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Trial registered on ANZCTR


Registration number
ACTRN12607000266460
Ethics application status
Approved
Date submitted
13/05/2007
Date registered
18/05/2007
Date last updated
18/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A General Practitioner intervention on frequent attenders
Scientific title
The "7H+T" intervention: An analysis of patient data to reduce the number of consultations with General Practitioners (GP), for patients who attend frequently
Universal Trial Number (UTN)
Trial acronym
7H+T
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frequent attendance in Primary Health Care 1806 0
Condition category
Condition code
Public Health 1894 1894 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hypothesis generation: analysis of available information.

The General Practitioners (GPs) analyse all the available information from clinical charts using a standardised questionnaire designed to facilitate analysis of this information.

1) The GPs count different types of patient visits in mutually exclusive categories and make a flow diagram of the relationships between the number of visits and time (months).
2) The GPs study the individual and family clinical history, as well as bio-psycho-social problems from the problems list.
3) Under the heading “In most interviews with this patient I feel …” the questionnaire provides a list of 12 emotions and feelings that the GPs are asked to rate on a 5-point Lickert scale. In the following section, headed “In most interviews with this patient I think …” the GPs are asked to indicate which of the different options apply (yes/no) from a list of 10 thoughts.
4) Other information obtained includes how the visits finished, giving prescriptions, ordering complementary tests, referring to consultants and/or whether another appointment was made by the GP.
5) The GPs are also asked to indicate their perceived capacity to solve the patient’s problems.
6) Other information gathered concerns whether the patient was referred during the preceding year for nursing care, social assistance, mental health care or any community resource.
7) The GPs then try to find common factors from the above six points.
8) Finally, the GPs indicate the type of hypothesis that they believe made the patient a frequent attender: biological, psychological, social, familial, cultural, administrative or related with the doctor-patient relationship.

Hypothesis confirmation

When necessary and in order to dispel uncertainty, the GPs can try out the hypothesis through three different strategies: another interview with the patient, biological and psychosocial tests, and/or asking for the opinion of other professionals.

Planning

The GPs make plans for each frequent attender on the basis of the confirmed hypothesis and available resources. The plans can be proposed previously by a specific GP or generated by any member of the GP team at the meetings. After obtaining consensus about the plan, the relevant GP negotiates it with the frequent attender, who may disagree with the proposals. The GP team contributes to modulate the GP’s expectations about the proposed interventions.

Intervention on professional and doctor-patient relationship

These processes of analysis enable the GPs to be aware of their emotions, thoughts and reactions when interviewing frequent attenders. Such introspection and awareness prepares them to accept that a good relationship with each patient is perhaps not a realistic goal, particularly with some frequent attenders. The reduction in emotional uncertainty also contributes to improving a dysfunctional relationship with the frequent attender. In addition, it gives them the chance to change their emotions, thoughts, attitudes and reactions. Moreover, the GP team gives emotional support to each GP and generates strategies to deal with frequent attenders from a more neutral perspective.

“T” (Team) ingredient

The three intervention GPs who received training form the “T” (Team) ingredient. They hold meetings to share analyses and reflections on their frequent attenders and make plans for each FA. Normally, the proposed plan is drawn up by each GP and explained to the Team using the GP’s personal structured analysis of his or her frequent attender candidates. The other members of the GP Team help, with comments about the data analysis of the frequent attender and sometimes suggesting different plans. The decision on a definitive plan is often taken by consensus. The time spent sharing each reflection about a FA ranges from 5 to 35 minutes. The mean is 20-25 minutes for most cases.
The GP Intervention Group undertake an interactive work-shop training session (15 hours) on the intervention "7 Hypothesis + Team" (“7H+T”).


The GPs randomly assigned to GP intervention group offer to their frequent attenders randomly selected the new intervention, and these give theirs consents. Therefore both GPs and frequent attenders are not blind. The GPs allocated to GP Control Group are not informed of the identity of the frequent attenders randomly selected to the Patient Control Group, and these FA neither are informed that they belong to the Patient Control Group, because of this the GP Control Group and the Patient Control Group are blind.
From the list of frequent attenders belonging to the GP Intervention Group, we randomly select a new group of FAs who receive usual care (Patient Control Group 2), these frequent attenders are not informed of that and their GPs neither are informed of the identity of this second Patient Control Group. Therefore, there is a crossover design for GPs (the GP group do, in the same time, as GP intervention and GP control), whereby the three groups of frequent attenders (Intervention Group, Control Group 1, and Control Group 2) are in a parallel design. No frequent attender is informed on our primary outcome (number of visits post-intervention).

