ReferralNCT01470963
Practical Health Co-operation - The Impact of a Referral Template on Quality of Health Care
A study testing Implementation of referral template in people with Referral and Quality of Health Care, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The purpose of this study is to examine whether the implementation of a referral template will increase quality of health care delivered and the quality of health care co-operation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Referral, Quality of Health Care
- What is being tested?
- Implementation of referral template
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2011to Jan 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- referral to medical department of University Hospital of North Norway, Harstad
Who cannot join
- children (< 18 years of age)
- patients with reduced capacity to consent
Trial locations and contacts
1 site in 1 country.
Norway1 site
Medical department - University Hospital of North Norway Harstad
Harstad, 9480
About this study
Official title: Practical Health Co-operation - a Randomised Controlled Intervention Study. The Impact of a Referral Template on Quality of Care and Health Care Co-operation Between Primary and Secondary Care
The purpose of this study is to examine whether the implementation of a referral template will increase quality of health care delivered and the quality of health care co-operation. The investigators intent to implement a referral template, at the level of the general practitioner (GP), for the referral of patients within 4 separate diagnostic groups:
- dyspepsia/upper GI symptoms
- colonic cancer investigation/lower GI symptoms
- chronic obstructive pulmonary disease (COPD)
- chest pain
Read more
Local GP clinics will be randomised to use the referral template or to use standard referral practice. Using a predefined set of quality criteria the investigators will score the process of care in each patient, and compare intervention and control groups. In addition other criteria will be collected and compared between the two groups, e.g.
- time to diagnosis/treatment
- quality of referral
- more appropriate referrals
- patient satisfaction (as measured by a questionnaire)
The investigators hypothesize that the implementation of a referral template will lead to a measurable increase in the quality of health care delivered.
Read the detailed description
There is a continuous work to improve the quality of health care delivered to an individual patient, both in primary and secondary care. The referral from primary to secondary care represents a key component in the communication between the levels of care, and therefore an important tool in developing the quality of care. There has been many attempts at improving the quality of referrals, but less work has been focussed on the consequence of such improvement on quality of health care. This study is designed as a randomised controlled intervention study where we intent to implement a referral templates, at the level of the general practitioner (GP). These templates will be for the referral of patients within 4 separate diagnostic groups:
- dyspepsia/upper GI symptoms
- colonic cancer investigation/lower GI symptoms
- chronic obstructive pulmonary disease (COPD)
- chest pain
Following the course of the health care process we will assess the quality of the care process by using predefined quality of care criteria, together with patient satisfaction (as measured by questionnaire) and other health process indicators.
Our primary hypothesis is that the implementation of a referral template in the communication between primary and secondary care, will lead to a measurable increase in the quality of health care delivered.
Secondary hypothesis include:
- the use of a referral template in the communication between the GP and secondary care, will lead to better patient satisfaction.
- the use of a referral template in the communication between the GP and secondary care, will lead to a change (up or down) in the amount of patients defined as being in need of prioritisation (as defined pr. national guidelines for prioritisation in health care)
- the use of a referral template in the communication between the GP and secondary care, will lead to a measurable referral quality improvement
- the use of a referral template in the communication between the GP and secondary care, will increase the "appropriateness" of the referrals
- Conditions
- Referral, Quality of Health Care
- Being tested
- Implementation of referral template
- Keywords
- Referral, Quality of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of referral templateOther
Implementation of referral template at the GP office
| Study group | Role | What they receive |
|---|---|---|
| Referral template | Experimental | Implementation of the referral templates at the GP office Receives: Other: Implementation of referral template |
| Control | No intervention | Normal referral pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collated quality indicator score
Based on treatment guidelines and international quality assessment tools we have developed quality indicators score sets for each of the 4 diagnostic groups in the study. The scores will be compared between intervention and control GP offices to assess the effect of the referral template.
Measured: The care period for each patient (approx. 3 weeks up to 1 year)
Secondary outcomes (8)
Improved referral quality
The investigators will evaluate each referral against the referral template, and then compare between intervention and control groups.
