Mental DisordersNCT01374035
The Western Norway Mental Health Interface Study on Referral Letters
A study testing Quality improvement intervention in people with Mental Disorders, run by Helse Fonna at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Quality improvement intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2010to 13 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral letters send from a GP to Public Specialised Mental Health Care
- Referrals for elective assessment or treatment
Who cannot join
- Referral letters send from other health personnel
- Referrals for acute care (within 24 hours)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Disorders
- Being tested
- Quality improvement intervention
- Keywords
- Health Service, Coordination, Referral letters, Mental Health, Adults
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality improvement interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participating GPs | Experimental | 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) Receives: Other: Quality improvement intervention |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
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.
Measured: Day of discharge assessed up to six months
Secondary outcomes (1)
Response time for referral letters in Specialised Mental Health Care
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study start1 Aug 2010
- Primary completion22 Jun 2016
- Study completion13 Dec 2019
Why it stopped: Were not able to conduct the intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Fonna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, KU Leuven
- Responsible party
- Principal investigator, Miriam Hartveit, Helse Fonna
- Investigators
- Aslak B Aslaksen, MD, PhD, Study chair, Faculty of Medicine and Dentistery, University of Bergen, NorwayKjell Haug, MD, PhD, Principal investigator, Faculty of Medicine and Dentistery, University of Bergen, NorwayKris Vanhaecht, RN, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374035
- Sponsor's protocol ID
- NSD-24340
- Status last verified
- Feb 2020
- First submitted
- 28 Apr 2011
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 22081994Hartveit 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.
PubMed 28049470Hartveit 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.
PubMed 23958371Nymoen 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.
PubMed 35655302
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interface Between Primary Care and Specialist Mental Health Care - the Referral Letters
- ClinicalTrials.gov ID
- NCT01374035
- Acronym / sponsor ID
- NSD-24340
- Conditions
- Mental Disorders
- Keywords
- Health Service, Coordination, Referral letters, Mental Health, Adults
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Were not able to conduct the intervention.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helse FonnaUniversity, hospital or other
- Collaborators
- University of Bergen, KU Leuven
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 22 Jun 2016 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participating GPs | Experimental | Other: Quality improvement interventionGPs 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) |
| Control group | No intervention | –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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Referral letters send from a GP to Public Specialised Mental Health Care
- Referrals for elective assessment or treatment
Key exclusion criteria (2 listed)
- Referral letters send from other health personnel
- Referrals for acute care (within 24 hours)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality improvement interventionA 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. | Other | Participating GPs |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Background: PubMed 22081994Hartveit 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.
- BackgroundHartveit 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
- Background: PubMed 28049470Hartveit 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.
- Results publication: PubMed 23958371Hartveit 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.
- Derived from this study: PubMed 35655302Nymoen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslak B Aslaksen, MD, PhD study chair
Faculty of Medicine and Dentistery, University of Bergen, Norway
Kjell Haug, MD, PhD principal investigator
Faculty of Medicine and Dentistery, University of Bergen, Norway
Kris Vanhaecht, RN, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality improvement intervention in people with Mental Disorders, run by Helse Fonna at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: Day of discharge assessed up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01374035, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.