a field evaluation Explore the role of specialized MDWCTs for community-based patients with chronic wounds in ON

Objectives of WIT study Primary To evaluate the effectiveness and cost-effectiveness of systematic referral to specialized MDWCTs with comprehensive primary care delivery vs. ‘usual care’ for the tx of community-based clients with chronic wounds in the GTA Secondary To evaluate satisfaction and QoL, and explore perceptions of study participants, their family caregiver(s), and service providers, using qualitative methods

WIT Study Design Two-arm pragmatic RCT in community-based patients with chronic wounds comparing: Systematic referral to specialized MDWCTs in conjunction with comprehensive primary care delivery (intervention arm) vs. Current practice of primary care delivery

Study Population WIT Inclusion criteria Exclusion criteria Newly referred to Toronto Central CCAC for wound management; >18 years of age; Patient/Proxy provides written informed consent; and Someone in the patient’s home must be able to speak English Exclusion criteria Surgical wounds; Burns; Malignant wounds; and Patients deemed palliative

Study Overview WIT

Stratification & Randomization WIT

Data Collection of WIT study Outcome Instruments/ Tools Data sources Primary Time to wound closure Planimetry wound measurement of digital wound photographs by blinded outcome assessors Monthly digital wound photographs captured by nurses Secondary Rate of wound healing (cm2/month) Wound recurrence during the 6 months after closure Tracked by Toronto Central CCAC Toronto Central CCAC electronic records Time to discharge (for healed wounds) from CCAC Chart abstraction at Toronto Central CCAC Additional Secondary Health-related quality of life (HRQoL) EQ-5D and SF-12 Monthly phone surveys carried out by study coordinator Satisfaction with care CSQ-8 Costs and resources used Cost survey Chart abstraction at MDWCTs MDWCTs’ medical records

Demographics WIT

WIT Study Result Systematic referral to MDWCTs in this study design did not appear to have a significant effect on either health outcomes or costs Lack of significant findings might be partially due to the pragmatic nature of the RCT and inclusion of subjects with different wound aetiologies in different care settings with insufficient power for subgroup analyses

Complex Interactions of Academic-Community Collaboration WIT

Process Evaluation Framework WIT

Process Measures for Evaluation WIT

Process Measures for Evaluation (cont’d) WIT

Qualitative Interviews WIT Characteristics of 11 frontline healthcare providers (purposive sampling) Designation of Healthcare Providers Role in the WIT study 1. CCAC Client Services Manager Recruitment 2. CCAC Case Manager 3. Coordinator of Nursing agency A Nurse assignment 4. Coordinator of Nursing agency B 5. MDWCT 1 Chiropodist Intervention 6. MDWCT 1 Nurse Practitioner 7. MDWCT 2 RN 8. MDWCT 2 MD 9. Intervention Arm Nurse Intervention and Data collection 10. Control Arm Nurse Data collection 11. Community Clinic Nurse

Qualitative Interviews WIT Demographics of 16 patients in qualitative interviews (purposive sampling) Gender Wound group (1,2,3,4) Randomization (C=control I=intervention) MDWCT (n=none 1=team 1 2=team 2) Service type (1=Clinic 2=in-home) Agency Clinic Duration in the study (months) Exit wound status (0=not healed 1=healed 2=withdrawn) F 3 I 1 6 M C 2 4

Implementation Challenges WIT Anticipated challenges Development of a meaningful research question Study integration into community practice Community members not familiar with research ethics and research processes Unanticipated challenges Complicated enrollment logistics Delay in transfer of care from non-study to study nurses Data collection problems Problems with the primary endpoint Pragmatic trial issues Low number of systematic referral to MDWCTs Fluctuation in the two MDWCTs’ capacity

Recommendations WIT Early collaboration with the frontline healthcare providers to understand their perspectives and their level of commitment and readiness Simplification of logistics to facilitate broader community participation Sample size estimation for pragmatic studies need to accommodate the impact of contextual issues Pilot study and modelling methods to evaluate the feasibility of complex intervention trial prior to full scale implementation A mixed methods design with the inclusion of qualitative study is particularly suitable for complex settings