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Does a multidisciplinary shared decision-making pathway influence decision quality in adults considering surgery for benign skin lumps?

Evaluation of a multidisciplinary shared decision-making pathway to improve decision quality, measured by the Decision Regret Scale, in adults considering office-based surgery for benign subcutaneous lesions: a mixed-methods quality improvement study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626001082392
Acronym
DIST-SDM (Distributed Shared Decision-Making)
Enrollment
12
Registered
2026-09-02
Start date
2026-05-15
Completion date
2027-05-31
Last updated
2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to find out whether a structured decision-making pathway can help adults make better-informed choices when considering treatment for benign skin lumps. Patients are supported by clinic staff and nurses to identify what matters most to them, and then discuss with their doctor the benefits and disadvantages of options such as surgery, less invasive treatment, or having no procedure. We expect that this approach will help patients choose treatment that better matches their personal priorities and expectations and will reduce regret about their decision afterwards. The outcomes of patients receiving this pathway will also be considered in comparison with information from patients who received usual care before the pathway was introduced.

Interventions

Intervention: Distributed multidisciplinary shared decision-making pathway Adult patients considering office-based surgical management of benign skin lesions receive a structured six-stage multidisciplinary shared decision-making (SDM) pathway integrated into routine clinical care. The pathway distributes decision support across existing administrative, nursing and medical staff rather than requiring all shared decision-making to occur during a single clinician consultation. No additional staff