The overall duration of the study is for one year.
Intervention code [1] 1756 0
Treatment: Other
Comparator / control treatment
Usual care is delivered in control group and it is just a normal consultation.
Control group
Active

Outcomes
Primary outcome [1] 2693 0
The primary outcome measure is the total number of consultations during the 12 months post-intervention
Timepoint [1] 2693 0
Measured at the beginning (time 0) and monthly until 12 month post-intervention.
Secondary outcome [1] 4557 0
Self reported health, as well as a set of psychosocial variables: anxiety, Stat-Trait Anxiety Inventory (STAI); depression, Beck Depression Inventory (BDI); hypochondria,Witheley Index and General Hypochondria (WI and GH); family dysfunction, The family Adaptability, Partnership, Growth, Affection, and Resolve (APGAR) index and the Family Environtment Scale (APGAR index and FES); and social support, the Duke Funcional Social Support Questionnaire (DUKE-UNC-11).
Timepoint [1] 4557 0
All measured at baseline, and at the end of follow-up (12 months).

Eligibility
Key inclusion criteria
Frequent attenders who had an annual rate of consultation at least twice as high as the Health Centre sex- and age-related mean.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive problems, living out of the district, and difficulty to understand Spanish.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The GPs are assigned to a number and randomly allocated to GP Control or GP Intervention Group by computer. The Frequent Attenders (FAs) belonging to each GP (they are in their patient lists) are all included with a code (number of clinical record) in the computer, and they are also randomly selected by computer in the same group (intervention or control) of their GPs
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This selection is done by computer-generated randomisation performed by a person independent of the research team and the GPs involved
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
'The GPs allocated to GP Control Group are not informed of the identity of the FAs randomly selected to the Patient Control Group, and these FA neither are informed that they belong to the Patient Control Group, because of this the GP Control Group (clinician) and the Patient Control Group (subjects) are blind'.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/06/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2040 0
Hospital
Name [1] 2040 0
Socieda Española de Medicina Familiar y Comunitaria
Country [1] 2040 0
Spain
Primary sponsor type
Individual
Name
Juan Angel Bellon
Address
Country
Secondary sponsor category [1] 1848 0
None
Name [1] 1848 0
none
Address [1] 1848 0
Country [1] 1848 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3776 0
San Agustin Hospital Ethical Committee
Ethics committee address [1] 3776 0
Linares
Ethics committee country [1] 3776 0
Spain
Date submitted for ethics approval [1] 3776 0
Approval date [1] 3776 0
Ethics approval number [1] 3776 0
Ethics committee name [2] 3777 0
Ethics Committee of the Complejo Hospitalario de Jaen
Ethics committee address [2] 3777 0
Ethics committee country [2] 3777 0
Spain
Date submitted for ethics approval [2] 3777 0
Approval date [2] 3777 0
Ethics approval number [2] 3777 0

Summary
Brief summary
We aimed to assess the effectiveness of a new GP intervention on FAs, decreasing their consultations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27859 0
Address 27859 0
Country 27859 0
Phone 27859 0
Fax 27859 0
Email 27859 0
Contact person for public queries
Name 10945 0
Juan Angel Bellon
Address 10945 0
Unidad de Investigación
Distrito Sanitario Málaga
C/ Sevilla
nº 23
3ª planta
29009 Malaga
Country 10945 0
Spain
Phone 10945 0
+34 951 031417
Fax 10945 0
+34 951 031305
Email 10945 0
[email protected]
Contact person for scientific queries
Name 1873 0
Juan Angel Bellon
Address 1873 0
Unidad de Investigación
Distrito Sanitario Málaga
C/ Sevilla
nº 23
3ª planta
29009 Malaga
Country 1873 0
Spain
Phone 1873 0
+34 951 031417
Fax 1873 0
+34 951 031305
Email 1873 0
[email protected]

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