Dataset Information

Patient-controlled outpatient follow-up on demand for patients with rheumatoid arthritis: a 2-year randomized controlled trial.

ABSTRACT:

Introduction

Scheduled routine visits in patients with rheumatoid arthritis (RA) may be in a stable period without active disease. Consequently, there is a demand for developing outpatient control procedures which cater to the needs of the individual patient.

Objective

This study aims to compare a patient-controlled outpatient follow-up system, Open Outpatient Clinic Programme (OOCP), with traditional scheduled routine follow-up (TSRF) regarding patient satisfaction and disease activity markers in RA patients.

Method

In a 2-year randomized controlled trial, RA patients were allocated to OOCP or TSRF. OOCP patients had no scheduled appointments but were allowed acute appointments with their rheumatologist and had access to nurse-led consultations and a telephone helpline. Appointments for the TSRF group were scheduled according to routine procedures (clinical parameters: DAS-28, C-reactive protein, VAS pain, tender and swollen joint count, HAQ-DI and radiographs; psychological parameters: VAS patient satisfaction and EQ-5D).

Results

Of 282 patients, 239 completed the study (OOCP/TSRF characteristics: age 61.4 ± 10.5/60.9 ± 12.2 years, females 77/74%, ACPA positive 66/65%). At years 1 and 2, OCCP had fewer visits (year 2: 2.6 ± 1.6 vs. 3.5 ± 2; p < 0.0005) but more phone calls (year 2: 0.7 ± 1.4 vs. 0.1 ± 0.3; p < 0.0005) compared to TSRF. OOCP was comparable to TSRF regarding clinical and psychological outcome measures, and no radiographic progression was observed.

Conclusions

OOCP was associated with significantly fewer visits but with more phone calls to the nurse and was comparable with TSGentofte University HospitalRF regarding clinical, psychological and radiographic outcomes. Thus, the organization of outpatient care according to OOCP may be applied to strengthen patient-centred care in patients with RA. ClinicalTrials.gov Identifier (July 20, 2020): NCT04476875 Key points • In a patient-controlled outpatient follow-up system, RA patients had significantly fewer visits compared to traditional follow-up. • The patient-controlled follow-up system was comparable with traditional follow-up regarding clinical, psychological and radiographic outcomes. • Organization of outpatient care according to a patient-controlled follow-up system may be applied to strengthen patient-centred care in patients with RA.

SUBMITTER: Poggenborg RP

PROVIDER: S-EPMC7936865 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

Patient-controlled outpatient follow-up on demand for patients with rheumatoid arthritis: a 2-year randomized controlled trial.

Poggenborg René Panduro RP Madsen Ole Rintek OR Sweeney Anne-Marie Tetsche AT Dreyer Lene L Bukh Gunhild G Hansen Annette A

Clinical rheumatology 20210306 9

<h4>Introduction</h4>Scheduled routine visits in patients with rheumatoid arthritis (RA) may be in a stable period without active disease. Consequently, there is a demand for developing outpatient control procedures which cater to the needs of the individual patient.<h4>Objective</h4>This study aims to compare a patient-controlled outpatient follow-up system, Open Outpatient Clinic Programme (OOCP), with traditional scheduled routine follow-up (TSRF) regarding patient satisfaction and disease ac ...[more]

