Non-Medical health related social needs (International Classification of Primary Care 3rd Edition, ICPC-3: ZC01-ZC99 “Social Problems”)
Conditions
Interventions
Group 1: Social Prescribing (SP):
Referral from the GP to a link worker. The link worker assesses the social needs, agrees on a goal and sets up an action plan together with the patient. The link wor
Sponsors
Institut für Allgemeinmedizin, Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients who 1) present to the GP practice with one or more non-medical health-related social needs and 2) are able to give informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients under legal guardianship in relation to health 2) A person living in the same household is already included in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the trial measured by (1) proportion of participants who have at least one appointment with the link worker (intervention arm only), (2) proportion of participants that drop out of the trial before the 6-month follow-up (loss to follow-up, both arms). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary feasibility endpoints: Acceptability (intervention-arm only): Satisfaction of GPs (Questionnaire after last patient out) and patients (6-month-follow-up) with the intervention; acceptance of the intervention by patients, GPs, link workers and local service providers (qualitative interviews); Practicality: proportion of patients excluded during eligibility screening due to a language barrier; proportion of eligible patients consenting to study participation; proportion of consenting patients randomized; proportion of randomized patients adhering to appointments with link worker (intervention-arm only) Demand/Utilization (intervention-arm only): Frequency of link worker consultations; delivery mode of the link worker interaction (in person (home visit, in GP practice), phone, mail); services recommended by the link worker; utilization of recommended services. Secondary feasibility endpoints will be assessed through questionnaires at 6-month follow-up, trial documentation and qualitative interviews. Clinical endpoints/Patient reported outcomes (PROM): Clinical endpoints are health status (WHODAS 2.0), well-being (WHO-5, L-1, ICECAP-A), loneliness (De Jong Gierveld Loneliness Scale), health-related quality of life (EQ-5D-5L), subjective health status, and community connection (assessed qualitatively). The proposed main clinical endpoint is the difference of the sum score of the 12-item WHODAS 2.0 between baseline and 6-month follow-up. Additionally: Goal based outcome (GBO, intervention-arm only); Health and social care utilization (relevant parts of PECUNIA RUM) All endpoints will be assessed via a computer assisted telephone interview at 3- and 6-months follow-up. The process evaluation consists of the continuous quantitative analysis of trial documentation data as well as of qualitative interviews with stakeholders (patients, GPs, link workers, service providers) involved. Assessment of safety: Adverse events related to the exac | — |
Countries
Germany
Contacts
Public ContactNiklas Jeske
Institut für Allgemeinmedizin, Charité - Universitätsmedizin Berlin
Outcome results
None listed