scholarly journals The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Carol Bugge ◽  
Rohna Kearney ◽  
Melanie Dembinsky ◽  
Aethele Khunda ◽  
Margaret Graham ◽  
...  
Keyword(s):  
Pelvic Organ Prolapse ◽  
Process Evaluation ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Pelvic Organ ◽  
Self Management ◽  
Trial Participation ◽  
Structured Interviews ◽  
Process Data ◽  
Management Intervention

Abstract Background Process evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to the intervention and provide valuable insights into what is effective in a practical setting by examining the context in which interventions are implemented. The TOPSY study consists of a large multi-centre randomised controlled trial comparing the effectiveness of pessary self-management with clinic-based care in improving women’s condition-specific quality of life, and a nested process evaluation. The process evaluation aims to examine and maximise recruitment to the trial, describe intervention fidelity and explore participants’ and healthcare professionals’ experiences. Methods The trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixed-methods approach. Semi-structured interviews will be conducted with randomised women (18 per randomised group/n = 36), women who declined trial participation but agreed to interview (non-randomised women) (n = 20) and healthcare professionals recruiting to the trial (n ~ 17) and delivering self-management and clinic-based care (n ~ 17). The six internal pilot centres will be asked to record two to three recruitment discussions each (total n = 12–18). All participating centres will be asked to record one or two self-management teaching appointments (n = 30) and self-management 2-week follow-up telephone calls (n = 30). Process data (quantitative and qualitative) will be gathered in participant completed trial questionnaires. Interviews will be analysed thematically and recordings using an analytic grid to identify fidelity to the intervention. Quantitative analysis will be predefined within the process evaluation analysis plan. Discussion The wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented. Understanding this contextual variance is central to understanding how and in what circumstances pessary self-management can be implemented (should it be effective). The inclusion of non-randomised women provides an innovative way of collecting indispensable information about eligible women who decline trial participation, allowing broader contextualisation and considerations of generalisability of trial findings. Methodological insights from examination of recruitment processes and mechanisms have the potential to inform recruitment mechanisms and future recruitment strategies and study designs. Trial registration ISRCTN62510577. Registered on 6 October 2017.

scholarly journals Patients’ experiences of a nurse-led home-based heart failure self-management programme: Findings from the process evaluation (Preprint)

2021 ◽  
Author(s):  
Wenru Wang ◽  
Ying Jiang ◽  
Karen Wei Ling Koh ◽  
Hadassah Joann RAMACHANDRAN ◽  
Yee Kian Tay ◽  
...  
Keyword(s):  
Heart Failure ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Self Care ◽  
The Elderly ◽  
Management Programme ◽  
Self Management ◽  
Structured Interviews ◽  
Additional Information ◽  
Home Based

UNSTRUCTURED Aims: To explore participants’ perspectives on a nurse-led home-based heart failure self-management programme (HOM-HEMP) in a randomized controlled trial conducted in Singapore to gain insight into the effectiveness or failure of the study intervention. Design: A descriptive, qualitative approach was adopted. Method: English or Chinese-speaking participants from the intervention arms were recruited through a purposive sampling method from January 2019 to July 2019. Individual, face-to-face, semi-structured interviews were conducted with 11 participants. All the interviews were audio-recorded and transcribed verbatim, with the identifiers of the participants omitted to ensure confidentiality. The thematic analysis approach was used for identifying, analyzing and reporting the patterns (themes) within the data. Results: Six themes emerged from the process evaluation interviews and were categorized according to Donabedian’s structure-process-outcome framework as "intervention structure," "intervention process," and "intervention outcome". These six themes were manageability of intervention, areas for improvement, benefits of visiting, personal accountability in self-care, empowered with knowledge and skills in self-care after the intervention, and increased self-efficacy in cardiac care. Conclusion: The findings of the process evaluation provided additional information about participants' perceptions and experiences with the HOM-HEMP intervention. While home visit may be perceived as resource intensive, it remains the preferred way of engagement for most of the elderly patients. The nurse plays an important role in promoting heart failure self-care. The process of interaction with the patient can be an important empowering process for self-care behaviour changes. Impact: Process evaluation is an important step in the evaluation of a complex intervention. It allows researchers and practitioners to better understand the mechanism by which an intervention generates impact. Therefore, future intervention programmes can leverage on these mechanisms and adapt them to different contexts for better intervention effectiveness.

scholarly journals Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Suzanne Hagen ◽  
Rohna Kearney ◽  
Kirsteen Goodman ◽  
Lynn Melone ◽  
Andrew Elders ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Pelvic Organ Prolapse ◽  
Controlled Trial ◽  
Pelvic Organ ◽  
Self Management ◽  
Vaginal Pessary ◽  
Randomised Controlled ◽  
Post Randomisation

