Clinical Decision-Support Systems, Comorbidities and Coexisting Conditions, Multimorbidity, Polypharmacy
Conditions
Keywords
Primary Health Care, Medication Adherence, Disability, Patient-Centered Care, Ariadne Principles
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.
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.
Interventions
OTHERMultiPAP 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.
OTHERUsual care
Patients will receive the usual clinical care based on current clinical practice guidelines.
Sponsors
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
Instituto Aragones de Ciencias de la Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalizations and/or mortality | From Baseline to Month 18 | Difference in percentages in the final combined variable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Hospitalizations and/or mortality (T2) | From Baseline to Month 12 | Difference in percentages in the final combined variable |
| 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 |
| 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. |
Countries
Spain
Outcome results
None listed