- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01374035
The Western Norway Mental Health Interface Study on Referral Letters
February 11, 2020 updated by: Miriam Hartveit, Helse Fonna
Interface Between Primary Care and Specialist Mental Health Care - the Referral Letters
The main object to this trial is to study the function of referral letters as a mean to coordinate the care process for adult people when referred from Primary Care to Specialised Mental Health Care.
The study will explore if and to what degree the quality of these referral letters can be improved, and the potential improvement's impact on defined patient-, professional and organisational related outcomes.
According to Medical Research Council guidelines for evaluating complex interventions, a stepwise design with the use of both qualitative and quantitative methods will be used to conduct a controlled intervention study.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
The study is based on a stepwise progression including four steps.
Within step one group interview with four mixed groups of health professionals (both Primary and Specialised Care), patient representatives and managers will be conducted.
The groups will give input on firstly, what information they think is important to include in the referral letters, and secondly, what impact they think improved referral letters can have for the organisation and care within Specialised Mental Health Care.
Within step two a validated check-list to assess the quality of referral letters will be developed.
Within step three outcome measures will be developed and tested.
Both step two and three will make use of the results from step one in addition to existing literature and testing.
Step four is the intervention study where measures from the former steps will be used.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Haugesund, Norway, 5504
- Helse Fonna Local Health Authorities
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Referral letters send from a GP to Public Specialised Mental Health Care
- Referrals for elective assessment or treatment
Exclusion Criteria:
- Referral letters send from other health personnel
- Referrals for acute care (within 24 hours)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participating GPs
GPs working at randomly selected GP centers/offices within the region that are invited to participate and signs a written informed consent to participate.
(N=30-40)
|
A complex intervention will be implemented within the group of GPs in the intervention group.
It includes participation in defining criteria for good referral letters, information about the correlation between information in the referral letters and outcome, introduction to the guideline, and consecutive feedback on own preformance regarding content of referral letter and outcome for the patient.
|
|
No Intervention: Control group
GPs working at randomly selected GP centers/office within the region that are not invited to participate, will form the control group.
(N=30-40)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of stay
Time Frame: Day of discharge assessed up to six months
|
From date of admission or onset of out-patient treatment until date of discharge (documented in Electronic Patient Record as end of treatment periode), assessed up to six months from admission.
|
Day of discharge assessed up to six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response time for referral letters in Specialised Mental Health Care
Time Frame: Referral letters will be followed for the duration of the assessment and prioritation process until response letter is sent, an expected avarage of 10 days.
|
Unit of measure: Number of days from receiving a referral letter to the response letter is sent to the patient and the General Practitioner.
The response time for all letters recieved in a six month periode before the intervention to improve the quality of referral letters will be compared with the response time after the intervention.
|
Referral letters will be followed for the duration of the assessment and prioritation process until response letter is sent, an expected avarage of 10 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Aslak B Aslaksen, MD, PhD, Faculty of Medicine and Dentistery, University of Bergen, Norway
- Principal Investigator: Kjell Haug, MD, PhD, Faculty of Medicine and Dentistery, University of Bergen, Norway
- Principal Investigator: Kris Vanhaecht, RN, PhD, KU Leuven
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hartveit M, Biringer E, Vanhaeht K, Haug K, Aslaksen A. The Western Norway mental health interface study: a controlled intervention trial on referral letters between primary care and specialist mental health care. BMC Psychiatry. 2011 Nov 14;11:177. doi: 10.1186/1471-244X-11-177.
- Hartveit M, Aslaksen A, Vanhaecht K, Thorsen O, Hove O, Haug K et al. Development and testing of an instrument in Western Norway to measure the quality of referral information from primary care to specialised mental health care. International Journal of Care Coordination18:2-3, 2015
- Hartveit M, Vanhaecht K, Thorsen O, Biringer E, Haug K, Aslaksen A. Quality indicators for the referral process from primary to specialised mental health care: an explorative study in accordance with the RAND appropriateness method. BMC Health Serv Res. 2017 Jan 3;17(1):4. doi: 10.1186/s12913-016-1941-1.
- Hartveit M, Thorsen O, Biringer E, Vanhaecht K, Carlsen B, Aslaksen A. Recommended content of referral letters from general practitioners to specialised mental health care: a qualitative multi-perspective study. BMC Health Serv Res. 2013 Aug 19;13:329. doi: 10.1186/1472-6963-13-329.
- Nymoen M, Biringer E, Hetlevik O, Thorsen O, Assmus J, Hartveit M. The impact of referral letter quality on timely access to specialised mental health care: a quantitative study of the reliability of patient triage. BMC Health Serv Res. 2022 Jun 2;22(1):735. doi: 10.1186/s12913-022-08139-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2010
Primary Completion (Actual)
June 22, 2016
Study Completion (Actual)
December 13, 2019
Study Registration Dates
First Submitted
April 28, 2011
First Submitted That Met QC Criteria
June 14, 2011
First Posted (Estimate)
June 15, 2011
Study Record Updates
Last Update Posted (Actual)
February 13, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSD-24340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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