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Pilot Study Examining Feasibility and Comparing the Effectiveness of Decision Aids for Hip and Knee Osteoarthritis: A Randomized Trial.

ABSTRACT: Background. There are many patient decision aids (DAs) available, yet there is limited evidence on comparative effectiveness of different tools. Objective. To examine feasibility of a study protocol and gather preliminary data on comparative effectiveness. Methods. Adult patients seeing a surgeon to discuss treatment for hip or knee osteoarthritis were randomized to hip and knee DAs from two vendors. Pre-visit survey included Hip/Knee Decision Quality Instrument, DA usage, health literacy, and quality of life (EQ-5D). Surgical status was ascertained 6 months post-visit. We examined response rates, eligibility, and compared the two DAs on amount of use, knowledge scores, and receipt of preferred treatment. Results. Overall response rate was 58/74 (78%) and did not differ by study arm. More patients in DA-A group reported reviewing all the DAs (64.5% DA-A v. 24.0% DA-B, P = 0.003). Knowledge scores were similar across arms (55.2% DA-A v. 48.8% DA-B, P = 0.4). For DA-B, knowledge scores were higher for those who reviewed all the DAs compared with those who did not (80% knowledge v. 39% knowledge, respectively, P = 0.004), while scores for DA-A did not vary by usage (62% knowledge v. 53% knowledge, respectively, P = 0.3). A similar percentage of each group received their preferred treatment (77% v. 73%, P = 0.8). Patients who were unsure about preferred treatment at baseline were more likely to have surgery in the DA-A arm compared with the DA-B arm (55% v. 20%, P = 0.1). Limitations. Small sample; patients were only surveyed pre-visit. Conclusion. Despite having different content and formats, the two DAs had similar overall effectiveness. Patients were more likely to review all of DA-A; however, patients who reviewed all of DA-B had the highest knowledge scores.

SUBMITTER: Mangla M

PROVIDER: S-EPMC6378444 | biostudies-literature | 2019 Jan-Jun

REPOSITORIES: biostudies-literature

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Pilot Study Examining Feasibility and Comparing the Effectiveness of Decision Aids for Hip and Knee Osteoarthritis: A Randomized Trial.

Mangla Mahima M Bedair Hany H Dwyer Maureen M Freiberg Andrew A Sepucha Karen K

MDM policy & practice 20190101 1

Background. There are many patient decision aids (DAs) available, yet there is limited evidence on comparative effectiveness of different tools. Objective. To examine feasibility of a study protocol and gather preliminary data on comparative effectiveness. Methods. Adult patients seeing a surgeon to discuss treatment for hip or knee osteoarthritis were randomized to hip and knee DAs from two vendors. Pre-visit survey included Hip/Knee Decision Quality Instrument, DA usage, h ...[more]

PMID: 30801033

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Project description:BACKGROUND:As guidelines and payers increasingly recommend use of patient decision aids (DAs), evidence about the comparative effectiveness of available DAs is critical for organizations interested in implementing them. The primary purpose of this study was to compare 2 DAs with regard to their ability to help patients become informed and receive their preferred treatment (that is, make an informed patient-centered decision), shared decision-making, surgical rates, and surgeon satisfaction. METHODS:We performed a multisite factorial randomized trial enrolling patients with hip or knee osteoarthritis. Patients were randomly assigned to use a long, detailed DA (long DA) or short, interactive DA (short DA). Eight surgeons were randomly assigned to receive a patient preference report detailing the patient's goals and treatment preferences or to administer usual care. RESULTS:We distributed 1,636 pre-visit surveys, 1,220 of which were returned (75% response rate), and 1,124 post-visit surveys, 967 of which were returned (86% response rate). The patients in the sample had a mean age (and standard deviation) of 65 ± 10 years, 57% were female, 89% were white non-Hispanic, and 67% had knee osteoarthritis. The majority (67.2%) made informed patient-centered decisions, and the rate did not vary significantly between the DA groups (p = 0.97) or between the surgeon groups (p = 0.23). Knowledge scores were higher for the short-DA group (mean difference = 9%; p < 0.001). More than half of the sample (60.5%) had surgery within 6 months after the visit, and rates did not differ significantly by DA or surgeon group. Overall, the surgeons were highly satisfied and reported that the majority (88.7%) of the visits were of normal duration or shorter. CONCLUSIONS:The DECIDE-OA study is, to our knowledge, the first randomized comparative effectiveness study of 2 orthopaedic DAs. The short DA outperformed the long DA with regard to knowledge scores and was comparable with respect to other outcomes. The surgeons reported high satisfaction and normal visit duration with both DAs. CLINICAL RELEVANCE:Surgeons need to ensure that patients with osteoarthritis are well-informed and have a clear preference regarding whether to undergo hip or knee replacement surgery. The DAs used in this study may help surgeons involve patients in elective surgery decisions and meet the requirements of informed consent.