PMID: 33677724

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Project description:ObjectivesTo determine whether direct access to hospital review initiated by patients with rheumatoid arthritis would result in improved clinical and psychological outcome, reduced overall use of healthcare resources, and greater satisfaction with care than seen in patients receiving regular review initiated by a rheumatologist.DesignTwo year randomised controlled trial extended to six years.SettingRheumatology outpatient department in teaching hospital.Participants209 consecutive patients with rheumatoid arthritis for over two years; 68 (65%) in the direct access group and 52 (50%) in the control group completed the study (P = 0.04).Main outcome measuresClinical outcomepain, disease activity, early morning stiffness, inflammatory indices, disability, grip strength, range of movement in joints, and bone erosion. Psychological status: anxiety, depression, helplessness, self efficacy, satisfaction, and confidence in the system. Number of visits to hospital physician and general practitioner for arthritis.ResultsParticipants were well matched at baseline. After six years there was only one significant difference between the two groups for the 14 clinical outcomes measured (deterioration in range of movement in elbow was less in direct access patients). There were no significant differences between groups for median change in psychological status. Satisfaction and confidence in the system were significantly higher in the direct access group at two, four, and six years: confidence 9.8 v 8.4, 9.4 v 8.0, 8.7 v 6.9; satisfaction 9.3 v 8.3, 9.3 v 7.7, 8.9 v 7.1 (all P < 0.02). Patients in the direct access group had 38% fewer hospital appointments (median 8 v 13, P < 0.0001).ConclusionsOver six years, patients with rheumatoid arthritis who initiated their reviews through direct access were clinically and psychologically at least as well as patients having traditional reviews initiated by a physician. They requested fewer appointments, found direct access more acceptable, and had more than a third fewer medical appointments. This radical responsive management could be tested in other chronic diseases.

Project description:ObjectiveA steadily increasing demand and decreasing number of rheumatologists push current rheumatology care to its limits. Long travel times and poor accessibility of rheumatologists present particular challenges for patients. Need-adapted, digitally supported, patient-centered and flexible models of care could contribute to maintaining high-quality patient care. This qualitative study was embedded in a randomized controlled trial (TELERA) investigating a new model of care consisting of the use of a medical app for ePRO (electronic patient-reported outcomes), a self-administered CRP (C-reactive protein) test, and joint self-examination in rheumatoid arthritis (RA) patients. The qualitative study aimed to explore experiences of RA patients and rheumatology staff regarding (1) current care and (2) the new care model.MethodsThe study included qualitative interviews with RA patients (n = 15), a focus group with patient representatives (n = 1), rheumatology nurses (n = 2), ambulatory rheumatologists (n = 2) and hospital-based rheumatologists (n = 3). Data was analyzed by qualitative content analysis.ResultsParticipants described current follow-up care as burdensome. Patients in remission have to travel long distances. Despite pre-scheduled visits physicians lack questionnaire results and laboratory results to make informed shared decisions during face-to-face visits. Patients reported that using all study components (medical app for ePRO, self-performed CRP test and joint self-examination) was easy and helped them to better assess their disease condition. Parts of the validated questionnaire used in the trial (routine assessment of patient index data 3; RAPID3) seemed outdated or not clear enough for many patients. Patients wanted to be automatically contacted in case of abnormalities or at least have an app feature to request a call-back or chat. Financial and psychological barriers were identified among rheumatologists preventing them to stop automatically scheduling new appointments for patients in remission. Rheumatology nurses pointed to the potential lack of personal contact, which may limit the holistic care of RA-patients.ConclusionThe new care model enables more patient autonomy, allowing patients more control and flexibility at the same time. All components were well accepted and easy to carry out for patients. To ensure success, the model needs to be more responsive and allow seamless integration of education material.Trial registrationThe study was prospectively registered on 2021/04/09 at the German Registry for Clinical Trials (DRKS00024928).

