The Effect of OPCSP on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases

NCT ID: NCT03024307

Last Updated: 2021-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-18

Study Completion Date

2020-12-31

Brief Summary

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This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.The purpose of this study is to evaluate:

1. rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
2. total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.

Detailed Description

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This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.Three types of rheumatic diseases were included in the study, Systemic lupus erythematosus (SLE), Ankylosing spondylitis (AS), and Rheumatoid Arthritis(RA). The purpose of this study is to evaluate:

1. rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
2. total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.

Conditions

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Rheumatic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Involvement of pharmacists in improving medication

Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up

Group Type EXPERIMENTAL

pharmacists involved OPCSP

Intervention Type OTHER

This was an open labelled randomised study. Rheumatic diseases patients were recruited and arbitrarily divided into the intervention group (usual care plus OPCSP) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups.

usual care only

Patients were provided with usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pharmacists involved OPCSP

This was an open labelled randomised study. Rheumatic diseases patients were recruited and arbitrarily divided into the intervention group (usual care plus OPCSP) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Willingness of the subject to participate in the study, proven by signing the informed consent;
* Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;
* Patients fulfilled the American College of Rheumatology criteria for RA and AS;

Exclusion Criteria

* Patients who are unwilling to sign the inform consent;
* Pregnancy or lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ting Li

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuang Ye, MD

Role: STUDY_CHAIR

RenJi Hospital

Locations

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South Campus, Ren Ji Hospital

Shanghai, , China

Site Status

Countries

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China

References

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Zhang L, Luan W, Geng S, Ye S, Wang X, Qian L, Ding Y, Li T, Jiang A. Lack of patient education is risk factor of disease flare in patients with systemic lupus erythematosus in China. BMC Health Serv Res. 2019 Jun 13;19(1):378. doi: 10.1186/s12913-019-4206-y.

Reference Type DERIVED
PMID: 31196083 (View on PubMed)

Other Identifiers

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OPCSP2016

Identifier Type: -

Identifier Source: org_study_id

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