Dataset Information

Primum non nocere: shared informed decision making in low back pain--a pilot cluster randomised trial.

ABSTRACT:

Background

Low back pain is a common and disabling condition leading to large health service and societal costs. Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection. The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments.

Methods

This was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service. We included adults with non-specific low back pain referred for physiotherapy. Intervention participants were sent an information booklet prior to their first consultation. Intervention physiotherapists were trained to enhance their skills in shared informed decision making. Those in the control arm received care as usual. The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into "satisfaction" (very satisfied or somewhat satisfied) and "non-satisfaction" (neither satisfied nor dissatisfied, somewhat dissatisfied or very dissatisfied).

Results

We recruited 148 participants. In the control arm 67% of participants were satisfied with their treatment and in the intervention arm 53%. The adjusted relative risk of being satisfied was 1.28 (95% confidence interval 0.79 to 2.09). For most secondary outcomes the trend was towards worse outcomes in the intervention group. For one measure; the Roland Morris Disability Questionnaire, this difference was clinically important (2.27, 95% confidence interval 0.08 to 4.47). Mean healthcare costs were slightly lower (£38 saving per patient) within the intervention arm but health outcomes were also less favourable (0.02 fewer QALYs); the estimated probability that the intervention would be cost-effective at an incremental threshold of £20,000 per QALY was 16%.

Conclusion

We did not find that this decision support package improved satisfaction with treatment; it may have had a substantial negative effect on clinical outcome, and is very unlikely to prove cost-effective. That a decision support package might have a clinically important detrimental effect is of concern. To our knowledge this has not been observed previously. Decision support packages should be formally tested for clinical and cost-effectiveness, and safety before implementation.

Trial registration

Current Controlled Trials ISRCTN46035546 registered on 11/02/10.

SUBMITTER: Patel S

PROVIDER: S-EPMC4247192 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Publications

Primum non nocere: shared informed decision making in low back pain--a pilot cluster randomised trial.

Patel Shilpa S Ngunjiri Anne A Hee Siew Wan SW Yang Yaling Y Brown Sally S Friede Tim T Griffiths Frances F Lord Joanne J Sandhu Harbinder H Thistlethwaite Jill J Tysall Colin C Underwood Martin M

BMC musculoskeletal disorders 20140821

<h4>Background</h4>Low back pain is a common and disabling condition leading to large health service and societal costs. Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection. The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments.<h4>Methods</h4>This was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy ...[more]

PMID: 25146587

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Project description:OBJECTIVE:To translate an informed shared decision-making programme (ISDM-P) for patients with type 2 diabetes from a specialised diabetes centre to the primary care setting. DESIGN:Patient-blinded, two-arm multicentre, cluster randomised controlled trial of 6 months follow-up; concealed randomisation of practices after patient recruitment and acquisition of baseline data. SETTING:22 general practices providing care according to the German Disease Management Programme (DMP) for type 2 diabetes. PARTICIPANTS:279 of 363 eligible patients without myocardial infarction or stroke. INTERVENTIONS:The ISDM-P comprises a patient decision aid, a corresponding group teaching session provided by medical assistants and a structured patient-physician encounter.Control group received standard DMP care. PRIMARY AND SECONDARY OUTCOME MEASURES:Primary endpoint was patient adherence to antihypertensive or statin drug therapy by comparing prescriptions and patient-reported uptake after 6 months. Secondary endpoints included informed choice, risk knowledge (score 0-11 from 11 questions) and prioritised treatment goals of patients and doctors. RESULTS:ISDM-P: 11 practices with 151 patients; standard care: 11 practices with 128 patients; attrition rate: 3.9%. There was no difference between groups regarding the primary endpoint. Mean drug adherence rates were high for both groups (80% for antihypertensive and 91% for statin treatment). More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated?haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8). ISDM-P patients achieved higher levels of risk knowledge, with a mean score of 6.96 vs 2.86, difference 4.06 (95% CI 2.96 to 5.17). In the ISDM-P group, agreement on prioritised treatment goals between patients and doctors was higher, with 88.5% vs 57%. CONCLUSIONS:The ISDM-P was successfully implemented in general practices. Adherence to medication was very high making improvements hardly detectable. TRIAL REGISTRATION NUMBER:ISRCTN77300204; Results.

