Feedback in the Consultation - a Dialogue-based Tool in Personalised Care Planning Using Systematic Patient Involvement
Condition: Melanoma; Quality of Life
Study type: Interventional

Summary: 
      The aim of the study is to examine the potentials of involving patients with metastatic
      melanoma in their own care planning through systematic use of patient-reported outcome
      measures (PROM). Furthermore, to examine the outcome of health-related quality of life,
      self-efficacy and impact on the patient-physician interaction.

      Patients (N=282) will be included from three highly specialized hospitals in Denmark. At one
      hospital patients will complete PROM before each consultation during a year (intervention
      group). At the two other hospitals patients will not complete PROM (control group). In
      addition to baseline, measurements will take place after three, six and 12 months. The
      project is organized and executed with patient involvement in the research process.
    

Detailed description: 
      Background:

      In recent years, treatment of metastatic melanoma has changed significantly, which has led to
      improved prognosis and greater expectations for the future. However, new concerns in relation
      to health-related quality of life and coping with disease in everyday life have emerged.
      Patient-reported outcome measures (PROM) is a promising tool to strengthen patient
      involvement. By systematically reporting real time PROM to the physician prior to a
      consultation, it may generate a continuous feedback loop, by which the patient physician
      dialogue can focus on what is most important to the patient.

      Hypothesis:

      The aim of the study is to investigate the potentials of using PROM as a dialogue-based tool.
      We hypothesize that PROM as a dialogue-based tool can:

        -  Improve patients' knowledge, skills, and confidence for managing their health and
           healthcare

        -  Reduce the perceived burden of physical symptoms and emotional dysfunction

        -  Improve the quality of the patient-physician interaction

      Material and methods:

      In this prospective study patients (N=282) will be included from three highly specialized
      hospitals in Denmark. At Aarhus University Hospital, patients will complete electronic PROM
      before the consultation and systematically participate in a dialogue about their
      self-assessments for a duration of one year (intervention group). At Herlev Hospital and
      Odense University Hospital, patients will not complete PROM (control group). In addition to
      baseline, self-reported measurements will take place after three, six and 12 months.

      To address the patient perspective, patients with melanoma are involved in the project
      management. A steering group with scientists and patient representatives has been
      established. This group have chosen the relevant PROM, determined primary objectives and
      given feedback on the written information material for the intervention by looking at
      relevance and readability. Moreover the group will ensure optimal implementation if results
      are promising. In addition, a patient focus group will be established to discuss how PROM
      should be used in the consultation and how patient involvement is expressed in practice. The
      recruitment of patients to these groups will be made in cooperation with the association for
      patients with melanoma and clinical practice where the patients are treated.

      Perspectives If results are positive, the intervention will be easy to apply to routine
      settings and in a slightly adjusted form in other groups of cancer patients too.
    

Intervention name(s): Feedback in the consultation
Intervention type(s): Behavioral
Intervention description(s): Patients will complete electronic Patient Reported Outcome Measures (PROM) before the consultation at the hospital. The results are fed back to physicians. In the consultation patients will systematically participate in a dialogue with their physician about issues that are most important for the patients.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention takes place at a highly specialized university hospital i Denmark. Two other higly specialized Danish hospitals recruit patients for the control group.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Patient activation measure; Self-efficacy; Patient participation in research; Patient reported outcome measures