Hip FracturesNCT06438640
Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)
A study testing My Anesthesia Choice-HF Model in people with Hip Fractures and Femoral Neck Fractures, run by University of Pennsylvania at 6 sites in United States.
Trial summary
The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fractures, Femoral Neck Fractures, Intertrochanteric Fractures
- What is being tested?
- My Anesthesia Choice-HF Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,881 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Aug 2024to 15 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 and older Planned surgery to treat a hip fracture
Who cannot join
- Contraindication to spinal anesthesia: current anticoagulant therapy or coagulopathy Contraindication to spinal anesthesia: critical aortic stenosis Contraindication to spinal anesthesia: skin infection over the lumbar spine
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Karah Whatley contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Cleveland Clinic-Fairview
Cleveland, Ohio, 44195
Sabry Ayad
Sabry Ayad, MD
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Carlos Guerra Londono
Carlos Guerra Londono, MD
- Recruiting
University of Florida Gainesville
Gainesville, Florida, 32608
Joshua Sappenfield
Joshua Sapenfield, MD
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Stacie G Deiner
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
James Baraldi, PhD
Mark Neuman, MD
- Recruiting
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
Lynette Harris, BSN
Christopher Edwards, MD
About this study
Official title: Implementation and Evaluation of a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)
The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 34 months.
Read the detailed description
The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 34 months.
Activities at each site will be divided into three phases: Pre-Implementation; Active Implementation; and Sustainment. Data collection will occur across all study phases at each site, although specific data elements collected will vary across phases. To facilitate evaluation, sites will be randomly assigned to one of three possible timing sequences (A, B, C) for project implementation (2 sites/sequence). The duration of the active implementation phase will be the same for each sequence (16 months); however, the duration of pre-implementation and sustainment phases will vary across sequences.
During the pre-implementation phase, data collection on selected outcome variables will occur but no interventions will be delivered. During the implementation phase, site clinicians will undergo training in use of the My Anesthesia Choice-HF tool and the tool will be made available for use in clinical areas with eligible patients. Data collection on key outcomes will continue over this period, and clinicians will receive reminders to encourage tool use. During Sustainment, the tool will remain available for use and outcomes will continue to be measured to assess sustainment of the intervention over time.
- Conditions
- Hip Fractures, Femoral Neck Fractures, Intertrochanteric Fractures, Subtrochanteric Fractures
- Being tested
- My Anesthesia Choice-HF Model
- Keywords
- hip fracture, femoral neck, intertrochanteric, subtrochanteric, fracture, anesthesia, observational study, survey, shared decision making, My Anesthesia Choice, MAC-HF
- Medical subject headings
- Hip Fractures, Femoral Neck Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Anesthesia Choice-HF ModelBehavioural
Brief clinician training on shared decision making, paired with provision of a 1-page tabular format conversation aid listing answers to frequently asked questions regarding common anesthesia options for hip fracture surgery (spinal anesthesia; general anesthesia)
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care will be delivered at each site during the pre-intervention phase. Patients treated in this arm will undergo pre-anesthesia care discussions as per existing clinical routine at each site. |
| My Anesthesia Choice- HF | Active comparator | During the intervention and sustainment phases, site clinicians will receive standardized in-personal or virtual training on shared decision making theory and approaches. The My Anesthesia Choice-HF tool will be made available for use during preoperative conversations. Clinicians will receive encouragement to use the tool on study-eligible patients based on their assessment of clinical appropriateness. Receives: Behavioral: My Anesthesia Choice-HF Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention reach (primary implementation outcome)
Reach of the intervention will be assessed as the rate of use of the conversation aid during the active implementation phase at each site among eligible patients during the pre-anesthesia evaluation. Data will be collected during the implementation phase at each site.
Measured: Day of surgery
Shared Decision-Making Process scale score (SDMP; primary effectiveness outcome)
SDMP is a 4-item measure of shared decision making; this will be assessed on eligible patients during the pre-implementation and implementation phases of the study to allow for comparison of scores among eligible patients treated in the two periods
Measured: Postoperative day 0-3
Secondary outcomes (1)
CollaboRATE shared decision making scale score (secondary effectiveness outcome).
A 3-item measure of shared decision making; this will be assessed on eligible patients during the pre-implementation and implementation phases of the study to allow for comparison of scores among eligible patients treated in the two periods
Measured: Postoperative day 0-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start15 Aug 2024
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped Wedge Cluster Randomized Trial
- Masking
- None (open label)
- Enrolment
- 1,881 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences, University of Florida, Dartmouth-Hitchcock Medical Center, Henry Ford Health System, The Cleveland Clinic, Dartmouth College, Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Mark Neuman, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438640
- Sponsor's protocol ID
- 855203
- Status last verified
- Mar 2026
- First submitted
- 23 May 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goldstein EC, Politi MC, Baraldi JH, Elwyn G, Campos H, Feng R, Mehta S, Whatley K, Schmitz V, Neuman MD. Refining, implementing, and evaluating an anesthesia choice conversation aid for older adults with hip fracture: protocol for a stepped wedge cluster randomized trial. Implement Sci Commun. 2024 Sep 12;5(1):97. doi: 10.1186/s43058-024-00635-3.
