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Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study.

ABSTRACT: The traditional system of routine outpatient follow-up of chronic disease in secondary care may involve a waste of resources if patients are well. The use of patient-reported outcomes (PRO) could support more flexible, cost-saving follow-up activities. AmbuFlex is a PRO system used in outpatient follow-up in the Central Denmark Region. PRO questionnaires are sent to patients at fixed intervals. The clinicians use the PRO data to decide whether a patient needs a visit or not (standard telePRO). PRO may make patients become more involved in their own care pathway, which may improve their self-management. Better self-management may also be achieved by letting patients initiate contact. The aim of this study is to obtain data on the effects of patient-initiated follow-up (open access telePRO) on resource utilisation, quality of care, and the patient perspective.The study is a pragmatic, randomised, controlled trial in outpatients with epilepsy. Participants are randomly assigned to one of two follow-up activities: a) standard telePRO or b) open access telePRO. Inclusion criteria are age???15 years and previous referral to standard telePRO follow-up at Aarhus University Hospital, Denmark. Furthermore, patients must have answered the last questionnaire via the Internet. The number of contacts will be used as the primary outcome measure. Secondary outcome measures include well-being (WHO-5 Well-Being Index), general health, number of seizures, treatment side effects, mortality, health literacy (Health Literacy Questionnaire), self-efficacy (General Self-Efficacy scale), patient activation, confidence, safety, and satisfaction. In addition, the patient perspective will be explored by qualitative methods. Data will be collected at baseline and 18 month after randomisation. Inclusion of patients in the study started in January 2016. Statistical analysis will be performed on an intention-to-treat and per-protocol basis. For qualitative data, the interpretive description strategy will be used.The benefits and possible drawbacks of the PRO-based open access approach will be evaluated. The present study will provide important knowledge to guide future telePRO interventions in relation to effect on resource utilisation, quality of care, and the patient perspective.ClinicalTrials.gov: NCT02673580 (Registration date January 28, 2016).

SUBMITTER: Schougaard LM

PROVIDER: S-EPMC5267418 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study.

Schougaard Liv Marit Valen LM Mejdahl Caroline Trillingsgaard CT Petersen Klaus Hvam KH Jessen Anne A de Thurah Annette A Sidenius Per P Lomborg Kirsten K Hjollund Niels Henrik NH

BMC health services research 20170126 1

<h4>Background</h4>The traditional system of routine outpatient follow-up of chronic disease in secondary care may involve a waste of resources if patients are well. The use of patient-reported outcomes (PRO) could support more flexible, cost-saving follow-up activities. AmbuFlex is a PRO system used in outpatient follow-up in the Central Denmark Region. PRO questionnaires are sent to patients at fixed intervals. The clinicians use the PRO data to decide whether a patient needs a visit or not (s ...[more]

PMID: 28122609

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Project description:BackgroundThe use of patient-reported outcome (PRO) could potentially contribute to the reorganization of the health care system. AmbuFlex is a PRO system used in remote patient monitoring, in which questionnaires are sent to patients at fixed intervals. The PRO data are used by clinicians to decide whether patients need clinical attention. Better self-management and cost-saving follow-up activities may be achieved by letting patients initiate need of contact. We evaluated the effects of patient-initiated PRO-based outpatient follow-up on health care resource utilization, quality of care, and the patient perspective.MethodsWe conducted a parallel two-arm pragmatic randomized controlled trial at the Department of Neurology, Aarhus University Hospital, Denmark. Outpatients with epilepsy (≥ 15 years old), attending fixed-interval PRO-based follow-up with web-based questionnaires, were randomly assigned in a ratio of 0.55:0.45 to either 1) patient-initiated PRO-based follow-up (open access telePRO) or 2) fixed-interval PRO-based follow-up (standard telePRO). The primary outcome was the number of outpatient hospital contacts related to epilepsy retrieved from a regional registry. Hospitals admissions and emergency room visits were also assessed. Secondary self-reported outcomes including general health, well-being, health literacy, self-efficacy, number of seizures, side effects, confidence, safety, and satisfaction were retrieved from questionnaires. Data were analyzed by the intention-to-treat and per-protocol approaches.ResultsBetween January 2016 and July 2016, 593 patients were randomized to either open access telePRO (n = 346) or standard telePRO (n = 247). At 18 months, no statistically significant differences were found between the arms regarding number of telephone consultations or outpatient visits. Patients in the open access arm had a slightly lower, statistically significant number of emergency room visits than patients in the standard arm. Self-reported mental well-being in the open access arm was slightly, statistically significantly lower than in the standard arm. Other secondary outcomes did not differ statistically significantly between arms.ConclusionThis study did not find, as hypothesized, less use of health care resources or improved patient self-management or satisfaction in the patient-initiated PRO-based initiative compared to fixed-interval PRO-based follow-up. Patient-initiated PRO-based follow-up may be used as an alternative to fixed-interval PRO-based follow-up in patients who prefer this approach, but there is insufficient evidence for recommending a system-wide shift to patient-initiated PRO-based follow-up.Trial registrationRegistered 4 February 2016 with ClinicalTrials.gov: NCT02673580 .