Project description:OBJECTIVE:To evaluate an informed shared decision-making programme (ISDM-P) for people with type 2 diabetes under high fidelity conditions. DESIGN:Randomised, single-blinded trial with sham control intervention and follow-up of 6 months. SETTING:Single-centre diabetes clinic providing care according to the national disease management programme in Germany. PARTICIPANTS:154 people with type 2 diabetes without diagnosis of ischaemic heart disease or stroke. INTERVENTIONS:The ISDM-P is executed by diabetes educators. Core component is a patient decision aid on the prevention of myocardial infarction supplemented by a 90 min group teaching session. The structurally equivalent control intervention addresses stress issues. MAIN OUTCOME MEASURES:Primary outcome was risk comprehension, including realistic expectations about benefits and harms of interventions. It was assessed by a 12-item questionnaire after the teaching session when patients set and prioritise their treatment goals. Key secondary outcome was adherence to treatment goals, operationalised as achievement of individual goals and medication uptake. ISDM-P teaching sessions were video-taped to monitor intervention fidelity. RESULTS:72 of 77 ISDM-P and 71 of 77 control patients completed the questionnaire (score 0-12). ISDM-P patients achieved higher levels of risk comprehension, mean score 8.25 vs 2.62, difference 5.63 (95% CI 4.82 to 6.44), and realistic expectations (score 0-6), 4.51 vs 0.85, 3.67 (3.23 to 4.11). More ISDM-P patients wished to take statins, 59.2% vs 30.4%, 28.7% (12.9% to 44.5%); more prioritised blood pressure control, 51.4% vs 25.7%, and fewer intensive glucose control, 33.3% vs 60%, p=0.002. More ISDM-P patients achieved their glycated haemoglobin goals, 95.8% vs 85.7%, 10.1% (0.6% to 19.5%). Achievement of prioritised goals and medication uptake were comparable between groups. CONCLUSIONS:The ISDM-P on preventive measures in type 2 diabetes was effective under high fidelity conditions. Involvement of diabetes educators may facilitate implementation of the informed shared decision-making. TRIAL REGISTRATION NUMBER:ISRCTN84636255.

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Project description:IMPORTANCE:For antidepressants, the translation of evidence of comparative effectiveness into practice is suboptimal. This deficit directly affects outcomes and quality of care for patients with depression. To overcome this problem, we developed the Depression Medication Choice (DMC) encounter decision aid, designed to help patients and clinicians consider the available antidepressants and the extent to which they improved depression and other issues important to patients. OBJECTIVE:Estimate the effect of DMC on quality of the decision-making process and depression outcomes. DESIGN, SETTING, AND PARTICIPANTS:We conducted a cluster randomized trial of adults with moderate to severe depression considering treatment with an antidepressant. Primary care practices in 10 rural, suburban, and urban primary care practices across Minnesota and Wisconsin were randomly allocated to treatment of depression with or without use of the DMC decision aid. INTERVENTION:Depression Medication Choice, a series of cards, each highlighting the effect of the available options on an issue of importance to patients for use during face-to-face consultations. MAIN OUTCOMES AND MEASURES:Decision-making quality as judged by patient knowledge and involvement in decision making, patient and clinician decisional comfort (Decisional Conflict Scale) and satisfaction, encounter duration, medication adherence, depression symptoms, and the Patient Health Questionnaire for depression (PHQ-9). RESULTS:We enrolled 117 clinicians and 301 patients (67% women; mean [SD] age, 44 [15] years; mean [SD] PHQ-9 score, 15 [4]) into the trial. Compared with usual care (UC), use of DMC significantly improved patients' decisional comfort (DMC, 80% vs UC, 75%; P = .02), knowledge (DMC, 65% vs UC, 56%; P =?.03), satisfaction (risk ratio [RR], from 1.25 [P =?.81] to RR, 2.4 [P =?.002] depending on satisfaction domain), and involvement (DMC, 47% vs UC, 33%; P<.001). It also improved clinicians' decisional comfort (DMC, 80% vs UC, 68%; P <?.001) and satisfaction (RR, 1.64; P =?.02). There were no differences in encounter duration, medication adherence, or improvement of depression control between arms. CONCLUSIONS AND RELEVANCE:The DMC decision aid helped primary care clinicians and patients with moderate to severe depression select antidepressants together, improving the decision-making process without extending the visit. On the other hand, DMC had no discernible effect on medication adherence or depression outcomes. By translating comparative effectiveness into patient-centered care, use of DMC improved the quality of primary care for patients with depression. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01502891.

