Effectiveness of the "7H" Intervention to Reduce Frequent Attendance in Primary Care
| Tracking Information | |
|---|---|
| First Received Date ICMJE | June 28, 2010 |
| Last Updated Date | February 21, 2013 |
| Start Date ICMJE | January 2010 |
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Effectiveness of the intervention "7H" [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE |
Effectiveness of the intervention "7H + T" [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
| Change History | Complete list of historical versions of study NCT01151969 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Cost-effectiveness and cost-utility [ Time Frame: 12 months ] [ Designated as safety issue: No ] To evaluate the cost-effectiveness and cost-utility of the intervention "7H" versus usual care. |
| Original Secondary Outcome Measures ICMJE |
Cost-effectiveness and cost-utility [ Time Frame: 12 months ] [ Designated as safety issue: No ] To evaluate the cost-effectiveness and cost-utility of the intervention "7H+T" versus usual care. |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Effectiveness of the "7H" Intervention to Reduce Frequent Attendance in Primary Care |
| Official Title ICMJE | Effectiveness of the "7H" Intervention to Reduce Frequent Attendance in Primary Care: Cluster Randomised Controlled Trial. The "7H" Study |
| 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
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| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Health Services Research |
| Condition ICMJE | Frequent Attenders |
| Intervention ICMJE | 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. |
| Study Arm (s) |
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| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Estimated Enrollment ICMJE | 510 |
| Estimated Completion Date | June 2013 |
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 14 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Spain |
| Administrative Information | |
| NCT Number ICMJE | NCT01151969 |
| Other Study ID Numbers ICMJE | PI-0505 |
| Has Data Monitoring Committee | No |
| Responsible Party | Juan Ángel Bellón Saameño, The Mediterranean Institute for the Advance of Biotechnology and Health Research |
| Study Sponsor ICMJE | The Mediterranean Institute for the Advance of Biotechnology and Health Research |
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided |
| Information Provided By | The Mediterranean Institute for the Advance of Biotechnology and Health Research |
| Verification Date | February 2013 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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