Abstract Background Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic-based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every 6 months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re-insert their pessary themselves; this is called self-management. This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care. Methods This is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support. The control group will receive the clinic-based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition-specific quality of life at 18 months’ post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months’ post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. Discussion The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic-based care in terms of improving women’s quality of life, and of its cost-effectiveness. Trial registration ISRCTN Registry ISRCTN62510577. Registered on June 10, 2017.

scholarly journals The effectiveness of nurse-led self-management support program for people with chronic kidney disease stage 3-4 (CKD-NLSM): Study protocol for a randomized controlled trial

2021 ◽  
Vol 104 (2) ◽  
pp. 003685042110261
Author(s):  
Al Sawad Ayat Ali ◽  
Soo Kun Lim ◽  
Li Yoong Tang ◽  
Aneesa Abdul Rashid ◽  
Boon-How Chew
Keyword(s):  
Kidney Disease ◽  
Controlled Trial ◽  
Self Management ◽  
Control Group ◽  
Management Support ◽  
Disease Knowledge ◽  
Management Intervention ◽  
Randomized Controlled ◽  
Ckd Stage ◽  
Management Behaviors

The complexity of chronic kidney disease (CKD) and its treatments have made self-management behaviors inevitably challenging. However, supplementing education with self-management skills may improve numerous health outcomes in people with nondialysis CKD. This study protocol describes a randomized controlled trial (RCT) aimed to evaluate the effects of a nurse-led self-management support program as an intervention for kidney disease knowledge and CKD self-management behaviors among people with pre-dialysis CKD. In Phase 1, people with CKD stage 3–4 and their family members are involved in co-designing, development and pilot testing of a theory-based self-management intervention. In Phase 2, we perform a cross-cultural adaptation of the Kidney Disease Knowledge Survey, CKD Self-Management and Self-efficacy for Managing Chronic Disease questionnaires. In Phase 3, a parallel RCT will be conducted to evaluate the intervention where 154 participants with CKD stage 3–4 will be randomly assigned to either the intervention ( n = 77) or control group ( n = 77). The intervention group will receive 6-week self-management program from a nurse-coach in addition to standard usual care, while the control group will receive only standard usual care. Outcome measures include kidney disease knowledge, CKD self-management behavior, self-efficacy, quality of life, blood pressure control and adherence to CKD diet as indicated by 24-h urine urea nitrogen, 24-h urine sodium and net endogenous acid production. Data will be collected at baseline and 12-week post-baseline. The between- and within-group intervention effects will be estimated using the Generalized Estimating Equations. The self-management intervention offers strategies to delay CKD progression and to encourage motivation to better self-manage at home. This study integrates self-management education and psychosocial support with culturally relevant scenarios, and evaluates important self-reported and objective outcomes. Clinical Trials Registration: www.ClinicalTrials.gov , identifier: NCT03974646.

Pharmacists in general practice: a qualitative process evaluation of the General Practice Pharmacist (GPP) study

2020 ◽  
Vol 37 (5) ◽  
pp. 711-718
Author(s):  
Oscar James ◽  
Karen Cardwell ◽  
Frank Moriarty ◽  
Susan M Smith ◽  
Barbara Clyne
Keyword(s):  
General Practice ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Qualitative Approach ◽  
Structured Interviews ◽  
Practice Staff ◽  
Practice Nurses ◽  
Practice Team ◽  
Prescribing Quality ◽  
Descriptive Qualitative

Abstract Background There is some evidence to suggest that pharmacists integrated into primary care improves patient outcomes and prescribing quality. Despite this growing evidence, there is a lack of detail about the context of the role. Objective To explore the implementation of The General Practice Pharmacist (GPP) intervention (pharmacists integrating into general practice within a non-randomized pilot study in Ireland), the experiences of study participants and lessons for future implementation. Design and setting Process evaluation with a descriptive qualitative approach conducted in four purposively selected GP practices. Methods A process evaluation with a descriptive qualitative approach was conducted in four purposively selected GP practices. Semi-structured interviews were conducted, transcribed verbatim and analysed using a thematic analysis. Results Twenty-three participants (three pharmacists, four GPs, four patients, four practice nurses, four practice managers and four practice administrators) were interviewed. Themes reported include day-to-day practicalities (incorporating location and space, systems and procedures and pharmacists’ tasks), relationships and communication (incorporating GP/pharmacist mode of communication, mutual trust and respect, relationship with other practice staff and with patients) and role perception (incorporating shared goals, professional rewards, scope of practice and logistics). Conclusions Pharmacists working within the general practice team have potential to improve prescribing quality. This process evaluation found that a pharmacist joining the general practice team was well accepted by the GP and practice staff and effective interprofessional relationships were described. Patients were less clear of the overall benefits. Important barriers (such as funding, infrastructure and workload) and facilitators (such as teamwork and integration) to the intervention were identified which will be incorporated into a pilot cluster randomized controlled trial.

