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

NCT01151969 | Completed

• 1 other identifier: PI-0505
• Study Type: interventional
• Target: 527
• Locations: 1 country
• Sites: 1

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.

Conditions

Frequent Attenders

Keywords

Health Service Misuse; Overutilization of Health Services; Primary Health Care; Cost Effectiveness; Quality of life; Randomised Controlled Trial; Multilevel analysis

Outcome Measures

Primary Outcomes (1)

• Effectiveness of the intervention "7H"

  12 months

Secondary Outcomes (1)

• Cost-effectiveness and cost-utility

  12 months

Study Arms (2)

New multicomponent intervention

EXPERIMENTAL

Behavioral: New multicomponent "7H" intervention

Usual Care

NO INTERVENTION

Interventions

New multicomponent "7H" intervention BEHAVIORAL

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.

New multicomponent intervention

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Frequent Attenders: 90th percentile of number of visits of the previous year, stratified by age and sex.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• The Mediterranean Institute for the Advance of Biotechnology and Health Research: lead
• Preventive Services and Health Promotion Research Network: collaborator
• Carlos III Health Institute: collaborator

Study Sites (1)

Servicio Andaluz de Salud. Distrito Sanitario Málaga

Málaga, Málaga, 29009, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Medicine

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 29, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 27, 2015

Record last verified: 2015-03

Locations

ES (1)