Project description:BackgroundThere is a tremendous opportunity for innovative mental health care solutions such as psychiatric care through videoconferencing to increase the number of people who have access to quality care. However, studies are needed to generate empirical evidence on the use of psychiatric outpatient care via videoconferencing, particularly in low- and middle-income countries and clinically unsupervised settings.ObjectiveThe objective of this study was to evaluate the effectiveness and feasibility of home-based treatment for mild depression through psychiatric consultations via videoconferencing.MethodsA randomized controlled trial with a 6- and 12-month follow-up including adults with mild depression treated in an ambulatory setting was conducted. In total, 107 participants were randomly allocated to the videoconferencing intervention group (n=53) or the face-to-face group (F2F; n=54). The groups did not differ with respect to demographic characteristics at baseline. The F2F group completed monthly follow-up consultations in person. The videoconferencing group received monthly follow-up consultations with a psychiatrist through videoconferencing at home. At baseline and after 6 and 12 months, in-person assessments were conducted with all participants. Clinical outcomes (severity of depression, mental health status, medication course, and relapses), satisfaction with treatment, therapeutic relationship, treatment adherence (appointment compliance and dropouts), and medication adherence were assessed.ResultsThe severity of depression decreased significantly over the 12-month follow-up in both the groups. There was a significant difference between groups regarding treatment outcomes throughout the follow-up period, with better results in the videoconferencing group. There were 4 relapses in the F2F group and only 1 in the videoconferencing group. No significant differences between groups regarding mental health status, satisfaction with treatment, therapeutic relationship, treatment adherence, or medication compliance were found. However, after 6 months, the rate of dropouts was significantly higher in the F2F group (18.5% vs 5.7% in the videoconferencing group, P<.05).ConclusionsPsychiatric treatment through videoconferencing in clinically unsupervised settings can be considered feasible and as effective as standard care (in-person treatment) for depressed outpatients with respect to clinical outcomes, patient satisfaction, therapeutic relationship, treatment adherence, and medication compliance. These results indicate the potential of telepsychiatry to extend access to psychiatric care to remote and underserved populations.ClinicaltrialClinicaltrials.gov NCT01901315; https://clinicaltrials.gov/ct2/show/NCT01901315 (Archived by WebCite at http://www.webcitation.org/6jBTrIVwg).

Project description:BACKGROUND:Tripterygium wilfordii Hook F (TwHF) alone or in combination with methotrexate (MTX) has been shown to be more effective than MTX monotherapy in controlling the manifestations in subjects with disease-modifying antirheumatic drug (DMARD)-naïve active rheumatoid arthritis (RA) over a 6-month period. The long-term impact of these therapies on disease activity and radiographic progression in RA has not been examined. METHODS:Patients with DMARD-naïve RA enrolled in the "Comparison of Tripterygium wilfordii Hook F with methotrexate in the Treatment of Active Rheumatoid Arthritis" (TRIFRA) study were randomly allocated into three arms with TwHF or MTX or the two in combination. Clinical indexes and radiographic data at baseline and year 2 was collected and compared using an intent-to-treat (ITT) and a per-protocol (PP) analysis. Two radiologists blinded to the treatment scored the images independently. RESULTS:Of 207 subjects 109 completed the 2-year follow up. The number of subjects withdrawing from the study and the number adhering to the initial regimens were similar among the three groups (p > =?0.05). In the ITT analysis, proportions of patients reaching American College of Rheumatology 50% (ACR50) response criteria were 46.4%, 58.0% and 50.7% in the MTX, TwHF and MTX + TwHF groups (TwHF vs MTX monotherapy, p = 0.004). Similar patterns were found in ACR20, ACR70, Clinical Disease Activity Index good responses, European League Against Rheumatism good response, remission rate and low disease activity rate at year 2. The results of the PP analysis agreed with those in the ITT analysis. The changes in total Sharp scores and joint erosion and joint space narrowing during the 2 years were associated with changes in disease activity measured by the 28-joint count Disease Activity Score and were comparable among the three groups (p >?0.05). Adverse events were similar in the three treatment groups. CONCLUSIONS:During the 2-year therapy period, TwHF monotherapy was not inferior to MTX monotherapy in controlling disease activity and retarding radiological progression in patients with active RA. TRIAL REGISTRATION:This is a follow-up study. Original trial registration: ClinicalTrials.gov , NCT01613079 . Registered on 4 June 2012.

