We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01151969
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : March 27, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Frequent Attenders Behavioral: New multicomponent "7H" intervention

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 527 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Effectiveness of the "7H" Intervention to Reduce Frequent Attendance in Primary Care: Cluster Randomised Controlled Trial. The "7H" Study
Study Start Date : January 2010
Primary Completion Date : February 2013
Study Completion Date : June 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: New multicomponent 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.
No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures :
  1. Effectiveness of the intervention "7H" [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Cost-effectiveness and cost-utility [ Time Frame: 12 months ]
    To evaluate the cost-effectiveness and cost-utility of the intervention "7H" versus usual care.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151969

Servicio Andaluz de Salud. Distrito Sanitario Málaga
Málaga, Spain, 29009
Sponsors and Collaborators
The Mediterranean Institute for the Advance of Biotechnology and Health Research
Preventive Services and Health Promotion Research Network
Carlos III Health Institute
More Information

Responsible Party: Juan Ángel Bellón Saameño, PhD Medicine, The Mediterranean Institute for the Advance of Biotechnology and Health Research
ClinicalTrials.gov Identifier: NCT01151969     History of Changes
Other Study ID Numbers: PI-0505
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by Juan Ángel Bellón Saameño, The Mediterranean Institute for the Advance of Biotechnology and Health Research:
Health Service Misuse
Overutilization of Health Services
Primary Health Care
Cost Effectiveness
Quality of life
Randomised Controlled Trial
Multilevel analysis