Measured: The care period for each patient (approx. 3 weeks up to 1 year)
Waiting time from referral to appointment
Measured: The care period for each patient (approx. 3 weeks up to 1 year)
Time from referral to initiation of treatment
Compare the time from referral to initiation of treatment/"decision no treatment" necessary between intervention and control groups
Measured: The care period for each patient (approx. 3 weeks up to 1 year)
Percentage of patients seen within investigation deadline
Compare the number of patients in the two groups seen within the limit set in national prioritisation guidelines
Measured: Assessed at end of study - approx 2 years
Number of patients designated with investigation deadline
Compare the number of patients in the intervention vs. control group that were designated with a investigation deadline according to national prioritisation guidelines
Measured: Assessed at end of study - approx 2 years
Patient satisfaction
Patient satisfaction as measured by self report questionnaire
Measured: The care period for each patient (approx. 3 weeks up to 1 year)
Positive predictive value of referral
Compare the percentage of referrals between the intervention and control groups which have lead to
- a diagnostic clarification, or
- a histological diagnosis, or
- a change in medical management
Measured: The care period for each patient (approx. 3 weeks up to 1 year)
Number of appointments needed for diagnostic clarification
Compare the number of appointments needed to clarify diagnosis between intervention and control groups
Measured: The care period for each patient (approx. 3 weeks up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ReferralStudies 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
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Sponsor
- Investigators
- Ann Ragnhild Broderstad, Dr. med, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470963
- Sponsor's protocol ID
- HST1026-11
- Status last verified
- Jul 2014
- First submitted
- 5 Sep 2011
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wahlberg H, Valle PC, Malm S, Hovde O, Broderstad AR. The effect of referral templates on out-patient quality of care in a hospital setting: a cluster randomized controlled trial. BMC Health Serv Res. 2017 Mar 7;17(1):177. doi: 10.1186/s12913-017-2127-1.
PubMed 28270128Wahlberg H, Braaten T, Broderstad AR. Impact of referral templates on patient experience of the referral and care process: a cluster randomised trial. BMJ Open. 2016 Oct 24;6(10):e011651. doi: 10.1136/bmjopen-2016-011651.
PubMed 27797992Wahlberg H, Valle PC, Malm S, Broderstad AR. Impact of referral templates on the quality of referrals from primary to secondary care: a cluster randomised trial. BMC Health Serv Res. 2015 Aug 29;15:353. doi: 10.1186/s12913-015-1017-7.
PubMed 26318734Wahlberg H, Valle PC, Malm S, Broderstad AR. Practical health co-operation - the impact of a referral template on quality of care and health care co-operation: study protocol for a cluster randomized controlled trial. Trials. 2013 Jan 7;14:7. doi: 10.1186/1745-6215-14-7.
PubMed 23295103
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Health Co-operation - a Randomised Controlled Intervention Study. The Impact of a Referral Template on Quality of Care and Health Care Co-operation Between Primary and Secondary Care
- ClinicalTrials.gov ID
- NCT01470963
- Acronym / sponsor ID
- HST1026-11
- Conditions
- Referral, Quality of Health Care
- Keywords
- Referral, Quality of Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Sep 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Nov 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 purpose of this study is to examine whether the implementation of a referral template will increase quality of health care delivered and the quality of health care co-operation. The investigators intent to implement a referral template, at the level of the general practitioner (GP), for the referral of patients within 4 separate diagnostic groups:
- dyspepsia/upper GI symptoms
- colonic cancer investigation/lower GI symptoms
- chronic obstructive pulmonary disease (COPD)
- chest pain
Local GP clinics will be randomised to use the referral template or to use standard referral practice. Using a predefined set of quality criteria the investigators will score the process of care in each patient, and compare intervention and control groups. In addition other criteria will be collected and compared between the two groups, e.g.
- time to diagnosis/treatment
- quality of referral
- more appropriate referrals
- patient satisfaction (as measured by a questionnaire)
The investigators hypothesize that the implementation of a referral template will lead to a measurable increase in the quality of health care delivered.
Detailed description
There is a continuous work to improve the quality of health care delivered to an individual patient, both in primary and secondary care. The referral from primary to secondary care represents a key component in the communication between the levels of care, and therefore an important tool in developing the quality of care. There has been many attempts at improving the quality of referrals, but less work has been focussed on the consequence of such improvement on quality of health care. This study is designed as a randomised controlled intervention study where we intent to implement a referral templates, at the level of the general practitioner (GP). These templates will be for the referral of patients within 4 separate diagnostic groups:
- dyspepsia/upper GI symptoms
- colonic cancer investigation/lower GI symptoms
- chronic obstructive pulmonary disease (COPD)
- chest pain
Following the course of the health care process we will assess the quality of the care process by using predefined quality of care criteria, together with patient satisfaction (as measured by questionnaire) and other health process indicators.