Project description:Background:We have reported previously the insufficient absolute number or functional defects of regulatory T cells (Tregs) in patients with rheumatoid arthritis (RA), challenging conventional unspecific immunosuppressive therapy. Sirolimus, a mTOR inhibitor, is reported to allow growth of functional Tregs; here, we investigated the efficacy of low-dose sirolimus combined with conventional immunosuppressants (sirolimus immunoregulation therapy) for RA treatment with lower side effects and better tolerance. Methods:In this nonblinded and parallel-group trial, we randomly assigned 62 patients to receive conventional glucocorticoids and immunosuppressants with or without sirolimus at a dosage of 0.5 mg on alternate days for 24 weeks in a 2 : 1 ratio. The demographic features, clinical manifestations, and laboratory indicators including peripheral blood lymphocyte subgroups and CD4+T subsets were compared before and after the treatment. Results:Finally, 37 patients in the sirolimus group and 18 in the conventional treated group completed the 6-month study. By 24 weeks, the patients with sirolimus experienced significant reduction in disease activity indicators including DAS28, ESR, and the number of tender joints and swollen joints (p < 0.001). Notably, they had a higher level of Tregs as compared with those with conventional therapy alone (p < 0.05), indicating that sirolimus could partly restore the reduced Tregs. Concomitantly, their usage of immunosuppressants for controlling disease activity was decreased as compared with the conventional group with no difference in blood routine, and liver and renal functions both before and after the treatment of sirolimus and between the two groups (p > 0.05). Conclusions:Low-dose sirolimus immunoregulatory therapy selectively upregulated Tregs and partly replaced the usage of immunosuppressants to control disease activity without overtreatment and evaluable side effect. Further study is required using a large sample of RA patients treated with sirolimus for a longer period. This trial is registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/showproj.aspx?proj=17245).

Project description:ObjectiveTo examine the long-term effects of early low-dose prednisolone use in patients with rheumatoid arthritis (RA) on cardiovascular (CV) morbidity and mortality.DesignRetrieval of data from a 2-year open randomised trial comparing prednisolone 7.5 mg/day in addition to disease-modifying antirheumatic drugs (DMARDs) with DMARD therapy alone. Participants were followed for 10 years since inclusion into the original prednisolone trial or until occurrence of the studied outcomes.SettingSecondary level of care; six participating centres from southern Sweden; both urban and rural populations.ParticipantsOverall, 223 patients with early RA were included. The participants had no history of CV events at baseline and incident cases were identified via the Swedish Hospital Discharge and Cause of Death Registries.OutcomesComposite CV events, that is, ischaemic coronary and cerebrovascular events, components of the composite CV outcome, and death. Relative HRs from Cox proportional-hazards regression models were calculated.ResultsWithin 2041 person-years, 17 incident composite CV events occurred in 112 patients (15%) randomised to prednisolone, and 15 events of 111 patients (14%) who were assigned not to receive prednisolone. There were nine deaths (8%) in each group. The age-adjusted relative hazards (HRs; 95% CI) for the first composite CV event, first coronary event and death in the prednisolone group versus the group not treated with prednisolone were 1.8 (0.9 to 3.6), 0.98 (0.4 to 2.6) and 1.6 (0.6 to 4.1), respectively. The risk for the first cerebrovascular event showed a 3.7-fold increased relative hazard (95% CI 1.2 to 11.4) among prednisolone treated patients.ConclusionsIn this inception cohort study of low-dose prednisolone use during the first 2 years of RA disease, the incidence of ischaemic coronary artery events was similar in the two treatment groups, whereas the long-term risk of ischaemic cerebrovascular events was higher in the prednisolone group. There was a trend towards reduced survival in the prednisolone group.Trial registration numberISRCTN20612367.

Dataset Information

Patient-controlled outpatient follow-up on demand for patients with rheumatoid arthritis: a 2-year randomized controlled trial.

Introduction

Objective

Method

Results

Conclusions

Publications

Patient-controlled outpatient follow-up on demand for patients with rheumatoid arthritis: a 2-year randomized controlled trial.

Similar Datasets

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