Intervention: Distributed multidisciplinary shared decision-making pathway Adult patients considering office-based surgical management of benign skin lesions receive a structured six-stage multidisciplinary shared decision-making (SDM) pathway integrated into routine clinical care. The pathway distributes decision support across existing administrative, nursing and medical staff rather than requiring all shared decision-making to occur during a single clinician consultation. No additional staff are employed specifically to deliver the pathway. Stage 1: Patient liaison officer contact. Following identification of an eligible patient, an existing patient liaison officer contacts the patient before the definitive treatment decision, usually by telephone approximately 1–2 weeks before the scheduled consultation. The contact lasts approximately 5–10 minutes. This contact addresses logistical and administrative issues, records initial expectations and identifies non-clinical concerns or questions relevant to the patient's forthcoming treatment decision. The liaison officer does not provide clinical advice. Completion of this stage is documented in the patient journey record. Additional contact may occur if required. Stage 2: Nurse-led values clarification. Before the definitive treatment decision, an existing practice nurse conducts a structured preoperative values-clarification process, usually face-to-face immediately before or at the beginning of the consultation visit. This component lasts approximately 10–15 minutes and uses the Pre-Surgery Shared Decision-Making Questionnaire developed specifically for this quality-improvement pathway. This is a study-specific/co-designed questionnaire rather than an externally published validated instrument. The nurse helps the patient identify and articulate the relative importance of issues including scar appearance, recurrence risk, procedural burden, recovery, personal circumstances and expectations regarding treatment. The patient's concerns and priorities are documented so that they are available to the treating clinician. This provides an opportunity for patients to articulate their preferences in a less pressured environment before the medical consultation. Stage 3: Clinician consultation informed by documented patient values. The treating clinician conducts a face-to-face consultation, usually immediately following Stage 2, lasting approximately 10–20 minutes. The clinician reviews the values and priorities documented during the preceding stages, undertakes the relevant clinical assessment and conducts the shared decision-making discussion. The consultation uses the Benefits, Risks, Alternatives and Nothing (BRAN) framework together with a co-designed patient decision aid. Benefits and risks of the clinically appropriate options are discussed, alternatives are considered, and observation/no procedure is explicitly presented as a legitimate option where clinically appropriate. Particular attention is given to preference-sensitive trade-offs, including scar appearance, recurrence risk and the possibility of further treatment. The decision aid supports, rather than replaces, individual clinician-patient discussion. Decision aid. The decision aid was developed specifically for this quality-improvement pathway with input from seven patient partners who had undergone benign lesion surgery, together with clinical input. Patient involvement resulted in simplification of risk language, inclusion of the BRAN framework and incorporation of a formal opportunity for reflection. The aid provides accessible information about the available management options and their principal trade-offs, including conventional excision, minimally invasive approaches where clinically appropriate, and observation/no procedure. Stage 4: Optional reflection and support. A treatment decision is not required during the initial clinician consultation. Patients who feel ready to decide may proceed to the final decision on the same day. Patients who remain uncertain or wish to consider their options may take the decision-support material away, discuss the options with family or another support person, contact the clinic with further questions, or arrange an additional clinical review. The need for reflection is determined by the patient's expressed preference rather than by a predetermined criterion. Reflection is therefore patient-directed rather than fixed at 24 hours. Depending on individual needs, the period between the initial decision-support process and final decision may range from the same day to several weeks and, occasionally, more than one month. There is therefore no fixed duration for this component. Stage 5: Shared treatment decision. Following completion of the preceding stages and any reflection requested by the patient, the patient and treating clinician reach and document the management decision. Where a separate contact is required following reflection, this occurs face-to-face or by telephone and lasts approximately 5–10 minutes; it commonly occurs within 1–7 days of the initial consultation, although timing remains patient-directed where further reflection is requested. Available decisions depend on clinical suitability and may include conventional excision, minimally invasive/keyhole excision, superficial shave or ablative treatment for appropriate superficial lesions, observation/no procedure, deferral, or further clinical review. Shared decision-making is therefore the process of ensuring that the eventual management choice reflects both the available clinical options and the patient's informed values and preferences. Surgery is not mandatory and choosing observation or deferring treatment is considered a valid outcome of the pathway. Stage 6: 12-week follow-up and outcome assessment. Approximately 12 weeks (±2 weeks) after surgery or the relevant treatment decision, participants undergo a nurse-led follow-up assessment. This is completed primarily by telephone, or face-to-face where required, and lasts approximately 10–15 minutes. The assessment evaluates decisional regret, expectation alignment, scar satisfaction where applicable, the patient's experience of the pathway and other patient-reported outcomes. Validated measures used in the evaluation include the Decision Regret Scale and the 9-item Shared Decision-Making Questionnaire (SDM-Q-9). Outcome assessment is undertaken independently of the operating clinician where practicable to reduce social desirability bias. If significant postoperative concerns, complications or regret are identified during the assessment, additional clinical follow-up is arranged as appropriate. Timing and overall duration. Stages 1–3 occur sequentially before the final management decision and may occur within the same clinical episode or across separate contacts according to routine workflow. Stage 1 lasts approximately 5–10 minutes, Stage 2 approximately 10–15 minutes, and Stage 3 approximately 10–20 minutes. Stage 4 is deliberately flexible: patients may decide on the same day or take additional time for reflection, family discussion or further consultation. Where a separate Stage 5 contact is required, it lasts approximately 5–10 minutes. Where a procedure is chosen, it is subsequently performed according to normal clinical scheduling. Stage 6 occurs approximately 12 weeks (±2 weeks) after the procedure or relevant management decision and lasts approximately 10–15 minutes. The formal pathway evaluation extends through this 12-week follow-up. Intervention fidelity. Fidelity is monitored using structured pathway documentation/patient journey records. Documentation records completion of liaison officer contact, nurse-led values clarification, clinician review and decision-aid use, whether reflection was offered and/or used, family involvement where applicable, the final treatment decision and completion of follow-up. Implementation fidelity is therefore assessed from documented completion of the individual pathway components rather than participant self-report alone. Relationship to routine clinical care and participation in the evaluation. The pathway is implemented as a quality-improvement/service-evaluation initiative within routine clinical practice. The decision aid and shared decision-making pathway are offered as part of routine care to eligible patients attending the participating clinics and are not restricted to patients who agree to contribute data to the evaluation. Participation in the evaluation determines the collection and analysis of evaluation-specific outcome data and does not determine access to the clinical decision-support pathway.

Sponsors

University of Oxford
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults aged 18 years or older who are attending participating primary care procedural clinics for consideration of office-based management of a benign subcutaneous lesion (including epidermoid cyst, lipoma or trichilemmal cyst), are able to provide informed consent, and are willing to participate in the multidisciplinary shared decision-making pathway and study follow-up. Patients unable to complete study procedures despite interpreter support where available.

Exclusion criteria

Patients unable to provide informed consent; patients with insufficient English proficiency where an interpreter was unavailable to complete study procedures; lesions requiring referral for specialist or tertiary management because of clinical complexity or suspected malignancy; patients unable or unwilling to complete study questionnaires or follow-up assessments; and patients who declined participation.

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026