Our primary hypothesis is that the implementation of a referral template in the communication between primary and secondary care, will lead to a measurable increase in the quality of health care delivered.
Secondary hypothesis include:
- the use of a referral template in the communication between the GP and secondary care, will lead to better patient satisfaction.
- the use of a referral template in the communication between the GP and secondary care, will lead to a change (up or down) in the amount of patients defined as being in need of prioritisation (as defined pr. national guidelines for prioritisation in health care)
- the use of a referral template in the communication between the GP and secondary care, will lead to a measurable referral quality improvement
- the use of a referral template in the communication between the GP and secondary care, will increase the "appropriateness" of the referrals
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referral template | Experimental | Other: Implementation of referral templateImplementation of the referral templates at the GP office |
| Control | No intervention | –Normal referral pattern |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- referral to medical department of University Hospital of North Norway, Harstad
Key exclusion criteria (2 listed)
- children (< 18 years of age)
- patients with reduced capacity to consent
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 |
|---|---|---|
| Implementation of referral templateImplementation of referral template at the GP office | Other | Referral template |
Primary outcome
Collated quality indicator score
Time frame: The care period for each patient (approx. 3 weeks up to 1 year)
Based on treatment guidelines and international quality assessment tools we have developed quality indicators score sets for each of the 4 diagnostic groups in the study. The scores will be compared between intervention and control GP offices to assess the effect of the referral template.
8 secondary outcomes
Improved referral quality
Time frame: The care period for each patient (approx. 3 weeks up to 1 year)
Waiting time from referral to appointment
Time frame: The care period for each patient (approx. 3 weeks up to 1 year)
Time from referral to initiation of treatment
Time frame: The care period for each patient (approx. 3 weeks up to 1 year)
Percentage of patients seen within investigation deadline
Time frame: Assessed at end of study - approx 2 years
Number of patients designated with investigation deadline
Time frame: Assessed at end of study - approx 2 years
Patient satisfaction
Time frame: The care period for each patient (approx. 3 weeks up to 1 year)
Positive predictive value of referral
Time frame: The care period for each patient (approx. 3 weeks up to 1 year)
Number of appointments needed for diagnostic clarification
Time frame: The care period for each patient (approx. 3 weeks up to 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
- Derived from this study: PubMed 28270128Wahlberg H, Valle PC, Malm S, Hovde O, Broderstad AR. The effect of referral templates on out-patient quality of care in a hospital setting: a cluster randomized controlled trial. BMC Health Serv Res. 2017 Mar 7;17(1):177. doi: 10.1186/s12913-017-2127-1.
- Derived from this study: PubMed 27797992Wahlberg H, Braaten T, Broderstad AR. Impact of referral templates on patient experience of the referral and care process: a cluster randomised trial. BMJ Open. 2016 Oct 24;6(10):e011651. doi: 10.1136/bmjopen-2016-011651.
- Derived from this study: PubMed 26318734Wahlberg H, Valle PC, Malm S, Broderstad AR. Impact of referral templates on the quality of referrals from primary to secondary care: a cluster randomised trial. BMC Health Serv Res. 2015 Aug 29;15:353. doi: 10.1186/s12913-015-1017-7.
- Derived from this study: PubMed 23295103Wahlberg H, Valle PC, Malm S, Broderstad AR. Practical health co-operation - the impact of a referral template on quality of care and health care co-operation: study protocol for a cluster randomized controlled trial. Trials. 2013 Jan 7;14:7. doi: 10.1186/1745-6215-14-7.
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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.
Ann Ragnhild Broderstad, Dr. med principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of referral template in people with Referral and Quality of Health Care, run by University Hospital of North Norway 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 1 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: finished, as of the sponsor's last update on 11 Jul 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Collated quality indicator score (time frame: The care period for each patient (approx. 3 weeks up to 1 year)). 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 NCT01470963, which also lists 4 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 11 Jul 2014.