PubMed 39267183
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)
- ClinicalTrials.gov ID
- NCT06438640
- Acronym / sponsor ID
- 855203
- Conditions
- Hip Fractures, Femoral Neck Fractures, Intertrochanteric Fractures, Subtrochanteric Fractures
- Keywords
- hip fracture, femoral neck, intertrochanteric, subtrochanteric, fracture, anesthesia, observational study, survey
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,881 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, University of Florida, Dartmouth-Hitchcock Medical Center, Henry Ford Health System, The Cleveland Clinic, Dartmouth College, Washington University School of Medicine
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 34 months.
Detailed description
The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 34 months.
Activities at each site will be divided into three phases: Pre-Implementation; Active Implementation; and Sustainment. Data collection will occur across all study phases at each site, although specific data elements collected will vary across phases. To facilitate evaluation, sites will be randomly assigned to one of three possible timing sequences (A, B, C) for project implementation (2 sites/sequence). The duration of the active implementation phase will be the same for each sequence (16 months); however, the duration of pre-implementation and sustainment phases will vary across sequences.
During the pre-implementation phase, data collection on selected outcome variables will occur but no interventions will be delivered. During the implementation phase, site clinicians will undergo training in use of the My Anesthesia Choice-HF tool and the tool will be made available for use in clinical areas with eligible patients. Data collection on key outcomes will continue over this period, and clinicians will receive reminders to encourage tool use. During Sustainment, the tool will remain available for use and outcomes will continue to be measured to assess sustainment of the intervention over time.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped Wedge Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care will be delivered at each site during the pre-intervention phase. Patients treated in this arm will undergo pre-anesthesia care discussions as per existing clinical routine at each site. |
| My Anesthesia Choice- HF | Active comparator | Behavioral: My Anesthesia Choice-HF ModelDuring the intervention and sustainment phases, site clinicians will receive standardized in-personal or virtual training on shared decision making theory and approaches. The My Anesthesia Choice-HF tool will be made available for use during preoperative conversations. Clinicians will receive encouragement to use the tool on study-eligible patients based on their assessment of clinical appropriateness. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 50 and older Planned surgery to treat a hip fracture
Key exclusion criteria (1 listed)
- Contraindication to spinal anesthesia: current anticoagulant therapy or coagulopathy Contraindication to spinal anesthesia: critical aortic stenosis Contraindication to spinal anesthesia: skin infection over the lumbar spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Anesthesia Choice-HF ModelBrief clinician training on shared decision making, paired with provision of a 1-page tabular format conversation aid listing answers to frequently asked questions regarding common anesthesia options for hip fracture surgery (spinal anesthesia; general anesthesia) | Behavioural | My Anesthesia Choice- HF |
Primary outcome
Intervention reach (primary implementation outcome)
Time frame: Day of surgery
Reach of the intervention will be assessed as the rate of use of the conversation aid during the active implementation phase at each site among eligible patients during the pre-anesthesia evaluation. Data will be collected during the implementation phase at each site.
Shared Decision-Making Process scale score (SDMP; primary effectiveness outcome)
Time frame: Postoperative day 0-3
SDMP is a 4-item measure of shared decision making; this will be assessed on eligible patients during the pre-implementation and implementation phases of the study to allow for comparison of scores among eligible patients treated in the two periods
1 secondary outcome
CollaboRATE shared decision making scale score (secondary effectiveness outcome).
Time frame: Postoperative day 0-3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Derived from this study: PubMed 39267183Goldstein EC, Politi MC, Baraldi JH, Elwyn G, Campos H, Feng R, Mehta S, Whatley K, Schmitz V, Neuman MD. Refining, implementing, and evaluating an anesthesia choice conversation aid for older adults with hip fracture: protocol for a stepped wedge cluster randomized trial. Implement Sci Commun. 2024 Sep 12;5(1):97. doi: 10.1186/s43058-024-00635-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karah Whatley contact
Mark Neuman, MD principal investigator
University of Pennsylvania
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Anesthesia Choice-HF Model in people with Hip Fractures and Femoral Neck Fractures, run by University of Pennsylvania at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Neuman, MD (215-746-7468, neumanm@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention reach (primary implementation outcome) (time frame: Day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06438640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.