scholarly journals Randomised controlled trial to investigate the effectiveness of local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS): a pilot study to assess feasibility of a large multicentre trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e025141
Author(s):  
Tina Sara Verghese ◽  
Lee Middleton ◽  
Versha Cheed ◽  
Lisa Leighton ◽  
Jane Daniels ◽  
...  
Keyword(s):  
Pelvic Organ Prolapse ◽  
Randomised Controlled Trial ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Pelvic Organ ◽  
Oestrogen Treatment ◽  
Pop Surgery ◽  
Randomised Controlled ◽  
Oestrogen Supplementation

ObjectiveTo evaluate the feasibility of a multicentre randomised controlled trial (RCT) comparing oestrogen treatment with no oestrogen supplementation in women undergoing pelvic organ prolapse (POP) surgery.Design and settingA randomised, parallel, open, external pilot trial involving six UK urogynaecology centres (July 2015–August 2016).ParticipantsPostmenopausal women with POP opting for surgery, unless involving mesh or for recurrent POP in same compartment.InterventionWomen were randomised (1:1) to preoperative and postoperative oestrogen or no treatment. Oestrogen treatment (oestradiol hemihydrate 10 μg vaginal pessaries) commenced 6 weeks prior to surgery (once daily for 2 weeks, twice weekly for 4 weeks) and twice weekly for 26 weeks from 6 weeks postsurgery.Outcome measuresThe main outcomes were assessment of eligibility and recruitment rates along with compliance and data completion. To obtain estimates for important aspects of the protocol to allow development of a definitive trial.Results325 women seeking POP surgery were screened over 13 months and 157 (48%) were eligible. Of these, 100 (64%) were randomised, 50 to oestrogen and 50 to no oestrogen treatment, with 89 (44/45 respectively) ultimately having surgery. Of these, 89% (79/89) returned complete questionnaires at 6 months and 78% (32/41) reported good compliance with oestrogen. No serious adverse events were attributable to oestrogen use.ConclusionsA large multicentre RCT of oestrogen versus no treatment is feasible, as it is possible to randomise and follow up participants with high fidelity. Four predefined feasibility criteria were met. Compliance with treatment regimens is not a barrier. A larger trial is required to definitively address the role of perioperative oestrogen supplementation.Trial registration numberISRCTN46661996.

scholarly journals Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial

Pain Medicine ◽  
2019 ◽  
Vol 20 (10) ◽  
pp. 2018-2032 ◽  
Author(s):  
M Bérubé ◽  
C Gélinas ◽  
N Feeley ◽  
G Martorella ◽  
J Côté ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Pain Catastrophizing ◽  
Controlled Trial ◽  
Self Management ◽  
Anxiety And Depression ◽  
Management Intervention ◽  
Randomized Controlled ◽  
Extremity Trauma ◽  
Experimental Group ◽  
Pilot Randomized Controlled Trial

Abstract Objective 1) To assess the feasibility of research methods to test a self-management intervention aimed at preventing acute to chronic pain transition in patients with major lower extremity trauma (iPACT-E-Trauma) and 2) to evaluate its potential effects at three and six months postinjury. Design A pilot randomized controlled trial (RCT) with two parallel groups. Setting A supraregional level 1 trauma center. Methods Fifty-six adult patients were randomized. Participants received the intervention or an educational pamphlet. Several parameters were evaluated to determine the feasibility of the research methods. The potential efficacy of iPACT-E-Trauma was evaluated with measures of pain intensity and pain interference with activities. Results More than 80% of eligible patients agreed to participate, and an attrition rate of ≤18% was found. Less than 40% of screened patients were eligible, and obtaining baseline data took 48 hours postadmission on average. Mean scores of mild pain intensity and pain interference with daily activities (<4/10) on average were obtained in both groups at three and six months postinjury. Between 20% and 30% of participants reported moderate to high mean scores (≥4/10) on these outcomes at the two follow-up time measures. The experimental group perceived greater considerable improvement in pain (60% in the experimental group vs 46% in the control group) at three months postinjury. Low mean scores of pain catastrophizing (Pain Catastrophizing Scale score < 30) and anxiety and depression (Hospital Anxiety and Depression Scale scores ≤ 10) were obtained through the end of the study. Conclusions Some challenges that need to be addressed in a future RCT include the small proportion of screened patients who were eligible and the selection of appropriate tools to measure the development of chronic pain. Studies will need to be conducted with patients presenting more serious injuries and psychological vulnerability or using a stepped screening approach.

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