|- candidate number||14776|
|- NTR Number||NTR3964|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-apr-2013|
|- Secondary IDs||417100005 ZonMw|
|- Public Title||Contribution of the Cultural Formulation Interview by practice nurses mental health in diagnosis and treatment of non-Western patients in general practice.|
|- Scientific Title||Contribution of the Cultural Interview by POH-GGZ in diagnosis and treatment of non-Western patients in general practice.|
|- hypothesis||Anxiety, depression and MUPS are common among first-generation non-Western migrants. The problem with the doctor also concerns motivating and treating these patients. The hypothesis is that attention to the social and cultural context of the patient might lead to better doctor-patient relationship and more effective treatment This could be accomplished by the Cultural Interview (CI) in primary care by the practice nurse mental health. |
|- Healt Condition(s) or Problem(s) studied||Depression, Anxiety disorders, Medically unexplained physical symptoms (MUPS)|
|- Inclusion criteria||1. Non-western migrant patients from Turkish, Moroccan, Surinamese of Antillian origin;|
3. Referred by general practioner to practice nurse mental health.
|- Exclusion criteria||Native patients or migrant patients not from Turkish, Moroccan, Surinamese or Antillian origin.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-sep-2013|
|- planned closingdate||31-aug-2014|
|- Target number of participants||210|
|- Interventions||Intervention: |
Use of the Cultural Interview by practice nurse mental health spread over 2 consultations. Further care as usual.
Usual intake and care.
|- Primary outcome||Compliance: Proportion patients not finishing their treatment prematurely within 6 months. Measured through reports from practice nurses and electronic patient record (EPR).|
|- Secondary outcome||Direct: Trust in health care provider (Health Alliance Questionnaire); no-shows (EPR).|
Indirect: Physical and mental health status (SF12), medical consumption [consultations, time for consultation, treatment, referral to 2nd care mental-physical-welfare] (EPR); level stepped care (EPR).
|- Timepoints||Primary: Compliance - timepoint 6 months;|
Secundary direct: Trust in health care provider (Health Alliance Questionnaire) - timepont month 0 an 6; no-shows (EPR) - timepoint month 6;
Secundary Indirect: Physical and mental health status (SF12) - timepoint month 0 and month 6, medical consumption [consultations, time for consultation, treatment, referral to 2nd care mental-physical-welfare] (EPR) - timepoint month 6 ; level stepped care (EPR) - timepoint month 6.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. Karen Hosper|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Walter Devillé|
|- Sponsor/Initiator ||NIVEL|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||In collaboration with care providers and representatives of the target group will the existing short form of the CI be developed inot a version that can be used in the primary care. Next, the study will examine the impact of the use of the CI by practice nurses mental health on diagnosis, confidence in care, adherence, patient satisfaction, and indirectly health gains among Turkish, Moroccan, Surinamese and Antillean / Aruban immigrants.
A mixed methods study involvies primary health care providers (GPs, nurses) to adapt the short version of the CI for use in primary care and tested in a pilot. Then a clustered effect controlled study will be conducted with the use of trained practice nurses applying the CI. A descriptive process evaluation supplemented by focus groups finally offer points for successful implementation in primary care. Quantitative data are collected with standardized questionnaires as well as information from electronic patient records. Qualitative information is obtained from the registration process, intake reports, EPR, interviews and focus groups with POH-GGZ, general practitioners and a focus group of patients in the intervention group.
|- Main changes (audit trail)|
|- RECORD||19-apr-2013 - 6-mei-2013|