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:ObjectiveTo determine whether ultraviolet B phototherapy at home is equally safe and equally effective as ultraviolet B phototherapy in an outpatient setting for patients with psoriasis.DesignPragmatic multicentre single blind randomised clinical trial (PLUTO study).SettingDermatology departments of 14 hospitals in the Netherlands.Participants196 patients with psoriasis who were clinically eligible for narrowband (TL-01) ultraviolet B phototherapy. The first 105 consecutive patients were also followed for one year after therapy.InterventionUltraviolet B phototherapy at home using a TL-01 home phototherapy unit compared with standard narrowband ultraviolet B phototherapy in an outpatient setting. Both therapies were done in a setting reflecting routine daily practice in the Netherlands.Main outcome measuresThe main outcome measure was effectiveness as measured by the proportion of patients with a 50% or more reduction of the baseline psoriasis area and severity index (PASI) or self administered psoriasis area and severity index (SAPASI), called the PASI 50 and SAPASI 50 (relevant treatment effect). Another outcome of effectiveness was the percentage reduction in median scores on the PASI as well as SAPASI. Also the proportions of patients reaching the PASI 75 and SAPASI 75 (successful treatment effect), and the PASI 90 and SAPASI 90 (almost complete clearance) were calculated. Other secondary outcomes were quality of life (SF-36, psoriasis disability index), burden of treatment (questionnaire), patients' preferences and satisfaction (questionnaire), and dosimetry and short term side effects (diary).Results82% of the patients treated at home compared with 79% of the patients treated in an outpatient setting reached the SAPASI 50 (difference 2.8%, 95% confidence interval -8.6% to 14.2%), and 70% compared with 73% reached the PASI 50 (-2.3%, -15.7% to 11.1%). For patients treated at home the median SAPASI score decreased 82% (from 6.7 to 1.2) and the median PASI score decreased 74% (from 8.4 to 2.2), compared with 79% (from 7.0 to 1.4) and 70% (from 7.0 to 2.1) for patients treated in an outpatient setting. Treatment effect as defined by the mean decline in PASI and SAPASI scores was significant (P<0.001) and similar across groups (P>0.3). Total cumulative doses of ultraviolet B light were similar (51.5 v 46.1 J/cm(2), difference 5.4, 95% confidence interval -5.2 to 16.0), and the occurrence of short term side effects did not differ. The burden of undergoing ultraviolet B phototherapy was significantly lower for patients treated at home (differences 1.23 to 3.01, all P</=0.001). Quality of life increased equally regardless of treatment, but patients treated at home more often rated their experience with the therapy as "excellent" (42%, 38/90) compared with patients treated in the outpatient department (23%, 20/88; P=0.001).ConclusionUltraviolet B phototherapy administered at home is equally safe and equally effective, both clinically and for quality of life, as ultraviolet B phototherapy administered in an outpatient setting. Furthermore, ultraviolet B phototherapy at home resulted in a lower burden of treatment and led to greater patients' satisfaction. Trial registration Current Controlled Trials ISRCTN83025173 and Clinicaltrials.gov NCT00150930.

Project description:BackgroundTimely, in-person access to health care is a challenge for people living with conditions such as stroke that result in frailty, loss of independence, restrictions in driving and mobility, and physical and cognitive decline. In Southeastern Ontario, access is further complicated by rurality and the long travel distances to visit physician clinics. There is a need to make health care more accessible and convenient. Home virtual visits (electronic visits, eVisits) can conveniently connect physicians to patients. Physicians use a secure personal videoconferencing tool to connect to patients in their homes. Patients use their device of choice (smartphone, tablet, laptop, or desktop) for the visit.ObjectiveThis study aimed to assess the feasibility and logistics of implementing eVisits in a stroke prevention clinic for seniors.MethodsA 6-month eVisit pilot study was initiated in the Kingston Health Sciences Centre stroke prevention clinic in August 2018. eVisits were used only for follow-up patient encounters. An integrated evaluation was used to test the impact of the program on clinic workflow and patient satisfaction. Patient satisfaction was evaluated by telephone interviews, using a brief questionnaire. Access and patient satisfaction metrics were compared with concurrent standard of care (patients' prior personal experience with in-person visits). Values are presented as median (interquartile range).ResultsThere were 75 subjects in the pilot. The patients were aged 65 (56-73.5) years, and 39% (29/75) resided in rural areas. There was a shorter wait for an appointment by eVisit versus in-person (mean 59.98 [SD 48.36] days vs mean 78.36 [SD 50.54] days; P<.001). The eVisit was also shorter, taking on an average of only 10 min to deliver follow-up care with a high degree of patient satisfaction versus 90 (60-112) min for in-person care. The total time saved by patients per eVisit was 80 (50-102) min, 44 (21-69) min of which was travel time. Travel distance avoided by the patients was 30.1 km (11.2-82.2). The estimated total out-of-pocket cost savings for patients per eVisit was Can $52.83 (31.26-94.53). The estimated savings (opportunity cost for in-person outpatient care) for our eVisit pilot project was Can $23,832-$28,584. The patient satisfaction with eVisits was very good compared with their prior personal experience with in-person outpatient care.ConclusionsThe eVisit program was well received by patients, deemed to be safe by physicians, and avoided unnecessary patient travel and expense. It also has the potential to reduce health care costs. We plan to scale the project within the department and the institution.

Dataset Information

Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study.

Publications

Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study.

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