- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01470963
Practical Health Co-operation - The Impact of a Referral Template on Quality of Health Care
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Harstad, Norway, 9480
- Medical department - University Hospital of North Norway Harstad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- referral to medical department of University Hospital of North Norway, Harstad
Exclusion Criteria:
- children (< 18 years of age)
- patients with reduced capacity to consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Referral template
Implementation of the referral templates at the GP office
|
Implementation of referral template at the GP office
|
|
No Intervention: Control
Normal referral pattern
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
The care period for each patient (approx. 3 weeks up to 1 year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improved referral quality
Time Frame: The care period for each patient (approx. 3 weeks up to 1 year)
|
The investigators will evaluate each referral against the referral template, and then compare between intervention and control groups.
|
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)
|
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)
|
Compare the time from referral to initiation of treatment/"decision no treatment" necessary between intervention and control groups
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The care period for each patient (approx. 3 weeks up to 1 year)
|
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Percentage of patients seen within investigation deadline
Time Frame: Assessed at end of study - approx 2 years
|
Compare the number of patients in the two groups seen within the limit set in national prioritisation guidelines
|
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
|
Compare the number of patients in the intervention vs. control group that were designated with a investigation deadline according to national prioritisation guidelines
|
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)
|
Patient satisfaction as measured by self report questionnaire
|
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)
|
Compare the percentage of referrals between the intervention and control groups which have lead to
|
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)
|
Compare the number of appointments needed to clarify diagnosis between intervention and control groups
|
The care period for each patient (approx. 3 weeks up to 1 year)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ann Ragnhild Broderstad, Dr. med, University Hospital of North Norway
Publications and helpful links
General 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.
- Wahlberg 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.
- Wahlberg 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.
- Wahlberg 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HST1026-11
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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