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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01470963
Other study ID # HST1026-11
Secondary ID
Status Completed
Phase N/A
First received September 5, 2011
Last updated July 10, 2014
Start date September 2011
Est. completion date January 2014

Study information

Verified date July 2014
Source University Hospital of North Norway
Contact n/a
Is FDA regulated No
Health authority Norway: Regional Ethics Commitee
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Implementation of referral template
Implementation of referral template at the GP office

Locations

Country Name City State
Norway Medical department - University Hospital of North Norway Harstad Harstad

Sponsors (2)

Lead Sponsor Collaborator
University Hospital of North Norway University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. The care period for each patient (approx. 3 weeks up to 1 year) No
Secondary Improved referral quality 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) No
Secondary Waiting time from referral to appointment The care period for each patient (approx. 3 weeks up to 1 year) No
Secondary 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 The care period for each patient (approx. 3 weeks up to 1 year) No
Secondary 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 Assessed at end of study - approx 2 years No
Secondary 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 Assessed at end of study - approx 2 years No
Secondary Patient satisfaction Patient satisfaction as measured by self report questionnaire The care period for each patient (approx. 3 weeks up to 1 year) No
Secondary 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
The care period for each patient (approx. 3 weeks up to 1 year) No
Secondary Number of appointments needed for diagnostic clarification 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) No
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