Effect of a Coordinated Primary-care-Based MDT-model on the Treatment of Hard-to-heal Ulcers

Number of individuals that achieve healing of their hard-to-heal ulcer(s), compared between two arms

Mean time (in days) to healing of healed hard-to-heal ulcer(s) in days - compared between groups

Incidence of recurrence of ulcer following healing of hard-to-heal ulcer(s) - compared between groups

Incidence of infections divided in

• Infection treated with tablet antibiotic
• Infection treated with intravenous antibiotics, admittance to hospital and/or surgery Compared between groups

Incidence and amputations in total and divided in

• Below ankle amputation
• Above ankle amputations Compared between groups

Number of visits to clinics due to hard-to-heal ulcer(s) - compared between groups

Days admitted to hospital due to hard-to-heal ulcer(s) - compared between groups

Patient related outcomes (Wound-QoL) - compared between groups Wound-Qol is a PROM tool designed for patients living with chronic ulcers, and is scored on 17-items, from 0 to 4 for each item. The higher the score the worse the outcome. The scores are registered as a global score for all 17 items and divided in three subscales.

Cost effectiveness of intervention will be assessed by comparing expenditures between intervention and control group at four levels;

• Hospital based care: Calculated using yearly Diagnosis Related Group (DRG) rates determined by the Danish Health Data Authority, obtained from the Danish National Patient Register
• Primary care: Calculated using fees paid to healthcare providers by the health management regions, including general practitioners, podiatrists, and other specialists in primary care.
• Prescribed medication: Calculated as the total cost of medication, including any out-of-pocket expenses, obtained from the Danish National Prescription Registry
• Municipal home care: Calculated based on the average number of minutes of home care provided weekly, summed to total monthly hours. These hours are multiplied by the average hourly cost found in the national database of municipal services Were cost are not directly discernable from the above mentioned data sources estimates of

RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (first given here)

o Reach will be assessed using data available from Frederikssund Kommune on number of individuals with hard-to-heal ulcer(s) treated that can be reached with the cross-sectional MDT intervention in the municipality.

RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (second given here)

o Effect will be assessed by the clinical outcomes described above i.e., ulcer healing, infection etc.

RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (third given here)

o Adoption will be assessed on a local (NOHs catchment area), regional (the Capital Region of Denmark) and on a Danish level, by the number of clinics that have adopted the cross-sectional MDT model.

RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (fourth given here)

o Implementation will be assessed by the proportion of eligible individuals with hard-to-heal-ulcers offered the MDT-approach in Frederikssund Kommune.

RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (fifth given here)

o Maintenance will be assessed by how many of the clinics that have adopted the intervention actually maintain the intervention over time.