Project description:ObjectiveTo determine the feasibility of conducting a randomised controlled trial (RCT) of a peer mentorship intervention to improve self-management of osteoarthritis (OA).DesignSix-month parallel group non-blinded randomised feasibility trial.SettingOne secondary care and one primary care UK National Health Service Trust.ParticipantsFifty adults aged ≥55 years old with hip and/or knee OA.InterventionsParticipants were allocated 1:1 to the intervention or control group using an online randomisation service. Intervention group participants received usual care (information resources) and up to eight community-based self-management support sessions delivered by a peer mentor (trained volunteer with hip and/or knee OA). Control group participants received usual care only.Outcome measuresKey feasibility outcomes were participant and peer mentor recruitment and attrition, intervention completion and the sample size required for a definitive RCT. Based on these feasibility outcomes, four success criteria for proceeding to a definitive RCT were prespecified. Patient-reported outcomes were collected via questionnaires at baseline, 8 weeks and 6 months.ResultsNinety-six individuals were screened, 65 were eligible and 50 were randomised (25 per group). Of the 24 participants who commenced the intervention, 20 completed it. Four participants did not complete the 6-month questionnaire. Twenty-one individuals were eligible for the peer mentor role, 15 were trained and 5 withdrew prior to being matched with a participant. No intervention-related harms occurred. Allowing for 20% attrition, the sample size required for a definitive RCT was calculated as 170 participants. The intervention group showed improvements in self-management compared with the control group.ConclusionsThe feasibility outcomes achieved the prespecified criteria for proceeding to an RCT. The exploratory analyses suggest peer mentorship may improve OA self-management. An RCT of the OA peer mentorship intervention is therefore warranted with minor modifications to the intervention and trial procedures.Trial registration numberISRCTN:50675542.

Project description:BackgroundIn the past few decades, there has been an increasing focus on the importance of patient involvement in the health care system. Patient participation executed through patient-reported outcomes (PROs) and the integration of such into clinical practice has been framed as positive for patients, care providers, and the health care system as a whole. This review aims to elucidate and discuss the current and future use of PROs in clinical practice and to identify the most common types of PRO measures (PROMs) used for patients with hip or knee osteoarthritis in different treatment settings.MethodsThe following databases were searched: PubMed, Embase, CINAHL, Scopus, the Cochrane Library, and EconLit. For inclusion in the study, studies had to cover either knee or hip osteoarthritis and report on PROs. The type of PROM, treatment setting, and study design of each included study were extracted from their respective abstracts. Additionally, the full text of studies concerning PROs as an integrated part of clinical practice was examined and information on the year of publication, study design, topic, and use of PROMs was extracted.ResultsIt was found that only two pilot studies reported on the use of PROs as an integrated part of patient treatment within hip or knee osteoarthritis. In 349 studies, a total of 38 different PROMs relevant for patients with either hip or knee osteoarthritis were identified. The EQ-5D, WOMAC, and VAS questionnaires were the most commonly reported generic, disease-specific, and domain-specific PROMs, respectively. However, a large variation in the use of different PROMs both within and between surgical and nonsurgical settings was found.ConclusionLimited evidence on the use of PROs as an integrated part of clinical practice for patients with hip and knee osteoarthritis was found. Further research is necessary to clarify the effects on patient outcomes of using PROs in clinical practice. In addition, there is limited agreement on a joint standard for the use of PROMs both within and across the sectorial boarders. Further exploration of PROMs to generate future standardisation is suggested.

