Effectiveness of the 7H Intervention to Reduce Frequent Attendance in Primary Care

Study Overview
=================
Brief Summary
-----------------
The main objective is to measure the effectiveness of a new intervention to decrease use of services of primary care frequent attenders (FA).Among the secondary objectives are to evaluate the cost-effectiveness and cost utility of the new intervention compared with usual care. METHODS: There will be a randomized controlled trial with cluster assignment. It will take place in the field of primary care in the city of Malaga.It will be evaluated a new multicomponent intervention called 7H (7 Hypothesis). This intervention will be applied on the FA by their family doctors in the intervention group. In the control group will be developed usual cares. The main outcome is the total of visits of FA at 12 months of the follow-up. The secondary outcomes include changes happened in biopsychosocial health, satisfaction, and quality of life measurements. The investigators will assess the dependent and independents (from FA, general practitioner [GP] and health centres) variables at baseline, and 12 months. At baseline it will be include a random sample of 450 FA (225 for each arm), belonging to 30 family doctors of 10 health centres. It will be performed linear regression multilevel models with 4 levels (time, patient, doctor and health centre) to evaluate the effectiveness of the intervention. . Moreover will be undertaken multivariate gamma and quantile regressions to assess the cost-effectiveness and cost-utility respectively of the new intervention versus usual cares, estimating their standard errors by bootstrap calculations.

Detailed Description
-----------------
The 7H intervention Hypothesis generation: analysis of available informationGPs analyze all the available information about possible reasons for frequent attendance from clinical charts using a standardized questionnaire designed to facilitate analysis of this information. This questionnaire prompts analysis of the following: (1) category of visits and their frequencies; (2) type of frequent attender according to the first point; (3) family and personal history, and biopsychosocial problem list that needed follow-up; (4) searching for common factors for frequent attendance from the previous points; (5) feelings and thoughts questionnaires, 'In most interviews with this patient I think ...' (11 items), 'I feel ...' (13 items); (6) rethinking issues of GP capacity (and processes) to resolve the frequent attendance in this patient; and (7) analyzing the different professionals who intervened in patient care and their contribution to resolving or continuing frequent attendance.Finally, GPs indicate the type of hypothesis from a list of seven that they believe made the patient a frequent attender: biological, psychological, social, family, cultural, administrative-organizational, or related to the doctor-patient relationship. Hypothesis confirmation: the decision to accept or refute each hypothesis is based on the GP's interpretation of the data (cognitive component) and the self-perception about feeling sure (emotional component). When necessary, the GPs can try out the hypothesis with one or more of the following strategies: another interview with the patient,biological and psychosocial tests, and/or asking for the opinion of other professionals. Planning: the GP makes plans for each frequent attender based on the confirmed hypothesis and available resources. There are many possible plans, examples of which include: making longer intervals between medical revisits for stable chronic patients, and asking for collaboration with nurses; looking for possible causes of the unstable physical chronic illness and intervening accordingly; scheduling an interview to search for a psychological, family or/and, social diagnosis; suppressing unnecessary face-to-face medical revisits for repeat prescriptions in stable chronic patients, and asking the health centre administrative staff for collaboration; asking the social worker at the health centre for help; referring to community resources if necessary; and being more realistic about the type of doctor-patient relationship expected. These plans are then commented on at the group meeting, after which the GP negotiates the plan with the frequent attender. The GP should never suggest to the patient: 'You have to attend less frequently'. This would be too aggressive and the patient might react with anger or guilt. It is better to offer a search for solutions to the patient's health problem from both points of view.

Official Title
-----------------
Effectiveness of the 7H Intervention to Reduce Frequent Attendance in Primary Care: Cluster Randomised Controlled Trial. The 7H Study

Conditions
-----------------
Frequent Attenders

Intervention / Treatment
-----------------
* Behavioral: New multicomponent 7H intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Frequent Attenders: 90th percentile of number of visits of the previous year, stratified by age and sex. Exclusion Criteria: < 14 years. Unable to understand or speak Spanish. Cognitive impairment. Terminal illness. Planning to be outside of the the city 3 or more months during the next 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New multicomponent intervention<br> | Behavioral: New multicomponent 7H intervention<br>* The GPs in the intervention group will undertake an interactive workshop training session (15 hours) on the '7 hypotheses' (7H) intervention. In short, this intervention encourages GPs to select from a list of seven possible hypotheses for why the patient is a frequent attender: biological, psychological, social, family, cultural, administrative-organisational, or related to the doctor-patient relationship.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the intervention 7H |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness and cost-utility | To evaluate the cost-effectiveness and cost-utility of the intervention 7H versus usual care. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health Service Misuse, Overutilization of Health Services, Primary Health Care, Cost Effectiveness, Quality of life, Randomised Controlled Trial, Multilevel analysis