Practical Health Co-operation - The Impact of a Referral Template on Quality of Health Care

This study has been completed.
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01470963
First received: September 5, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Referral
Quality of Health Care
Other: Implementation of referral template

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Collated quality indicator score [ Time Frame: The care period for each patient (approx. 3 weeks up to 1 year) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Improved referral quality [ Time Frame: The care period for each patient (approx. 3 weeks up to 1 year) ] [ Designated as safety issue: No ]
    The investigators will evaluate each referral against the referral template, and then compare between intervention and control groups.

  • Waiting time from referral to appointment [ Time Frame: The care period for each patient (approx. 3 weeks up to 1 year) ] [ Designated as safety issue: No ]
  • Time from referral to initiation of treatment [ Time Frame: The care period for each patient (approx. 3 weeks up to 1 year) ] [ Designated as safety issue: No ]
    Compare the time from referral to initiation of treatment/"decision no treatment" necessary between intervention and control groups

  • Percentage of patients seen within investigation deadline [ Time Frame: Assessed at end of study - approx 2 years ] [ Designated as safety issue: No ]
    Compare the number of patients in the two groups seen within the limit set in national prioritisation guidelines

  • Number of patients designated with investigation deadline [ Time Frame: Assessed at end of study - approx 2 years ] [ Designated as safety issue: No ]
    Compare the number of patients in the intervention vs. control group that were designated with a investigation deadline according to national prioritisation guidelines

  • Patient satisfaction [ Time Frame: The care period for each patient (approx. 3 weeks up to 1 year) ] [ Designated as safety issue: No ]
    Patient satisfaction as measured by self report questionnaire

  • Positive predictive value of referral [ Time Frame: The care period for each patient (approx. 3 weeks up to 1 year) ] [ Designated as safety issue: No ]

    Compare the percentage of referrals between the intervention and control groups which have lead to

    1. a diagnostic clarification, or
    2. a histological diagnosis, or
    3. a change in medical management

  • Number of appointments needed for diagnostic clarification [ Time Frame: The care period for each patient (approx. 3 weeks up to 1 year) ] [ Designated as safety issue: No ]
    Compare the number of appointments needed to clarify diagnosis between intervention and control groups


Enrollment: 500
Study Start Date: September 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Referral template
Implementation of the referral templates at the GP office
Other: Implementation of referral template
Implementation of referral template at the GP office
No Intervention: Control
Normal referral pattern

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470963

Locations
Norway
Medical department - University Hospital of North Norway Harstad
Harstad, Norway, 9480
Sponsors and Collaborators
University Hospital of North Norway
University of Tromso
Investigators
Principal Investigator: Ann Ragnhild Broderstad, Dr. med University Hospital of North Norway
  More Information

No publications provided by University Hospital of North Norway

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01470963     History of Changes
Other Study ID Numbers: HST1026-11
Study First Received: September 5, 2011
Last Updated: July 10, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by University Hospital of North Norway:
Referral
Quality of Health Care

ClinicalTrials.gov processed this record on August 01, 2014