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

Frequent Attenders Clinical Trial

— "7H"  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151969
• Other study ID #: PI-0505
• Status: Completed
• Phase: N/A
• First received: June 28, 2010
• Last updated: March 26, 2015
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: March 2015
• Source: The Mediterranean Institute for the Advance of Biotechnology and Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Description:

The "7H" intervention

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Frequent Attenders

Intervention

Behavioral:
• New multicomponent "7H" intervention
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.

Locations

Country	Name	City	State
Spain	Servicio Andaluz de Salud. Distrito Sanitario Málaga	Málaga

Sponsors (3)

Lead Sponsor	Collaborator
The Mediterranean Institute for the Advance of Biotechnology and Health Research	Carlos III Health Institute, Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the intervention "7H"		12 months	No
Secondary	Cost-effectiveness and cost-utility	To evaluate the cost-effectiveness and cost-utility of the intervention "7H" versus usual care.	12 months	No