What is the clinical evidence from this study?

Study design: RCT. Population: Patients on warfarin therapy (n=131). Intervention: Pharmacists' interventions vs. Standard care. Primary outcome: Duke anticoagulation satisfactions scale (Cro-DASS) overall score (p=<0.001).

November 9, 2021Open Access

Pharmacists’ interventions improve health-related quality of life of rural older person on warfarin: a randomized controlled trial

Q: What are the key findings of this study?

Community pharmacist interventions significantly improved health-related quality of life in older rural patients on warfarin, reducing the median Cro-DASS score to 66.0 compared to 86.5 in the control group.

Key Result

Community pharmacist interventions significantly improved health-related quality of life in older rural patients on warfarin, reducing the median Cro-DASS score to 66.0 compared to 86.5 in the control group.

Study Design

Type

RCT (n=131)

Blinding

Single-blind

Randomization

Computer-generated randomization program

Multicenter

Structured PICO

Does a community pharmacist's intervention improve health-related quality of life in older rural patients on warfarin therapy?

Population

131 older adults (median age 73, 48.9% female) living in a rural area and taking warfarin for at least three months, followed for six months.

Intervention

Pharmacist's intervention including medication review, identification of drug-related problems, 45-minute one-to-one education, follow-up plan, pillbox if needed, and monthly 20-minute follow-up visits with therapy optimization recommendations to general practitioners over 6 months.

Comparator

Standard care consisting of regular visits to the general practitioner and community pharmacy to obtain prescribed medicines, with no regular consultation or collaboration between the GP and community pharmacist over 6 months.

Outcome

Health-related quality of life (HRQoL) measured by the Croatian-adapted Duke anticoagulation satisfaction scale (Cro-DASS) questionnaire score at 6 months.patient reported

A multi-component community pharmacist intervention significantly improves health-related quality of life in older, rural patients taking warfarin.

Main Result

Absolute Event Rate: 66% vs 86.5%

p-value: p=<0.001

Limitations

The HRQoL instrument was not applied before and after the pharmacists' intervention, preventing observation of the magnitude or direction of change.
Power analysis was not performed for the HRQoL outcome as it was a secondary outcome.
Patients potentially may have been unblinded during the process, which could have caused bias.
The intervention was multi-component, making it impossible to determine which specific action had the most significant impact.
Results are applicable to a specific population of elderly rural patients.

Abstract

Abstract Warfarin therapy can significantly affect patients’ quality of life and cause therapy discontinuation. This study aimed to investigate the effect of the pharmacists’ interventions on the health-related quality of life (HRQoL) in older rural patients on warfarin therapy. Eligible older patients from rural area of Croatian province Slavonia were randomized into the intervention and control groups and followed for six months. Repeated education and a follow-up plan were provided to the participants in the intervention group, and if needed, the pharmacist intervened to optimize warfarin therapy. Secondary analysis on HRQoL data are presented here. Main outcome measure was Duke anticoagulation satisfactions scale questionnaire score. In total, 131 participants finished the study (median age 73 years; 51.1% male). Participants in the intervention group scored significantly lower (median being 86.5 and 66.0 in the control and intervention groups, respectively; p < 0,001), indicating higher HRQoL. Adverse drug reactions and pharmacist’s intervention were identified as predictive factors for patients’ HRQoL (r 2 = 65.5%, P < 0.001). The study demonstrated that community pharmacist’s interventions can improve HRQoL of older patients taking warfarin what is of particular significance for patients living in rural areas with less accessible healthcare and lower socio-economic status. Clinicaltrials.gov (ID: NCT03212898), 11/07/2017, retrospectively registered.

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