Project description:IntroductionThere are several different interventions available to promote shared decision making (SDM); however, little is known about the comparative effectiveness of different approaches.ObjectiveTo examine the impact of patient-directed and physician-directed decision support strategies on the quality of treatment decisions for hip and knee osteoarthritis (OA).Trial designA 2×2 factorial randomised controlled trial.SettingOne academic medical centre, one community hospital and one orthopaedic specialty hospital.Participants and interventionsThe enrolment targets were 8 surgeons and 1120 patients diagnosed with hip or knee OA. Patients were randomly assigned to receive one of two different decision aids (DAs) stratified by site. The DAs varied in length, content and the level of detail regarding treatment options. Both DAs were available by paper or online.Surgeons were randomly assigned to receive a report detailing patients' goals and treatment preferences at the time of the visit or not. Eligible patients received their assigned DA before their visit and completed three surveys: before the visit (timepoint (T)1), 1-week postvisit (T2) and 6 months from either the visit date or surgery date for patients who underwent surgery (T3). Study staff and participating surgeons were not blinded, but the statistician conducting the analyses was blinded to the arms.Main outcome measure and analysisThe primary study outcome was decision quality, the percentage of patients who were well informed and received their preferred treatment. Secondary outcomes included involvement in decision making, surgical rates, health outcomes, decision regret and satisfaction. A logistic regression model with the generalised estimating equations approach was used to compare rates of decision quality between the groups and account for the clustering of patients within providers.Ethics and disseminationEthics approval was obtained through the institutional review board at the main site. The findings will be published in peer-reviewed journals.Trial registration numberNCT02729831; Pre-results.

Project description:BackgroundAlthough previous clinical studies suggest possible benefits of acupuncture for knee osteoarthritis (KOA), the value of acupuncture at sensitized points is uncertain. We aimed to preliminarily assess the feasibility of performing a definitive randomized controlled trial to explore the effectiveness of acupuncture for KOA with highly sensitized acupoints.MethodsIn this randomized, single-blind, parallel, pilot trial, 36 participants with KOA were randomly assigned to receive acupuncture at highly sensitized acupoints (high-sensitization group) or at low/non-sensitized points (low/non-sensitization group) by a computer-generated random sequence. Both groups received three treatment sessions per week for four consecutive weeks (12 sessions in total). Assessments were performed at screening and at 4, 8, 12, and 16?weeks after randomization. Primary feasibility outcomes were patient recruitment, retention rate, and adherence to group treatment. Secondary outcomes included the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score from baseline to 16?weeks, the change of Short Form (SF)-12 health survey score, and safety outcomes.ResultsPatient recruitment of 36 patients took 2 months, achieving the recruitment target. Retention rates were similar between the treatment groups, 14 (77.8%) patients in the high-sensitization group completed the 16-week follow-up and compared to 14 (77.8%) patients in low/non-sensitization group, but the result was lower than expected. All patients received at least ten treatment sessions in total. The WOMAC total score and the pain, stiffness, and physical function score in the high-sensitization group were lower or very close to those in the control group at each assessment point. Similar results were observed on quality of life. No adverse events occurred.ConclusionThis trial has presented preliminary data on the feasibility of conducting a large trial to test the effectiveness of acupuncture at sensitized points in KOA patients.Trial registrationClinicalTrials.gov, NCT03008668. Registered on 26 December 2016-retrospectively registered.

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Pilot Study Examining Feasibility and Comparing the Effectiveness of Decision Aids for Hip and Knee Osteoarthritis: A Randomized Trial.

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Pilot Study Examining Feasibility and Comparing the Effectiveness of Decision Aids for Hip and Knee Osteoarthritis: A Randomized Trial.

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