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

2. 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

3. 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

4. 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

5. 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

6. Study Overview WIT

7. Stratification & Randomization WIT

8. 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

9. Demographics
WIT

10. 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

11. Complex Interactions of Academic-Community Collaboration WIT

12. Process Evaluation Framework WIT

13. Process Measures for Evaluation
WIT

14. Process Measures for Evaluation (cont’d)
WIT

15. 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

16. 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 =healed 2=withdrawn) F 3 I 1 6 M C 2 4

17. 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

18. 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