Clinical trial NCT01482481: Effectiveness of Nursing Care Plans Based in Nursing Diagnoses in Metabolic Control of Type 2 Diabetes Mellitus
Official title: Effectiveness of Implementing Nursing Care Plans Based on Scientific Methodology in Improving Metabolic and Blood Pressure Control of Type 2 Diabetes Mellitus Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Cardiovascular Risk Factors
Keywords: Patient Care Planning
Type 2 Diabetes Mellitus
Cardiovascular Risk Factors
Primary Health Care
Spain
Lead sponsor: Hospital Carlos III, Madrid
Sponsor class: OTHER
Collaborators: name: Gerencia de Atención Primaria, Madrid
First posted: 2011-11-30
Enrollment: 23488
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 23,488 DM2 patients (full universe).

Brief summary: Background: Nurses in clinical practice implement care to patients with Type 2 diabetes mellitus (DM2) in order to maintain normal blood glucose readings, promote weight loss and provide nutrition counseling to improve metabolic and blood pressure control. Because many disciplines contribute to patient's health outcomes, it is important to distinguish how nurses contribute to patient care and the achievement of health outcomes and the differences between the use or not the classification of Nursing Diagnoses, and the Nursing Interventions Classification (NIC) in clinical practice settings.

Methods: Prospective observational study with 2-year follow-up to assess the effect of Nursing Care Plans based on Scientific Methodology (NCPSM) on changing the control parameters in routine clinical practice conditions.

Settings: 31 Primary care centers in northeastern urban area of Madrid (Spain). Subjects: 24,124 DM2 patients (full universe).

Detailed description: The computerized clinical record system (CCR) form for primary care of the Madrid Health Service was used as the data source. NCPSM was identified by clinical records of NANDA and NIC nursing taxonomies, and were defined as nursing care based on the following three criteria:

Criterion 1.- A patient's CCR must register valuation data based on Marjory Gordon "functional pattern" in at least the following areas:

* Health perception
* Nutritional-metabolic
* Activity-exercise. Criterion 2.- The problems identified and the proper management of treatment will be described using coded diagnoses with NANDA.

Criterion 3.- The nursing interventions carried out by standardized language will be registered according to the NIC taxonomy.

Eligibility criteria for patients were: older than 30 years of age, with previously diagnosed diabetes (cardinal clinical, plus random blood glucose \>200 mg/dl or oral glucose of \>200 mg/dl at 2 h, twice, or plasma fasting glucose of \>126 mg/dl on two occasions or being diagnosed previously, received specific treatment for diabetes) and exclusion criteria were: gestational diabetes, patients involved in clinical trials, patients with life expectancy of less than one year (according to clinical judgment), homebound patients.

The primary outcome was HbA1c, lipid levels, blood pressure, and BMI after 24 and 48 months of follow-up.

Eligibility criteria: Inclusion Criteria:

* older than 30 years of age,
* with previously diagnosed diabetes (cardinal clinical, plus random blood glucose \> 200 mg/dl or oral glucose of \>200 mg/dl at 2 h, twice, or plasma fasting glucose of \>126 mg/dl on two occasions or being diagnosed previously, received specific treatment for diabetes)

Exclusion Criteria:

* gestational diabetes,
* patients involved in clinical trials,
* patients with life expectancy of less than one year (according to clinical judgment),
* homebound patients

Primary outcomes:
measure: HbA1c level
timeFrame: Final (before 4 years follow-up)
Secondary outcomes:
measure: Blood Pressure
timeFrame: Final (before 4 years follow-up)
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: Final (before 4 years of follow-up)
measure: Body Mass Index (BMI)
timeFrame: Final (before 4 years of follow-up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gerencia Atención Primaria
Study officials:
affiliation: Atención Primaria Madrid
name: JUAN CARDENAS
role: STUDY_DIRECTOR
References:
citation: Cardenas-Valladolid J, Salinero-Fort MA, Gomez-Campelo P, de Burgos-Lunar C, Abanades-Herranz JC, Arnal-Selfa R, Andres AL. Effectiveness of standardized Nursing Care Plans in health outcomes in patients with type 2 Diabetes Mellitus: a two-year prospective follow-up study. PLoS One. 2012;7(8):e43870. doi: 10.1371/journal.pone.0043870. Epub 2012 Aug 27.