MultiPAP Plus: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efectiveness of the MultiPAP Plus Intervention in Young-old Patients With Multimorbidity and Polypharmacy Aimed at Improving Prescription in Primary Care: Cluster RCT

Conditions
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Multimorbidity, Polypharmacy, Comorbidities and Coexisting Conditions, Clinical Decision-Support Systems

Intervention / Treatment
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* Other: MultiPAP Plus
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MultiPAP Plus intervention<br>Complex intervention with general practitioners and patients | Other: MultiPAP Plus<br>* 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.<br>Other: Usual care<br>* Patients will receive the usual clinical care based on current clinical practice guidelines.<br>|
| Active Comparator: Usual care<br>Patients will recieve the usual clinical care | Other: Usual care<br>* Patients will receive the usual clinical care based on current clinical practice guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations and/or mortality | Difference in percentages in the final combined variable | From Baseline to Month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations and/or mortality (T2) | Difference in percentages in the final combined variable | From Baseline to Month 12 | 
| Therapeutic adherence questionnaire | Morisky-Green questionnaire. Dicotomous variable. Any wrong answer to any of the four questions would mean worse adherence | Baseline, 6, 12 and 18 months | 
| Medication Safety: Potentially Drug-Drug interactions (DDI), Potentially Innappropiate Medication (PIM), Adverse Drug Reactions | Number of Potentially Drug-Drug interactions (DDI) per patient, Number of Potentially Innappropiate Medication (PIM) per patient, Number of Adverse Drug Reactions per patient | Baseline, 6, 12 and 18 months | 
| Use of health services | Number of Unscheduled and/or avoidable hospitalizations, number of visits to emergency services and primary care (Family Physician and nurse). | at 12 and at 18 months | 
| Disability | 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. | Baseline, 12 and 18 months | 
| Perceived Quality of Life: Euroqol 5D-5L questionnaire | 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. | Baseline, 12 and 18 months | 
| System Usability Scale of the CDSS | It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree | at 6 and 18 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disability, Primary Health Care, Medication Adherence, Patient-Centered Care, Ariadne Principles