Cooperation for Better Treatment of Polypharmacy in the Community

NCT06020391 | Completed

• 1 other identifier: 2022066
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

The elderly population today relies heavily on medication consumption. While there are cases where using multiple medications is necessary and reasonable, it also increases the risk of inappropriate treatment and adverse drug effects. This randomized, controlled trial aims to examine the effectiveness of incorporating drug reviews as an integral part of clinical practice for older patients admitted to a Municipal in-patient acute care (MipAC) unit in Oslo, Norway. The intervention involves a clinical drug review conducted by a MipAC physician under the guidance of a geriatrician, followed by a telephone consultation between the MipAC physician and the patient's family physician (FP). The primary outcome measure is health-related quality of life, while secondary outcome measures include physical and cognitive function, dry mouth, hospital admissions, and survival. The environmental impact of the study intervention will also be assessed and compared to usual care.

Conditions

Drug Usage

Keywords

Polypharmacy; Geriatrics; Drug review; Medication review; Elderly

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life (HRQoL)

  HRQoL assessed with the 15-dimensional instrument 15D. 15D is a generic, 15-dimensional instrument concerning different aspects of HRQoL. The dimensions are mobility, vision, hearing, breathing, sleeping, eating, speech, elimination, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. Each dimension is rated on an ordinal scale with five levels, and the respondent chooses the level best describing his/her present health status. Single index scores are calculated by population-based utility weights, and range from 0 to 1, with higher scores indicating better HRQoL.

  16 weeks

Secondary Outcomes (11)

• Handgrip strength

  16 weeks

• Digit span forward

  16 weeks

• Digit span backwards

  16 weeks

• Unstimulated whole saliva flow

  16 weeks

• The Shortened Xerostomia Inventory (SXI)

  16 weeks

Other Outcomes (1)

• Environmental impact measures

  16 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Collaborative drug review.

Other: Collaborative drug review

Control group

NO INTERVENTION

Usual care.

Interventions

Collaborative drug review OTHER

1. Structured, clinical drug review including medical history, physical examination, and supplementary tests. The work-up will be aimed at evaluating whether current medications are indicated, whether the patient's medical conditions are satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse drug effects, and whether drug-drug or drug-disease interactions are present or likely to occur. The MipAC physicians will receive clinical supervision from a consultant in geriatric medicine. 2. The MipAC physician will offer the patient's FP a telephone meeting with the purpose of combining the assessments of the MipAC physician and the competence of the FP in a common drug review. The two physicians will review the patient's drug list systematically and discuss if any adjustments should be done, as well as the patient's need for further follow-up.

Intervention group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 70+
• Admitted to the MipAC unit
• Use of at least six different systemic medications taken regularly
• Informed consent by the patient

You may not qualify if:

• Previously included in the study
• Not speaking or understanding Norwegian
• Residing outside of the municipality of Oslo
• Planned discharge within 24 hours
• Isolated for infection control reasons
• Considered too ill to approach or life expectancy judged to be less than six months

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• South-Eastern Norway Regional Health Authority: collaborator
• City of Oslo: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• Santervas LR, Wyller TB, Skovlund E, Jensen JL, Fjeld KG, Hove LH, Ringstad IB, Nordberg LB, Mellingen KM, Kristoffersen ES, Romskaug R. Cooperation across healthcare service levels for medication reviews in older people with polypharmacy admitted to a municipal in-patient acute care unit (The COOP II Study): study protocol for a randomized controlled trial. Trials. 2024 Sep 13;25(1):612. doi: 10.1186/s13063-024-08442-w.

  PMID: 39272164 DERIVED

Study Officials

• Rita Romskaug, MD, PhD

  Dept. of Geriatric Medicine, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 31, 2023
• Study Start: September 6, 2023
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 9 months and ending 3 years following publication of the main results of the study.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. As for now, we plan to upload data to Sikt (www.sikt.no) or a similar service for depositing and sharing data.

Locations

NO (1)