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Table 6 Outcomes

From: Targeted prevention in primary care aimed at lifestyle-related diseases: a study protocol for a non-randomised pilot study

Outcome Data input
Change in proportion of patients at increased risk of lifestyle related disease from baseline to the 12 weeks follow up Questionnaire at baseline (Q2) and end of study period (Q6 and Q7). Risk of lifestyle related disease is based on the algorithms previously described in the methods section and in Tables 3, 4 and 5
Determinants of participation and non-participation Questionnaire at baseline (Q2). Participants and non-participants will be compared with regard to socio-demographic characteristics, morbidity and contextual characteristics
Evaluation of the digital support system with focus on design, usability and effect of the decision support system Focus group interviews before study start comprising 6 GPs, 6 practice staff members, 6 municipality staff members, 6–8 patients and representatives from 6 to 8 stakeholder organizations, respectively
Qualitative interviews with 8–10 patients before and after the health dialogue at the GP, and qualitative interviews with 6–8 GPs after health dialogues, focusing on the experienced usefulness of the digital support system
Questionnaire to all participating patients immediately after signing the consent form (Q1) and after receiving the health profile (Q3 and Q4) and to all participating GPs and municipality staff members following each study related patient encounter (Q8-Q13)
Process evaluation focusing on the intervention in general practice and the municipality Participant observation of 10–15 health dialogues in different general practices, followed by qualitative interviews with the participating patients, GPs and practice staff
Focus group interviews with 6–8 municipality staff members involved in the study and interviews with 10–15 patients who have attended a health dialogue in the municipality
Questionnaire to all participating GPs, practice staff members and municipality staff members following each study related patient encounter (Q8-Q13)
Process evaluation focusing on the organizational basis of the pilot implementation Interviews with stakeholders involved in the planning, implementation and evaluation of the study; GPs, practice staff members, municipality staff members, patients, project leaders, researchers
Process evaluation focusing on the common training course for enrolled GPs, practice staff and health professionals from the municipalities Interviews with GPs and municipal health professionals and questionnaire at the end of the course
GP and patients preferences with regard to the content of the health dialogue, and change in preferences during the study period Questionnaire using discrete choice modelling (Q4, Q7, Q8, Q11)
Patients’ perceptions of relational empathy following the health dialogue at the GP Questionnaire including The Consultation And Relational Empathy (CARE) measure following each behavior counseling session in general practice (Q5)
Quality of Life Subscale on the Hip injury and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire at baseline (Q2). Participants replying “yes” to any of the osteoarthritis related questions on hip/knee pain, GP care seeking or surgery at baseline will receive additional questions on knee/hip related quality of life and mechanical alignment of the leg and foot [55]
Patient enablement following the health dialogue at the GP Questionnaire with Patient Enablement Instrument (PEI) (Q5)
Patient reported 1. Meaning-Making and Health, 2. Spiritual Wellbeing, 3. Religious belief and practices Questionnaire items are sampled from the validated questionnaire SoMe (Sources of Meaning) and European Value Study (EVS) (Q6 and Q7)
GP reported 1. Perceived importance of communication on existential and spiritual issues, 2. Self-efficacy and barriers in communication on existential and spiritual issues, 3. Personal belief Questionnaire items sampled from the validated Self-efficacy questionnaire, European Value Study (EVS) and two items developed for this study evaluation (Q6 and Q7)
Patient reported self-efficacy and change in self-efficacy during the study period as a result of participation Questionnaire incl. The General Self-Efficacy Scale (Q3, Q4, Q6 and Q7)
Patient reported mental well-being and change in mental well-being during the study period as a result of participation Questionnaire incl. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (Q3, Q4, Q6 and Q7)