MultiPAP Plus: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy
Study Details
Study Description
Brief Summary
This study assesses the effectiveness of a complex intervention in young-old patients with multimorbidity and polypharmacy aimed at improving physician drug prescription in primary care, measured by hospitalization-mortality at six 6 (T1), 12 (T2) and 18 (T3) months from baseline compared to usual care.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Design: Pragmatic cluster randomized clinical trial with 18 months follow-up.
Unit of randomization: general practitioner.
Unit of analysis: patient.
Setting: Primary Health Care Centres in three different Spanish Autonomous Communities (Aragón, Madrid and Andalucía).
Population: Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and polypharmacy (5 or more drugs taken for at least three months). N=1234 patients (617 in each arm, 8 patients per physician) will be recruited by general practitioners before randomization.
Intervention: Complex intervention incorporating previous MultiPAP intervention (based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient-centered clinical interview) And it adds a clinical-decision support system to help structured treatment-plan review.
Control group: usual care.
Variables: First level (Patient): a) Main: hospitalizations and/or mortality; b) Secondary:
health services use, quality of life (Euroqol 5D-5L), disability (WHODAS), fractures, pharmacotherapy and adherence to treatment (Morisky-Green), clinical and socio-demographic. Second level (Physician): a) Socio-demographic. b) CDSS use: acceptance and satisfaction of health care provider use c) Professional background: time in the position, center characteristics and medical education involvement.
Analysis: All analyses will be carried out adhering to the intention-to-treat principle. Description of baseline characteristics. Basal comparison between groups. Analysis of primary outcome: difference in percentages in the final combined variable from 0 (T0) to 18 months (T3), with its corresponding 95% CI. Adjustement by main confounding and prognostic factors will be performed through a multilevel analysis.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MultiPAP Plus intervention Complex intervention with general practitioners and patients |
Other: MultiPAP Plus
Complex intervention incorporating previous MultiPAP intervention (based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient-centered clinical interview) And it adds a clinical-decision support system to help structured treatment-plan review.
Other: Usual care
Patients will receive the usual clinical care based on current clinical practice guidelines.
|
| Active Comparator: Usual care Patients will recieve the usual clinical care |
Other: Usual care
Patients will receive the usual clinical care based on current clinical practice guidelines.
|
Outcome Measures
Primary Outcome Measures
- Hospitalizations and/or mortality [From Baseline to Month 18]
Difference in percentages in the final combined variable
Secondary Outcome Measures
- Hospitalizations and/or mortality (T2) [From Baseline to Month 12]
Difference in percentages in the final combined variable
- Therapeutic adherence questionnaire [Baseline, 6, 12 and 18 months]
Morisky-Green questionnaire. Dicotomous variable. Any wrong answer to any of the four questions would mean worse adherence
- Medication Safety: Potentially Drug-Drug interactions (DDI), Potentially Innappropiate Medication (PIM), Adverse Drug Reactions [Baseline, 6, 12 and 18 months]
Number of Potentially Drug-Drug interactions (DDI) per patient, Number of Potentially Innappropiate Medication (PIM) per patient, Number of Adverse Drug Reactions per patient
- Use of health services [at 12 and at 18 months]
Number of Unscheduled and/or avoidable hospitalizations, number of visits to emergency services and primary care (Family Physician and nurse).
- Disability [Baseline, 12 and 18 months]
World Health Organization Disabilty Assessment (WHODAS). 12-items abbreviated scale (0=No Difficulty, 1=Mild Difficulty, 2=Moderate Difficulty, 3=Severe Difficulty, and 4=Extreme Difficulty or Cannot Do). Maximum 48 points.
- Perceived Quality of Life: Euroqol 5D-5L questionnaire [Baseline, 12 and 18 months]
EQ5D is one of the most widely used health states descriptive system and has a valuation in Spain. EQ-5D questionnaires have 5 dimensions: "Mobility", "Human Autonomy," "Current Activities", "Pain / Discomfort", "Anxiety / Depression" and all dimensions are described by 5 problem levels corresponding to patient response choices. A quality of life score is obtained according to the answers to the questionnaires.
- System Usability Scale of the CDSS [at 6 and 18 months.]
It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and polypharmacy (5 or more drugs taken for at least three months).
-
Informed consent.
Exclusion Criteria:
-
Institutionalized patient at nursing homes or similar
-
Life expectancy < 12 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Servicio Andaluz de Salud | Málaga | Andalucía | Spain | |
| 2 | Instituto Aragonés de Ciencias de la Salud (IACS) | Zaragoza | Aragón | Spain | |
| 3 | Gerencia Asistencial de Atención Primaria de Madrid | Madrid | Spain |
Sponsors and Collaborators
- Instituto Aragones de Ciencias de la Salud
- Gerencia de Atención Primaria, Madrid
- Aragon Institute for Health Research (IIS Aragón)
- Andaluz Health Service
- Fundación de Investigación e Innovación Biomédica Atención Primaria (FIIBAP)
- Red de Investigación en Servicios de Salud en Enfermedades Crónicas
- Instituto de Salud Carlos III
Investigators
- Principal Investigator: Alexandra Prados-Torres, MD,PhD, Instituto Aragonés de Ciencias de la Salud (IACS)
- Principal Investigator: Daniel Prados-Torres, MD, PhD, Servicio Andaluz de Salud (Andaluz Health Service)
- Principal Investigator: Isabel Del Cura-González, MD,PhD, Gerencia Asistencial de Atención Primaria, Madrid
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PI 18/01303,18/01515,18/01812