Project description:BackgroundStrabismus is a complex disease that has various treatment approaches each with its own advantages and drawbacks. In this context, shared decisions making (SDM) is a communication process with the provider sharing all the relevant treatment alternatives, all the benefits, and risks of each procedure, while the patient shares all the preferences and values regarding his/her choices. In that way, SDM is a bidirectional process that goes beyond the typical informed consent. Therefore, it is known a little of the extent to which SDM influences the satisfaction with the treatment outcome along with strabismus patients. To study this correlation, an SDM-Q-9 questionnaire was provided within surgical consultations where treatment decisions were made; the SDM-Q-9 aims to assess the relationship between the post-operative patient's satisfaction and their SMD score.MethodsThe study is considered a prospective observational pilot study. Eligible patients were adult patients diagnosed with strabismus, who had multiple treatment options, were given at the right of choice without being driven into a physician's preference. Ninety-three strabismus patients were asked to fill out the SDM-Q-9 questionnaire related to their perception of SDM during the entire period of strabismus treatment. After the treatment, patients were asked to rate their satisfaction level with the surgical outcome as excellent, good, fair, and poor. Descriptive statistics and the linear regression statistical tests (Spearman, Mann Whitney U, and Kriskal-Wallis) were used as analysis tools.ResultsThe average age of the participants was 24, where 50.6% were women. The mean SDM-Q-9 score among patients was 32 (IQR = 3). The postoperative patient satisfaction was rated as being excellent by 16 (17.2%) patients, good by 38 (40.9%), fair by 32 (34.4%), and poor by 7 patients (7.5%). Data analysis by linear regression statistical tests showed a positive correlation between the SDM-Q-9 score and the patient satisfaction related to the surgery outcome (B = 0.005, p < 0.001). Criteria in assessing patients' satisfaction were age, gender, and strabismus type. A positive correlation between SDM and real satisfaction (r = 0.834, p < 0.01) was found with age, and no significant relationship was found while taking into consideration the responder's gender and the strabismus type.ConclusionsAssessing patient satisfaction after choosing a treatment for strabismus method helped us evaluate the gaps in constructive dialogue that would lead to a positive outcome for both patient and clinician. The correlation between the SDM process and the patients' satisfaction with surgery outcome, adjusted by age, has been established. These findings can serve as a springboard to further communicative improvements related to the SDM process and between patients and physicians, thereby consequently leading to patients' satisfaction raise in strabismus care. The study underlines the importance of further analysis and validation of on-ground interactions among the adolescent and adult patients and the clinicians across the strabismus management trajectory. A multicentral study and its validation will follow.

Project description:INTRODUCTION:Despite the observed and theoretical advantages of shared decision-making in a range of clinical contexts, including contraceptive care, there remains a paucity of evidence on how to facilitate its adoption. This paper describes the protocol for a study to assess the comparative effectiveness of patient-targeted and provider-targeted interventions for facilitating shared decision-making about contraceptive methods. METHODS AND ANALYSIS:We will conduct a 2×2?factorial cluster randomised controlled trial with four arms: (1) video+prompt?card, (2) decision aids+training, (3) video+prompt?card and decision aids+training and (4) usual care. The clusters will be clinics in USA that deliver contraceptive care. The participants will be people who have completed a healthcare visit at a participating clinic, were assigned female sex at birth, are aged 15-49 years, are able to read and write English or Spanish and have not previously participated in the study. The primary outcome will be shared decision-making about contraceptive methods. Secondary outcomes will be the occurrence of a conversation about contraception in the healthcare visit, satisfaction with the conversation about contraception, intended contraceptive method(s), intention to use a highly effective method, values concordance of the intended method(s), decision regret, contraceptive method(s) used, use of a highly effective method, use of the intended method(s), adherence, satisfaction with the method(s) used, unintended pregnancy and unwelcome pregnancy. We will collect study data via longitudinal patient surveys administered immediately after the healthcare visit, four weeks later and six months later. ETHICS AND DISSEMINATION:We will disseminate results via presentations at scientific and professional conferences, papers published in peer-reviewed, open-access journals and scientific and lay reports. We will also make an anonymised copy of the final participant-level dataset available to others for research purposes. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Identifier: NCT02759939.

Project description:IMPORTANCE:Intensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk among patients with prediabetes. However, real-world uptake remains low. Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned with their preferences. OBJECTIVE:To test the effectiveness of a prediabetes SDM intervention. DESIGN:Cluster randomized controlled trial. SETTING:Twenty primary care clinics within a large regional health system. PARTICIPANTS:Overweight/obese adults with prediabetes (BMI???24 kg/m2 and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics. Propensity score matching was used to identify control patients from 10 usual care clinics. INTERVENTION:Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care. MAIN OUTCOMES AND MEASURES:Primary endpoint was uptake of DPP (??9 sessions), metformin, or both strategies at 4 months. Secondary endpoint was weight change (lbs.) at 12 months. RESULTS:Uptake of DPP and/or metformin was higher among SDM participants (n =?351) than controls receiving usual care (n =?1028; 38% vs. 2%, p <?.001). At 12-month follow-up, adjusted weight loss (lbs.) was greater among SDM participants than controls (-?5.3 vs. -?0.2, p?<?.001). LIMITATIONS:Absence of DPP supplier participation data for matched patients in usual care clinics. CONCLUSIONS AND RELEVANCE:A prediabetes SDM intervention led by pharmacists increased patient engagement in evidence-based options for diabetes prevention and was associated with significantly greater uptake of DPP and/or metformin at 4 months and weight loss at 12 months. Prediabetes SDM may be a promising approach to enhance prevention efforts among patients at increased risk. TRIAL REGISTRATION:This study was registered at clinicaltrails.gov (NCT02384109)).

Dataset Information

Primum non nocere: shared informed decision making in low back pain--a pilot cluster randomised trial.

Background

Methods

Results

Conclusion

Trial registration

Publications

Primum non nocere: shared informed decision making in low back pain--a pilot cluster randomised trial.

Similar Datasets

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